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372 Annals of Clinical & Laboratory Science, vol. 49, no. 3, 2019
Evaluation of Cobas 8000 Analyzer Series Module e801
Analytical Performance
Sangeun Lim, Kyunghoon Lee, Hee-Yeon Woo, Hyosoon Park, and Min-Jung Kwon

Department of Laboratory Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine,
Seoul, Korea

Abstract. Background. Immunoassays are important tests that provide essential information for patient
care. The e801, a module of the recently released Cobas 8000 series (Roche Diagnostics, Mannheim,
Germany), is an automated immunoassay system based on streptavidin-biotin interactions. In this study,
we evaluated the analytical performance of the e801. Methods. We evaluated the precision, linearity, assay
comparison, and reference range validation of 16 analytes (AFP, CA19-9, CA125, CEA, CYFRA, ferritin,
NSE, PSA, Vitamin D, E2, fT4, TSH, FSH, insulin, NT-proBNP, and T) according to the guidelines of
the Clinical Laboratory Standards Institute. Results. In precision evaluations, the coefficients of variation
were less than each allowable total error for all analytes. Linearity was observed for all analytes over the
entire tested analytical range (r2≥0.99). Performance comparisons revealed that the two systems are compa-
rable, with correlation coefficients (r)>0.975 for all analytes. The reference range validation was also within
the allowable criteria. Conclusions. In this study, the Cobas 8000 e801 analyzer demonstrated acceptable
performance with respect to precision, linearity, reference range validation, and correlation. Therefore, the
e801 analyzer is expected to be useful for routine immunoassays in clinical laboratories, although educa-
tion and awareness about biotin interference is necessary for successful implementation in clinical practice.

Key words: Immunoassay, Performance, Evaluation.

Introduction The Cobas 8000 e801 analyzer (Roche Diagnostics,

Immunoassays are important tests that provide
essential information for patient care. Clinical
laboratory automation of immunoassays is inevi-
table in modern medicine. A variety of immuno-
assays have been developed since radioimmuno-
assay use was first introduced in the 1960s, and
antibody sensitivity and marker studies have im-
proved over time [1]. Immunoassay analyzers are
used to test patient samples for a variety of sub-
stances, including cardiac markers, tumor mark-
ers, allergy testing, or endocrine hormone testing.
Modern immunoassay systems have greater re-
producibility and sensitivity and shorter response
times than previous technologies [2]. Despite
these improvements, there is a need to analyze
larger amounts of data more quickly and cost-ef-
fectively [3]. In addition, as the results of immu-
noassays are essential for patient care and clinical
decisions, accurate test results and quality control
are critical.
Address correspondence to Min-Jung Kwon, MD, PhD, Department
of Laboratory Medicine, Kangbuk Samsung Hospital, Sungkyunkwan
University School of Medicine, 29 Saemunan-ro, Jongno-gu, Seoul
03181, Korea; phone: +82 2 2001 5211; fax: +82 2 757 0711; e mail:
mjkkmd@gmail.com
Mannheim, Germany) uses electrochemilumines-
cence sandwich assays based on biotin and streptavi-
din interactions. The analyte and antibody form a
sandwich, and magnetic particles coated with strep-
tavidin are then added. The free biotin prevents some
of the antibody-analyte sandwich from binding to
the microparticle by binding to streptavidin-coated
microparticles instead. This method is hampered by
false decreases in results in sandwich assays and in-
creases the accuracy of the test. It can also be used to
examine various analytes, such as tumor markers and
hormones. The reagents are ready to use and are
packed in closed cassettes to allow completely auto-
mated reagent handling. Up to four e801 modules
can be configured in series, yielding throughput of
up to 1,200 tests per hour, delivering steady, fast re-
sults in a relatively small space and allowing for con-
tinuous analysis loading when reagents are supplied.
A recent study evaluated the analytical performance
of the Cobas 8000 c702 chemistry analyzer and e602
immunoassay analyzer [4,5]. However, as far as we
know, the e801 immunoassay analyzer has never
been evaluated. Therefore, in this study, we evaluated
the overall analytical performance of the Cobas 8000
e801 using 16 immunoassay assays.

0091-7370/19/0300-372. © 2019 by the Association of Clinical Scientists, Inc.

 Evaluation of the e801 immunoassay analyzer 373
Table 1. Precision profiles for the 16 analytes.

