Vitamin B12 CLIA Test CE

The Vitamin B12 (Vit-B12) Chemiluminescence ImmunoAssay (CLIA) Test is a chemiluminescence-based immunoassay for the quantitative detection of Vit-B12 in human serum or plasma (lithium heparin) using the ALTA CLIAlyzer.

Vitamin B12 (cobalamin) is an essential, water-soluble B vitamin that plays an important role in DNA synthesis, protein metabolism, the formation of red blood cells, and the maintenance of the central nervous system. Vitamin B12 deficiency, generally caused by inadequate intake or malabsorption, is common in developing countries and among the elderly, vegetarians, and individuals with gastrointestinal conditions. Vitamin B12 deficiency typically causes anemia and pernicious anemia, loss of balance, numbness or tingling in the arms and legs, and weakness.

If left untreated, it will lead to macrocytic anemia, neurological disease and cognitive impairment. In addition, children with severe B12 deficiency can suffer severe developmental delays, often times without full recovery. Vitamin B12 serves as a co-factor in the production of critical biomolecules: the conversion of methylmalonic acid into succinyl-CoA, as well as generation of methionine or cysteine from homocysteine. Thus, decreased levels of circulating B12 in serum/plasma, and increased methylmalonic acid and homocysteine, can serve as diagnostic indicators of Vitamin B12 deficiency.

Initial laboratory tests for suspected B12 deficiency should include measurement of B12 serum levels by CLIA test and a complete blood cell count. In patients that present symptoms of deficiency but have normal B12 serum levels, or are considered “high risk” but are asymptomatic, measurement of homocysteine and/or methylmalonic acid in the serum may also be used to confirm deficiency.