10.1515 - CCLM 2017 5031

Poster Abstracts – EuroMedLab Athens 2017 – Athens, 11-15 June 2017 • DOI 10.
1515/cclm-2017-5031 S1055
Clin Chem Lab Med 2017; 55, Special Suppl, pp S1 – S1121, June 2017 • Copyright © by Walter de Gruyter • Berlin • Boston
Patient sample management, (standardization, harmonization,reference ranges, etc)
Cod: W251
REFERENCE INTERVALS FOR VITAMIN D IN INDIAN VOLUNTEERS: C-RIDL IFCC INITIATIVE
T. Ashavaid 1, S. Shah 1, K. Ichihara 2, A. Dherai 1, R. Kawano 2
1
P. D. HINDUJA NATIONAL HOSPITAL AND MEDICAL RESEARCH CENTRE
2
YAMAGUCHI UNIVERSITY GRADUATE SCHOOL OF MEDICINE
(India)
dr_tashavaid@hindujahospital.com
Background: The International Federation of Clinical Chemistry’s (IFCC) committee on Reference Interval and Decision
limits (C-RIDL) initiated a worldwide multicenter study on common reference values by providing a common protocol.
Vitamin D is crucial for calcium (Ca) homeostasis in regulation with parathyroid hormone (PTH). Data on the reference
interval (RI) for vitamin D in India have seldom been documented. Most laboratories adopt RI based either on manufacturer’s
kit inserts or literature which does not represent our population. The present study attempts to determine RI for 25-
hydroxyvitamin D [25-OH Vitamin D] in healthy Indian volunteers and attempt to correlate the results with other associated
bone markers such as serum Ca & PTH.
Methods: Under the aegis of C-RIDL IFCC, a total of 512 healthy Indian volunteers were recruited for estimation of 25(OH)
vitamin D, Ca and PTH. Beckman Coulter’s UniCel DxC 800 analyzer was used for Ca and PTH estimation, whereas
Abbott Architect i1000SR analyzer was used for 25(OH) vitamin D. Both parametric and non-parametric methods were
used for RI derivation. Need for iterative optimization procedure called latent abnormal values exclusion (LAVE) method
were also examined. Multiple regression analysis (MRA) and 3-level nested ANOVA were used to identify potential source
of variations.
Results: The upper and lower limit of RI [Reported v/s observed] for 25(OH) vitamin D [40 – 100ng/ml v/s 8.4 – 44.3 ng/
ml] and PTH [12 – 72 pg/ml v/s 34 – 146 pg/ml ] showed wide variation as compared to reported standard RI whereas Ca [8
- 10mg/dl v/s 8.5 – 9.8 mg/dL] remained within the reported standard RI. The mean 25(OH) vitamin D levels did not differ
significantly (21.9 ± 13.0 v/s 19.8 ± 13.1) in volunteers with normal PTH(12-72 pg/ml) and high PTH (>72 pg/ml), also the
Ca levels were almost the same in both the groups. Further, MRA results indicated age to be a common source of variation,
whereas ANOVA results suggest that partitioning of reference values may not be necessary for the target analytes.
Conclusion: The striking difference in the RI observed for Vitamin D in healthy Indian volunteers really questions the
long standing notion of Indians being vitamin D deficient. Thus it really underscores the importance to further corroborate
this finding by the scientific community which could also possibly decrease the country’s financial burden by limiting the
vitamin D supplementation as per the RI applicable to Indians.
Poster Abstracts – EuroMedLab Athens 2017 – Athens, 11-15 June 2017 • DOI 10.1515/cclm-2017-5031 S1056
Cod: W252
CHANGES IN SERUM URIC ACID LEVELS DURING NORMAL AND PATHOLOGICAL PREGNANCIES
A.I. Corominas 2, S.M. Balconi 2, M. Ortiz 2, N. Martinez 1, A. Damiano 3
1
Laboratorio de Biología de la Reproducción, IFIBIO-CONICET.
2
Posadas Hospital
3
Universidad de Buenos Aires, Facultad de Farmacia y Bioquímica, Departamento de Ciencias Biológicas.
(Argentina)
balconis@gmail.com
Determination of serum uric acid (SUA) is used to monitor maternal renal function during pregnancy. Despite its great
biological variability in non pregnant and in pregnant healthy women, most laboratories reported as reference range, those
of non pregnant women, a fact that promotes misinterpretation of the results.
Our aim was to describe the range of SUA in pregnant women throughout pregnancy in normal and pathological conditions.
We conducted a prospective approach in which we studied all patients who attended her pregnancy in the Hospital Posadas
during 2014. SUA (mg/dl), urea and creatinine were measured along gestation and were evaluated in the context of normal
or pathological pregnancy.
In diabetic pregnant women (n=164) SUA increased statistically after the 30th week compared to normal pregnancy
(3.92±0.85 vs 3.56±0.77, p=0.014); but at the end of pregnancy, SUA were similar to normal ones.
In women with gestational hypertension without preeclampsia (PE) (n=32) we observed a continuous increase of SUA levels
but the difference between the end and the beginning of pregnancy was lower than 1.5. In women with PE (n=40), SUA
increased progressively with a difference between the 30th week and the beginning of gestation higher than 1.5 (p=0.0001)
and the highest increased at the end of the pregnancy (3.92±0.95 vs 6.04±1.40, p<0.0001).
In women with intrauterine growth retardation (IUGR) without PE (n=22) SUA were similar to those of normal pregnancy,
however in PE with IUGR (n=6), SUA increased significantly after the 35th week (3.93±0.47 vs 7.10±0.56, p=0.0019),
more than any other obstetric situation.
In all cases, urea and creatinine showed normal values, confirming that patients had no renal compromise.
In conclusion, we suggest that the range of SUA in normal pregnant women is narrow throughout gestation. Thus, an
increase in the levels of SUA may be useful to define risk groups to detect clinical changes involved in the manifestation
of pregnancy disorders.
Cod: W253
A BIOMARKER QUALITY CONTROL FOR DRIED BLOOD SPOT
J. Bobillo Lobato 1, S.I. Villanueva Heráiz 1, E. Lepe Balsalobre 1, M.d.M. Viloria Peñas 1, I. Peral Camacho 1, A. Moro Ortiz 1
1
Unit of Clinical Management of Laboratory. University Hospital Nuestra Señora de Valme. Southern Sanitary Area, Seville.
(Spain)
joaquin.bobillo.lobato.sspa@juntadeandalucia.es
INTRODUCTION
The definitive diagnosis of lysosomal storage diseases depends on the determination of enzymatic activities responsible
in cells, tissues or body fluids. The use of dried blood spot (DBS) has shown a good correlation with them, becoming
the main way to approach the diagnosis. As quality control index enzymatic stability of the sample, determining the beta-
galactosidase activity can be used.
MATERIALS AND METHODS

20 DBS samples sent to the laboratory for diagnosis of different lysosomal diseases, preserved at 4 ° C and moisture
protected were used. The beta-galactosidase enzyme activity was quantified by spectrofluorimetry in discs of 3 mm in
diameter, according to the method of Chamoles et al, using as substrate 4-methylumbelliferyl-beta-D-galactopyranoside.
All measurements were performed in duplicate.
Activities were tested against a calibration curve with 4-methyl-umbelliferone, including ranges expected in normal samples.
RESULTS
The results are expressed in µmol/mL/minute. Thus, 19 showed good enzyme activity (10-40 µmol/mL/minute), indicative
of good preservation of the sample. One of them, showing a activity close to the lower limits of normal (10.3 µmol/mL/
minute) activity was considered not acceptable, so sending a new sample for the study requested enzyme was necessary.
CONCLUSIONS
The beta-galactosidase enzyme activity is a good quality control for samples DBS in this type of studies.
Cod: W254
APPROXIMATION TO THE VALUES OF REFERENCE OF OUR POPULATION IN STUDY OF FABRY DISEASE IN
SAMPLES OF DRIED BLOOD SPOT
J. Bobillo Lobato 1, M.J. Vélez González 1, E.M. García Agudo 1, M.d.M. Viloria Peñas 1, I. Peral Camacho 1, A. Moro Ortiz 1
1
Unit of Clinical Management of Laboratory. University Hospital Nuestra Señora de Valme. Southern Sanitary Area, Seville.
(Spain)
joaquin.bobillo.lobato.sspa@juntadeandalucia.es
INTRODUCTION
The determination of alpha-galactosidase enzyme activity is the basis of diagnosis for Fabry disease, a disease with a
recessive X-linked transmission.
The use of dried blood spot (DBS) is especially useful for the diagnosis of this lysosomal disease that causes serious kidney
and cardiac abnormalities in patients not diagnosed and treated.
MATERIALS AND METHODS

250 samples of dried blood spot from the neonatal screening were used.
The alpha-galactosidase enzyme activity was quantified in discs of 3 mm in diameter obtained by manual puncher
by spectrofluorimetry it, according to the method of Chamoles et al, using as substrate 4-methylumbelliferyl-alpha-D-
galactopyranoside. All measurements were performed in duplicate.
Activities were tested against a calibration curve with 4-methyl-umbelliferone, including enzyme activity ranges expected
in normal samples.
RESULTS
The results were expressed in µmol/mL/minute and statistical study showed the following results:
Mean: 4.06
Standard deviation: 2.18
Minimum: 2.10
Maximum: 10.80
5th percentile: 2.30
95th percentile: 7.19
CONCLUSIONS
From the results, and taking into account the criteria for establishing reference values, we believe that an approach to our
population would be in the range between 2.30 and 7.19 µmol/mL/minute.
Cod: W255
NUMBER: NATIONAL REFERENCE INTERVALS AND DECISION LIMITS IN THE NETHERLANDS USING A ‘BIG
DATA’ APPROACH
N. Brouwer 4, W. Den Elzen 2, M. Thelen 1, I. Haagen 3, C. Cobbaert 2
1
Laboratory for Clinical Chemistry and Haematology, Amphia Ziekenhuis, Breda, The Netherlands; Stichting Kwaliteitsbewaking
Medische Laboratoriumdiagnostiek, Nijmegen, The Netherlands
2
Department of Clinical Chemistry and Laboratory Medicine, Leiden University Medical Center, Leiden, The Netherlands
3
Department of Hematology and Clinical Chemistry Laboratories, Onze Lieve Vrouwe Gasthuis, Amsterdam, The Netherlands
4
Laboratory for Clinical Chemistry and Hematology, LangeLand Ziekenhuis, Zoetermeer, The Netherlands
(Netherlands)
nanbrouw@xs4all.nl
BACKGROUND
External Quality Assessment (EQA) programs for general chemistry tests have evolved from between laboratory comparison
programs to trueness verification tools. In the Netherlands, the implementation of a type 1 EQA program ‘SKML Combi
New Style’ in 2005 has been very effective in reducing inter-laboratory coefficients of variation for electrolytes, substrates
and enzymes. However, universal and metrologically traceable reference intervals are still lacking, hindering universal use of
guidelines and preventing adequate interpretation of test results. Under the umbrella of Calibration 2.000, we have initiated
a national endeavour named NUMBER, to set up a sustainable system for the determination and long-term monitoring of
traceable reference intervals in the Netherlands.
METHODS
We adjusted the evidence-based ‘big-data’ approach for deducing reference intervals from primary care data from Australia
and New Zealand to the Dutch setting, using millions of test results readily available in clinical laboratory databases. Thirteen
clinical laboratories across the country, covering all local IVD-manufacturers, have agreed to provide anonymous test results
of primary care patients (July 2015-June 2016). Per laboratory, per test, outliers are excluded, data are transformed to a
normal distribution (if necessary), means and standard deviations (SDs) are calculated. Then, means and SDs per test are
combined using a random effects model to generate pooled reference intervals. Suitability of these reference intervals is
evaluated using EQA-trueness and precision data. Flagging rates are tested and discussed with participating laboratories
and manufacturers in expert meetings before national implementation.
RESULTS and DISCUSSION

