Vitamin B12 ELISA

The CTK Vitamin B12 ELISA is a solid-phase enzyme-linked immunosorbent assay.  The four main kit components are:

  • A 96-well breakable solid microwells pre-coated with streptavidin;
  • Vitamin B12 (VB12) Calibrators,
  • VB12 Biotin Reagent comprised of anti-Vitamin B12 biotinylated purified rabbit IgG conjugate, and
  • VB12 Enzyme Reagent comprised of Vitamin B12 analog-HRP conjugate in a protein stabilizing matrix.

This test is intended for the quantitative determination of Vitamin B12 level in human serum. Accurate measurement of Vitamin B12 levels in patients is very important for the diagnosis of Vitamin B12 deficiency and for the monitoring of deficient patients in order to achieve optimal levels. Any interpretation or use of this test result must also rely on other clinical findings as well as on the professional judgment of health care providers.

Recommended test for suspected Vitamin B12 deficiency related anemia and pernicious anemia, loss of balance, numbness or tingling in the arms and legs, and weakness.

Initial laboratory tests for suspected Vitamin B12 deficiency should include measurement of Vitamin B12 serum levels by ELISA immunoassay and a complete blood cell count. In patients that present with 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.

  • Analytical Sensitivity: 70.13 pg/mL at 2SD
  • Specificity: No cross-reactivity with bilirubin, cobinamide, hemoglobin, lipemia, or RF
  • Accuracy: correlation coefficient 0.9506 with a reference method
  • Intra-assay Precision: CV ≤ 7.3%
  • Inter-assay Precision: CV ≤ 11.6%
  • Shelf life: 15 months
  • Open kit stability:  60 days at 2-8°C, or until the expiration date
  • Streptavidin Coated Microwells
  • VB12 Calibrators:  C1 (0 pg/mL)
    • C2 (100 pg/mL)
    • C3 (200 pg/mL)
    • C4 (400 pg/mL)
    • C5 (1000 pg/mL)
    • C6 (2000 pg/mL)
  • Stabilizing Agent
  • VB12 Enzyme Reagent
  • VB12 Biotin Reagent
  • Neutralizing Buffer
  • Releasing Agent
  • Wash Buffer (50X Concentrate)
  • TMB Substrate
  • Stop Solution
  • Product Insert

Catalog #

Product

Quantity

Specimen

E8030Vitamin B12 ELISA96/kitS

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