Rapid one step assay for Vitamin D levels

NanoSpeed, incorporated in 2009, is developing proprietary diagnostic/screening test kit platforms based on our Lateral Flow ImmunoAssay (LIFA) and our “Lab-On-a-Chip”(LOC) technology. These technological advancements provide our value proposition to clients with cost effective and reliable testing tools that will address the increasing needs of the healthcare industry, regulatory agencies and consumers.

INTENDED USE
Test4DTM is a rapid chromatographic immunoassay for the detection of vitamin D levels in human blood at a cut-off concentration of 32ng/mL±6ng.mL (80nmol/L±15nmol/L). This assay is designed for qualitative determination of Vitamin D and may be used in the point of care setting.

TEST PRINCIPLE
Test4DTM is based on the principle of a competitive enzyme immunoassay. The assay system utilizes a monoclonal antibody specific for vitamin D. The assay relies on the competition for binding antibody between vitamin D present in blood sample and vitamin D present on the test strip. The vitamin D present in the blood sample competes with the vitamin D on the test strip for limited number of antibody-gold conjugate. When the amount of vitamin D is 32± 6ng/mL (80 ±15nmole/L) or more, it will prevent the binding of vitamin D present on the test strip to antibody-gold conjugate. Therefore a sufficient sample will not show the colored line in the test line zone. When amount of vitamin D is less than 32±6ng/mL (80±15nmole/L), there will be free antibody-gold conjugate molecule that will bind to vitamin D on the test strip and will show a colored line in test line zone.
A control line is present in the test window to work as procedural control. This colored band should always appear on the control line zone if the test device is stored in good condition and the test is performed appropriately.

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