Test item Level Mean Standard CV (%) Total

concentration Deviation Repeatability Within- allow-
labora able
tory error
precision (%)

AFP (ng/mL) Low 10.67 0.16 1.6 1.5 21.9

High 112.40 1.87 1.5 1.7
CA19-9 (U/mL) Low 21.03 0.42 2.0 2.3 46.03
High 81.22 1.91 2.3 2.4
CA125 (U/mL) Low 29.21 0.38 1.1 1.3 35.4
High 84.13 0.87 1.1 1.0
CEA (ng/mL) Low 5.90 0.09 1.3 1.5 24.7
High 51.33 0.76 1.4 1.5
CYFRA (ng/mL) Low 2.64 0.06 1.5 2.2 27.9
High 25.28 0.51 1.6 2.1
Ferritin (ng/mL) Low 25.68 0.47 1.7 1.9 16.9
High 211.64 4.80 2.4 2.2
NSE (ng/mL) Low 12.29 0.15 1.0 1.2 15.7
High 98.06 1.00 0.8 1.1
PSA (ng/mL) Low 4.44 0.06 1.4 1.4 33.6
High 37.40 0.66 1.9 1.7
Vitamin D(ng/mL) Low 11.20 0.77 6.3 6.9 25
High 25.54 1.06 4.4 4.1
E2 (pg/mL) Low 82.69 1.55 1.7 1.9 26.86
High 457.88 4.50 1.0 1.0
fT4 (ng/dL) Low 1.20 0.03 2.3 2.6 8.0
High 3.28 0.09 2.3 2.8
TSH (μIU/mL) Low 1.41 0.04 2.4 2.7 23.7
High 8.95 0.24 2.8 2.7
FSH (mIU/mL) Low 15.43 0.29 1.1 2.0 21.19
High 46.84 0.80 1.2 1.8
Insulin (μU/mL) Low 26.53 0.83 1.2 3.4 32.9
High 81.01 2.20 1.2 2.9
NT-proBNP (pg/mL) Low 140.36 2.23 1.4 1.6 13.0
High 4547.08 65.33 1.2 1.5
Testosterone (ng/mL) Low 2.51 0.08 1.1 1.5 13.61
High 5.67 0.06 1.4 1.4

Abbreviations: AFP, alpha fetoprotein; CA19-9, cancer antigen 19-9; CA125, cancer antigen 125; CEA, carcinoembry-
onic antigen; CYFRA, cytokeratin 19 fragment; CV, coefficient of variation; E2, estradiol; FSH, follicle stimulating
hormone; fT4, free thyroxine; NSE, neuron specific enolase; NT-proBNP, N-terminal prohormone of brain natriuretic
peptide; TSH, thyroid stimulating hormone.

Materials and Methods neuron-specific enolase (NSE), prostate-specific antigen

This study was performed between December 2017 and
April 2018. The e801 was evaluated for precision, linear-
ity, comparison, and reference range validation. We
tested 16 representative immunoassay analytes to evalu-
ate its performance in routine laboratory work; alpha-
fetoprotein (AFP), cancer antigen 19-9 (CA19-9), can-
cer antigen 125 (CA125), carcinoembryonic antigen
(CEA), cytokeratin fragment (CYFRA), ferritin,
(PSA), total 25-hydroxyvitamin D (vitamin D), estradiol
(E2), free thyroxine (fT4), thyroid-stimulating hormone
(TSH), follicle-stimulating hormone (FSH), insulin,
N-terminal prohormone of brain natriuretic peptide (NT-
proBNP), and testosterone (T). Reagent preparation and
settings were based on the manufacturer’s recommenda-
tions. The performance of the e801 was compared to that
of a currently used routine immunoassay analyzer with the
e602. Quality control (QC) materials of levels 1 and 2
374 Annals of Clinical & Laboratory Science, vol. 49, no. 3, 2019
Table 2. Linearity.