A sustainable procedure for determining traceable reference intervals for general chemistry tests is set up using a ‘big-data’
approach that was validated and successfully implemented in Australia and New Zealand. To continuously support medical
laboratories in the verification and long-term monitoring of reference intervals, as required by NEN-EN-ISO 15189:2012,
the Calibration 2.000 steering committee and the Dutch EQA-organizer SKML will also set up a surveillance system to
structurally monitor reference intervals in time and space.
Cod: W256
SERUM IGF-1 REFERENCE RANGES IN HEALTHY ROMANIAN CHILDREN: PRELIMINARY RESULTS
A. Caragheorgheopol 1, A. Padure 1, L. Parvu 1, S. Schipor 1, S. Galoiu 2, I. Gherlan 1, C. Dumitrescu 1, C. Procopiuc 1
1
"C.I.Parhon" National Institute of Endocrinology, Bucharest, Romania
2
"Gr. Alexandrescu" Emergency Hospital for Children, Bucharest, Romania
(Romania)
andracaragheor@yahoo.com
Background. Insulin-like growth factor-1(IGF-1) is a reliable marker of growth disorders and therapy monitoring. IGF-1
serum levels are regulated not only by age, gender and pubertal stage, but also by genetic and social factors, so that reference
ranges should be ethnically and geographically assigned.
Aims. To establish the reference values for serum IGF-1 in healthy Romanian children, aged between 2-16 years, and to
stratify them according to Tanner sexual development stage.
Materials and methods. This is an ongoing study, with 174 children (90 boys) with height and weight appropriate for
chronological age enrolled so far. Subjects with major disorders of endocrine axes, chronic pathologies/medication, or
genetic diseases were excluded. Auxological parameters were recorded and z scores for age and sex were calculated. Serum
IGF-1 was measured by a commercial kit on an automated immunochemiluminiscent analyser (reference standard 1st WHO
International std NIBSC code 02/254, analytical sensitivity 3 ng/ml). The study has the approval of Ethical Committees and
the parental informed consent was obtained.
Results. The children were divided by sex and then by age for each gender, in pre-pubertal and pubertal groups, as follows:
2-5 years (gr I), 6-8 years (gr II), 9-11 years (gr III), and 12-15 years (gr IV). IGF-1 positively correlated with chronological
age and Tanner stage in boys, as well as in girls. The IGF-1 levels increase with age and reached a peak in group IV in
boys (median 344.4ng/ml), meanwhile in girls IGF-1 levels increase earlier (group III, median 324.85ng/ml). We found a
significant difference between IGF-1 levels within the same chronological age group in boys with different Tanner stage
(p=0.008).
We noticed different values for IGF-1 levels in our study toward reference ranges of the commercial kit in the same age-
group, for both sexes.
Conclusions. These are the first results aiming to underlie the completion of data for defining the age-related serum IGF-1
reference ranges in Romanian children, stratified on sex, chronological age and sexual development stage, expecting to
improve the diagnosis and monitoring of growth disorders and the follow-up of the response at growth promoting therapy.
Cod: W257
BIOLOGICAL VARIATION ESTIMATES OBTAINED FROM 91 HEALTHY SUBJECTS FOR SIX ELECTROLYTES IN
SERUM. EBIOVAR STUDY OF THE EFLM WORKING-GROUP ON BIOLOGICAL VARIATION.
A. Carobene 10, I. Marino 10, E. Guerra 10, N. Jonker 3, G. Barla 4, W.A. Bartlett 2, S. Sandberg 8, M. Sverresdotter Sylte 8, A.K. Aarsand
8
, T. Røraas 9, U. Ørvim Sølvik 5, P. Fernandez-Calle 7, J. Díaz-Garzón 7, T. Tosato 6, M. Plebani 6, A. Coşkun 1, M. Serteser 1, I. Unsal
1
, F. Ceriotti 11
1
Acibadem University, School of Medicine, Atasehir, Istanbul, Turkey
2
Blood Sciences, Ninewells Hospital & Medical School, Scotland, UK DD1 9SY.
3
Certe, Wilhelmina Ziekenhuis Assen, Europaweg-Zuid 1, 9401 RK Assen, the Netherlands
4
Certe, Wilhelmina Ziekenhuis Assen, Europaweg-Zuid 1, 9401 RK Assen, the Netherlands.
5
Department of Global Public Health and Primary Care, University of Bergen, Bergen, Norway
6
Dept. of Laboratory Medicine University Hospital, Padua, Italy
7
Hospital Universitario La Paz, Madrid, Spain, and Quality Analytical Commission of Spanish Society of Clinical Chemistry (SEQC).
8
Laboratory of Clinical Biochemistry, Haukeland University Hospital, Bergen, Norway
9
Norwegian Quality Improvement of Primary Health Care Laboratories (Noklus), Haraldsplass, Hospital, Bergen, Norway.
10
Servizio Medicina di Laboratorio, Ospedale San Raffaele, Milan, Italy
11
Servizio Medicina di Laboratorio, Ospedale San Raffaele, Milan, Italy.
(Italy)
carobene.anna@hsr.it
Aim: EBioVar (European Biological Variation) study, an EFLM project, was established to deliver new biological variation
(BV) data. The results of serum Sodium (Na), Potassium (K), Chloride (Cl), Calcium (Ca), Magnesium (Mg) and Phosphate
(P) are presented.
Method: A cohort of 91 healthy subjects (38 male and 53 female, 21-69 years old ) were phlebotomized for 10 consecutive
weeks at six European laboratories. An equivalent and stringent pre-analytical protocol was followed at each center to deliver
the blood samples. Separated sera were stored at -80°C prior to analysis in duplicate within a single run on ADVIA 2400
(Siemens Healthcare) at San Raffaele Hospital, Milan. The data were subject to outlier analysis prior to CV-ANOVA, to
determine the BV estimates with confidence intervals (CI).
Results: CVA calculated by ANOVA on sample’s replicates for Na and Mg were higher than desirable analytical performance
specification (APS) currently used (Na: 0.4% vs 0.3%; Mg 2.5% vs 1.8%) while for the others electrolytes CVAs obtained
were always within their APS. No statistical differences between genders in within-subject estimates (CVI(95%CI)) were
found. CVIs obtained were: Na (142.7 mmol/L): 0.53% (0.50-0.57); K (4.28 mmol): 3.92% (3.7-4.1); Cl (105.6 mmol/L):
0.98% (0.93-1.04); Ca (2.24 mmol/L): 1.81 (1.72-1.92); Mg (0.832 mmol/L): 2.88% (2.7-3.1); P (1.17 mmol/L): 7.67%
(7.2-8.1). All CVIs were significantly lower than the ones reported in Westgard database.
Between-subject biological variation estimates (CVG) obtained were: Na: 1.21% (1.06-1.43); K: 4.08% (3.6-5.0); Cl: 1.34%
(1.2-1.6); Ca: 2.73 (2.4- 3. 2); Mg: 5.79% (5.0-6.8); P: 10.5% (9.2-12.6). CVG obtained are similar to those reported in
Westgard database with the exception of Na (higher) and K (lower).
Conclusion: The new estimates of CVIs obtained using a stringent protocol are statistically significantly lower than existing
published data whereas CVGs are similar.
Cod: W258
DETERMINATION OF REFERENCE INTERVALS IN SELECT BIOCHEMICAL PARAMETERS IN INDIAN
VOLUNTARY BLOOD DONORS
P. Chavan 1, S. Ojha 1, M. Poojary 1, V. Bhat 1, U. Gavhane 1, B. Pillai 1, S. Pal 1
1
ACTREC-TATA MEMORIAL CENTRE
(India)
pchavan@actrec.gov.in
Background:
Major clinical decisions depend on biochemical test reports based on reliable reference intervals. Reference values are used to
describe the dispersion of variables in healthy individuals. They are usually reported as population-based reference intervals
comprising 95% of the healthy population. They may vary significantly in different populations and cultures depending
on the dietary preferences, race, geography as well as socio-economic status. Most of the reference intervals provided by
various manufacturers for their reagents and methods are based on European or American population (Caucasian) studies
and recommend laboratories to establish their own reference intervals. However, very few Indian studies are available on
this subject.
Aim of this study is to establish 95% reference interval for select biochemical parameters in Indian voluntary blood donor
population and to correlate the above with respect to physiognomic parameters like gender.
Methods:
Blood samples from 751 voluntary blood donors (Male:558; Female:193) were analyzed for Serum Protein, Serum Albumin,
Serum Globulin, Serum Immunoglobulin A,G,M (IgA,IgG.IgM) on Siemens Dimension RXL fully automated clinical
chemistry analyser. The biological reference intervals (BRI) were calculated between the 0.025 and 0.975 percentile and
represent the central 95% confidence limit for male and female donors and compared with the ranges in current use.
Results:
The reference ranges obtained for the various parameters were as follows with their respective reference ranges in current
use:
Serum Protein: M:41.8-94.6 g/L ; F:63.5-96.7 g/L (Reference Range used 64-82g/L)
Serum Albumin: M:23-52.6 g/L; F:34.2-49.5 g/L (Reference Range used 34-50 g/L)
Serum Globulin: M:18.8-42; F:29.3-47.2 g/L (Reference Range used 30-32g/L)
Serum IgG : M:7.59-21.14; F:7.88-23.71 g/L (Reference Range used 6.8116.48 g/L)
Serum IgA: M:0.33-3.94; F:1.19-4.17 g/L (Reference Range used 0.87-4.74g/L)
Serum IgM: M:0.15-3.24; F:0.57-3.26 g/L (Reference Range used 0.48-3.12 g/L)
Conclusion:
Lower range for Serum protein and albumin levels in male donors was lesser compared to established BRI. Serum globulin
and IgG levels in all donors were very high compared to BRI in current use. This difference may be attributed to genetic
differences as well as dietary preferences in our population. However, further studies with larger sample size need to be
conducted to substantiate the above findings.
Cod: W259
EFFECT OF FREEZING-THAWING PROCESS ON S100B PROTEIN CONCENTRATION IN SEVERE TRAUMATIC
BRAIN INJURY SERA SAMPLES
C. Hernández-García 3, A. Rodríguez-Rodríguez 3, J.J. Egea-Guerrero 3, L. González García 1, Á. Vilches-Arenas 2, J.M. Guerrero
Montávez 1
1
Department of Clinical Biochemistry, Virgen del Rocio University Hospital, IBIS/CSIC/University of Seville, Seville, Spain
2
Department Preventive Medicine and Public Health, University of Seville, Seville, Spain
3
NeuroCritical Care Unit, Virgen del Rocio University Hospital, IBIS/CSIC/University of Seville.
(Spain)
conarita@hotmail.com
Background: S100B is the most abundant calcium-binding protein in neuronal tissue. S100B levels result altered in
several neurodegenerative diseases as well as in brain injury of different nature: traumatic brain injury (TBI), stroke and
subarachnoid haemorrhage, among others. The usefulness of S100B as a brain injury biomarker in the clinical setting is
limited by the deficiency of data regarding the relationship between measurement methods, poor validation of reference
levels and moderate high cost. However, there is little published about the optimal storage conditions of blood samples
prior to determination of S100B. The aim of this study was to analyze the effect of freezing-thawing process in S100B
measurement.
Methods: We obtained serum samples from patients suffering a mild TBI. The protocol was approved by the Hospital
Institutional Review Board. Written consent was obtained from the patients’ relatives. Samples were centrifugated at 1800×g
for 10 min at room temperature. The separated sera were then frozen at −80°C until analyzed. Once S100B was measured,
samples were re-frozen at −80°C. Three months later, the samples were defrosted to analyze the S100B concentration
again. Serum S100B levels were measured by automated electrochemiluminescence assay (ECLIA) (Cobas E602, Roche
Diagnostics, Germany). All statistical analyses were conducted using software from the Statistical Package for the Social
Sciences (Version 20.0, Chicago, IL, USA) and Epidat (Version 4.0, OPS-OMS, SERGAS, Spain).
Results: We analysed a total of 88 serum samples, and performed 176 measurements. The intraclass correlation coefficient
showed a positive correlation between the two values (r=0.991; CI 95% 0.986:0.994; p<0.05). The data were represented
in a Bland-Altman (B&A) plot, which shows the differences between two assays. This test stated that the mean of the
differences was −0.0035 (SD=0.135; CI 95% −0.025:0.032; p<0.05). Hence, the agreement range for differences between
the two methods defined by the B&A plot (mean ± 1.96 SD) was -0.2602 and 0.2673.
Conclusion: The results of this study showed that S100B levels measured by ECLIA assay remain stable after storage
procedure. We could safely incorporate a freezing protocol in ordinary laboratory routine, quality control and research work.
Serum S100B concentration is not altered by freezing, thawing and re-freezing process.
Cod: W260
OPTIMIZATION OF BIOLOGIC SAMPLES SHIPMENT BETWEEN CLINICAL SITES AND SYNEVO CENTRAL
LABORATORY
G. Enache 1, I. Ghita 1, C. Florescu Moraid 1, M. Cristache 1, A. Marineac 1, N. Banu 1, C. Ganciu 1, C. Radulian 1
1
Synevo Central Lab Clinical Trials Romania
(Romania)
gabriel.enache@synevo.eu
BACKGROUND
Maintaining the Clinical Trials samples stability is an issue of critical importance in order to assess the quality standards
of the shipment.
Our approach was to simulate monitor different temperature conditions which might occur during the sample transport in
order to improve our shipment containers.
Our scope was to demonstrate the proper maintaining of temperature stability and patients sample viability during different
extreme temperature ranges.
METHODS
A number of 90 shipments were temperature monitored in ambient, refrigerated and frozen conditions during max. 72 hours’
period. Different sample kit design was created for shipping the sample in different temperatures conditions.Temperature
monitoring was performed using calibrated data loggers. Environmental temperature was modified to different situations
which could occur during the sample shipment.
RESULTS&CONCLUSIONS
The results downloaded from data loggers demonstrated that the temperature inside our shipment containers is correctly
maintained in different ranges of temperature by using different methods of sample packaging and respect the three layers
of protection each biological sample:
- 1st level - shipment container plus absorption material,
- 2nd level - thermo bag (thermal protection),
- 3rd level – cardboard and styrofoam boxes (mechanical protection).
Cod: W261
RUSSIAN STUDY ON REFERENCE INTERVALS FOR MAJOR BIOCHEMICAL ANALYTES CONDUCTED AS A PART
OF GLOBAL MULTICENTER STUDY ON REFERENCE VALUES.
S. Evgina 1, K. Ichihara 2, A. Ruzhanskya 1, S. Kimura 2, I. Skibo 3, D. Butlitski 1, E. Volkova 1, E. Vilenskaya 1, V. Emanuel 4
1
Beckman Coulter LLC Moscow Russia
2
Faculty of Health Sciences, Yamaguchi University Graduate School of Medicine, Ube, Japan
3
Laboratories HELIX, Saint-Petersburg, Russia
4
Pavlov Fist Saint Petersburg State Medical University, Saint-Petersburg, Russia
(Russian Federation)
evgina@list.ru
Background
Establishment of reference intervals (RIs) is a difficult task for any laboratory. Statistically it requires a large number of
samples to derive RIs in a reproducible manner; a rational approach is to conduct a national multicenter study. In 2013
Russian team joined the global multicenter study on reference values (RVs) launched in 2011 by IFCC Committee (C-RIDL)
to establish country specific RIs and explore possible sources of variation (SV) of RVs.
Methods
