Vitamin B12 participates in the development of bone marrow red blood cells in the human body, promotes the growth of red blood cells in the human body, prevents malignant anemia, and can effectively reduce the adverse symptoms caused by anemia. Vitamin B12 can also exist in the form of auxiliary enzymes to increase the utilization of folic acid, promote the digestion and metabolism of carbohydrates, proteins and sugars, and effectively promote the metabolism in the human body.

2. Test principle:The reagent adopts the principle of competitive method. Take the sample to be tested, add it into the sample diluent and mix it evenly. Add the mixed sample into the sample adding hole. VB12 in the sample combines with the fluorescent labeled antibody on the binding pad to form a complex. Under the action of chromatography, the complex moves forward along the nitrocellulose membrane, and the fluorescent labeled antibody that does not bind to the test line is captured by VB12-BSA coated on the nitrocellulose membrane detection line. The more VB12 in the sample, the fewer complexes gathered on the detection line, and the signal of fluorescent antibody is inversely proportional to the number of objects to be tested in the sample. The quantitative detection results were obtained by NIR-1000 dry fluoroimmunoassay analyzer.

3. Package specification:25 Tests/kit

Ⅳ.Product Usage Procedure

1. Before the test, please read the instructions completely. If the test card and sample are stored in cold storage, they should be balanced at room temperature (15-30)℃ for not less than 30min before use.

2. Start NIR-1000 dry fluoroimmunoassay analyzer and correctly select the corresponding sample type on the instrument.

3. Take out the ID card, make sure that the batch number of the ID card is consistent with that of the test card, and insert the ID card into the ID card port of the instrument.

4. Take out the test card from the aluminum foil bag and use it within 15 minutes.

5. Place the test card on a clean horizontal table and mark it horizontally.

6. Add 100µL diluent buffer to the tube containing VB12 antibody lyophilized powder(white). One tube is used by one test.

7. Add 20 µL sample to the tube, mix the solution thoroughly and keep incubation for 5 minutes.

8 Apply 100 µL of incubated sample to the tube containing fluorescent lyophilized powder(blue), mix the solution thoroughly and keep incubation for 5 minutes.

9. Apply 100 µL of incubated sample to the well of the test card.

10. At 15 minutes after addition of incubated sample, insert the test card into dry fluorescent immunoanalyzer, read and record the results then dispose of used test appropriately.

Ⅴ.Performance

1. Limits of detection

No higher than 20.00 pmol/L.

2. Accuracy

The relative deviation from the target value is within ±15%.

3. Precision

The within and between assay coefficient of variations are within 15%.

4. Linear range

Within the linear range (20.00 ~ 1500.00) pmol/L, the linear correlation coefficient R≥0.990.

Ⅵ.VB12.pdf