Test item Range Slope (95% CI) Intercept R2 Recovery (%)

AFP (ng/mL) 0.908-1077 0.990 (0.950-1.029) 6.246 0.999 98.1-104.8

CA19-9 (U/mL) 2.215-986.0 0.997 (0.945-1.050) -9.880 0.999 94.9-100.0
CA125 (U/mL) 0.6-3050.5 0.999 (0.957-1.041) -26.64 0.999 95.5-100.0
CEA (ng/mL) 0.3-910.5 0.993 (0.963-1.024) 3.382 0.999 98.8-100.0
CYFRA (ng/mL) 0.1-49.7 0.980 (0.904-1.056) 0.432 0.998 96.0-108.0
Ferritin (ng/mL) 7.125-2819.5 1.012 (0.953-1.070) -26.032 0.999 94.6-102.0
NSE (ng/mL) 0.382-53.85 0.997 (0.979-1.015) 0.008 0.999 98.9-100.0
PSA (ng/mL) 0.0285-91.5 1.004 (0.987-1.021) -0.032 0.999 98.7-101.0
Vitamin D (ng/mL) 1.605-57.7 1.002 (0.952-1.052) -0.650 0.999 94.9-100.0
E2 (pg/mL) 5.0-2631.0 0.950 (0.884-1.016) 38.051 0.999 94.8-106.9
fT4 (ng/dL) 0.545-3.250 0.935 (0.870-1.001) 0.0331 0.997 103.1-107.3
TSH (μIU/mL) 0.1045-122.0 0.980 (0.887-1.074) -0.450 0.997 93.4-100.0
FSH (mIU/mL) 1.12-192.5 0.999 (0.970-1.028) -0.837 0.999 97.0-100.0
Insulin (μU/mL) 1.37-514.0 1.001 (0.919-1.084) 8.150 0.998 100.0-108.5
NT-proBNP (pg/mL) 32.25-4826.5 0.997 (0.911-1.082) -77.488 0.997 91.5-100.0
Testosterone (ng/mL) 0.1195-12.95 0.994 (0.965-1.023) 0.084 0.999 100.0-105.9

Abbreviations: AFP, alpha fetoprotein; CA19-9, cancer antigen 19-9; CA125, cancer antigen 125; CEA, carcinoem-
bryonic antigen; CYFRA, cytokeratin 19 fragment; CI, Confidence interval; E2, estradiol; FSH, follicle stimulating
hormone; fT4, free thyroxine; NSE, neuron specific enolase; NT-proBNP, N-terminal prohormone of brain natri-
uretic peptide; TSH, thyroid stimulating hormone; R2, coefficient of determination.

Table 3. Comparison results between the cobas 8000 e801 ande602 analyzer.

Test item Number Range Slope (95% CI) Intercept R

AFP (ng/mL) 105 0.974-263.5 0.966 (0.952-0.981) 0.178 1.000

CA19-9 (U/mL) 96 3.42-271.5 0.968 (0.958-0.978) -1.462 0.999
CA125 (U/mL) 105 3.37-465 0.996 (0.978-1.013) 0.250 0.996
CEA (ng/mL) 105 0.392-35.5 1.066 (1.056-1.076) 0.123 0.999
CYFRA (ng/mL) 105 0.413-24.300 0.984 (0.974-0.985) -0.051 0.998
Ferritin (ng/mL) 104 3.71-2000 0.998 (0.980-1.017) 16.320 0.996
NSE (ng/mL) 109 3.805-40.05 1.009 (0.984-1.034) 0.795 0.992
PSA (ng/mL) 107 0.1545-33.4 1.045 (1.035-1.054) -0.034 0.999
Vitamin D (ng/mL) 100 6.54-65.54 0.941(0.907-0.976) -0.293 0.984
E2 (pg/mL) 98 5-824 0.955 (0.943-0.967) -6.516 0.998
fT4 (ng/dL) 103 0.387-7.77 0.888 (0.857-0.920) 0.127 0.984
TSH (μIU/mL) 99 0.0053-17.80 0.996 (0.991-1.001) 0.043 1.000
FSH (mIU/mL) 100 1.07-173.5 1.036 (1.030-1.042) 0.006 1.000
Insulin (μU/mL) 100 0.664-179 1.065 (1.060-1.070) -0.189 1.000
NT-proBNP (pg/mL) 100 6.14-35000 0.995 (0.992-0.998) -37.367 1.000
Testosterone (ng/mL) 100 1.54-41.28 1.012 (0.999-1.025) -0.131 0.998

Abbreviations: AFP, alpha fetoprotein; CA19-9, cancer antigen 19-9; CA125, cancer antigen 125; CEA, carcinoem-
bryonic antigen; CYFRA, cytokeratin 19 fragment; E2, estradiol; FSH, follicle stimulating hormone; fT4, free thy-
roxine; NSE, neuron specific enolase; NT-proBNP, N-terminal prohormone of brain natriuretic peptide; R,
Correlation coefficient; TSH, thyroid stimulating hormone.