796 healthy individuals 18-80 year-old (yo) were recruited in Saint-Petersburg, Moscow and Yekaterinburg. IFCC C-RIDL
protocol was used for the sample collection and handling. 35 analytes were measured on the clinical chemistry analyzer
AU5800 (Beckman Coulter Inc.) in Helix lab in Saint-Petersburg which acted as the central laboratory. To explore SV 3-
level nested ANOVA and multiple regression analysis were used. Latent abnormal values exclusion method was applied
to cope with latent diseases like metabolic syndrome. Volunteers with body mass index (BMI)>28 were excluded from
calculation of RIs for analytes associated with BMI. For analytes with age-related changes, RVs were partitioned at 45 yo.
RIs were computed by the parametric method after normalizing data by modified Box-Cox power transformation method.
A value-assigned serum panel provided by C-RIDL was measured to ensure standardization of the final RIs.
Results
No between-city difference was observed in any analytes. Strong correlations with BMI of RVs were found for 11 analytes
in both sexes, and for amylase (AMY) and alkaline phosphatase (ALP) only in females. Age related changes were observed
for 9 analytes in males and 14 analytes in females. RIs were partitioned by age for lipids, glucose, γ-glutamyltransferase
(GGT) and immunoglobulin A (IgA) in both sexes, C-reactive protein in males and ALP, AMY, lactate dehydrogenase, urea
in females. The upper-limits of RIs for 9 analytes were higher than those of the manufacturer: IgA in both sexes, urea and
AMY in females>45 yo, total and direct bilirubin, GGT, creatine kinase, urea and uric acid in males. Our RIs for magnesium
and potassium were shifted to the lower side.
Conclusion
RIs for Russian population for 35 biochemical analytes were established by use of up-to-date methods.
Cod: W262
DERIVATION OF REFERENCE INTERVALS OF COMPLETE BLOOD COUNTS AND IRON MARKERS FOR RUSSIAN
POPULATION USING BECKMAN COULTER ANALYZERS.
S. Evgina 2, K. Ichihara 3, E. Sukhacheva 1, A. Ruzhanskya 2, I. Skibo 4, S. Kimura 3, A. Vasiliev 4, D. Butlitski 2, V. Emanuel 5
1
Beckman Coulter Eurocenter S.A., Nyon, Switzerland
2
3
4
5
evgina@list.ru
Background
Interpretation of laboratory test results starts with comparison of the values with reference intervals (RIs) served by the
laboratory. RIs provided by manufacturers are usually defined for American or European population, which may not match
to Russian population. The aim of this study was to establish RIs for complete blood counts (CBC) for adult Russian. Since
RIs for CBC can be influenced by latent diseases which cause anemia or infection, iron markers (ferritin:Ferr, iron:Fe, UIBC,
TIBC, transferrin:TF) were also included in our study for use in the secondary exclusion of individuals with such conditions.
Methods
796 healthy volunteers 18−80 year old (yo) were recruited. All the procedures for sampling, measurements, data analyses
were performed using IFCC C-RIDL protocol for the global study on reference values (RV). Fe, UIBC and TF were measured
on AU5800 (Beckman Coulter [BC], USA) and ferritin, folate, Vitamin B12 (VitB12) on DxI 800 (BC). CBC composed of
23 parameters were tested using DxH800 analyzer (BC). The need for partitioning RIs by sex and age were judged based
on SD ratio (SDR) computed by 3-level nested ANOVA. Latent abnormal values exclusion (LAVE) method was applied to
reduce influence of latent diseases on RVs in reference to test results for erythrocyte parameters (RBC, Hb, MCV), Fe, UIBC,
and Ferr. RIs were derived by the parametric method after normalizing data by modified Box-Cox power transformation.
Results
Using SDR≥0.3 as a guide, we judged that partition of RVs by gender was necessary for Fe, UIBC, TF, Ferr, folate, VitB12,
RBC, Hg, Ht, MCV, MCH and MCHC. While, RIs of leukocyte and platelet parameters were derived without partition
by gender. Since body mass index (BMI) related change was noted for Ferr, volunteers with BMI>28 were excluded in
deriving RIs for Ferr. SDR for age-related changes in RVs of Ferr in females was 0.50, thus its RVs were partitioned at 45
yo. Application of the LAVE method to cope with common latent diseases led to prominent elevation of lower limits of RIs
for Hg, Ht, MCV, MCH, and MCHC, and lowering of upper limits for UIBC, TIBC, and TF.
Conclusions
RIs for CBC and iron markers were established for adult Russian population. Application of the LAVE method to reduce
the influence of highly prevalent latent diseases with anemia was essential to determine RIs for a majority of hematological
parameters.
Cod: W263
PRE-ANALYTIC OF AMMONIA: STABILITY, TRANSPORT AND TEMPERATURE OF CENTRIFUGATION.
J. Favresse 1, N. Despas 2
1
Cliniques Universitaires Saint Luc
2
Cliniques Universitaires Saint-Luc
(Belgium)
julien.favresse@uclouvain.be
Background: Ammonia is particularly sensitive to pre-analytical requirements with errors from contamination, collection
or sampling handling. Pre-analytical errors could account for ammonia values 2-3 times upper normal range and may be
confusing for the clinician. We designed a study protocol to assess multiple factors affecting the pre-analytic of ammonia.
Methods: In the first protocol, we evaluated the post-decantation stability of ammonia in 20 volunteers and 11 intensive care
unit (ICU) patients according to the temperature (T°C) of centrifugation (4°C vs room T°C).
In the second protocol, four blood samples were drawn from 21 healthy volunteers and 20 ICU patients. The first sample
was conserved at room T°C and spun at room T°C (3.500 rpm, 10 min), the second conserved at room T°C and spun at
4°C, the third conserved in icy water and spun at room T°C and the last conserved in icy water and spun at 4°C. All these
samples were stored for 30 min before centrifugation.
Finally, blood from 20 volunteers and two ICU patients was used to test the performance of Crioplast® containers in
comparison to icy water. Samples were left for 30 and 60 min in icy water and then spun at 4°C before measurement.
Results: The stability study showed non-statistical difference between samples spun at 4°C and at room T°C for healthy and
ICU patients (P > 0.05). The period of stability in healthy subjects achieved 1h30 and at least 4h30 in ICU patients.
In healthy volunteers, ammonia values for samples left in icy water and spun at 4°C were statistically lower compared to all
other combined conditions, especially in comparison to samples left and spun at room T°C (absolute difference of 28.7%,
P = 0.0001). However, no statistical difference was observed in ICU patients (P > 0.05). The lower red blood cell count of
ICU patients may explain this difference (3.3 x 10^6; normal range 4-6 x 10^6).
The Crioplast® device brought results in agreement with samples conserved in icy water for 30 and 60 min (P > 0.05).
Conclusions: All routine samples must be kept in icy water or in Crioplast® containers and be spun at 4°C. The major
reason is to avoid false elevated ammonia values leading to unnecessary additional blood sampling and laboratory testing.
Discussion between physicians and biologists is primordial to reach such pre-analytical requirements.
Cod: W264
ESTIMATES OF WITHIN-SUBJECT BIOLOGICAL VARIATION FOR TOTAL CHOLESTEROL,HDL-
CHOLESTEROL,LDL-CHOLESTEROL,TRIGLYCERIDES AND APOLIPOPROTEINS A1,B BASED ON REVIEW OF
PUBLISHED PAPERS USING A CRITICAL APPRAISAL CHECK LIST - RESULTS FROM THE EFLM TFG-BV
P. Fernandez-Calle 1, J. Diaz-Garzon 1, J. Minchinela 1, T. Roraas 2, A. Aarsand 2, S. Sandberg 2
1
Analytical Quality Comission of the Spanish Society of Laboratory Medicine and EFLM Task and Finish Group for the Biological
Variation Database
2
EFLM Task and Finish Group for the Biological Variation Database
(Spain)
pfernandez.hulp@gmail.com
Aim: To provide evidence-based estimates of within-subject biological variation (BV) for lipid components by critically
appraising published studies and to compare these estimates with those presently available in the BV Database developed
by the Analytical Quality Commission of the Spanish Society of Laboratory Medicine (SEQC)
Method: Studies on BV for total cholesterol, HDL-cholesterol, LDL-cholesterol, triglycerides and apolipoproteins A1 and
B included in the current BV database were evaluated. Two independent reviewers scored the quality of each paper by
the help of the BV Data Critical Appraisal Checklist (BIVAC). The BIVAC has been developed by the EFLM TFG-BV
and verifies whether all elements essential for a study on BV are included. Articles are scored as category A, B, C and
D depending on which quality items are present or missing. Studies lacking essential quality items are scored D and their
results were not included.
Results: Out of a total of 43 papers (82 studies ), seven were classified as D, 33 as C and three as B. No A papers
were identified. B-classification was given due to statistically-related quality items (lack of analysis for outliers, variance
homogeneity, etc) . C-papers lacked or provided inadequate information on the statistical approach used (94% of studies) and/
or the applied method (9%) The median within-subject biological variation estimates were slightly higher for all measurands
except for triglycerides, when compared to estimates available in present BV database.
Conclusion: This study provides updated and evidence-based estimates of within-subject biological variation for lipids
components by the use of a validated critical appraisal checklist. Few papers were classified as B and none as A, therefore
higher quality studies to estimate BV for lipids are encouraged. A meta-analysis for summarizing published BV estimates
is under development by the BV-TFG and updated estimates will in the future be available on the EFLM website.
Other members of the EFLM TFG-Biological variation group / Analytical Quality Comission of the Spanish Society of
Laboratory Medicine: Aslan B, Bartlett WA, Braga F, Carobene A, Coskun A, Fraser C, Jonker N, Panteghini M, Petersen
PH/ Alvarez V, , Boned B, Cava F, Fernandez-Fernandez P, Garcia-Lario JV, González E, Perich C, Ricos C, Simon M.
Cod: W265
QUALITY REVIEW OF SPERMIOGRAMS IN A HEALTH AREA.
D. González Benito 1, R. Escobar Conesa 1, V. García Moreira 1, M.P. Pueyo Mateo 1, A.I. Llorente Torres 1, E. Fernández Rodríguez 1
1
Departamento de Análisis Clínicos, Hospital Universitario de Cabueñes, Gijón.
(Spain)
dgonzalezbenito@gmail.com
Background: Spermiogram are useful for the diagnosis of male sterility. Over the years, semen quality has deteriorated
mainly due to environmental factors and life styles, which has caused that millions of partners are affected by fertility
problems. The aim of this study is to analyze sperm quality of our received in our laboratory over the last three years (April
2013-March 2016) according to the latest recommendations of the World Health Organization (WHO).
Methods: 754 spermiograms were conducted following the recommendations of the WHO in 2010 and they were analyzed
following these parameters: volume, sperm count, motility, vitality and morphology. For the sperm count (million of sperm
by milliliter) the Neubauer improved chamber was used, to analyze the motility, we employed the Makler chamber, for the
vitality, slide extensions with Eosin-Nigrosin dye, and for the morphology also slide extension with Diff-Quick.
Results: From the examined samples, 38.59% (291) were Normozoospermic, whereas, 14.19% were Hipospermic (<1.5
ml), with a median volume of 2.80 ml and a percentile 5 of 0.9 ml. Concerning the count sperm, the median was 39 million
of sperm by ml, the percentile was between 5 of 4.6 million by ml and 20.82% of the samples were Oligozoospermic (<15
million / ml). In regard to the sperm progressive motility, the median percentage was 38% with a 5 percentile in 10%,
suffering 36.34% of patients from Asthenozoospermia (<32%). In the vitality study, the median percentage of livie sperm
was 83% and 58% were placed in the 5 percentile, ranking the Necrozoospermia (<58%) in just 4.77%. Finally, thenormal
morphology sperm median stood at 5% with a 1% placed in the 5 percentile and Teratozoospermia was in 31.70% (<4%).
In the same simple, according to the deficit of several parameters, 13.62% suffered from Oligoastenozoospermia, while
8.09% were affected by Oligoastenoteratozoospermia.
Conclusions: Over all the studied samples, 38.59% met the new WHO normality principles. The remained, failed to meet
one or more parameters. The most frequent sperm abnormality was the motility (36.34%), followed by the morphology
(31.70%). On the other hand, the less common abnormality was the alteration in the vitality (5.57%).
Cod: W266
EVALUATION OF THE SHORT AND LONG TERM STABILITY OF COMMON CLINICAL CHEMISTRY ANALYTES
FOR HUMAN BIOBANKING SPECIMEN
M. Han 2, N.K. Lee 1, H.J. Lee 1, S.H. Song 1, S.S. Park 1
1
Seoul National University Hospital
2
Sheikh Khalifa Specialty Hospital
(United Arab Emirates)
minjehan@gmail.com
Background: The necessity of biobanking is growing more and more nowadays for clinical research. Since most of the
researches with biobanking specimen are for later use, the stability of specimen is the most important factor for maintaining
quality of research and biobanking. However, there are few researches on the stability of biobanking specimens, particularly
long term stability. This study performs the evaluation of the short term and long term stability of common clinical chemistry
tests for biobanking specimen.
Methods: Blood specimens are drawn from healthy volunteers. For short term evaluations, specimens are stored at four
different temperatures (20, 4, -20, and -70 degree of Celsius), and analytes are measured at the time of basal, 2, 6, 24, 48,
72 hours and 1 week for 28 kinds of analytes including calcium, phosphorus, glucose, urea nitrogen, uric acid, cholesterol,
total protein, albumin, total bilirubin, alkaline phosphatase, AST, ALT, gamma GT, creatinine, sodium, potassium, chloride,
total carbonates, iron, total iron binding capacity, triglycerides, HDL, LDL, Immunoglobulin G, A, M, Complement 3 and
4. For long term evaluations, specimens are stored at 2 different temperatures (-20 and -70 degree of Celsius), and analytes
are measured at the time of 1, 3, 6 months, 1 and 2 years intervals for same analytes as short term evaluations. Percent
differences from basal level for each analyte are evaluated.
Results: For short term evaluation, percent changes of total bilirubin, total carbonates, Complement 3 and 4 show greater
than 10 % from basal levels mainly at 20 degree of Celsius. However, for long term evaluations, percent changes of total
bilirubin, alkaline phosphatase, AST, ALT, total carbonates, HDL, LDL, Complement 3 and 4 show greater than 10 %
starting from 6 months storage mainly at -20 degree of Celsius.
Conclusions: From this study, we can predict how biobanking specimens can be used in clinical researches. Furthermore,
alkaline phosphatase, AST, and ALT can be suggested as easily available biomarkers for evaluation of the stability of
