INTENDED USE
The Vitamin D Rapid Test Cassette (Whole Blood) is a lateral flow chromatographic immunoassay for the semi-quantitative detection of 25-hydroxyvitamin D, 25 (OH) Vitamin D, in human fingerstick Whole blood at a cut-off concentration of 30 ng/mL. This assay provides a preliminary diagnostic test result and can be used to screen for Vitamin D deficiency.
This assay provides only a preliminary analytical test result. A more specific alternate chemical method must be used to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any test result, particularly when evaluating preliminary positive results.
SUMMARY
Vitamin D is a steroid hormone that can be naturally produced via dermal synthesis from ultraviolet light exposure and acquired from diet. Vitamin D is involved in increasing intestinal absorption of calcium and phosphorous. Vitamin D deficiency is a global health issue in all age groups since it may cause issues with bones and muscles. Many people may not be meeting the minimum requirement of Vitamin D through diet and ultraviolet exposure alone. Prolonged Vitamin D deficiency can result in serious conditions such as Osteomalacia and Rickets in children. Measurement of the Vitamin D metabolite 25-hydroxyvitamin D in circulating blood is the best indicator of Vitamin D concentration in the body. The testing of current 25-OH Vitamin D level in the blood using the immunoassay for the assessment of Vitamin D is an efficient tool to ensure maintenance of sufficient Vitamin D levels necessary for optimal health.
PRINCIPLE
The Vitamin D Rapid Test Cassette (Whole Blood) is a lateral flow chromatographic immunoassay based on the principle of the double antibody–sandwich technique.
In this test, the 25-OH Vitamin D antibody is fixed in the test line area of the test strip in the test device. After the sample is added to the sample well of the cassette, it reacts with the particles coated with 25-OH Vitamin D antibody in the test. The mixture chromatographed along the length of the test strip and interacted with the 25-OH vitamin D antibody immobilized on the NC membrane. If the specimen contains 25-OH vitamin D, one or two colored lines will appear in the test line area. The higher the concentration of 25-OH vitamin D in the sample, the deeper the colored lines will be in the test line area. To serve as a procedural control, a colored line will always appear at the control line region indicating that proper volume of specimen has been added and membrane wicking has occurred.
REAGENTS
The test kit contains a pair of mouse monoclonal anti-25 hydroxyvitamin D antibodies, and goat antibodies are used in the control line system.
