Vitamin B12 Quanti Microlisa

Intended Use

Vitamin B12 Quanti Microlisa is designed for in-vitro quantitative determination of Vitamin B12 in human serum.

Salient Features

• Principle : Based on competitive immunoassay
• Quantitative detection of Vitamin B12 (cyanocobalamin) in human serum.
• Excellent sensitivity & specificity.
• Linearity Range: 50- 2000 pg/ml.
• Analytical Sensitivity: 50 pg/ml
• Breakaway microwell strips.
• Color coded reagents to monitor procedural steps.
• Assay procedure: 125 mins.
• Prompt service back-up
• Longer shelf life:18 Months at 2-8°C.
• Convenient pack size: 96 tests

Principle

Vitamin B12 Quanti Microlisa is an enzyme immuno assay based on competitive ELISA. First samples have to be pre-treated and separate in glass test tubes with working denaturation reagent to extract the vitamin B12 as circulating B12 is bound to binding protein in-vivo. After denaturation and neutralization, treated sample is added in the microwells.

During incubation, endgenous vitamin B12 of a sample competes with the vitamin B12 biotinylated conjugate for binding of anti-vitamin B12 antibodies which is immobilized on the plate (this delayed competition increases the sensitivity for low concentration Vitamin B12 samples). Incubation is followed by a washing step to remove unbound components. During a second incubation, binding of Vitamin B12-Biotin is detected by enzyme conjugate (peroxidase labelled streptavidin). Washing is followed. In the third incubation color reaction is star ted by addition of substrate and stopped after a defined time. The color intensity is inversely proportional to the concentration of Vitamin B12 in the sample.

Ordering Information

Performance Characteristics (Internal Evaluation) Of Vitamin B12 Quanti Microlisa Test

1. Accuracy : The kit has been tested in comparison using clinical samples commercially available reference tests ; LC/MS-MS and NIST REFERENCE STANDARDS .The Accuracy co-efficient is > 0.970
2. Precision :
   1. The test results are repeatable in Within run precision testing with CV <10%.
   2. The test results are reproducible in between run precision testing with CV <10%.