biobanking specimen.
Cod: W267
URGENT AND STRONG NEED FOR HARMONIZATION OF DIFFERENT FECAL CALPROTECTIN ASSAYS ON THE
MARKET – RESULTS AND OBSERVATIONS FROM AN EXTERNAL QUALITY ASSESSMENT (EQA) SCHEME FOR
FECAL CALPROTECTIN
A. Havelka 2, G. Nordin 3, S. Ekvall 3, L. Hansson 1, A. Larsson 1
1
Department of Medical Sciences, Uppsala University, Uppsala, Sweden
2
Department of Molecular Medicine and Surgery, Karolinska Institute and Clinical Chemistry, Karolinska University Hospital,
Stockholm, Sweden
3
Equalis, Uppsala, Sweden
(Sweden)
aleksandra.havelka@gmail.com
Background
The interest in fecal calprotectin is strong and increasing, due to its potential as a non-invasive, cheap and sensitive marker for
intestinal inflammation. Currently, calprotectin can be measured with several commercially available assays from different
manufacturers. Despite the fact that results between various methods differ considerably, most of the methods refer to an
identical reference interval and cut-off value. Unfortunately, neither certified reference material, nor a reference method
exists for fecal calprotectin.
Methods
The EQA scheme for fecal calprotectin from Equalis has currently about 70 participants from different European countries.
Several methods are represented in the scheme, such as EliA, CLIA and turbidimetric method as well as several ELISAs
and rapid tests. Distributed samples consist of both extracted and non-extracted fecal material.
Results
We have observed substantial differences between results from various manufacturers with a total CV of about 50 %; for
some results, the difference can even be more than 300 %. Additionally, even within the same method group, the variation
is considerable with CV up to 40 %. However, the latter may be due to different routines in the processing of fecal samples,
e.g. weighing of fecal sample prior to extraction or not, or if the method is manual or automated.
Conclusions
The substantial variation of reported results, both within the same method group and between different methods, for
fecal calprotectin is alarming; particularly given that most of the manufacturers recommend the same cut-off value.
Standardization or harmonization of the methods is extremely important for the clinical usefulness of the assay and for
patient safety. A harmonization, by introducing a common reference material, will prevent misinterpretation of the results
and avoid costly and invasive investigations of the patients. Therefore, Equalis suggests a harmonization project for fecal
calprotectin in open collaboration with the manufacturers.
Cod: W268
EFFICACY OF HCL AS ACID PRESERVATIVE FOR ALKALINE UTI SAMPLES
R. Hawkins 1
1
Laboratory Medicine, Tan Tock Seng Hospital, Singapore
(Singapore)
Robert_Hawkins@ttsh.com.sg
Introduction: Urinary catecholeamines are degraded at alkaine pHs and samples should be collected using an acid
preservative to ensure pH<6.0. This is easily achieved in most cases but is potentially challenging in patients with urinary
tract infections (UTIs) with initial urine pHs of 8-9. This study examined whether our routine acid preservative of 15mL 6
mol/L HCL is sufficient to acidify samples collected in UTI patients with urine pHs 8-9.
Methods: 20 anonymised leftover urine samples with urine pH 8-9, bacterial counts > 100 per uL and white blood cells
> 6 per uL were selected for urinary ammonium measurement (using a 1+200 saline modification of the Beckman Coulter
Ammonia method on DxC-800) and manual titration of 20 mL of urine with 6 mol/L HCL to achieve pH<6.0. The theoretical
final pH of different (NH4)2HPO4 and HCl mixtures was modeled using an online pH calculator (http://www.aqion.onl/).
Results: The average ammonium concentration was 16.4 mmol/L (range 7-24.7). The theoretical pH for samples with
(NH4)2HPO4 concentrations of 7, 16 and 25 mmol/L were 8.01, 7.98 and 7.97 respectively. Assuming 15 mL 6 mol/HCL
was used to acidify a 2 L specimen, a final concentration of 45 mmol/L HCL would be achieved. The theoretical pH after
mixing this with samples with (NH4)2HPO4 concentrations of 7, 16 and 25 mmol/L were 1.55, 1.8 and 2.14 respectively.
The samples required on average 60 uL of 6 mol/L HCl added to 20 mL urine to achieve pH 5.03-5.73. This is equivalent
to 6 mL 6 mol/L HCl for a 2 L urine volume.
Conclusions: Both theoretical calculations and practical titration studies suggest that 15 mL 6 mol/L HCL is more than
sufficient to achieve final pH <6 in UTI samples with pH 8-9. Although delaying collection until the UTI is resolved is
probably the safest approach, our routine acid preservative protocol seems able to adequately preserve even alkaline UTI
samples.
Cod: W269
CALIPER PEDIATRIC REFERENCE INTERVALS FOR BIOCHEMICAL ASSAYS ON ORTHO VITROS 5600
CHEMISTRY SYSTEM
V. Higgins 2, A. Woroch 1, M.K. Chan 1, K. Adeli 2
1
CALIPER, Pediatric Laboratory Medicine, The Hospital for Sick Children, Toronto, ON
2
CALIPER, Pediatric Laboratory Medicine, The Hospital for Sick Children, Toronto, ON; Laboratory Medicine and Pathobiology,
University of Toronto, Toronto, ON
(Canada)
victoria.higgins@sickkids.ca
Background: Evidence-based reference intervals (RIs) developed from a healthy reference population are essential to
accurately interpret pediatric test results. To fill current critical gaps in pediatric RIs, the CALIPER (Canadian Laboratory
Initiative on Pediatric Reference Intervals) project developed an age- and sex-specific pediatric RI database for over 100
biochemical markers. Originally established for assays on the Abbott Architect, CALIPER RIs have subsequently been
transferred to additional analytical systems, including Roche, Beckman, and Siemens. This study further broadens the
CALIPER database by transferring RIs for 32 biochemical assays to the Ortho Vitros 5600 Chemistry System.
Methods: Transference and verification of RIs from Abbott to Ortho assays were performed according to CLSI C28-A3 and
EP9-A2 guidelines for 32 biochemical analytes. 200 pediatric patient serum samples were analyzed on the Abbott Architect
and Ortho Vitros systems. The method comparison correlation was determined and the appropriateness of the linear model
was assessed to determine ability to transfer. For those which transferred successfully, the equation of the line of best fit
was used to transfer 95% RIs from Abbott to Ortho assays and corresponding 95% confidence intervals were calculated.
Transferred RIs were validated using 100 healthy serum samples from the CALIPER biobank.
Results: 29 of 32 chemistry analytes successfully transferred from Abbott to Ortho assays. Three analytes (i.e. CO2,
phosphate, and calcium) failed to transfer due to poor correlation (r2 <0.70). Of the 29 successfully transferred analytes, 19
showed excellent correlation (r2 ≥0.95) and 10 showed strong correlation (0.81≤ r2 ≤0.94). The majority of transferred analytes
successfully validated according to the following criteria: >90% of reference samples fall within transferred confidence
limits. However, it is recommended that individual laboratories validate these transferred RIs for their local population and
individual analyzer.
Conclusions: This study broadens the utility of the CALIPER pediatric RI database to laboratories using the Ortho Vitros
5600 analyzer, enabling further implementation of CALIPER RIs across Canada and worldwide. This will improve the
accuracy of pediatric test result interpretation in healthcare institutions using this clinical chemistry analyzer.
Cod: W270
CALIPER AGE- AND SEX-SPECIFIC PEDIATRIC REFERENCE INTERVALS FOR BIOCHEMICAL ASSAYS ON
SIEMENS ADVIA 1800 AND SIEMENS DIMENSION EXL
V. Higgins 2, A. Woroch 1, A. Woroch 1, M.K. Chan 1, K. Adeli 2
1
CALIPER, Pediatric Laboratory Medicine, The Hospital for Sick Children, Toronto, ON
2
CALIPER, Pediatric Laboratory Medicine, The Hospital for Sick Children, Toronto, ON; Laboratory Medicine and Pathobiology,
University of Toronto, Toronto, ON
(Canada)
victoria.higgins@sickkids.ca
Background: Correct laboratory test result interpretation requires accurately established reference intervals (RIs)
developed based on a healthy reference population. Growth and development profoundly influence circulating biomarker
concentrations, necessitating age- and sex-stratified RIs specific for the pediatric population. The CALIPER (Canadian
Laboratory Initiative on Pediatric Reference Intervals) program, a national research initiative, has made considerable strides
in addressing gaps in pediatric RIs. Here, age- and sex-specific pediatric RIs are reported for routine chemistry analytes on
two Siemens clinical chemistry analyzers.
Methods: A total of 593 healthy children and adolescents were recruited from Toronto and Hamilton areas with informed
consent and whole blood samples collected in SST tubes. Before sample analysis, subjects with acute or chronic illness
and/or prescription medication use within the past week were excluded. Serum samples were used to measure 21 and 33
biochemical analytes on the Siemens Dimension EXL and Siemens ADVIA 1800, respectively. Scatterplots of the data for
each analyte was visually inspected and statistically relevant age and sex partitions were determined. After outlier removal,
age- and sex-specific RIs with corresponding 90% confidence intervals were calculated using CSLI C28-A3 guidelines.
Results: Age- and sex-related trends for 21 analytes measured on both analyzers were very similar between systems. 15 of
these analytes required numerous age and sex partitions. The remaining six analytes (e.g. glucose, potassium, and sodium)
required limited age partitions and no sex partitions. Of the 12 analytes only measured on Siemens ADVIA, only cystatin
C and GGT required sex partitions. C3, C4, IgA, IgG, IgM and iron levels required no sex partitioning and only showed
an age-related change at the first year of life.
Conclusions: The CALIPER database was expanded in this study to include age- and sex-specific RIs for several routine
chemistry assays on the Siemens Dimension EXL and Siemens ADVIA 1800. This will enable more accurate diagnosis and
laboratory assessment in the pediatric population based on laboratory tests performed on Siemens analyzers in healthcare
institutions worldwide. Validating these RIs for the local pediatric population and specific analyzer prior to clinical
implementation based on CLSI guidelines is recommended.
Cod: W271
EFFECT OF FOOD INTAKE ON THE RESULTS OF COMPLETE BLOOD COUNT
B. Kościelniak 1, A. Charchut 1, K. Sztefko 1, P. Tomasik 1
1
Department of Clinical Biochemistry, University Children Hospital, Jagiellonian University, Medical College
(Poland)
b.k.koscielniak@gmail.com
Background: Complete blood count (CBC) is one of the basic tests performed in the diagnostic laboratories. The effective
and trustworthiness laboratory service is the amalgamation of accuracy, precision, and rapidity of results delivered to the
clinicians as well as to the patients. The credibility of the results of analyses in large part is associated with the preanalytical
phase of laboratory testing. It seems obvious that in order to receive reliable results of laboratory tests, the proper patient’s
prep is required according to laboratories guidelines. The aim of study was to determine the effect of food intake on the
result of CBC.
Materials and methods: The study group was represented by 33 apparently healthy volunteers, 18 women (54%) and 15
men (46%) with median of age 24 years (20-26). All subjects denied taking any medication on a long-term basis and within
the previous month. We analyzed CBC in whole capillary blood drawn from subjects between 8 and 11 am into microtubes
(Kabe Laboratory Technik, Germany) according to the hospital standard procedures. The first blood sample was drawn on
fasting state. Next samples were collected one hour and two hours after consumption a light meal, containing standardized
amounts of carbohydrates, protein and lipids. All measurements were performed on the hematological analyzer Sysmex
XN-1000 (Sysmex Corp. Japan).
Results: We observed increase of total white blood cells after first and second hour after meal consumption when compare
with the primary measurements (p=0.0014 and 0.002 respectively). Moreover we found that the number of neutrophils
increased while the number of lymphocytes decreased after first and second hour after meal consumption (p=0.003, 0=0.006,
p=0.004 and p=0.013 respectively) when compare to the to the baseline samples. We noted that the number of red blood
cells, hematocrit, concentration of hemoglobin, number of platelets decreased after two hours after meal consumption when
compared to the results obtained from fasting sample (p=0.0007, p=0.008, p=0.003, p=0.028 respectively).
Conclusions: Food intake has impact on the CBC results. High quality and repeatability of CBC analysis as well as
comparability between results in the same person require samples drawn from fasting patients.
Cod: W272
BLOOD MICROSAMPLING FOR CBC
B. Kościelniak 1, J. Merak 2, P. Tomasik 1
1
Department of Clinical Biochemistry, University Children Hospital, Jagiellonian University, Medical College
2
University of Agriculture in Krakow
(Poland)
b.k.koscielniak@gmail.com
Background: Complete blood count (CBC) is one of the basic health screening and target tests performed in the diagnostic
laboratories. The credibility of the result of a complete blond count is closely connected with the preanalytical phase.
Aim of the study: The aim of the study was to assess the accordance of volume of blood samples drawn for laboratory testing
in a pediatric wards with recommendations of manufacturer as well as with hospital standard operating procedures (SOPs).
Moreover we analysed the influence of time of blood storage in microtubes on the CBC results.
Methods: Volume of blood 1485 microsamples collected in the Cracow’s Children’s University Hospital wards during one
month were analyzed. Blood was collected using capillary connected to the Microtube GK 150 EDTA 200 µl produced
by KABE Labortechnik GmbH, Nümbrecht - Elsenroch, Germany. The blood volume in each microtube was evaluated
by comparing to series of standard volumes. In the stability studies, overfilled and underfilled samples stored at ambient
temperature were analyzed at: 1, 2, 3 and 12 hours after phlebotomy. The analysis were made with the SYSMEX XT-1800i
analyzers.
Results: The median of blood volume, which was collected into microtube equaled 250 (190-330) µl. Only 335 microtubes
(22%) were filled in accordance with the manufacturer’s instructions (180 – 220 µl), while 930 (63%) of the samples were
filled above the manufacturer's recommended volume and 228 (15%) of test-tubes were filled below the recommended
blood volume. We observed the tendency to collection more blood volume from older children (p=0,00012). The storage of
overfilled and underfilled microtubes for CBC for 1,2,3 and 12 h at room temperature had no effect on the results of this test.
