About the product
Roche Elecsys Vitamin B12 II is a binding assay developed for the in vitro quantitative determination of vitamin B12 in human serum and plasma. Roche calls the method electrochemiluminescence immunoassay (ECLIA) and states that the test is designed for use on cobas e immunoassay analyzers. For brand information, the Roche Diagnostics page can be consulted.
The parameter measured and its clinical meaning
According to MedlinePlus, vitamin B12 (cobalamin) helps the body make energy. It keeps nerves and blood cells healthy. The test measures the B12 level and is often requested together with a folate test. According to the FDA summary, measurements obtained with this device are used in the diagnosis and treatment of anemias resulting from gastrointestinal malabsorption.
Technical information
- Method: competitive ECLIA. B12 in the sample competes with biotinylated B12 for binding to the ruthenium-labeled B12-specific binding protein (intrinsic factor). The complexes are collected on the electrode surface with streptavidin-coated microparticles, and the applied voltage produces light emission (FDA summary)
- Reagent components: streptavidin-coated microparticles, ruthenium-labeled recombinant porcine intrinsic factor, biotinylated vitamin B12 and two pretreatment solutions that release bound B12 (FDA summary)
- Measuring range: 150 to 2,000 pg/mL (range declared by the applicant, FDA summary)
- Sample type: human serum and plasma. The FDA summary recommends serum and lithium heparin, sodium heparin, K2-EDTA and K3-EDTA plasma
- Calibrator: two-level lyophilized Elecsys Vitamin B12 II CalSet, approximately 250 and 1,500 pg/mL (FDA summary)
- Packs: 100 and 300 tests (Roche product page)
Use and compatibility
According to the Roche product page, the test is listed 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. The FDA summary specifies the cobas e 411 as the particular instrument requirement. Hemolyzed samples are not used. For instrument information, the cobas e 411 and cobas e 402 pages can be consulted. The analyte and clinical context for the same test are covered separately on the Elecsys Vitamin B12 II page.
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 the FDA summary, the test is a competitive ECLIA. B12 in the sample competes with biotinylated B12 for binding to ruthenium-labeled intrinsic factor, and light emission is measured on the electrode surface.
According to Roche, the test is for determination of vitamin B12 in human serum and plasma. The FDA summary recommends serum and heparin or EDTA plasma. Hemolyzed samples are not used.
In the FDA summary, the measuring range declared by the applicant is given as 150 to 2,000 pg/mL.
