HbA1c Reagent Kits (HPLC)

Shenzhen Lifotronic Technology Co., Ltd.

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In vitro diagnostic medical device

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【Product Name】
HbA1c Reagent Kits (HPLC)
【Packing Specification】
200T/box, 400T/box, 800T/box.
【Intend Use】
Applicable to quantitative examination the content of HbA1c in the whole blood of human body with Lifotronic H
series hemoglobin analyzer. It adopts High Performance Liquid Chromatography (HPLC) method to measure the
level of HbA1ab, HbA1c and HbA0. And the Analyzer calculates the rest items.
Synthesis process of HbA1c is slow and irreversible. And it accumulates in the 120 days lifetime of erythrocytes.
The synthesis rate is proportional to the concentration of blood glucose and its structure is stable. Therefore, the
level of HbA1c reflects the average level of blood glucose in the past 2-3 months. It’s a reliable marker to indicate
the control of blood glucose levels.
【Principle】
Ion Exchange Chromatography: When passing through cation-exchange column, the hemoglobin will be absorbed
by resin which was balanced by acidic buffer. Since the charges of different glycosylated hemoglobin and
un-glycosylated hemoglobin, absorbing forces will be different. The less cation of glycosylated hemoglobin means
the less absorbing force. On the contrary, the cation level of un-glycosylated hemoglobin is high. Elute those
glycosylated hemoglobin with different buffer solutions in sequence, as HbA1a, HbA1b, HbA1c. The strongest
absorbing force of HbA0 will be eluted in the end. Therefore, the content of HbA1c in whole blood could be
calculated in this method.
【Components】
Item Main Volume for Volume for Volume for
Ingredients 200T/box 400T/box 800T/box
Eluent A Phosphate
800mL 950mL 1000mL
buffer
Eluent B Phosphate
800mL 950mL 1000mL
buffer
Eluent C Phosphate
700mL 800mL 900mL
buffer
Hemolytic Deionized
5000mL 5000mL 5000mL
Agent L Water

Remark: Do not mix use the components of regent kits of different batch codes.
Components Required But Not Provided
level 1 0.1ml
HbA1c Calibrator
level 2 0.1ml

level 1 0.1ml
HbA1c Control Material
level 2 0.1ml

Column / 1500tests

filter / 400tests
 Please order these Components from lifotronic or our representative.
【Storage and Shelf Life】
Stored the reagent kits at 10~30°C.
Shelf life is 18 months, and open-vial shelf life is 3 months.
Use the reagent kit before valid date marked on the box.
【Application】
Lifotronic H Series Hemoglobin Analyzer
【Sample collection , handling and storage】
1．Requires fasting blood, and use EDTA-K2 for anticoagulation.
2．Recommends fresh sample blood.
3．If the sample needs to store, refrigerate it at 2 ~ 8°C for 7 days without direct illumination.
【Operation Step】
1. Place samples on sample loader.
2. Once complete assay, the content of HbA1c will present on the screen and print out result
【Reference Range】
Normal reference range: 4.0%-6.1%.
The reference value is measured a number of cases in the normal content of HbA1c in whole blood samples, based
on the mean value X +3 SD to be the upper limit. Recommends that each laboratory establish its own reference
ranges according to the tested groups of patients.
【Explanation of Test Results】
If the result of certain sample exceeds the maximum measurement range, the system will prompt further dilution of
sample for re-test. Then multiply by the appropriate dilution factor.
1. Please follow below instructions to obtain acceptable accurate results.
a) For each test, the total area of all peaks range should be between 5 to 20, otherwise, the test result was
affected;
b) QC value should be within normal range;
c) Reportable value range: The reagent kit’s linerity range is 3%-18%, once the test result extend this range,
Lifotroinc H series hemoglobin analyzer will mark it with (*), and not to report.
2. Glycated hemoglobin concentration is in NGSP units (%) and IFCC unit (mmol/mol) two concentration unit,
conversion formula for the 2 units are: IFCC=（NGSP-2.15）*10.929.
3. The level of HbA1c reflects the average level of blood glucose in the past 120 days, the test results are only for
aided diagnosis, and it needs to be combined with clinical presentation, medical history and other diagnostic results
before taking appropriate clinical management.
【Limitation of Measurement Method】
1. The test results are only for aided diagnosis, and it needs to be combined with clinical presentation, medical
history and other diagnostic results before taking appropriate clinical management.
2. This product can only be used for measuring EDTA-K2 anticoagulated whole blood sample, and can not be used
for other body fluid samples.
3. To avoid interference, it’s suggested to pretreat high blood lipids sample before testing. Obviously contaminated
sample can lead to erroneous results, so it’s required to avoid using that type of sample.
4. Dilution Ration Effect.
Lifotronic H series hemoglobin analyer will automatically dilute the sample according to preset dilution ration. For
each acceptable test, the total area of all peaks range should be between 5 to 20. otherwise, the test result was
affected; Please manually dilute the sample according to instrument user manual and test it again.
5. Abnormal Red Blood Cell Survival Time.
Hemolytic anemia patient sample has shorter red blood cell life than normal patient’s, thus, the HbA1c test result
will be lower according to hemolysis degree. Sick cell disease patient and patient after splenectomy sample results
will be higher since their red blood cell life are longer than normal patient’s.
【Performance Indicators】
1. Sensitivity：Limit of detection ＜3%
2. Measurement Range：3%～18%
3. Accuracy: Test a known concentration calibrator, the measured concentration and the concentration of the
calibrator relative deviation (Bias%)should be in the range of ± 8%.
4. Intra-assay precision：CV≤3%
5. Inter-assay precision：CV≤3%

【Precautions】
1. Only for IVD.
2. Please strictly follow the instructions in use manual.
3. All the used blood raw materials have been inactivated at 60 ℃ during the preparation process, and has been
proven negative by CFDA for HBsAg, anti-HCV, anti-HIV, anti-TP tests.But there is no test method to be
absolute safe. All the samples that are taken from human blood, samples and kits, should be regard as potentially
infectious source.
4. Wear personal protective equipment when operate the sample and reagents.
5. The reagents use NaN3 in very low concentrations as the preservatives. In case of skin and eye contact,
immediately cleanse the affected skin areas with soap under running water. Remove contaminated clothing and
shoes.
【Literature References】
[1] Hoelzel W,Weykamp C,Jeppsson JO, et al.IFCC reference system for measurement of hemoglobin A1c in
human blood and the national standardization schemes in the United States,Japan,and Sweden:a
method-comparison study[J].Clin Chem, 2004,50(1):166-174.
[2] Tu Guohua, Jiang Xunjin etc. The build and evaluation of HPLC in HbA1c test[J].Journal of Jiangsu
University(MEDICINE),2011,21(2):147-150.
【Version and Modification Date】
Version: A7
Modification Date: 2018-12-29