Quick Details
- Processing Time:5
- Port:Hongkong
- Supply Ability: 200000 Pieces Per Day
- Brand Name:AIVD / OEM
Product Name
Glycosylated Hemoglobin(HbA1c)Test Kit (Immunofluorescence Chromatography)
Purpose
To detect the content of HbA1c in human whole blood in vitro quantitatively.For Professional Use
only.
Principles of Detection
The HbA1c Test is a fluorescent lateral flow immunoassay. The test consists of: 1) a conjugate
pad containing HbA1c antibody conjugated with fluorescent microspheres and
a control antibody (goat anti-chicken IgY antibody) conjugated with fluorescence microspheres, 2) a nitrocellulose membrane strip containing a test line (T line) and a control line (C line). The T line is pre-coated with another HbA1c
antibody, and the C line is pre-coated with a control line antibody (chicken
IgY antibody).
HbA1c concentration in specimen is positively correlated with the fluorescent density of the microspheres,
after the measure and calculation of the quantitative fluorescence immunoassay analyzer,
then the analyzer would calculate the concentration of HbA1c according to the preset calibration curve in the machine and display the result, detection unit is %units. C line should appear
in any cases, which indicates the reaction system is effective.
Storage conditions and shelf life
Store in a sealed aluminum foil bag at 2~30°C. After unpacking the aluminum foil bag under
temperature 20~30 ºC , humidity 35~65%, please use it immediately.
Shelf life 18 months.
Applicable instrument
Avid fluorescent immunoanalyzer model: AI-IF 600
Manufacturer& After-Sales Company: Shenzhen Aivd Biotechnology Co., LTD.
Address:C501,Building B5,China Merchants Guangming Science Park, #3009 Guanguang Road, Guangming
District, Shenzhen,Guangdong Province, China
Specimen collection and preparation
1. Human whole blood samples can be used for this test.
2. Specimen collection:Collect blood specimen into a collection tube containing EDTA , evenly
mixed before use. Do not use hemolyzed blood for testing.
Whole blood specimens should be stored at 2-8°C for no more than 4 hours if not test
immediately.
3. Do not test patients' samples with severe hemolysis, lipemia and jaundice, all specimens should be
treated as infectant.
4. Restore the specimen to 20-30°C before the detection, cryopreserved specimen should be completely
thawed, rewarmed and evenly mixed before use.
Test procedure
Read the complete instruction before the test
1. Bring the specimen and test
components to room temperature (recommended temperature is about 20-30 ºC ) to
test. Open the aluminum foil bag containing the test kit after it get back to the
room temperature. Keep the test kit in a dry place to prevent spoilage from dampness. Before unpacking, check whether the aluminum foil bag is in good condition. Do not use it if it is damaged. The test card should be used within 1 hour after
unpack.
2. Open the instrument as its instruction and Insect the ID card to get the curve.
3. Collect 10μl of sample(whole blood), add to the
sample diluent (mix thoroughly for 30 sec with vortex mixer) collect 80μl of a sample mixture and load
it into the sample vertically and slowly.
4. Leave the sample-loaded cartridge at room temperature (recommended temperature is about 20-30ºC) for
15 minutes. After time is over, immediately insert it into the cartridge holder of
the instrument, press "Test" button and read the results.
5. Treat the tested card as potential biological hazard
6. Quality Control:
1) As an effectiveness indicator, C line should appear in any cases.
2) Aivd's internal control materials or other approved applicable control materials can be used to
control the quality of the product, the test results should be within the specified
quality control range.
Note: Perform the test under the condition of temperature 20~30ºC, humidity 35~65%.
Reference range
Positive: reading value ≥6%, a positive result.
Negative: reading value <6%, a negative result.
Reading value 4%-6%, normal blood glucose.
Reading value 6%-8%, controllable blood glucose.
Reading value > 8%, poorly controlled blood glucose.
The reference value is verified with reference to similar products that have been marketed. Due to
ethnic and geographical differences, each laboratory can establish its own
reference interval according to the actual situation.
Explanation of the result
1. If the sample is cloudy, it will affect the flow rate of the sample, resulting in prolonged or
undetectable test time, which may lead to incorrect test results, please
centrifuge and discard the precipitate before use.
2. The accuracy of the spiked volume will directly affect the accuracy of the test
results.
3. Please check the integrity and expiration date of the kit package before use, then open the
package, and when stored at low temperature, it should be restored to 20~30ºC before opening the package for use. Direct use at low temperature will affect the test results.
4. Whether the patient has inflammatory bacterial infection should be judged by the physician in combination with clinical features and symptoms,
as well as other diagnostic methods of the patient.
Limit of the Test Method
1. The test results can only be used as an aid to physicians or other diagnoses, and need to be
combined with other clinical and laboratory data; if the test results do not
match the clinical assessment, further examination is required.
2. Bilirubin ≤0.5mg/mL, triglycerides ≤10mg/mL, hemoglobin ≤5mg/mL, within ±10% deviation to the
test results.
3. The HOOK effect will not occur when the HbA1c concentration content in the sample is
≤20%.
4. If the sample test result shows more than 14%, it is recommended to dilute the sample with
saline (the maximum dilution should not exceed 1:5), and the concentration value
of the test obtained after its dilution, then multiply the dilution times to calculate the sample concentration value.
Performance Characteristics
1. Linear range
In the range of 4%-14%, the r value should be ≥ 0.990.
2. Accuracy
Detected with the enterprise internal control accuracy reference (C1, C2), the test results should
be within the following ranges.
(1) Detection with the enterprise internal control accuracy reference C1, the instrument
measurement range is 6.4% ±15% at 15 minutes.
(2) Detection with the enterprise internal control accuracy reference C2, the instrument
measurement range is 8.4% ±15% at 15 minutes..
3. Intra-batch precision
Using the enterprise internal control precision reference (C9, C10) each parallel test 10 times, at
15 minutes instrumentation, the concentration value coefficient of variation
CV≤15%.
4.Inter-batch precision
For three batches of reagent kits, 10 times of parallel testing with each enterprise internal
control precision reference (C9, C10), and the instrument measurement at 15
minutes, the concentration coefficient of variation CV≤15%.
5.Detection limit
Detection with the enterprise internal control of the detection limit reference L1, instrumentation
at 15 minutes, the results should be ≤4%.
6.Specificity
Detection with the enterprise internal control specificity reference (C3, C4, C5), the instrument
measurement value at 15 minutes should be less than 6%.
Notes
1. This kit is only for in vitro diagnosis, one-time use, please do not reuse.
2. Kits should be treated as containing infectious material.
3. Please check the integrity of the kit packaging and expiration date before
use.
4. Please read the instructions for use of this reagent and instrument in detail before all
operations.
5. Please operate in strict accordance with the requirements of the instructions. After the test
starts, it cannot be stopped halfway. If it is stopped halfway, the test cannot
be resumed. If you need to retest, you must update the reagents and retest.
6. Each batch of reagents has corresponding parameters in the supporting instrument, and the
manufacturer updates the parameters in the instrument regularly. If the new
batch of reagents is not recognized by the instrument, please contact the manufacturer to update the parameters in time.
7. The test card should not be used for more than 1 hour after opening.
8. Reagents with different batch numbers cannot be mixed, and ID cards and test cards cannot be
used with different batch numbers.
9. Excessive experimental temperature should be avoided, and the test card stored at low
temperature needs to be restored to room temperature before opening to avoid
moisture absorption.