Description Rapid immunochromatographic test for the semi-quantitative detection of 25-hydroxyvitamin D in human fingerstick blood.
This test provides a preliminary diagnostic result and can be used for screening for vitamin D deficiency.
Immunoassay based on the principle of competitive binding. During the test, the mixture migrates upwards along the membrane chromatographically by capillary action. The membrane is pre-coated with 25 (OH) D antigens in the test line (T) region of the strip. During the test, the 25 (OH) D present in the sample competes with the 25 (OH) D on the test line (T) for the limited amount of anti-25 OH vitamin D antibodies in the conjugate. The higher the concentration of 25 (OH) D in the sample, the fainter the T line will be.
The result can be interpreted using the colour chart supplied with this kit.
As a procedural control, a coloured line will always appear in the control line (C) region, indicating that a sufficient sample volume has been added and that the membrane has been wetted.
How to use Wash your hands with soap and rinse with clean, lukewarm water.
Bring the pack to room temperature before opening it. Open the pack, remove the test and place it on a clean, flat surface. Carry out the test within one hour of opening; the best results are obtained by performing the test immediately after opening the foil pouch.
Remove the dropper, buffer vial, sterile lancet and alcohol wipe, placing them near the test.
Gently pull to remove the protective cap of the lancet. Use the alcohol wipe to clean the fingertip of the middle or ring finger, where the puncture will be made. Wait until the area is dry again. Press the lancet, on the side where the cap was removed; the tip retracts automatically and safely after use.
Massage the hand towards the fingertip of the punctured middle or ring finger (without touching the puncture site) to obtain a drop of blood.
Bring the capillary dropper into contact with the blood, without squeezing the bulb. The blood will migrate into the capillary dropper until it reaches the line marked on the dropper. You can massage the finger again to obtain more blood if the fill line has not been reached. As far as possible, try to avoid air bubbles.
Pour the collected blood into the sample well (S) on the device by squeezing the dropper bulb.
Wait until all the blood has gone into the well. Unscrew the cap of the buffer vial, add 2 drops of buffer to the buffer well (B) on the device and start the timer.
Wait for the coloured line(s) to appear. Read the results at 10 minutes. Compare the intensity of the T line with the "Vitamin D colour chart" supplied in the kit to interpret the vitamin D level in the blood. Do not interpret the result after 20 minutes.
Reading the results | 25-OH Vitamin D level | Reference range (ng/mL) | Reference range (mcmol/L) |
| Deficient | 0-10 | 0-25 |
| Insufficient | 10-30 | 25-75 |
| Sufficient | 30-100 | 75-250 |
- Deficient: Two coloured lines appear. One line in the control region (C) and another line should appear in the test region (T). The line in the test region (T) is darker than or equal to the line corresponding to 10 mcg/mL shown on the DEFICIENT colour chart supplied in the kit.
- Insufficient: Two coloured lines appear. One line in the control region (C) and another line should appear in the test region (T). The line in the test region (T) is darker than the line corresponding to 30 mcg/mL and lighter than the line corresponding to 10 mcg/mL, both shown on the colour chart supplied with the kit.
- Sufficient: Two coloured lines appear; one line should always appear in the control region (C) and another line should appear in the test region (T). The intensity of the line in the test region (T) is lighter than or equal to the line corresponding to 30 mcg/mL shown on the colour chart.
- Excessive: One coloured line appears in the control region (C). No coloured line appears in the test region (T). If the result shows excess Vitamin D, you are advised to consult your doctor.
- Invalid: The control line does not appear. The most likely reasons for the control line not appearing are insufficient sample volume or incorrect procedural technique. Review the procedure and repeat the test with a new kit. If the problem persists, stop using the kit immediately and contact your local distributor.
Warnings Please read all the information in this leaflet before performing the test.
For in vitro self-testing use only.
Do not eat, drink or smoke in the area where samples or kits are handled.
Do not use the test if the sealed pack is damaged or open.
The kit is intended for use as a preliminary test, and repeated abnormal results should be discussed with a doctor or specialist.
Strictly follow the times indicated.
Use the test only once. Do not dismantle or touch the test window on the cassette.
The kit must not be frozen or used after the expiry date printed on the pack.
Keep out of the reach of children.
Once used, the test must be disposed of in accordance with local regulations.
The Vitamin D Rapid Test provides only a semi-quantitative analytical result. A secondary analytical method must be used to confirm the result.
Technical or procedural errors, as well as interference from substances in the blood sample, may cause incorrect results. As with all diagnostic tests, all results must be evaluated together with the other clinical data available to your doctor. In the case of a questionable result, clinical tests with other analytical methods must be carried out.
Storage Store packaged at room temperature or refrigerated (2-30 °C).
Do not freeze.
The test is stable until the expiry date printed on the sealed pouch or closed box. The test must remain in the sealed pouch until use. Do not use after the expiry date.
Shelf life in intact packaging: 24 months.
Format The pack contains:
- test;
- dropper;
- buffer;
- alcohol wipe;
- lancets;
- instruction leaflet;
- colour chart.
Code SF006