(PreciControl, Roche Diagnostics, Indianapolis, IN,
USA) and pooled sera from subjects who visited our in-
stitution were used for analyses. The comparative study
was performed using sera from at least 100 subjects.
Samples were non-randomly selected to fulfill criteria
including broad value range and proper distribution for
methods comparisons using the 16 analytes. Only non-
hemolytic and non-lipemic sera were used. This study
was approved by the Institutional Review Board of
Kangbuk Samsung Hospital (2017-11-040) and com-
plied with the World Medical Association Declaration of
Helsinki guidelines.
Evaluation of the e801 immunoassay analyzer 375
376 Annals of Clinical & Laboratory Science, vol. 49, no. 3, 2019

Figure 1. Comparisons between the cobas e801 and e602. (A) Alpha
fetoprotein. (B) Cancer antigen 19-9. (C) Cancer antigen 125. (D)
Carcinoembryonic antigen. (E) Cytokeratin 19 fragment. (F) Ferritin.
(G) Neuron-specific enolase. (H) Prostate-specific antigen. (I) Vitamin
D. (J) Estradiol. (K) Free thyroxine. (L) Thyroid-stimulating hormone.
(M) Follicle-stimulating horm. (N) Insulin. (O) N-terminal prohor-
mone of brain natriuretic peptide. (P) Testosterone.

Repeatability and within-laboratory precision. For
evaluations of repeatability and within-laboratory preci-
sion, we tested all analytes using both lower and higher
levels of QC materials according to Clinical and
Laboratory Standards Institute (CLSI) guideline EP5-A3
[6]. The QC materials at each level were analyzed in five
replicates per run on five consecutive days. The coeffi-
cients of variation (CV) per assigned analyte were calcu-
lated from the 25 results generated for each assay. The
CV was deemed acceptable for the analysis if equal to or
less than desirable for the allowable total error based on
the biological variation database specification on the
Westgard website [7,8] and other journals [9].
Linearity. The linearity of the assays was validated ac-
cording to CLSI guideline EP6-A [10]. For each analyte,
we generated five equally-spaced concentrations of sam-
ples, and three intermediate concentration pools were
prepared by mixing the high (H) and low (L) level pa-
tient sera as follows: 0.75L+0.25H, 0.50L+0.50H, and
0.25L+0.75H. To determine the best-fit polynomial,
each sample was measured in duplicate, and the mean
values were determined. In the first polynomial, it was
determined that linearity was maintained. When the sec-
ond- or third-degree polynomial appeared, it was deter-
mined whether it was a clinically meaningful nonlinear-
ity based on the document [11].
Comparisons. Comparisons were performed following
CLSI guideline EP9-A3 [12]. Specimens from at least
100 subjects with variable values distributed over the
analytical measurement range were collected from left-
over serum samples. All test samples were divided into
two aliquots and stored at -70°C. A comparison study
was performed between the e801 and e602 on the same
day. The concentration of each analyte was measured in
duplicate using each of the two instruments. The mean
values were used for regression analyses and for calculat-
ing the correlation coefficient (r). The results were con-
sidered acceptable if the correlation coefficient was
≥0.975.
Reference range validation. Selection of reference
specimens and reference range validation were per-
formed according to CLSI guideline C28-A3c [13].
The reference ranges were validated using sera from 20
healthy subjects aged 20 to 60 years for the following
test analytes: AFP, CA19-9, CA125, CEA, CYFRA,
fT4, TSH, insulin, NSE, NT-proBNP, and vitamin D
for 10 males and 10 females; T and PSA for 20 males;
E2 and FSH for 20 females; ferritin for 20 males and
20 females. If two or fewer of the 20 tested values for
each analyte (or 10% of the tested values) fell outside
of those reference ranges, the result was considered to
be acceptable for reference range validation. If three or
four test results fell outside of reference ranges, another
20 reference specimens similar to the first set were ob-
tained and retested.
Statistics. For repeatability and within-laboratory pre-
cision, LaboStats (version 1.5, Laboratory Medicine
Foundation, Seoul, Korea) was used to calculate the
mean, standard deviation, and CV for each level of QC
material in the 16 analytes. LaboStats was also used to
validate the best fit model in the linearity test results.
IBM SPSS, version 24.0 (IBM Co., New York, NY,
USA) was used to calculate slope, intercept, 95% CI,
coefficient of determination (R2) at validation of lin-
earity, and correlation coefficient (r) during compari-
sons. All measured data were entered into relation ta-
bles using Excel 2010 (Microsoft Corporation,
Redmond, WA, USA).
Results
Repeatability and Within-Laboratory
Precision.The e801 yielded repeatability CVs
ranging from 0.8% to 6.3% and within-laborato-
ry precision CVs ranged from 1.0% to 6.9% for
all analytes. In our evaluation of precision, all ana-
lytes showed acceptable coefficients of variation
 Evaluation of the e801 immunoassay analyzer 377
Table 4. Reference Range Validation.

