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.

  • Individual ready-to-use cartridges
  • Combines competitive immunoassay technique with enzyme-catalyzed chemiluminescence detection
  • Sample volume: 75 μL

Range

Working range: 125-2000 pg/mL

Detection Limits

Limit of Detection (LOD): 125 pg/mL

Precision

Intra-lot Precision

CV less than 12%

Inter-lot Precision

CV less than 12%

Linearity

Linearity greater than 0.9900 within the interval from 125 and 2000 pg/mL

Specificity

Cross-reactivity was evaluated by spiking zero serum samples, with 200 pg/mL cross-reactive compound. The results of this study are shown in the following table:

SubstanceCross Reaction rate
Dicyanobalinol amide< 0.05%

Interference

No significant interference was detected up to the concentrations mentioned below:

SubstanceConcentration
Hemoglobin≤ 400 mg/dL
Bilirubin≤ 65 mg/dL
Triglyceride≤ 1500 mg/dL
Total Protein≤ 10 g/dL
Rheumatoid factors≤ 1500 IU/mL

Reagents and materials provided:

  1. 19-well Vit-B 12 reagent cartridge
    1. Sample well (1st well)
    2. Reading well for chemiluminescent signal (19th well)
    3. Foil-sealed wells (2nd to 18th wells) comprised of a barcode indicating reagent assay information, the reagent lot number and the expiration date
  2. 3 Calibrators containing Vit-B12 at:
    1. 0 pg/mL
    2. 250 pg/mL
    3. 1000 pg/mL
  3. Registration card
  4. Calibrator card
  5. Instructions for Use

Materials maybe required but not provided:

  1. Commercial controls

Materials required but not provided:

  1. Pipette with disposable tip to dispense up to 100 μL.
  2. For other specific materials and disposables, refer to CLIAlyzer user manual.
  3. CLIAlyzer instrument
  4. Powderless gloves
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L8030Vitamin B12 CLIA Test36/kitS/P
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