LTH Medical LTD.

The Vitamin D Rapid Test Device (Whole Blood/Serum/Plasma) is used for qualitative determination and monitoring of 25-OH Vitamin D concentrations in whole blood/serum/plasma specimens.

The Vitamin D Rapid Test Device (Whole Blood/Serum/Plasma) is an immunochromatographic test, based on the principle of competitive immunoassay. The assay relies on the competition for binding antibody between 25-OH Vitamin D present in the blood sample and 25-OH Vitamin D present on the test strip. The 25-OH Vitamin D present in the blood sample competes with the 25-OH Vitamin D on the test strip for a limited number of antibody-gold conjugate. When the amount of 25-OH Vitamin D is around 30ng/mL (75nmol/L) or more, it will prevent the binding of 25-OH Vitamin D present on the test strip to antibody-gold conjugate. Threrefore a sufficient sample will not show the colored line in the Test Line area. When the amount of 25-OH Vitamin D is less than 30ng/mL (75nmol/L), there will be free antibody-gold conjugate molecules that will bind to 25-OH Vitamin D on the test strip and will show a colored line in the Test Line area. A control line consisting of goat anti-rabbit IgG is present in the Control Line area to work as procedural control. This colored band should always appear on the Control Line area if the test device is stored in good condition and the test is performed appropriately.

Allow test device, specimen, buffer and/or controls to reach room temperature (1530°C) prior to testing.

Bring the pouch to room temperature before opening it. Remove the test device from the sealed pouch and use it as soon as possible.

Place the test device on a clean and level surface.

For Serum or Plasma specimens:

1. Hold the dropper vertically and transfer approximately 10 µL to the specimen well (S) of the test device, then add 3 drops of buffer to the buffer well and start the timer.

2. For Whole Blood, Finger stick Whole Blood specimens:

Transfer 1 drop (approximately 10 µL) of sample to the specimen well (S) of the test device, then add 3 drops of buffer to the buffer well and start the timer.

3. Wait for the colored line(s) to appear. Read results at 10 minutes. Do not interpret results after 15 minutes.