Vitamin D Quanti Microlisa

Intended Use

Vitamin D Quanti Microlisa is designed for in-vitro quantitative determination of vitamin D (total) in human serum.

Salient Features

• Principle : Based on competitive immunoassay
• Quantitative detection of 25 –OH Vitamin-D2 & D3.
• Excellent sensitivity & specificity.
• Slandered are calibrated against international slandered reference NIST-SRM 972a.
• Linearity Range: 2.57 – 130 ng/ml.
• Analytical Sensitivity: 2.57 ng/ml
• Breakaway microwell strips.
• Color coded reagents to monitor procedural steps.
• Assay procedure: 90 mins.
• Prompt service back-up
• Long shelf life: 18 Months at 2-8°C.
• Convenient pack size: 96 tests.

Principle

Vitamin D Quanti Microlisa is an enzyme immuno assay based on delayed competitive ELISA. First samples are incubated with assay diluent to release vitamin-D from binding protein in the sample. Vitamin D biotin conjugate is added in the microwells.

During incubation endogenous 25-OH vitamin D of a sample competes with a 25-OH vitamin D3-biotin conjugate for binding of the anti-vitamin D antibodies immobilized on the plate (this delayed competition increases the sensitivity for low concentration vitamin-D samples). Incubation is followed by a washing step to remove unbound components. During a second incubation, binding of 25-OH vitamin D-Biotin is detected by enzyme conjugate (peroxidase labelled streptavidin). Washing is followed. In the third incubation color reaction is started by addition of substrate and stopped after a defined time. The color intensity is inversely proportional to the concentration of 25-OH vitamin D in the sample.

Ordering Information

Performance Characteristics (Internal Evaluation) Of Vitamin D 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%.