HbA1c Fast Test kit (Immunofluorescence Assay) PRECAUTIONS

1. For in vitro diagnostic use only.

For In Vitro Diagnostic Use
2. For professional use only.
Cat.# IF1017
3. Do not use the kit beyond the expiration date.
User Manual
4. Do not use the test card if the foil pouch is damaged.
INTENDED USE 5. Do not open pouches until ready to perform the test.
HbA1c fast test kit is intended for the quantitative measurement of HbA1c in 6. Do not reuse the test card.
whole blood. This test is used as an aid for monitoring glycemic control in 7. Do not reuse the pipet.
diabetics. In addition, it can identify people at risk of developing the disease 8. Handle all specimens as potentially infectious. Proper handling and
and ongoing monitoring. disposal methods should be followed in accordance with local regulations.
9. Carefully read and follow user manual to ensure proper test performance.
SUMMARY
SPECIMEN COLLECTION AND PREPARATION
Hemoglobin is the protein molecule in red blood cells with the main function
transport oxygen and carbon dioxide in blood. HbA1c belongs to the glycated 1. This test can be used for whole blood samples. Heparin, sodium citrate
hemoglobins, a fraction formed by the attachment of various sugars to the Hb and EDTA can be used as the anticoagulant under aseptic conditions.
molecule and is proportional to average blood glucose concentration over the 2. The test is for human blood, other specimens or bodily fluids may not get
previous four weeks to three months. One advantage of using HbA1c for accurate results.
diagnosis is that the test does not require a fasting blood sample. Although 3. The test should be performed within 4 hours after whole blood collection.
HbA1c testing is mainly used for monitoring blood sugar control in patients 4. Samples could be kept for 7days at 2~8℃ and avoid cryopreservation.
with diabetes, the World Health Organization (WHO) now recommends that 5. Samples must be recovered to room temperature before testing.
HbA1c can be used as a diagnostic test for diabetes, provided that stringent 6. SAMPLE VOLUME: 10 μl
quality assurance tests are in place and assays are standardised to criteria TEST PROCEDURE
aligned to the international reference values.
1. Collect specimens according to user manual.
PRINCIPLE 2. Test card, sample should be brought to room temperature before testing.
The test uses an anti-human Hb monoclonal antibody conjugated with 3. Confirm SD card lot No. in accordance with test kit lot No.. Perform “QC
fluorescence latex and an anti-human HbA1c monoclonal antibody coated on (SD)” calibration when necessary (Details refer to 8.5.2 of Getein1100
the test line. After the sample has been applied to the test strip, the User Manual).
fluorescence latex-labelled anti-human Hb monoclonal antibody binds with 4. On the main interface of Getein1100, press "ENT" button to enter testing
the HbA1c and Hb in sample proportionally and forms marked interface.
antigen-antibody complex. The complex moves to the detection zone by 5. Remove the test card from the sealed pouch immediately before use.
capillary action. Then marked antigen-antibody complex is captured on the Label the test card with patient or control identification.
test line by the anti-human HbA1c monoclonal antibody. The fluorescence 6. Put the test card on a clean table, horizontally placed.
intensity of the test line increases in proportion to the amount of HbA1c in 7. Using sample transfer pipette, deliver 10 μl of sample into one tube of
sample. sample diluent, mix gently and thoroughly. Then drop 100 μl of sample
Then insert test card into the Getein1100 Immunofluorescence Analyzer mixture (or 3~4 drops of sample mixture when using disposable pipet) into
(hereafter referred to as Getein1100), the concentration of HbA1c is the sample port on the test card.
measured and displayed on the screen. The HbA1c concentration is stored in 8. Reaction time: 5 minutes. Insert the test card into Getein1100 and press
the Getein1100 and is available on demand. The result can be easily "ENT" button after reaction time is elapsed. The result will be shown on
transmitted to the lab or hospital information system, if it is connected to the screen and printed automatically.