Conclusion: Medical staff does not keep SOPs of blood collecting to the microtubes. Despite the incorrect blood volume
collected into microtubes 12h storage in ambient temperature does not affect the CBC results.
Cod: W273
STANDARDIZATION OF TOTAL BILIRUBIN MEASUREMENT FOR IMPROVED DIAGNOSIS AND MANAGEMENT
OF NEONATAL JAUNDICE
V. Delatour 2, M. Vaubourdolle 3, E. Lasnier 3, N. Mario 3, S. Bailleul 3, M. Haguet 3, A. Mailloux 1
1
Centre National de Référence en Hémobiologie Périnatale (CNRHP), Hôpital Saint Antoine, AP-HP, Paris, France
2
Laboratoire National de métrologie et d’Essais, Paris France
3
Services de Biochimie, Hôpitaux Universitaires Est Parisien, AP-HP, Paris, France
(France)
agnes.mailloux@sat.aphp.fr
BACKGROUND
In pediatrics, accurate measurement of total serum bilirubin is of major importance for reliable diagnosis and appropriate
management of neonatal jaundice. However, several studies evidenced poor comparability of results obtained with the
different available methods. This situation is partly due to the lack of Reference Materials, especially for high bilirubin
concentrations. In this study, we produced different candidate calibrators that were used to recalibrate the most popular
routine assays.
METHODS
Commutability of 1 EQA material consisting in lyophilized serum and of 4 candidate materials consisting in frozen primary
standard or serum pools with or without PEG was assessed through a split sample study. The same 30 clinical specimens
and the candidate reference materials were measured in triplicate with 8 different methods (Reagent analyzer combinations).
The materials exhibiting sufficient commutability were then value assigned with a reference method. Raw results were then
compared with those obtained after virtual recalibration using different strategies: single point and 2 point recalibration
using different combinations of calibrators.
RESULTS
The lyophilized EQA material was found non-commutable for almost all methods and was considered inappropriate to
assess methods trueness. In contrary, the 4 frozen primary standards were found highly commutable for almost all methods
except some spectral methods. After discarding spectral methods, between method CV was 5.5% without recalibration, 2%
after single point and 5% after 2 point recalibration. This result can be explained by the limitations of routine assays to
measure for low bilirubin concentrations (<60 µmol/L). Using a single calibrator with high bilirubin concentration results
in a great improvement of results comparability for medium and high bilirubin concentrations but this benefit is lost when
a calibrator with low bilirubin concentration is added.
CONCLUSIONS
Recalibration of assays for serum bilirubin with commutable calibrators can improve comparability of the different methods.
However, concentration of calibrators should be carefully chosen depending on the field of application. In pediatrics, single
point calibration with high bilirubin concentration was shown to be the most appropriate. On this basis, a more extensive
study will be conducted with French biological society (SFBC) to progress in harmonization process for neonatal bilirubin.
Cod: W274
VERIFICATION OF CALIPER (2009) REFERENCE INTERVALS FOR SERUM IRON IN BRAZILIAN CHILDREN
M. D Farace 1, L. G Assunção 1, L. Moutinho 1, B. S De Moura 1
1
Lab Rede
(Brazil)
betania@labrede.com.br
Background: Pediatric-specific reference intervals remain inadequate or unavailable for many analytes. Published at 2009,
the Canadian Laboratory Initiative for Pediatric Reference Intervals (CALIPER) established reference intervals for children
metabolically stable, from five age groups; 0–12 months, 1–5 years, 6–10 years, 11–14 years and 15–20 years. Reference
intervals were established according to CLSI/IFCC C28-P3 guidelines by the Robust statistical method. The ranges
reflect the central 95% confidence intervals for the population tested. Samples were analyzed for 24 chemistries and 15
immunoassays. These intervals were determined in the Abbott ARCHITECT System®, but could be validated in other
analytical immunoassay platforms and local populations, as recommended by the CLSI.
Objective: Since iron deficiency is the most common cause of anemia, this study aims to assess the applicability of serum/
plasma iron CALIPER reference intervals for pediatric Brazilian population, using laboratory database, Lab Rede® -
Minas Gerais, Brazil. Methodology: Plama/serum samples were collected from 2698 children, both genders, with normal
ferritin (7-140 ng/mL), from December 2014 to November 2015 and stored at 2-8°C. The ARCHITECT i2000 platform
(Abbott Park, IL, USA), chemiluminescent microparticle immunoassay, was used. The results were distributed by age as
the CALIPER data: 1-5 years old (n: 1289); 6-10 years (n: 647); 11-14 years (n: 403) and 15-18 years (n: 359). Data were
submitted to EP Evaluator® program for reference interval verification and statistical analysis (C28-A CLSI).
Results: The results for groups (central interval of 95%) and their CALIPER reference intervals were approved for all groups.
Conclusions: It is a challenge to obtain reference intervals for pediatric population, therefore the use of database sampling
constitutes a viable option for checking the ranges proposed at scientific literature. The iron CALIPER (2009) data are
applicable to our population.
Cod: W275
REFERENCE INTERVAL FOR SERUM FOLATE MEASURED WITH AN ASSAY TRACEABLE TO THE WHO
INTERNATIONAL STANDARD
S. Ferraro 1, A. Panzeri 2, S. Borille 1, D. Szoke 1, M. Panteghini 2
1
Clinical Pathology Unit, ‘Luigi Sacco’ University Hospital, ASST Fatebenefratelli-Sacco, Milan, Italy
2
Research Centre for Metrological Traceability in Laboratory Medicine (CIRME), University of Milan, Milan, Italy
(Italy)
elena.aloisio@unimi.it
BACKGROUND: Most folate immunoassays have been recently recalibrated to the WHO International Standard-NIBSC
03/178 to improve inter-assay harmonization. However, we observed that the recalibration of Roche Diagnostics Folate III
assay yielded a significant shift in the average folate measured values, with a 50% difference vs. the old Roche assay at
concentrations around the lower reference limit (LRL). Here we report data from apparently healthy individuals obtained
with the WHO-recalibrated assay for defining the traceable reference interval for serum folate.
METHODS: We enrolled 322 healthy blood donors (50% males; median age, 45.5 years) with haemoglobin and erythrocyte
MCV values within reference limits and not undertaking folic acid supplementation. Serum samples were measured by
using WHO-recalibrated Roche Folate III assay (code 07559992190) on a Cobas 6000 analyzer (CV≤7.2% and limit of
detection of 0.6 µg/L). Reference interval derivation was according to CLSI C28-A3c standard. Multiple regression models
were used to estimate the influence of age, gender, Italian origin, smoking habit and portions of consumed fruit/vegetables
on folate concentrations.
RESULTS: We found no gender-related difference. Folate median (25-75th percentile) concentrations were 4.1 (2.9-5.6) µg/
L. The estimated reference interval [2.5-97.5th percentile limits (90%CI)] was 1.3 (1.1-1.4) - 9.8 (8.6-12.2) µg/L. Notably,
the LRL was markedly lower than the one (3.3 µg/L) previously estimated by us using the old Roche assay on a similar
population. Folate values significantly (P<0.001) increased with age and with the number of taken portions of fruit/
vegetables per day (adjusted R2, 18.9%), with no influence by smoking and non–Italian origin.
CONCLUSIONS: Our experimental estimate of LRL using Roche WHO traceable assay on a population free of folate
supplementation reveals that this value is far lower than that reported by the manufacturer in the assay package insert (3.9
µg/L), likely including fortified subjects. Laboratories using folate assays harmonized to NIBSC 03/178 material may adopt
the LRL of 1.3 µg/L to detect vitamin deficiency, providing that there are no differences in test results across populations
due to biological or environmental factors.
Cod: W276
ELECTROLYTE DISORDERS IN A HEALTH AREA
A. Peña Cabia 3, S. Peña Cabia 2, M.L. Giménez Alarcón 3, M. Chilet Saez 3, E. Prada De Medio 3, S. Serrano Martínez 3, G. Seseña
Del Olmo 4, F. Marqués García 1
1
Clinical Biochemistry Department / University Hospital of Salamanca, Salamanca, Spain.
2
Hospital Pharmacy / University Hospital HM Sanchinarro, Madrid, Spain.
3
Medical laboratory Unit / Virgen de la Luz Hospital, Cuenca, Spain.
4
Medical microbiology Unit / Virgen de la Luz Hospital, Cuenca, Spain.
(Spain)
anapcabia@hotmail.com
INTRODUCTION
Electrolyte determination is very significant in clinical diagnostic and treatment because of ions performs important organic
tasks.
The aim of this study was to determinate the prevalence of electrolyte disorders in our Health Area but taking into account
the role of hemolysis, high glucose levels or renal function.
METHODS
Serum electrolyte requests were analyzed from June to August 2016. The clinical significance results were evaluated
according to age, sex, creatinine and urea values, hemolysis rate and hyperglycemia.
Samples were measured using three different analyzers: C8000, C6000 and C311 (Roche Diagnostics®). Ions values were
determined by indirect potentiometry method, glucose and urea by photometry and creatinine by Jaffé method.
RESULTS
We determined sodium (135-145 mEq/L) and potassium (3.5 – 5.1 mEq/L) in 34 737 samples. 5 375 (15.5%) results were
out of the reference intervals. Serious electrolyte disturbance prevalence was: 13% hypernatremia (>155mEq/L), 5.74%
hyponatremia (<125mEq/L), 10% hyperkalemia (>6mEq/L) and 2.84% hypokalemia (<2.5mEq/L). Severe disorders mean
age was 71.8 years, without differences due to sex.
Hemolysis results were found in 2.85% samples, for this reason our Laboratory repeat 1.3% samples per month due
to increase potassium levels. We also found 757 pseudohyponatremia samples due to hypertonic hyperglycemia and,
additionally, 121 samples with creatinine >1.60 mg/dL and urea >70 mg/dL showed severe hyperkalemia, possibly by renal
failure.
CONCLUSIONS
A low percentage of determinations were out of the reference intervals. The most extreme values belong elderly patients.
In our Health Area the main serious electrolyte disturbance is hypernatremia.
In our study a low percentage of potassium determinations were repeated due to hemolysis, however it would be desirable a
reduction goal in order to improve the laboratory efficiency and to avoid patient discomfort. Furthermore, the influence of
hyperglycemia in sodium levels and influence of renal failure in potassium levels should be taken into account in laboratory
reports.
Cod: W277
A CASE OF INTERFERENCE IN THE MEASUREMENT OF THYROTROPIN BY AN IMMUNOASSAY THAT USES
CHIMERIC ANTIBODY
M. Pijanović 1, B. Mićović 1
1
Medical Laboratory Medilab Požega, Serbia
(Serbia)
marinamicovic@yahoo.com
Objective: Heterophilic antibodies are rare and unpredictable interferences in immunoassays. They are usually detected
when the results are incompatible with the clinical condition of the patient. Various strategies can be applied in order to
reduce their impact on patients’ results, but because of their heterogeneity, it is impossible to eliminate their interference
completely.
Methods: A 41 y/o female patient was treated with levothyroxine after her initial results of high thyrotropin (TSH) and
borderline-low free thyroxine (FT4) by immunometric assay performed on the Cobas e411 analyzer (Roche Diagnostics).
After two months of therapy, her TSH was unexpectedly higher. The chief biochemist decided to run it on another platform
( DPC Immulite 1000), do the dilution study, and use the blocking tubes (Heterophilic Blocking Tube, HBT, Scantibodies
Laboratory, Santee, USA). Eventually, the sample was tested in Roche laboratories (Penzberg, Germany).
Results: Patient’s results before the treatment were TSH 15.8 uIU/mL and FT4 10.9 pmol/L and were obtained on Cobas
e411, Roche. After two months of therapy, TSH was 22.3 uIU/mL and FT4 24.7 pmol/L. Her RF was within the reference
range, thyroid autoantibodies were negative, and her clinical condition unclear. The result obtained on Immulite 1000 was
<0.004 uIU/mL. Serial dilution with saline yielded nonlinear pattern. However, treatment with HBT tubes, following the
manufacturer’s instructions, failed to give a different result. The treatment with levothyroxine was discontinued. A sample
aliquot was sent to the Roche laboratory which discovered the presence of anti-human F(ab’)2 fragment antibodies in the
patient’s serum.
Conclusion: Roche TSH assay uses chimeric antibodies which eliminate interference from human anti-mouse antibodies.
Although rare, atypical interfering antibodies, like anti-human F(ab’)2 fragment antibodies, which were present in this case,
can greatly impact the clinical management of patients. Since there is no single procedure that can detect or eliminate all
interferences, a close communication between clinicians and laboratory staff is crucial to circumvent inappropriate testing
and treatment.
Cod: W278
PREPARATION OF PATIENT– IMPORTANT FACTOR IN PRE-ANALYTICAL PHASE
D. Popovic 1
1
“Codra” Hospital, Podgorica, Montenegro
(Montenegro)
midpopovic@t-com.me
BACKGROUND: Pre-analytical errors account for to 70% of all mistakes made in laboratory. Many non-analytical factors
can change the concentration of one or more substances in the sample, so the results obtained are not an indicator of the
physiological state of the patient.
METHODS: In this study samples from patients (workers in electrification) were evaluated during regular systematic review
in Department of laboratory diagnostic of Codra Hospital, in Podgorica. For all of them, standard program was performed
(blood count, ESR, glucose, cholesterol, triglycerides, AST, ALT, urea, creatinine) on Abbott analysers (Architect ci4100
and Cell Dyn 3700). For interpretation of the results, we used producer’s reference intervals (glucose: 3.9-5.5 mmol/L,
cholesterol: 0.00-5.18 mmol/L, triglycerides: 0.00-1,70 mmol/L, AST: 5-34U/L, ALT: 0-55U/L, urea: 2.5-7.2 mmol/L,
creatinine: 64-110µmol/L)
RESULTS: From total number of patients, 60% had increased values of glucose (82% in range 5.6-6.6 mmol/l, 11% in range
6,7-7,7 mmol/, 5% in range 7,8-8.8 mmol/L and 2% in range 8.9-10.0 mmol/L), 64% had increased values of cholesterol
(50% in range 5.2-6.2 mmol/L, 32% in range 6.3-7.3 mmol/L, 14% in range 7.4-8.4 mmol/L, 4% in range 8.5-10.2 mmol/L),
39% had increased values of triglycerides (66% in range 1.70-2.70 mmol/L, 18% in range 2.71-3.71 mmol/L, 10% in range
3.72-4.72 mmol/L, 5% in range 4.73-5.13 mmol/L and 1% value bigger than 10.00 mmol/L), 5% patients had values of AST
in range 35-65 U/L, and 5% patients had values of ALT in range 56-140 U/L. Values of urea and creatinine were, mostly , in
reference ranges. From the results obtained, we perceive that more than 50% patients had values of glucose, cholesterol and
