INTRODUCTION

The Vitamin D Rapid Test Kit is a lateral flow immunoassay intended for the qualitative detection of Vitamin-D in human whole blood, serum or plasma specimens. It is intended to be used by healthcare professionals as an aid in the assessment and evaluation of patients with vitamin D deficiency related diseases. The test only provides preliminary analysis results but not critical diagnosis criteria.

INTENDED USE

The Vitamin D Rapid Test Kit is an immunoassay based on the principle of sandwich method. During testing, the mixture migrates upward on the membrane chromatographically by capillary action. The membrane is pre-coated with 25 (OH) D antigens on the test line region (T). During testing, the specimen reacts with the particle coated with 25 (OH) D antigens. The mixture migrates upward on the membrane chromatographically by capillary action to react with 25 (OH) D antigens on the membrane and generates a colored line(s). The presence of this colored line in the test line region (T), indicates a positive result, while its absence indicates a negative result.An internal quality control is included in the test, in the form of a colored line appearing in the control line region (C), indicating that the test is functional, and proper and sufficient volume of specimen has been applied to enable migration through the test and control line, regardless of whether there is a test line or not. If the control line (C) does not appear within the testing time, test result is invalid and the test should be repeated with a new test device.