Getein1100. Notes:
CONTENTS 1. It is required to perform “SD Card Calib” calibration when using a new
A kit contains: batch of kits.
2. It is suggested to calibrate once for one batch of kits.
1. Getein HbA1c test card in a sealed pouch with desiccant ················25
3. Make sure the test card insertion is correct and complete.
2. Disposable pipet·······································································25
3. User manual ··········································································1 TEST RESULTS
4. SD card ·················································································1 Getein1100 can scan the test card automatically and display the result on the
5. Sample diluent ·········································································25 screen. Please follow the procedure in user manual of Getein1100 for result
A test card consists of: printing.
A plastic shell and a reagent strip which is composed of a sample pad, For additional information, please refer to the user manual of Getein1100.
nitrocellulose membrane (one end of the membrane is coated with a
EXPECTED RANGE OF VALUE
fluorescence latex-labelled anti-human Hb monoclonal antibody, the test line
is coated with an anti-human HbA1c monoclonal antibody-, and the control HbA1c concentration is determined using samples obtained from 345
line is coated with rabbit anti-mouse IgG antibody), absorbent paper and liner. apparently healthy individuals. The normal value for HbA1c is 3.8%-5.8% .
Sample diluent: It is recommended that each laboratory establish its own expected values for
the population it serves.
Phosphate buffered saline, proteins, detergent, preservative, stabilizer.
PERFORMANCE CHARACTERISTICS
Note: Do not mix or interchange different batches of kits.
Measuring Range 2%-14%
APPLICABLE DEVICE
Lower Detection Limit ≤2%
Getein1100 Immunofluorescence Quantitative Analyzer Within-Run Precision (n=10) ≤5%
STORAGE AND STABILITY Between-Run Precision ≤8%
Accuracy: verify with comparison experiments, the correlation coefficient r
Store the test card at 4~30 ℃ with a valid period of 24 months.
≥0.990, the relative error ≤20%
Use the test within 1 hour once the foil pouch is opened.
Store the sample diluent at 0~30℃ with a valid period of 24 months. LIMITATIONS
Store the sample diluent at 2~8℃ for better results. 1. The result of the test should be evaluated in the context of all the clinical
and laboratory data available. In those instances where the laboratory results
do not agree with the clinical evaluation, additional tests should be performed DESCRIPTION OF SYMBOLS USED
accordingly. The following graphical symbols used in or found on HbA1c Fast Test Kit
2. Some substances in blood as listed below may interfere with the test and (Immunofluorescence Assay) are the most common ones appearing on
cause erroneous results. The maximum allowance concentration of them is medical devices and their packaging. They are explained in more details in
as follows: the European Standard EN 980: 2008 and International Standard ISO
Interferent Concentration (Max) 15223-1:2007.
Triglyceride 25g/L
Bilirubin 0.1g/L Key to symbols used
REFERENCES
1. Cagliero E, Levina E V, Nathan D M. Immediate feedback of HbA1c levels Manufacturer Expiration Date
improves glycemic control in type 1 and insulin-treated type 2 diabetic
patients[J]. Diabetes care, 1999, 22(11): 1785-1789.
2. Özdamar Ö, G ü n İ , Keskin U, et al. The role of maternal Do not reuse Date of manufacture
serumbeta-HbA1c and PAPP-A levels at gestational weeks 10 to 14 in the
prediction of pre-eclampsia[J]. 2014.
Consult instructions
Batch code
for use

Temperature In vitro diagnostic

limitation medical device

Authorized
Sufficient for representative in the
European Community

CE mark

Thank you for purchasing HbA1c Fast Test Kit (Immunofluorescence Assay).
Please read this user manual carefully before operating to ensure proper use.
Version: WIF-DLSM-20-01

GeTein BioMedical Inc.

4640 SW Macadam Avenue, Suite 130C;
Portland, OR 97239, USA
Tel: 1-971-407-3868
Fax: 1-971-407-3868
E-mail: [email protected]; [email protected]
Website: www.gp-diagnostics.com