triglycerides above the reference ranges, which points that majority of them did not follow the recommendation of adequate
preparation (to be 12 hours on fasting).
CONCLUSIONS: Inadequate preparation of patients for certain analysis, can lead to drastic deviation of results from the
real values, and obtained results will be interpreted as pathologic. Non respect of adequate preparation of patients, lead to
addition consumption of reagents, addition time for repetition of analyses, respectively to increase cost of analyses.
Cod: W279
STANDARDIZATION OF THE CDT MEASUREMENT: VALIDATION OF THE NEW CDT-IFCC TEST ON CAPILLARYS
3 TERA
G. Deschamps 1, G. Proczek 1, D. Simonin 1, F. Robert 1
1
SEBIA, R&D department, Lisses, France
(France)
frobert@sebia.com
Background: The CDT test developed by Sebia for CAPILLARYS 2 instrument is currently used in many countries, e.g.
France, Italy, BNL, Russia, Germany, UK, etc. In 2016, according to the IFCC Working Group recommendations, this test
was standardized in order to harmonize all the existing CDT measurement methods and to report the standardized CDT (=
2-sialo) as CDT-IFCC. The new Sebia capillary instrument with 12 capillaries, CAPILLARYS 3 TERA, has up to now four
available techniques on board: Protein 6, Immunotyping, HbA1c and Hemoglobin. Now Sebia has adapted the new CDT-
IFCC test to CAPILLARYS 3 to answer the expectations of new customers and of current CAPILLARYS 2 users willing
to switch to CAPI 3 CDT.
Methods: A comparison study vs CAPILLARYS CDT and the IFCC HPLC reference method was carried out according
to the CLSI EP09-A2 protocol. The CDT-IFCC values (obtained after calibration of the system; 2 calibrators levels with
CDT-IFCC target measured by the IFCC reference method) were compared to those obtained by the reference method, and
CDT values (i.e., not standardized 2-sialo and 0-sialo) were compared to those obtained with CAPILLARYS 2. Precision
was evaluated according to CLSI EP5-A2 protocol. Linearity was studied according to the CLSI EP6-A protocol. Bilirubin
& Hemoglobin interferences were studied according to the CLSI EP 07 protocol.
Results: Accuracy (correlation): for CDT-IFCC values, the results of linear regression analysis, the sensitivity and
specificity of the CAPILLARYS 3 TERA CDT-IFCC procedure compared to the reference procedure show that the results
obtained on CAPILLARYS 3 instrument follow the requirements.
For CDT values, the correlation between CAPILLARYS 3 and CAPILLARYS 2 is excellent.
Precision: the reproducibility for the CDT and CDT-IFCC percentages follow the requirements.
Linearity: the results obtained on the different mixtures follow the requirements. The tests were determined to be linear
within the entire ranges studied for CDT and CDT-IFCC percentage.
Interference: no interference is observed for hemolyzed or icteric samples at the tested levels, for CDT and CDT-IFCC
values.
Conclusion: The new CDT-IFCC test for CAPILLARYS 3 TERA gives precise, linear and well correlated vs the IFCC
reference procedure. This new test can thus be used as a routine test and is also able to report CDT results, i.e. not standardized
2-sialo and 0-sialo.
Cod: W280
DERIVATION OF RUSSIAN REFERENCE INTERVALS FOR IMMUNOCHEMISTRY ANALYTES MEASURED BY
BECKMAN COULTER ANALYZER: A STUDY CONDUCTED AS A PART OF IFCC GLOBAL MULTICENTER STUDY
ON REFERENCE VALUES.
A. Ruzhanskya 1, K. Ichihara 2, S. Evgina 1, I. Skibo 3, S. Kimura 2, A. Vasiliev 3, D. Butlitski 1, G. Agarkova 1, V. Emanuel 4
1
2
3
4
anchen_@inbox.ru
Background
A multicenter study was organized to explore sources of variation (SVs) of reference values (RV) for immunochemistry
analytes and to determine reference intervals (RIs) specific for Russian population as a part of a global study coordinated
by IFCC Committee on Reference Intervals and Decision Limits (C-RIDL).
Methods
By the use of C-RIDL protocol for the global study, 796 healthy volunteers 18-80 year old (yo) in 3 cities were recruited. 23
analytes were measured on the DxI 800 analyzer in Helix lab in Saint-Petersburg. To explore SVs, 3-level nested ANOVA
and multiple regression analysis were used. Latent abnormal values exclusion method was applied to reduce influence of
latent diseases on RVs of insulin, growth hormone (GH), testosterone and thyroid hormones. Individuals with high anti-
thyroid antibodies or taking L-thyroxine were excluded from the analysis of thyroid panel. Pre-menopause females with
total β human chorionic gonadotropin (TbHCG) > 2.9mIU/ml or those taking oral contraceptives were excluded from the
analysis of reproductive panel. Volunteers with body mass index (BMI) >28 were excluded from deriving RIs for analytes
with BMI-related changes in RVs. Partition by the status of menopause (MP) was done for reproductive panel, for other
analytes with age-related changes in RVs were partitioned at 45 yo. RIs were computed by the parametric method.
Results
No between-city difference was observed in any analyte. Significant BMI-related changes in RVs were found for insulin,
GH in both sexes, testosterone, sex hormone binding globulin (SHBG), free androgen index (FAI), progesterone in males,
cortisol and parathyroid hormone in females. The upper limits (UL) of RIs for insulin, thyrotropin (TSH), and testosterone
were lower than those of the manufacturer. The lower limit (LL) of testosterone decreased with age slightly, while UL of
SHBG increased. Thus, the RI for FAI strongly shifted to the lower side with age. RIs were also partitioned by age for
αfetoprotein, carcinoembrionic antigen. Median and LL of the RI for CA125 decreased with age in females, but partition
by age was not performed because its UL was constant. The RI for TbHCG strongly shifted to the higher side after MP,
especially the UL after MP, which strongly exceeded that of the manufacturer for non-pregnant women.
Conclusion
RIs for 23 immunochemistry analytes and FAI for Beckman Coulter analyzer were established in Russia by use of up-to-
date methods proposed by C-RIDL.
Cod: W281
METHOD COMPARISON BETWEEN DRY AND WET CLINICAL CHEMISTRY ANALYZER FOR 24 BIOCHEMICAL
ANALYTES: C-RIDL IFCC INITIATIVE
S. Shah 1, T. Ashavaid 1, K. Ichihara 2, A. Dherai 1, R. Kawano 2
1
P. D. HINDUJA NATIONAL HOSPITAL AND MEDICAL RESEARCH CENTRE
2
YAMAGUCHI UNIVERSITY GRADUATE SCHOOL OF MEDICINE
(India)
dr_swarup.shah@hindujahospital.com
Background: Laboratories use different clinical chemistry analyzers, which utilizes either dry (slide-based) or wet (liquid)
reagents for routine biochemical testing. However, there is limited literature on the comparison between the two analyzer
type. The IFCC’s committee on Reference Interval and Decision limits (C-RIDL) initiated a global multicenter study on
common reference values. As an extension to the global study, we conducted the present study to compare the performance
of dry & wet reagent chemistry analyzer for routinely tested 24 biochemical analytes.
Methods: Under the aegis of C-RIDL IFCC, 512 healthy Indian volunteers were recruited for reference intervals estimation.
However, for the present method comparison study, 126 healthy volunteers were used to estimate the levels of 24 biochemical
analytes (Alb, AMY, ALP, ALT, AST, BUN, Ca, CK, Cl, Cre, Fe, GGT, Glu, HDL-C, IP, K, LDH, Mg, Na, TBil, TC, TG,
TP & UA) using both Ortho clinical diagnostics’s VITROS 250 (dry chemistry) analyzer as well as Beckman Coulter’s
UniCel DxC 800 (wet chemistry) analyzer. Beckman coulter served as a reference method, as the data obtained from UniCel
DxC 800 analyzer were recalibrated and aligned to the IFCC panel of sera, which in turn were traceable to the reference
measurement procedures. Correlation coefficient & Bland altman plots were used for analysis.
Results: Out of 24 biochemical analytes measured on both analyzers, 16 analytes showed almost perfect correlation (r
=0.8-1.0), 3 analytes (Ca, Glu & IP) showed substantial correlation (r =0.6-0.8), 4 analytes (Alb, Cl, Mg, Na & TP) showed
moderate correlation (r =0.4-0.6) and Na showed zero correlation. Bland altman plot revealed that 05/24 analytes (AMY,
ALP, ALT, LD & TG) showed greater bias between the two analyzers, whereas, the bias for the remaining analytes were
close to zero.
Conclusion: In view of limited literature on the method comparion between the dry and wet reagent analyzers, the present
study observed that with respect to the reference method only 13/24 (GGT, Ca, K, Tbil, Cre, UA, AST, BUN, CK, HDL-
C, Glu, Fe & Tchol) analytes showed good correlation and lesser bias, suggesting a good agreement between the analyzers.
Comparison of two analytes (Na & LD), with zero correlation & high bias was unacceptable. However for the remaining
analytes, the method comparison data for each analyte (with either good correlation or minimum bias) should be evaluated
individually for its clinical relevance.
Cod: W282
ASSAY AND REPORTING OF SERUM CREATININE IN SRI LANKAN STATE SECTOR LABORATORIES: IS IT
HARMONIZED?
I.D. Siriwardhana 1
1
Department of Pathology, Faculty of Medicine, University of Ruhuna, Galle
(Sri Lanka)
deepanisrilanka@hotmail.com
Background:
Serum creatinine (SC) concentration and estimated glomerular filtration rate (eGFR) are essential tools in the diagnosis and
management of patients with chronic kidney disease (CKD). CKD of uncertain aetiology is emerging in certain geographical
localities of Sri Lanka. Use of standardized serum creatinine assays across the nine provinces of the country is important
in correctly identifying patients with CKD. There have been no previous studies describing the assay methodology and
reporting practices of SC either in the state or private sector laboratories of Sri Lanka.
This study aimed to ascertain the current status of SC measurement and eGFR reporting practices in the Sri Lankan state
sector hospital laboratories.
Methods:
An observational study was conducted using a self-administered questionnaire, inviting 109 Pathology Laboratories in
hospitals nationwide under the purview of the Ministry of Health. Data was collected through email and in the absence of
electronic mail via postal mail.
Results:
Thirty seven hospitals representing all nine provinces participated in the survey giving a response rate of 34%. The
laboratories were from nine Teaching Hospitals (TH), one Provincial General Hospital (PG), three District General Hospitals
(DG) and 24 Base Hospitals (BH). Thirty six participant laboratories performed the SC assay. The majority declared the use
of alkaline picrate (86%) method. One TH used the enzymatic method in addition. Five participants (BH) did not state their
method. Most used automated (75%) or semi-automated (19%) analyzers. Only half of the laboratories declared traceability
to the IDMS reference method. Only 31% laboratories used SI units for reporting, the rest used conventional units. Age and
sex specific reference intervals were reported only by two laboratories.
Altogether 16 (44%) laboratories reported eGFR either routinely (2/16) or when requested (14/16) only. MDRD formula
was used by more than 50% (9/16) laboratories to report eGFR.
Conclusions:
Automated modified Jaffe method is the most common method used in Sri Lankan state sector laboratories. However more
efforts are needed to harmonize, issues related to metrological traceability, use of SI units, reference intervals and eGFR
reporting practices, to ensure uniformity in CKD diagnosis.
Cod: W283
A MULTI-SITE EVALUATION OF BD BARRICOR™ PLASMA BLOOD COLLECTION TUBE WITH A NON GEL
SEPARATOR FOR A RANGE OF IMMUNOASSAYS & CARDIAC MARKERS.
S. Church 2, F. Apple 4, C. Bonato 6, R. O’brennan 5, V. Palicka 3, A. Ahuja 1, J. Berube 1, A. Mouser 1, N. Niwinski 1, M. Parikh 1, E.
Plokhoy 1, A.K. Stankovic 1
1
BD Life Sciences, Preanalytical Systems, Franklin Lakes, NJ, USA
2
BD Life Sciences, Preanalytical Systems, Oxford, UK
3
Charles’ University, University Hospital Institute for Clinical Biochemistry & Diagnostics, Králové, Czech Republic
4
Hennepin County Medical Center and Minneapolis Medical Research Foundation, Minneapolis, MN, USA
5
Infectious Disease Associates of Central Virginia, Lynchburg, VA, USA
6
Ospedale San Leopolodo, Mandic, Italy
(United Kingdom)
stephen.church@bd.com
BACKGROUND
Blood collection tubes that contain a gel barrier offer many advantages such as suitability for transportation & sample
stability. However some analytes can interact with the gel over time altering their concentration e.g. TDMs, the gel itself
may lead to inefficiencies if it contacts instrument probes, and in separated plasma based samples, cells are trapped in the
supernatant reducing analyte accuracy & sample stability. The BD Vacutainer® Barricor™ Plasma Blood Collection tube
has a non-gel barrier reducing this potential for analyte and instrumentation interactions. Studies were conducted at multiple
sites to assess the performance of the BD Barricor™ tube in comparison with gel tubes for selected special chemistry
analytes and cardiac markers.
METHODS
Blood was collected into BD Vacutainer® Barricor™, BD PST™II (Plasma/Gel) and BD SST™II Advance (Serum/
Gel) tubes. Special chemistry analytes (385 subjects) and cardiac markers (95 subjects), were measured on a number of
instruments. Within-tube stability was also measured for some cardiac markers. Results for the BD Barricor™ samples were
compared with those of the BD PST™II and BD SST™II using Deming regression to calculate mean biases and 95% limits.
RESULTS
BD Barricor™ tubes were clinically equivalent or clinically acceptable when compared with BD PST™II and BD
SST™II Advance tubes for the measurement of β-hCG; Complement C3; Cortisol; CRP; Estradiol; Ferritin; Folate; Follicle
Stimulating Hormone; Free Thyroxine; Free Triiodothyronine; Haptoglobin; Immunoglobulins A, G and M; Luteinizing
Hormone; Progesterone; Rheumatoid Factor; Testosterone; Thyroid Stimulating Hormone; Total Prostate Specific Antigen;
Total Thyroxine; Total Triiodothyronine; Transferrin & Vit B12.
BD Barricor™ tubes were clinically equivalent for the measurement of the cardiac markers Creatine Kinase MB Fraction;
Total Creatine Kinase; Cardiac Troponin I; Cardiac Troponin T. In addition, samples that had been stored in BD Barricor™
tubes for 24h at RT were clinically equivalent when compared with initial time for CKMB, Cardiac Troponin I and Cardiac
Troponin T.
CONCLUSIONS
BD Barricor™ tubes are suitable for the measurement of cardiac markers and a wide range of special chemistry analytes
on a number of instrument platforms.
Cod: W284
DELTA CHECK AS A POSSIBILITY FOR CLINICAL MONITORING OF LABORATORY PARAMETERS.
N. Steriopolo 2, M. Vershinina 1
1
"Central clinical hospital with polyclinic" Department for Presidential Affairs (of the Russian Federation)
2
"Clinical hospital" Department for Presidential Affairs (of the Russian Federation)
stenika@yandex.ru
Goal.
To determine the significance of changes in the number of leukocytes (Delta check) from patients with nosocomial
pneumonia.
The materials and methods.

