Vitamin B12 (VB12) Rapid Test

Sample

Human serum or plasma

Intended Use

The Vitamin B12 Test Cassette (Serum/Plasma) is a fluorescence immunoassay for the quantitative detection of Vitamin B12 in human serum or plasma specimen.

Storage

1. The kit should be stored at 2-30°C until the expiry date printed on the sealed pouch.
2. The test must remain in the sealed pouch until use.
3. Do not freeze.
4. Care should be taken to protect the components of the kit from contamination.
5. Do not use if there is evidence of microbial contamination or precipitation. Biological contamination of dispensing equipment, containers or reagents can lead to false results.

Performance Characteristics

1. Accuracy
The deviation is ≤15%
2. Analytical sensitivity
The Vitamin B12 Test Cassette (Serum/Plasma) can detect levels of Vitamin B12 as low as 50 pg/mLin serum or plasma specimens.
3. Detection Range
The Detection range of the Vitamin B12 Test Cassette (Serum/Plasma) is 50-2000 pg/mL or 36.9-1476 pmol/L

Precision

Intra-Assay
Within-run precision has been determined by using 10 replicates of 2 different concentrations of Vitamin B12 control. C.V.is ≤15%.
Inter-Assay
Between-run precision has been determined by using 10 replicates for each of three lots using 2 different concentrations of Vitamin B12 control. C.V. is ≤ 15%.

General Description

Vitamin B12 (B12), a member of the corrin family, is a cofactor for the conversion of methylmalonyl Coenzyme-A (CoA) to succinoyl CoA In addition, B12 is a cofactor in the synthesis of methionine from homocysteine, is implicated in the formation of myelin, and, along with folate, is required for DNA synthesis.
Causes of vitamin B12 deficiency can be divided into three cdasses: nutritional deficiency, malabsorption syndromes, and other gastrointestinal causes. B12 deficiency can cause megaloblastic anemia (MA), nerve damage and degeneration of the spinal cord. Lack of B12 even mild deficiencies, damages the myelin sheath that surrounds and protects nerves, which may lead to peripheral neuropathy. The nerve damage caused by a lack of B12 may become permanently debilitating, if the underlying condition is not treated. People with intrinsic factor defects who do not get treatment eventually develop a MA called pemicious anemia (PA).
Disorders associated with elevated serum B12 levels include renal failure, liver disease, and myeloproliferative diseases.