REAGENT PREPARATION AND STABILITY: PERFORMANCE CHARACTERISTICS:

ALBUMIN Reagent 1 is ready for use. Performance results can vary with the instrument used. Data obtained in each individual laboratory may differ
from these values.
Perfect Plus® Liquid Reagent Before use, mix reagent by gently inverting each bottle.
If stored and handled properly, unopened component is stable until expiry date stated on the label.
Linearity:
Stability On Board the Instrument: up to 28 days. This assay is linear up to 60 g/l (6.0 g/dl).
KIT SPECIFICATIONS: For samples with a higher concentration:

Reassay using, when available, “Rerun” function. Refer relevant user’s manual for instructions.
TYPE OF SPECIMEN:
Cat. No. Quantity Reagent Storage
Or, dilute 1:1 with 0.9% NaCl (9g/l) and re-assay. Multiply result obtained by 2.

GLM307 6 x 50 ml ALB Use serum as specimen as albumin measurements can be affected in the presence of fibrinogen.
15-25°C Interfering substances:
GLM317 5 x 30 ml ALB It is recommended to follow CLSI procedures (or similar standardised conditions) regarding specimen Results of study are as follows:
handling. Specimen should be collected in an appropriate sample container, with proper specimen
identification. Serum should be separated from cells within 1 hour after collection. 7 Bilirubin (mixed isomers): Less than 10% interference up to 600 µmol/l Bilirubin.
INTENDED USE: Haemolysis: Less than 10% interference up to 2.5 g/l Haemoglobin.
Stability: up to 3 days at 4°C. Lipemia: Less than 10% interference up to 5 g/l Intralipid.
®
In Vitro Diagnostic reagent pack for the quantitative determination of Albumin in serum on Perfect Plus
automated analysers. Sensitivity:
TEST PROCEDURE: The Lowest Detectable Level was estimated at 0.56 g/l.
SUMMARY AND EXPLANATION: 1
Materials required but not supplied: Precision:
Albumin accounts for more than half the plasma protein mass in normal patients. It has no carbohydrate side Within Run Between Run
Description Catalog. No. Description Catalog. No. Mean (g/l) SD % CV Mean (g/l) SD % CV
chains but it is highly soluble in water, due to its negative charge at physiological pH. It maintains oncotic N = 20 N = 20
pressure and is involved in the transport and storage of a wide variety of ligands. Increased levels of albumin General Chemistry Calibrator GL983 Perfect Plus ® Analyser N/A Level 1 25.9 0.42 1.61 Level 1 25.7 0.70 2.73
are of little diagnostics value except in the case of dehydration. Decreased levels are found in a wide range of General Chemistry Control Level 1 GL922 Perfect Plus® Consumables N/A Level 2 45.2 0.62 1.37 Level 2 45.0 1.19 2.64
illnesses including inflammation, hepatic disease, urinary loss and gastrointestinal loss. General Chemistry Control Level 2 GL932 General Laboratory Equipment N/A
Method Comparison:
Assay procedure: Using 50 samples, a comparison, between this Albumin test (y) and another commercially available test (x),
PRINCIPLE OF THE TEST: 3 Refer to relevant user’s manual for instructions on instrument start-up, loading components and samples, gave the following results:
calibration, sample testing procedures, calculating and reporting results.
The measurement of serum albumin is based on its quantitative binding to the indicator 3,3’,5,5’-tetrabromo-
m,cresol sulphonphthalein (bromocresol green). The albumin-BCG-complex formed absorbs maximally at y = 1.006x + 1.420 r = 0.989 Sample range: 19.9 to 56.0 g/l
Calibration:
578nm and its quantity is directly proportional to the albumin concentration in the sample. Using recommended Calibrator, calibrate the assay:

When using a new reagent kit or changing lot number. BIBLIOGRAPHY:
pH4.1
Following preventive maintenance or replacement of a critical part.
Albumin + BCG → albumin BCG complex 1. Burtis CA., Ashwood ER. Tietz Fund. Of Clin. Chem. 5th ed.; 30-54 and 350.

