【Product Name】Detection Kit for vitamin B12 (enhanced chemiluminescence immunoassay

【Registration certificate number】 京械注准20172401077

【Packing】48 tests/box，96 tests/box.

【Storage conditions and validity】Storage at  2 ~ 8℃，validity for 6 months.

This kit is mainly used for quantitative determination of vitamin B12 (VB12) in human serum in vitro.

Lack of vitamin B12 (VB12) caused by the lack of meat and fungi can lead to nutritional and giant cell anemia. Malabsorption is a major cause of this deficiency，always found in pancreatic dysfunction, gastric atrophy or gastrectomy, bowel damage, loss of enteral VB12 binding protein (intrinsic factor), autoantibodies against intrinsic factor produced in vivo, or other related factors. The determination of VB12 or folic acid VB12 has diagnostic value, especially for the identification of megaloblastic anemia.

This kit uses competitive approach. The reagents used in the kit are VB12 standard, horseradish peroxidase labeled VB12 (HRP-VB12), microplate coated with VB12 antibody, chemiluminescent substrate (with enhancer), enzyme-labeled antigen competes with unlabeled antigen (antigen of test sample) for coating a limited number of wells binding site of the specific antibody in the microplate and combines into antigen-Antibody complex, the number of unlabeled antigen (antigen of test sample ) affects the number of antigen-antibody complex,  the more antigens in the sample to be tested, the less labeled antigen-antibody complex formed. Unbound labeled antigen is removed after the immune reaction, it cancan produce optical signals by adding chemiluminescent substrate, the optical signal will decrease with the increase of antigen in the sample to be tested. According to the relative luminescence intensity of VB12 series and its concentration, the dose-response curve can be drawn by log-logit mathematical model or other suitable mathematical model fitting and the content of VB12 in the tested sample can be calculated from this curve by the relative luminescence intensity.

Clinical symptoms

Symptoms of deficiency:

1. Pernicious anemia (deficiency of red blood cells);

2. Bad menstruation;

3. The eyes and skin are yellowish, the skin appears local (small) redness (not painful and not itchy) and with the exudation;

4. Nausea, loss of appetite and weight loss;

5. Lip, tongue and gingival bleaching, gum bleeding;

6. Headache, memory loss, dementia;

7. It may cause a person's mental distress;

8. It may cause nuclear megaloblastic anemia (pernicious anemia);

9. Spinal degeneration, neural and peripheral neurodegeneration;

10. Inflammation of the mucosa of the tongue, mouth and digestive tract;

11. If there are symptoms of poor appetite, indigestion, inflammation of the tongue and loss of taste, it is a warning for vitamin B12 deficiency.

12. Early signs of vitamin B12 deficiency in children are characterized by abnormal mental mood, sluggish expression, less crying, less responsiveness, and sleeping, which can lead to anemia.

Clinical laboratory, physical examination center.