Instructions for Use of Albumin (ALB) Kit (Bromocresol Green System Information

Hitachi 7180, Zybio EXC400/420, Zybio EXC200/220 Chemistry Analyzer. Other

Method)
models can be used after verification.

Package Specification
Specimen Information
REF Reagent Systems
Non-hemolytic serum is suitable for samples, which are stable at 2 - 8 ℃ for 14
01.09.00.04.EC.01 R 30 mL × 6 Zybio EXC200/220
days.
Hitachi 7180
01.09.00.04.EC.03 R 60 mL × 2
Zybio EXC400/420 Warnings and Precautions
1. For in vitro diagnostic use only. In case of contact, immediately flush the affected
Intended Use area with plenty of water.
In vitro test for the quantitative determination of albumin (ALB) concentration in 2. The dosage of reagents and samples can be appropriately increased or
human samples (serum). Clinically, it is mainly used as an aid to evaluation of liver decreased according to various instruments, under the condition that the volume
function as well as nutritional assessment. proportion of reagents and samples is invariable.
3. The necessary precautions should be taken to use the reagents. The bottle cap
Summary should be tightened immediately after use to avoid contamination.
Albumin is a carbohydrate-free protein, which constitutes 55 - 65% of total plasma 4. When reagent becomes turbid or the blank absorbance > 0.500, the reagent is
protein. It maintains plasma oncotic pressure, and is also involved in the transport failed and should be discarded.
and storage of a wide variety of ligands and is a source of endogenous amino acids. 5. All samples and reaction wastes should be treated as sources of infection. The
Albumin binds and solubilizes various compounds, e g. bilirubin, calcium and long- waste liquid generated during the experiment and the used packaging materials
chain fatty acids. Furthermore, albumin is capable of binding toxic heavy metal ions shall be collected and disposed in accordance with relevant regulations.
as well as numerous pharmaceuticals, which is the reason why lower albumin 6. The same sample tested with reagents from different manufacturers may lead to
concentrations in blood have a significant effect on pharmacokinetics. different measured values.
Hyperalbuminemia is of little diagnostic significance except in the case of 7. Warning: This product contains ingredients of human or animal origin. At present,
dehydration. Hypoalbuminemia occurs during many illnesses and is caused by there is no way to completely guarantee that it is free from infectious substances
several factors: compromised synthesis due either to liver disease or as a and may be contaminated during use. This product and samples shall be considered
consequence of reduced protein uptake; elevated catabolism due to tissue damage as potential sources of infection, and operators should take protective measures
(severe burns) or inflammation; malabsorption of amino acids (Crohn’s disease); and comply with laboratory safety regulations. All waste shall be disposed of in
proteinuria as a consequence of nephrotic syndrome; protein loss via the stool accordance with local regulations.
(neoplastic disease). In severe cases of hypoalbuminemia, the maximum albumin
concentration of plasma is 2.5 g/dL (380 µmol/L). Due to the low osmotic pressure Test Process
of the plasma, water permeates through blood capillaries into tissue (edema). The 1. Parameters
determination of albumin allows monitoring of a controlled patient dietary End-Point
Method Sample/Reagent 1/100
supplementation and serves also as an excellent test of liver function. Method
Main Wavelength 630 nm Reaction Temperature 37 ℃
Principle
Sub Wavelength 700 nm Reaction Time 2 min
Albumin in serum binds to bromocresol green to form a blue-green complex at pH
Reaction Direction +
4.2, which has an absorption peak at the wavelength of 630 nm, and the change in
2. Operation
color intensity is directly proportional to the albumin concentration. The albumin
Addition Blank Calibration Detection
concentration in the serum can be obtained by comparing with that in calibrator
Sample (μL) / / 3
treated in the same manner.
Calibrator (μL) / 3 /
Purified Water (μL) 3 / /
Reagents Components and Concentration
Reagent (μL) 300 300 300
Components Main Constituents Concentration
Mix well, measure absorbance A after 2 min.
Bromocresol Green 0.15 mmol/L
R 3. Calibration
Succinic Acid buffer 74.9 mmol/L
Use Zybio Clinical Chemistry Multi-analyte Calibrator or Randox multi-analyte
The components in different batches are non-interchangeable.
calibrator. Calibration cycle: Re-calibration is needed in case of replacement of the
reagent batch, deviation of quality control, or the major repair and maintenance of
Storage and Validity
equipment.
1. The reagents should be stored at 2 - 8 ℃ and kept away from direct light and
4. Quality Control
freezing. The unopened reagents are valid for 18 months.
To ensure the reliability of the test results, quality control is required after each
2. Once opened, the reagents are stable for 30 days at 2 - 8 ℃. For reagents not in
calibration, and the quality control value should be within the specified range. If it is
use, the cap should be tightened to avoid contamination.
out of the specified range, the user should check the measurement system and
3. The production date and expiration date are available on package insert.
recalibrate it if necessary. It is recommended that users conduct regular quality
Floor 1 to Floor 5, Building 30, No. 6 of Taikang Road, Block C of Jianqiao Industrial Park, Dadukou District, 400082 Chongqing, PEOPLE’S REPUBLIC OF CHINA
Tel: +86 (0)23 6865 5509 Fax: +86 (0)23 6869 9779 E-mail: [email protected] Web: www.zybio.com
control according to their own needs to ensure the accuracy of the measurement References
system and the reliability of the test results. [1] Guo J, Xie J, Zhao H. Design of method comparison study and bias estimation
5. Calculation for albumin assays[J]. Chin J Lab Med, 2000, 23:343-345.
Linear calibration was used to draw the working curve. The concentration of albumin
(ALB) in the sample can be calculated on the working curve based on its absorbance Symbol Interpretation
change value. In Vitro Diagnostic
Batch Code
Medical Device
Reference Intervals
Consult Instructions for
35.0~55.0 g/L Use-By Date
Use
This reference interval is determined based on 95% distribution interval obtained
from 200 healthy human specimens without related diseases, and is for reference Catalogue Number Manufacturer
only. It is recommended that each laboratory establish its own reference range.