When Quality Controls are out of range.
2. Pa: WB Saunders. Tietz NW ed. Clinical Guide to Laboratory Tests. 3rd ed. Philadelphia, 1995; 22-24.
3. Grant GH and Kachmar JF. Fundamentals of Clinical Chemistry. Tietz, NW ed. WB Saunders Co. Philadelphia.1976.
WARNINGS AND PRECAUTIONS: Quality Control:
All clinical laboratories should establish an Internal Quality Control program. Verify instrument and reagent
performance with recommended controls or similar. The values obtained for QC should fall within
SYMBOLS:
For In Vitro Diagnostics Use Only - For Professional Use Only
Carefully read instructions for use. Deviations from this procedure may alter performance of the assay. manufacturer’s acceptable ranges or should be established according to the Laboratory’s QC program. The following symbols are used in the labelling of Glenbio systems:
Controls should be assayed:
Components Colour and Appearance:
Prior to reporting patient results. IVD REF
Reagent 1: Clear Dark Green liquid.
Following any maintenance procedure. In Vitro Diagnostics Catalogue No
Any significant changes could indicate that the assay might be compromised. Refer to Laboratory’s QC
At intervals established by the laboratory’s QC programme. LOT CONT
Batch Code Content
program for actions to be taken. In case of serious damage to the bottle and/or cap, resulting in product
leakage and/or contamination, do not use the reagent pack and contact your distributor CALCULATION: REAG Reagent Ab Antibody

Safety precautions: The analyser automatically calculates the Albumin concentration in the sample. CAL Calibrator SUBS Substrate
This product is not hazardous under EU specifications. Contains Sodium Azide. Material Safety Data Sheet is (Conversion Factor: Qty in g/l = 10 x Qty in g/dl).
available upon request. BUF
Buffer CE Mark - Device comply with the Directives 98/79/EC
Handling precautions: EXPECTED VALUES: 2

Take the necessary precautions required for handling all laboratory reagents. Storage temperature → Reconstitute with

Do not use components past the expiry date stated on the Bottles. g/l g/dl

Do not Freeze Reagents. Adults 34 - 48 3.4 – 4.8 Expiry Date Manufactured By

Do not use components for any purpose other than described in the “Intended Use” section. (Last day of the month)
Newborn 0 – 4 days 28 - 44 2.8 – 4.4

Do not interchange caps among components as contamination may occur and compromise test results.
Children 4 days – 14 years 38 - 54 3.8 – 5.4

Refer to local legal requirements for safe waste disposal. Biological risk Consult Instruction for Use
14 – 18 years 32 - 45 3.2 – 4.5
INSTRUMENTS: Each laboratory should establish its own reference range. Albumin results should always be reviewed with the
patient’s medical examination and history.
This assay is designed to run on Perfect Plus clinical chemistry analysers. Refer to relevant user’s manual or Manufactured By: GLENBIO LTD.
Laboratory internal practice for routine maintenance procedures. All information is encoded in the barcode. If 10 Kilbegs Road, Antrim, Co. Antrim, BT41 4NN, UK
analyser fails to read or if the barcode is damaged, enter the series of numbers beneath the barcode. Tel/Fax: +44(0) 28796 59842
Email: info@glenbio.com
Website: www.glenbio.com
COMPONENT COMPOSITION:

Component Ingredients Concentration in Tests

Reagent 1 Succinic acid Buffer pH 4.0 75 mmol/l
Bromocresol Green 0.17 mmol/l
PRESERVATIVES & SURFACTANTS ---

Page 1 of 2 Revision: 01 Issued: 26 August 2019

Albumin Perfect Plus/Mindray® Instruments Settings
Catalogue No(s):GLM307, GLM317

Test Information Reagent Volume Sample Volume

No. R1 150 Standard 2 40 4
Test ALB R2 Increased 3 40 4
Full Name Albumin R3 Decreased 2 40 4
Std.No R4
Reaction Parameters Result Setup
Reac.Type Endpoint Direction Increase Decimal 0.01 Slope 1
Pri .Wave 605 Rgt. Blank 10 12 Unit g/dl Inter 0
Sec.Wave Reac. Time 44 46
Judgement Criteria Prozone Rate Antigen
Absorbance 0 0 Lin Range 0 10
Incre. Test 0 Lin Limit Q1 0 Q2 0 Q3 0 Q4 0
Decre Test 0 Subs Limit PC 0 ABS 0

Page 2 of 2 Revision: 01 Issued: 26 August 2019