Test item Proposed reference Total Outside %

interval count count Outside

AFP (ng/mL) 0-7 20 0 0

CA19-9 (U/mL) 0-26.6 20 0 0
CA125 (U/mL) 0-39 20 0 0
CEA (ng/mL) 0-4.7 20 0 0
CYFRA (ng/mL) 0-3.3 20 0 0
Ferritin (male, ng/mL) 59-507 20 0 0
Ferritin (female, ng/mL) 6-174 20 0 0
NSE (ng/mL) 0-16.3 20 0 0
PSA (ng/mL) 0-2.99 20 0 0
Vitamin D (ng/mL) 20-100 20 2 10
E2 (female, pg/mL) 5-498 20 0 0
fT4 (ng/dL) 0.84-1.74 20 0 0
TSH (μIU/mL) 0.27-4.2 20 2 10
FSH (female, mIU/mL) 1.7-21.5 20 0 0
Insulin (μU/mL) 1.5-14.5 20 0 0
NT-proBNP <115 (20 ~ 45 years) 20 0 0
(male, pg/mL) <172 (45 ~ 54 years) 20 0 0
<263 (> 55 years) 20 0 0
Testosterone 2.49-8.36 (20 ~ 50 years) 20 1 5
(male, ng/mL) 1.93-7.40 (> 51 years) 20 0 0

Abbreviations: AFP, alpha fetoprotein; CA19-9, cancer antigen 19-9; CA125, cancer antigen 125; CEA, carcinoem-
bryonic antigen; CYFRA, cytokeratin 19 fragment; E2, estradiol; FSH, follicle stimulating hormone; fT4, free thy-
roxine; NSE, neuron specific enolase; NT-proBNP, N-terminal prohormone of brain natriuretic peptide; TSH, thy-
roid stimulating hormone.