Temperature Limit Date of Manufacture

Explanation of Results
If the concentration of ALB in the sample exceeds 60.00 g/L, the reduction mode of Authorized
CE marking of
the chemistry analyzer will be used, or the high concentration sample shall be diluted Representative in the
conformity
with normal saline, with its report result multiplied by the dilution factor. European Community

The professional is responsible for the review of the test result, which may be
affected by the subject's age, sex, or weight. The test values within the critical range Zybio Inc.
should be confirmed by remeasuring, if it is obviously beyond the reference value Floor 1 to Floor 5, Building 30, No. 6 of Taikang Road, Block C
range or if it is still beyond the reference range after confirmation detection, the of Jianqiao Industrial Park, Dadukou District, 400082 Chongqing,
target concentration in the sample is considered to be abnormal. If the test result is PEOPLE’S REPUBLIC OF CHINA.
inconsistent with or even contrary to the clinical situation, cause analysis should be Web: www.zybio.com
performed correspondingly. E-mail: [email protected]
Tel: +86 (0)23 6865 5509
Limitations Fax: +86 (0)23 6869 9779
1. The deviation of test results caused by interferents is less than 10% if the
concentrations of the following interferents are at or below the given values: Lotus NL B.V.

Substances Concentrations Koningin Julianaplein 10, 1e Verd, 2595AA, The Hague,

Vc 0.5 g/L Netherlands.

Chyle 0.30%
Bilirubin 342 µmol/L Current Version: 03 Date of Issue: September, 2023

2. The test results of this product are only for clinical reference and cannot be used
as the basis for diagnosis or exclusion of cases. The clinical diagnosis and treatment
of patients should be combined with their symptoms/signs, medical history, other
laboratory tests and treatment response. For achieve diagnostic purposes, the test
results should be combined with clinical tests, medical history and other test results.

Performance Characteristics
1. The reagent blank absorbance ≤ 0.500.
2. Analytical sensitivity: at the test concentration of 40.0 g/L, the reagent absorbance
change (ΔA) ≥ 0.50.
3. Accuracy: relative deviation ≤ 6.0%.
4. Precision: within-run CV ≤ 2.0%, between-run relative range ≤ 5.0%.
5. Linear Range:
[10.0, 60.0] g/L, the correlation coefficient (r) ≥ 0.990.
[10.0, 20.0] g/L, the absolute deviation ≤ 4.0 g/L;
(20.0, 60.0] g/L, the relative deviation ≤ 10%.

Materials Required (but not provided)

Chemistry analyzer, Zybio Clinical Chemistry Multi-analyte Calibrator or Randox
multi-analyte calibrator, Control, General lab equipment and consumable.

Floor 1 to Floor 5, Building 30, No. 6 of Taikang Road, Block C of Jianqiao Industrial Park, Dadukou District, 400082 Chongqing, PEOPLE’S REPUBLIC OF CHINA
Tel: +86 (0)23 6865 5509 Fax: +86 (0)23 6869 9779 E-mail: [email protected] Web: www.zybio.com