A retrospective analysis of electronic patient records and laboratory data information system (10 patients with an established
diagnosis of pneumonia and a known number of leukocytes according outpatient observation).
Results and discussions.

The diagnosis of " nosocomial pneumonia" is defined when the patient has objective evidence of: a shortening of percussion
tones over the affected part of the lung, locally listen to bronchial breathing, sonorous focus finely wheezing or inspiratory
of crepitate, strengthening bronchophony and voice jitter (approximately 20% of patients these symptoms may be absent),
X-ray confirmed focal infiltration of the lung tissue and at least two of the following clinical signs:
- acute onset (body temperature above 38.0°C);
- cough with a sputum;
- leukocytosis (>10x109/l) and/or band (>10%).
The accuracy of changes in the count of leukocytes, the critical difference (reference change value (RCV) was 33.6% for
being used in the laboratory analytical system (CellDyn Ruby hematology analyzer by Abbott Diagnostics).
RCV = 20.5* Z * (CVа2+ CVi2)0.5, then Z = 1.96 (p<0.05)
The calculation of Delta check for 10 patients in comparison with RCV and cut off revealed 3 patients in whom, despite the
presence of leukocyte count below the cut off - RCV > 33.6%, i.e. increasing the number of leukocytes can be considered
meaningful. And back: in 2 patients the number of leukocytes above the cut off, have RCV < 33.6%, i.e., the leukocytosis
in these cases cannot be considered as a clinical symptom.
Leukocytes have high individuality index (II = 0.37). Therefore, for the individual patient by comparison the count of
leucocytes with the reference interval (4.00 - 9.00x 109) or the specified cut off (>10.00x 109) is less efficient than using
Delta check and RCV.
Modern laboratory information system allow us to calculate Delta check for the specified performance automatically and
provide additional information to clinicians for the correct interpretation of laboratory parameters.
Cod: W285
COMPARISON OF TWO IMMUNOCHEMICAL METHODS FOR THE DETERMINATION OF TPSA
A. Stojnić 1, D. Stojanović 2, S. Avram 1
1
Department of Clinical Laboratory Diagnostics,University Clinical Centre of the Republic of Srpska,Banja Luka
2
Health Center „dr Mladen Stojanović“ , Laktaši
(Bosnia and Herzegovina)
sandrastojnic@gmail.com
Introduction: Tumor marker Total Prostate Specific Antigen TPSA is the primary prostate specific marker. Determination
of the concentration of TPSA can be done at the time of diagnosis, before, during or after completion of therapy and at
detecting early recurrence. However, the results obtained by different analysis methods when determining tumor markers
are different, and changes of methods during the monitoring may be causing problems.
Objective: The aim of this study was to compare two immunochemical methods for determining the concentration of TPSA.
CMIA (Chemiluminescent Micro particle Immune Assay) and ELFA (Enzyme Linked Fluorescent Assay)
Materials and Methods: TPSA concentrations were determined using following analyzers: Abbott ARCHITECT and mini
VIDAS (BioMerieux Clinical Diagnostics). Correlation between methods was examined on 30 serum samples.
Results: Coefficient of correlation between the two methods was 0.994 (P <0.0001). Cusom’s linearity test was carried out
as part of regression after Passing - Bablok showed no significant deviation from linearity (P = 0.91). Results of regression
after Passing - Bablok analysis were as follows: 95% CI intercept for the y axis was: 0.0212 (-0.00510 - 0.1058), 95% CI
for the slope amounted to: 1.4327 (1, 3887 to 1.4641).
Conclusion: The concentration of TPSA obtained on two analyzers failed to meet fully the regression priority according
Passing - Bablok. The slope does not include 1, and a intercept of the Y axis includes 0, and the intercept is very small.
Regardless of the high correlation we can conclude that there is a difference between the values of the concentration of
TPSA obtained by different analyzers. Given that the results confirmed observations from daily routine, monitoring the each
individual patient is best done by using the same immunoassay and reagents on the same analyzer.
Cod: W286
EFFECT OF INTERFERENCE FROM HEMOLYSIS AND LIPEMIA ON ROUTINE CLINICAL CHEMISTRY ASSAYS:
DETERMINTAION OF DIFFERENT INTERFERENCE LIMITS
S. Szakony 1, T. Holzer 2, M. Radáni 2
1
Central Laboratory, St. Imre Teaching Hospital, Budapest
2
Faculty of Chemical Technology and Biotechnology, Budapest University of Technology and Economics, Budapest
(Hungary)
szilvia_szakony@hotmail.com
Background: Clinical chemistry assays can be affected by interferents like hemoglobin and lipids. Considering that third
party reagents are used for chemistry tests in our laboratory we evaluated the effect of these interferences. We also determined
different interference limits and established cut-off indices above which these interferences confound sample results.
Methods: Two separate serum pools were spiked with increasing concentration of hemolysate or Intralipid® according to
Clinical and Laboratory Standards Institute (CLSI) EP7 guideline. The hemolysis (H) and lipemia (L) indices were measured
on Abbott Architect c8000 analyzer. Interferences were evaluated for 25 parameters. Analytes affected by lipemia were
treated with LipoClear® and reanalyzed. Besides the determination of the traditional ±10% change of concentrations from
baseline (±10% ∆) further two limits were defined: analytical change limit (ACL) and reference change value (RCV).
Results: Considering the ACL, 17 analytes concentrations were changed by hemolysis. Considering the ±10% ∆, 14
parameters were affected. Whereas considering the RCV, the analyte concentrations enhanced by hemolysis were: albumin,
phosphate, aspartate aminotransferase, uric acid, potassium, creatinine, lactate dehydrogenase, magnesium, total protein
and iron. In the case of lipemia the following 7 parameters were affected according to each of the three limits: total and
conjugated bilirubin, glucose, total protein, lactate dehydrogenase, aspartate aminotransferase and alanine aminotransferase.
Following LipoClear® treatment sodium, potassium, chloride, total and conjugated bilirubin, phosphate concentrations were
above the ACL, while CK-MB and total protein concentrations exceeded the RCV limit.
Conclusions: The ACL based interference indeces are used as flag cut-off for comment to clinicians along with reported
result. RCV based indeces are retained as decision cut-off for not reporting the impacted result. Accurate reporting of patient
samples for the analytes affected by hemolysis and/or lipemia interferences will lead to better clinical interpretation.
Cod: W287
NUMBER REDUCTION OF HAEMOLYSED SAMPLES USING LOW VACUUM TUBES.
A. Tapia Lanuza 1, M. Sanchez Gonzalez 1, M.M. Larrea Ortiz-Quintana 1, M. Lalana Garces 1, A. Fontán Abad 1, A. Sopena Murilo 1
1
Hospital de Barbastro, Huesca, Spain
(Spain)
atapia@salud.aragon.es
Introduction
One of the main problems in the clinical laboratory is the sample quality, being one of the most important, the haemolysis.
Studying the haemolysis average rate by services, we observed that there are some units in our hospital, where this problem
manifests itself with particular intensity as Critical Care Unit, Oncology and Emergency Department. After a causes analysis,
we concluded that the differentiating factor between them, was the blood samples extraction from all patients through a
venous catheter.
Objective
We propose a solution to reduce the haemolysis level and its intensity, in samples of these services, changing the extraction
devices but keeping their special work system.
Method
Several materials from different suppliers were tested to improve the process of extraction tube, like holder, adapters and
tubes. Comparations for each one were established between the new devices against the habitual one, in order to evaluate if
there were a haemolysis reduction. Results were monitored for seven months, and recorded the percentages of haemolysed
samples according to haemolysis index greater than or equal to 20, 50, 100 and 500.
Results
The best results were obtained using low vacuum tubes from Becton Dickinson, due to reducing the suction force effect over
the red blood cells. All categories significantly improve and virtually disappear haemolysis >500 mg/dL, which previously
was a 2 or 3% of the samples. If we use as a measure the percentage of samples with haemolysis index greater than or equal
to 50 mg/dL we find the following results:
• Tubes with lithium heparin and separator gel to obtain plasma (BD PST LH II Ref. 367374), we observed a reduction
from 17% to 5% of haemolysed samples.
• Tubes with separator gel and coagulation activator (BD SST II advance Ref. 367374), we observed a reduction from 18%
to 3% of haemolysed samples.
Conclusions
The use of low vacuum tubes in units that extract the blood sample for laboratory through a venous catheter, reduces
dramatically the percentage of haemolysed samples.
Cod: W288
IMPACT OF A PRE-ANALYTICAL PHASE PROTOCOL FOR HOMOCYSTEINE DETERMINATION.
A. Martinez-Escribano Garcia-Ripoll 1, E. Valencia Vera 1, R. Gallardo MagaÑa 1, L. Marin Rasal 1, A.M. Fernandez Ramos 1
1
LABORATORY UNIT, VIRGEN DE LA VICTORIA UNIVERSITARY HOSPITAL, MALAGA, SPAIN.
(Spain)
estefaniavalenciavera@gmail.com
BACKGROUND
Serum homocysteine determination requires special conditions of sample collection, handling, transport, processing and
storage. The blood specimen must be collected into K3 EDTA (ethylenediaminetetraacetic acid), held refrigerated during
transportation and centrifuged refrigerated within 20 minutes of phlebotomy to obtain the plasma. Immediately following
centrifugation, a aliquot of plasma is put into a non-activating secondary tube and, in case they are not going to be tested
in that moment, held at -20ºC until determination. The cut-off over 15umol/L is considered as a risk factor of cardio
and cerebrovascular events. In 2014 we evaluated the preanalytical phase of homocysteine and, from the high number of
determinations that were rejected, we put in place a protocol. The aim of this study is to evaluate the results of that protocol.
METHODS
Determination of homocysteine was carried out in the BN ProSpec (Siemens Healthcare®, Malburg, Germany) by
nephelometry. Hemolyzed and/or lipemic samples were rejected because of its increased turbidity, which generated non
accurate results. In 2014, 745 samples were received and 172 (23.09%) of them were rejected. The reason of the rejection
was: no refrigeration (n=162, 94.19%), hemolysis (n=6, 3.49%) and lipemia (n=4, 2.32). We developed and a protocol
available in the laboratory, rooms for blood extraction and the hospital intranet.
RESULTS
In 2015, 675 samples were received. 79 were from Primary Care Centers so they were not considered. The special conditions
of processing and the geographical distance of the centers to the hospital laboratory made carrying the determinations out
inappropriate. The rest of the patients were hospitalized or came to the hospital to have the specimen collected. 109 (16.14%)
of them were rejected. The reason of the rejection was: no refrigeration (n=101, 92.66%), hemolysis (n=4, 3.67%) and
lipemia (n=4, 3.67%).
CONCLUSION
Although the percentage of rejected samples continues to be important, is lower than the year before. Still, a considerable
number of collections have to be repeated, with the damage it takes to the patient, the increase in the amount of laboratory
money spent and the delay of the therapeutic approach. To avoid this situation, we must improve the staff training and the
written procedure. We should continue on monitoring this pre-analytical phase.
Cod: W289
THE EFFECT OF TIME AND TEMPERATURE OF STORAGE ON THE STABILITY OF SOME ANALYTES
C. Reynolds 1, C. Domingues 1, R. Carneiro 1, M. Dias 1
1
Centro Hospitalar Tâmega e Sousa
(Portugal)
claudiareynolds_@hotmail.com
Background: In the laboratory daily routine new analytes are often added after the initial sample has been processed. One
of the factors that can potentially change the quality of the analytical results is the storage conditions of the sample. For this
reason, the present study will discuss the effect of time and storage temperature in seven serum analytes.
Methods: We used the UniCel DxC 880i - BECKMAN COULTER (DxC) analyzer. The parameters evaluated were: aspartate
aminotransferase (AST), creatinine (Cr), creatine kinase (CK), total bilirubin (TB), C-reactive protein (CRP), glucose and
amylase.
The methods were calibrated and controlled according to the protocol implemented in the service, resembling the day-to-
day basis. We used samples from the daily routine of the laboratory with volume greater than 1ml and free from noticeable
macroscopically interferences.
Samples were collected using the vacuum system (Vacutainer®) and centrifuged at 3500 rpm for 10 minutes. After the initial
determination (0h) two aliquots were made, one of which was stored at room temperature and the other in a refrigerator (2-8
°C). Determinations of the selected analytes were made at 2, 4 and 8 hours in both aliquots. The mean percentage deviation
was determined and compared do Total allowable Error (TEa).
Results: When using the TEa as an acceptable limit, most of the investigated analytes remained stable. However, glucose
and Cr had an acceptable TEa at room temperature only until 4h of storage. There is also a significant difference in all
measurements of any analyte when comparing the values obtained at room temperature to the refrigerated. This difference
became more pronounced over time, being more significant on amylase, glucose and Cr.
Conclusions: There is an influence of storage time and temperature in some analytes. Amylase, glucose and creatinine were
the most affected. This study reflects the necessity to follow rigorously the storage rules on a daily basis.
Cod: W290
DRUG INTERFERENCE IN TRINDER REACTION
O. Wiewiorka 1, Z. Čermáková 2, M. Dastych 2
1
Department of Clinical Biochemistry, University Hospital Brno; Department of Biochemistry, Faculty of Medicine, Masaryk University,
Brno
2
Department of Clinical Biochemistry, University Hospital Brno; Department of Laboratory Methods, Faculty of Medicine, Masaryk
University, Brno
(Czech Republic)
wiewiorka.ondrej@fnbrno.cz
Background: The Trinder reaction brought indisputable benefits to the clinical laboratory analysis providing specific and
precise measurement of several clinical markers. However, multiple recent studies showed chemical interferences in Trinder
reaction that significantly alter laboratory results. The aim of this study was to quantify interference effects of six widely
prescribed drugs with analytical methods utilizing the Trinder chromogenic reaction.
Material and methods: Samples were prepared by spiking a pooled blood plasma with the specific medical solution. The first
set of samples was prepared with therapeutic concentrations of six drugs: ACC® (N-acetylcysteine; 875 mg/L), Dicynone®
(etamsylate; 50 mg/L), ascorbic acid (25 mg/L), Novalgin® (metamizol; 150 mg/L), Tensamin® (dopamin; 75 µg/l) and
Dobutamin Admeda (dobutamin; 400 µg/L). The second set of samples was prepared to contain a unified concentration
of 1 mmol/L. The results of Trinder-based methods - cholesterol, creatinine, triacylglycerol and uric acid were compared
to the values obtained from the pooled plasma with blank addition. The analyses were performed with the C8000 c702
(Roche) analyzer with the reagent sets for cholesterol (CHOL2), creatinine (CREP2), uric acid (UA2) and triacylglycerides
(TRIGL) by Roche.
Results: In the samples with therapeutic concentrations, interference occurred in three out of the six drugs – ACC®,
(triglycerides -83,3%, cholesterol -54,2%, creatinine -33,3%, uric acid 22,1%), Dicynone® (creatinine -54,3%, triglycerides
-24,6%, uric acid -10,7%) and Novalgin® (creatinine -28,4%, triglycerides -15,9%, uric acid -10,7%). The samples
containing 1 mmol/L drug concentration showed interference in all of the samples with the strongest in Dobutamine,
Tensamin® and Dicynone®. The effective molecules have similar hydroquinone structure, which may help us predict the
risk of interference in drugs of the same type.
Conclusion: This study shows how significantly are common medications able to alter the measurement results. Although
some information of these interferences were available in the past, their acknowledgement in the field of laboratory medicine
is still low. This may be fixed by application of a sophisticated software informing doctors of a known substance interfering
with analysis along with the results.
Dedication: This report was a part of the project number MUNI/A/1056/2015 with the support of the Specific University
Research Grant in the year 2016.
Cod: W291
AGE-SPECIFIC SERUM C1Q LEVEL IN 970 HEALTHY CHILDREN FROM BIRTH TO THE AGE OF 13 YEARS
S. Yan 1, H. Zhang 1, J. Yu 1, R. Hou 1
1
Department of Clinical Laboratory, Shanghai Children’s Hospital, Shanghai Jiao Tong University,Shanghai
(China)
yanshu1029@126.com
Background: The function of C1q in the complement cascade is to activate the classical complement pathway. It plays
an important role in many diseases, especially immune mediated disorders. However, only few studies have reported the
reference intervals in children from birth to the age of 13 years. Thus, the aim of this study was to establish age-specific
reference intervals for serum C1q in the healthy children population.
Methods: A total of 940 clinically healthy children from birth to 13 years were selected and the concentration of C1q
was measured by Beckman Coulter chemistry analyzer AU5800. The centiles of C1q distribution were estimated with
the exponential-normal 3-parameter model. Age-specific reference intervals were calculated according to the Clinical
Laboratory Standards Institute (CLSI) C28-A2 document. Age groups were ranging from 1 day to 2 months, 2 - 6 months,
6 months - 2 years and 2 - 13 years, respectively.
Result: Serum samples from 940 children were analyzed, and nomograms of C1q for the 5th, 10th, 25th, 50th, 75th, 90th, and
95th percentiles were produced, which showed C1q varies against age. No sex-differences were found for C1q between age-
matched serum samples. Median concentration of C1q was lowest during the first month of life, followed by a continuous
increase with age. By nonparametric method, a statistical test of separate reference intervals was established.
Conclusion: Monograms and separate intervals of C1q in a large sample of children within the general population were
presented. These could help clinicians in more accurate individual interpretation of serum C1q level in health children.