within each allowable total error. A statistical
summary of precision evaluated using low- and
high-concentration QC materials is shown in
Table 1.
Linearity. The results of the linearity evaluation of
the five concentrations of serum samples prepared
by mixing sera at high and low concentrations are
shown in Table 2. Coef¬ficients of determination
(R2)≥0.99 were observed for all analytes evaluated.
The first polynomial was noted for 8 analytes
(CA19-9, CEA, ferritin, FSH, NSE, PSA, T, and
TSH), and it was thus determined that linearity
was maintained. For the CA125, insulin and vita-
min D analytes, a second-degree polynomial was
observed, while a third-degree polynomial was not-
ed for the remaining analytes (AFP, CYFRA, E2,
NT-proBNP, and fT4). We next evaluated the data
set to determine whether it showed any clinically
significant differences, and determined that there
was no clinically meaningful nonlinearity.
Consequently, the linearity of the data was deemed
acceptable.
Comparisons. We compared the performances of
Cobas 8000 e801 and e602. The slopes ranged be-
tween 0.888 and 1.066, intercepts between -37.37
and 16.32, and correlation coefficients (r) between
0.984 and 1.000 (Table 3&Figure 1). The correla-
tion coefficients for all 16 analytes were >0.975,
suggesting that the two instruments produced com-
parably acceptable results.
Reference Range Validation. In the validation
study, we determined that one measured result for
T and two results for THS and vitamin D were be-
yond the reference ranges. However, as less than
10% of the values were outside the reference ranges,
the data were deemed acceptable (Table 4).
Discussion
Routine immunoassays are routine procedures in
any clinical laboratory. Therefore, the utility of a
routine clinical immunoassay analyzer should be
carefully determined by evaluating its performance.
In this study, we used CLSI guidelines to assess the
378 Annals of Clinical & Laboratory Science, vol. 49, no. 3, 2019
performances of the Cobas 8000 analyzer series
module e801. We determined it to be a stable ana-
lytical system for routine laboratory work based on
the results of precision, linearity, comparison, and
reference range validation.
The CV values for repeatability and within-labora-
tory precision were <5%, excluding low-level vita-
min D. For vitamin D, the repeatability and with-
in-laboratory precision values were 6.3% and 6.9%
for QC material at lower concentrations of 11.20
ng/mL. According to the Westgard recommenda-
tions [8], the allowable total error for vitamin D
measurement is traditionally set for analytical per-
formance and can be traditionally calculated using
a total error of 25%. Moreover, in a previous study
of the repeatability and within-laboratory precision
values for vitamin D, the Cobas 8000 e602 assay
produced repeatability and precision CVs of 3.9%
and 6.0% for low concentrations of 21.1 ng/mL
[5], and the DiaSorin LIAISON assay showed a
within-run precision range of 2.9% to 5.5% and a
between-run precision range of 6.3% to 12.9% for
the vitamin D assay [14]. Both studies evaluated
the quality of the data using CVs and concluded
that the systems provided acceptable precision for
vitamin D measurement. Likewise, we demonstrat-
ed that repeatability and within-laboratory preci-
sion for vitamin D measurements were within ac-
ceptable limits.
For linearity evaluation, we performed data pro-
cessing using linear regression analysis to determine
whether the regression equation best fit a model of
a straight line or a nonlinear curve in the form of a
second or third-degree polynomial, according to
CLSI guideline EP6-A [10]. The goal of maintain-
ing linearity is a fundamental characteristic of good
analytic measurement methods and should follow
the first-degree model, which produces a straight-
line graph. However, in actual diagnostic tests, if
the deviation of the data set due to linearity is not
clinically important, such clinical results are con-
sidered acceptable according to clinically relevant
criteria for assessing linearity [11,15,16]. In this
study, the extremely low levels of eight analytes
seemed to represent second- or third-degree poly-
nomial results in formal statistical tests. Therefore,
we further evaluated clinical relevance for data sets
with nonlinear results. We found that most of the
deviation from linearity was not clinically relevant
and that the overall linearity was acceptable for sec-
ond- or third-degree polynomial analytes.
In this study, we determined that the Cobas 8000
e801 and e602 produced comparable data
(r>0.975) for all tested analytes. The reference
range validation for all analytes was also acceptable,
with equal or less than 10% of the values falling
outside of the proposed reference range. The man-
ufacturer notes that the reference ranges for E2 and
FSH vary throughout the menstruation cycle and
with age. However, we were not able to consider
the menstruation cycle when performing reference
range validation for E2 and FSH.
Many automated immunoassays incorporating bi-
otinylated antibodies and streptavidin-coated mag-
netic beads are widely used for routine clinical lab-
oratory tests because this approach offers amplified
signals and relatively high sensitivity [17]. These
assays, however, may be vulnerable to interference
from high biotin concentrations within the sample,
because excess biotin competes with biotinylated
antibody. This competition may yield erroneously
low results in sandwich immunoassays and errone-
ously high results in competitive immunoassays
[18,19]. The biotin tolerance of any given assay is
ultimately a function of assay design and the par-
ticular assay microenvironment. The problem of
unwanted and unexpected interference has yet to
be overcome, so laboratory and clinical staff remain
the best strategy to avoid clinical mismanagement
due to unsuspected interference. For clinical use of
Cobas 8000 e801 including patients taking more
than 5 mg/day of biotin supplement, we recom-
mend waiting for 8 hours after supplementation
before blood collection [20]. American Thyroid
Association Guidelines recommend that patients
do not take biotin for at least 2 days before thyroid
function tests [21].
In conclusion, the Cobas 8000 e801 analyzer
showed excellent performance in terms of preci-
sion, linearity, comparisons, and reference range
validation for 16 analytes tested according to the
CLSI guidelines. Therefore, we conclude that the
e801 is a reliable component of the Cobas 8000
modular analyzer series for use in clinical laborato-
ries, although education and awareness about bio-
tin interference is necessary for successful imple-
mentation in clinical practice.

Acknowledgements
This work was supported by the National Research
Foundation of Korea(NRF) grant funded by the Korea
government(MSIT) (No. 2017R1D1A1B03036425).
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