Dry immunofluorescence quantitative analyzer | HbA1c test kit

【PRINCIPLES】

The HbA1c detection kit is made by the antigen－antibody reaction. The specimen is diffused forward due to capillarity, in which HbA1c binds to the antibody bound to the fluorescent granules. The composite is attached to a detection region with solidified antibody, and other fluorescent antibody particles attached to the quality control area. When the test kit inserted into the analyzer, the analyzer automatically scans the two ribbons and detects the fluorescence intensity emitted by the composite in the detection area and the quality control area, and calculates the content of the substance with the ratio of the two fluorescence values.

Dry immunofluorescence quantitative analyzer | HbA1c test kit

【MAIN INGREDIENTS】

1、HbA1c Test Strip

2、Other Ingredients: Instruction、SD Card、Diluent；

Note: Avoid affecting the test result, please do not use different batches of products.

【PRESERVATION AND STABILITY】

  The kit is preserved at 4℃—30℃, validity period is 12 months.

【SPECIMEN DEMANDS】

The sample can use the whole blood, but the test should be made within 1 hour after the blood collection.

1.Whole Blood statically settled and precipitated.

2.Add 10ul of precipitated sample, slightly blown and hit for 20 times, fully mixed.

【TESTING STEPS】

1.Turn on the analyzer.

2.Read SD card.

3.Dispense 90ul of dilute whole blood sample at test strip.

4.Insert the strip into the analyzer after 5 minutes.

5.Analyze and detect, and then display test results.

6.Pull out the strip.

Dry immunofluorescence quantitative analyzer | HbA1c test kit

【REFERENCE INTERVAL】

4%-6%: blood glucose control

6%-8%: blood glucose control up to standard

＞8%: suggest to intensify blood glucose control

  Note: It is suggested that each laboratory establish its own reference interval.

 Reference Basis: With a sample book of 200 healthy people, the reference interval is determined by statistics.

【TEST RESULT EXPLANATION】

The incidence of diabetes in the world is very high, accounting for the ratio of immune diseases, which is as high as 2-5% in developed countries. The incidence of diabetes in China is also 2-3%, and also grows at 1‰ per year. Recent medical research shows that glycated hemoglobin in the blood (glycosylatedhemoglubin, GHb) (HbA1c) concentration is relatively stable, which can accurately reflect the blood glucose level during the last 1-3 months, for the early diagnosis of diabetes mellitus; it also can be applied to monitoring of blood glucose and judgment of chronic complications for patients with diabetes, , which brings widely clinical importance.

【LIMITATIONS】

  This kit is only for the whole blood test.

  The test result of this kit is only one of the diagnostic aids for the clinicians.

【PERFORMANCE CHARACTERISTICS】

1．Blank Limit: The blank limit of the kit is not more than 4%.

2．Accuracy: The relative deviation within the range of ±10%.

3．Repeatability: CV%≤15%.

4．Linear Range: within 4%-14%, R≥0.990.

5．HOOK Test: No Hook effect in high concentration samples.

6．Inter batch difference: Difference between the three batch of kits is not more than 15%.

7．Stability: Te kit conforms to the above 1-5 indicators after expiry time is full.

【PRECUSTIONS】

1．For in vitro diagnostic use only.

2．Do not insert the wet strip with blood or other fluids into the analyzer.

3．Do not use the damaged strip or strip in damaged pack.

Do not mix the ingredients of different kits.

 

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