About the product
Elecsys Vitamin B12 II is Roche Diagnostics’ binding assay for the quantitative measurement of vitamin B12 in human serum and plasma. Roche states that the test is designed for use on cobas e immunoassay analyzers. According to the FDA, measurements obtained with this device are used in the diagnosis and treatment of anemias resulting from gastrointestinal malabsorption. For brand information, the Roche Diagnostics page can be consulted.
The parameter measured and its clinical meaning
According to MedlinePlus, a vitamin B12 test measures the level of cobalamin in the blood or urine. B12 helps the body make energy and keeps nerves and blood cells healthy. The test is often requested together with a folate test. Groups at risk of low B12 include celiac and Crohn’s disease, alcohol use disorder, malabsorption syndromes, diets low in animal products and digestive system surgeries including gastric bypass. MedlinePlus notes that a few hours of fasting may be needed for the blood test.
Technical information
- Sample acceptance: the FDA summary recommends serum and lithium heparin, sodium heparin, K2-EDTA and K3-EDTA plasma, and lithium heparin gel tubes. Hemolyzed samples are not used
- Calibrator: Elecsys Vitamin B12 II CalSet. Two-level lyophilized human serum matrix, approximately 250 and 1,500 pg/mL (FDA summary)
- The reagent uses recombinant porcine intrinsic factor. The earlier Elecsys B12 test contains native porcine intrinsic factor (FDA summary)
- Packs: 100 tests and 300 tests (Roche product page)
- Regulatory record: FDA 510(k) K151786, decision date September 24, 2015, predicate device K060755 (FDA summary)
Use and compatibility
The Roche product page lists the test for the cobas e 402, e 801, e 411, e 601 and e 602 analyzers and for the cobas e 100 and cobas smart e systems. For instrument information, the cobas e 411 and cobas e 402 pages can be used. The method principle and measuring range are given as a separate entry on the Roche Vitamin B12 II page. Results are used together with physician evaluation.
For product, quotation and technical information requests, the form on the contact page or info@tiliamedical.com can be used.
Frequently asked questions
According to MedlinePlus, the test measures the level of cobalamin in the blood or urine. B12 helps the body make energy and keeps nerves and blood cells healthy.
According to Roche, the test works on human serum and plasma. The FDA summary recommends serum and heparin or EDTA plasma. Hemolyzed samples are not used.
Roche lists the test for the cobas e 402, e 801, e 411, e 601 and e 602 analyzers and for the cobas e 100 and cobas smart e systems.
