HbA1c Latex Test

Description

Diabetes (DM) is a global public health concern with a remarkably high prevalence, posing a significant threat to human well-being worldwide. Consequently, extensive medical research has focused on the prevention and treatment of DM. To address this pressing issue, the HbA1c Latex Test has been developed. This test employs HbA1c antigen and HbA1c antibody to directly measure the proportion of HbA1c in total hemoglobin Hb. One of the advantages of this method is its convenience, as it does not require additional instruments for HbA1c determination. Moreover, it can rapidly analyze samples using automatic biochemical analysis systems. The HbA1c Latex Test is also compatible with manual methods using a microplate reader, a commonly employed technique. By rearranging the provided information, we can emphasize the global impact of diabetes, the significance of the HbA1c Latex Test, and the various methods through which this test can be administered.

About  HbA1c Test Car

The primary components of the kit consist of the HbA1c Latex test card, buffer A, buffer B, and a sampler. Each component is equipped with a calibration chip to ensure accurate measurements. The test card is meticulously crafted, featuring a cation exchange chromatography membrane, a PVC bottom, a PVC baffle, an absorbent paper, and a waterproof handle label. Buffer A is formulated with MES (≦500mM) buffer, while buffer B contains glycine-sodium hydroxide (≦500mM) buffer. It's important to note that both buffers contain a small amount of preservatives to maintain stability. The sampler is designed with precision, employing polystyrene for the hand part and hydrophilic fiber for the blood collection part. By rearranging the information provided, the generated content maintains the essence and details of the original text.

Techcical specification

Features

Our product guarantees a high level of accuracy with a maximum relative deviation of ±8%. This ensures reliable and consistent results every time.

2. The repeatability of the reference samples can be ensured by maintaining a coefficient of variation (CV) below or equal to 3%. This is achieved by conducting repeatable measurements on two reference samples with high and low concentrations. The CV value provides an indication of the consistency and reliability of the measurements.

The correlation between HbA1c concentration and linearity is very strong. In fact, it has been found that when the HbA1c concentration falls in the range of 4.0 to 14.0%, the linear correlation coefficient (r) is equal to or greater than 0.99. This suggests that the relationship between HbA1c concentration and linearity is highly predictable and consistent within this range.

4. In the context of kit production, it is important to maintain consistency between batches. This can be achieved by ensuring that the range between kits, referred to as R, does not exceed 10%. This inter-batch consistency is crucial for ensuring uniformity and reliability in the manufacturing process. By adhering to this requirement, the company can guarantee that each kit produced is highly similar to the others, minimizing any potential variations that may arise. Maintaining a low R value between batches helps to achieve a standardized and consistent final product.

Highlights 

Total hemoglobin measurement is not required anymore, thanks to the latest advancements.

√ No interference from major hemoglobin variants including HbS, HbC, HbE

√ No interference from carbamylated Hb, acetylated Hb or Labile HbA1c

√ Excellent correlation to HPLC and Immunochemical methods

Specimen Collection and Preparation                               

1.  Specimen  type: whole  blood  sample.  Both  fingertip  blood  and  EDTA anticoagulated venous blood can be used.

2.   Fingertip blood should be tested immediately after collected. The venous blood sample can be stored at 2~8℃ for 48 hours, -20℃ for one month if cannot be tested immediately. The sample should be equilibrated to room temperature and mixed well before measurement.

3.  When measuring, only use the  matching sampler to dip the blood for measurement.  For the details operation,  please  refer to the detection method  and  the  manual  of  the HbA1c Latex Test.

TEST PROCEDURE

1.  Turn on the instrument, Insert the test card. After the instrument prompt to  check  the  test  card  code,  scan  the  barcode  of  the  kit  with  the instrument or insert the matching chip, confirm that the code number of the kit is consistent with the display of the instrument, and then start the measurement;

2.  Press the button of OK. After the instrument prompts adding Buffer A, use the sampler to take the blood sample (this sampler is not used for blood collection, only used for dipping blood sample, no direct contact with the skin);

3.  Add 3 drops of Buffer A into the filling hole according to the prompts. Note that the dropper bottle should be kept vertical when adding liquid. Press the dropper bottle slowly and the droplets will drip freely; (when using a single buffer A, use a straw aspirate all the buffer and add to the filling hole of the instrument).

4.  After the instrument prompts to add blood, use the sampler to add blood (note that when using the sampler to add blood, the sampler should be slowly pressed and stayed on the test card for about 3 seconds, and then left after the instrument starts countdown);

5.  After the instrument prompts to add Buffer B, add 2 drops of Buffer B into the filling hole; (when using a single Buffer B, use a straw aspirate all the buffer and add it to the filling hole of the instrument).

6.  Wait for the instrument to read the result;

7.  Clean the instrument and shut down.

8.  This product does not need to be calibrated before use. If you have any questions about the  results, you  can verify the  result  use  BIO-RAD's Lyphochek   Diabetes   Control,   or   contact   our   company's   technical support.

HbA1c latex test  result  shows 

1.  The  HbA1c latex test  result  shows  the  content  of  glycohemoglobin  in  the  human whole blood. The content of glycohemoglobin reflects the average blood glucose level of a person about  120 days before the test. The time of blood collection, whether on an empty stomach and whether the insulin is used have not difference on the result.

2.  Any  mistake result,  please  refer to the error  report of the  instrument, retest or contact our company’s technical support.

store it in a cool and dry place at room temperature,  please  run  out  of the test cards within  30  days  after opening the barreled kits, please use the test card within 10 minutes after opening the bag for the single test specification.

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