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Poster Abstracts – EuroMedLab Athens 2017 – Athens, 11-15 June 2017 • DOI 10.

Patient sample management, (standardization, harmonization,reference ranges, etc)

Patient sample management, (standardization, harmonization,reference ranges, etc)

Patient sample management, (standardization, harmonization,reference ranges, etc)

MATERIALS AND METHODS

Patient sample management, (standardization, harmonization,reference ranges, etc)

MATERIALS AND METHODS

Patient sample management, (standardization, harmonization,reference ranges, etc)

RESULTS and DISCUSSION

Patient sample management, (standardization, harmonization,reference ranges, etc)

Patient sample management, (standardization, harmonization,reference ranges, etc)

Patient sample management, (standardization, harmonization,reference ranges, etc)

Patient sample management, (standardization, harmonization,reference ranges, etc)

Patient sample management, (standardization, harmonization,reference ranges, etc)

Patient sample management, (standardization, harmonization,reference ranges, etc)

Patient sample management, (standardization, harmonization,reference ranges, etc)

Patient sample management, (standardization, harmonization,reference ranges, etc)

Patient sample management, (standardization, harmonization,reference ranges, etc)

Patient sample management, (standardization, harmonization,reference ranges, etc)

Patient sample management, (standardization, harmonization,reference ranges, etc)

Patient sample management, (standardization, harmonization,reference ranges, etc)

Patient sample management, (standardization, harmonization,reference ranges, etc)

Patient sample management, (standardization, harmonization,reference ranges, etc)

Patient sample management, (standardization, harmonization,reference ranges, etc)

Patient sample management, (standardization, harmonization,reference ranges, etc)

Patient sample management, (standardization, harmonization,reference ranges, etc)

Patient sample management, (standardization, harmonization,reference ranges, etc)

Patient sample management, (standardization, harmonization,reference ranges, etc)

Patient sample management, (standardization, harmonization,reference ranges, etc)

Patient sample management, (standardization, harmonization,reference ranges, etc)

Patient sample management, (standardization, harmonization,reference ranges, etc)

Patient sample management, (standardization, harmonization,reference ranges, etc)

Patient sample management, (standardization, harmonization,reference ranges, etc)

Patient sample management, (standardization, harmonization,reference ranges, etc)

Patient sample management, (standardization, harmonization,reference ranges, etc)

Patient sample management, (standardization, harmonization,reference ranges, etc)

Patient sample management, (standardization, harmonization,reference ranges, etc)

Patient sample management, (standardization, harmonization,reference ranges, etc)

The materials and methods.

Results and discussions.

Patient sample management, (standardization, harmonization,reference ranges, etc)

Patient sample management, (standardization, harmonization,reference ranges, etc)

Patient sample management, (standardization, harmonization,reference ranges, etc)

Patient sample management, (standardization, harmonization,reference ranges, etc)

Patient sample management, (standardization, harmonization,reference ranges, etc)

Patient sample management, (standardization, harmonization,reference ranges, etc)

Patient sample management, (standardization, harmonization,reference ranges, etc)

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