Vitamin D Instructions

A rapid test for the semi-quantitative detection of 25-hydroxyvitamin D in human fingerstick Whole Blood. For self-testing in vitro diagnostic use.

INTENDED USE

The Vitamin D Rapid Test Cassette is a rapid chromatographic immunoassay for the semi-quantitative detection of 25-hydroxyvitamin D (25 (OH) D) in human fingerstick Whole blood. This assay provides a preliminary diagnostic test result and can be used to screening for Vitamin D deficiency.

PRECAUTIONS

Please read all the information in this package insert before performing the test.

  • For self-testing in vitro diagnostic use only.
  • Do not eat, drink or smoke in the area where the specimens or kits are handled.
  • Store in a dry place at 2-30 °C (36-86 °F), avoiding areas of excess moisture. If the foil packaging is damaged or has been opened, please do not use.
  • This test kit is intended to be used as a preliminary test only and repeatedly abnormal results should be discussed with doctor or medical professional.
  • Follow the indicated time strictly.
  • Use the test only once. Do not dismantle and touch the test window of the test cassette.
  • The kit must not be frozen or used after the expiration date printed on the package.
  • Keep out of the reach of children.
  • The used test should be discarded according to local regulations.

STORAGE AND STABILITY

Store as packaged in the sealed pouch either at room temperature or refrigerated (2-30 °C). The test is stable through the expiration date printed on the sealed pouch. The test must remain in the sealed pouch until use. DO NOT FREEZE. Do not use after the expiration date.

KIT CONTENTS

  • Test Cassette
  • Buffer
  • Lancet
  • Alcohol Pad
  • Capillary Dropper
  • Package Insert
  • Colour Card

MATERIALS REQUIRED BUT NOT PROVIDED

  • Timer

PROCEDURE

  1. Wash your hands with soap and rinse with clear warm water.
  2. Bring the pouch to room temperature before opening it. Open the foil pouch, remove the test cassette and place it on a clean and level surface. Run the test within one hour and best results will be obtained if the test is performed immediately after opening the foil pouch. Remove the dropper, buffer vial, lancet and Alcohol pad, place them close to the test cassette.
  3. Carefully pull off and dispose the released cap of the lancet.
  4. Use the provided Alcohol pad to clean the fingertip of the middle or ring finger as the puncture site. Allow to air dry.
  5. Press the lancet, on the side from where the cap was extracted; the tip retracts automatically and safely after use. Massage the hand without touching the puncture site by massaging the hand towards the fingertip of the middle or ring finger to be punctured.
  6. Keeping the hand down massage the end that was pricked to obtain a blood drop.
  7. Without squeezing the capillary dropper bulb, put it in contact with the blood. The blood migrates into the capillary dropper through the capillarity to the line indicated on the capillary dropper. You may massage again your finger to obtain more blood if the blood does not reach the indicated line. Avoid air bubbles.
  8. Release the blood collected into the Specimen well (S) of the cassette, by squeezing the dropper bulb.
  9. Wait for the blood to be totally dispensed in the well. Unscrew the cap of the buffer bottle and add 2 drops of buffer into the Buffer well (B) of the cassette and start a timer.
  10. Wait for the coloured line(s) to appear. Read results at 10 minutes. Compare the T line intensity with “Vitamin D Colour card” provided with the kit to get the Vitamin D level in your blood. Do not interpret the result after 20 minutes.

READING THE RESULTS

DEFICIENT: Two coloured lines appear. One is in the control region (C) and another should be in the test region (T). The line intensity in the test region (T) is equal to or darker than 10 ng/mL line depicted on colour card provided with the kit.

INSUFFICIENT: Two coloured lines appear. One is in the control region (C) and another should be in the test region (T). The line intensity in the test region (T) is darker than the 30 ng/mL line depicted on the colour card provided with the kit and lighter than 10 ng/mL line depicted on Colour card provided with the kit.

SUFFICIENT: Two coloured lines appear, one line should be always in the control region (C) and faint coloured line appears in the test region (T). The line intensity in region (T) is equal to or lighter than 30 ng/mL line depicted on Colour card.

EXCESS: One coloured line appears in the control line region (C). No coloured line appears in the test line region (T). If the result is excess, it is recommended to consult a physician.

INVALID: Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test. If the problem persists, discontinue using the test kit immediately and contact your local distributor.

CONTROL PROCEDURE

A procedural control is included in the test. A coloured line appearing in the control region (C) is the internal procedural control. It confirms sufficient specimen volume and correct procedural technique.

LIMITATIONS

  1. The Vitamin D Rapid Test Cassette provides only a semi-quantitative analytical result. A secondary analytical method must be used to obtain a confirmed result.
  2. It is possible that technical or procedural errors, as well as other interfering substances in the whole blood specimen may cause erroneous results.
  3. As with all diagnostic tests, all results must be considered with other clinical information available to the physician.
  4. Other clinically available tests are required if questionable results are obtained.

PERFORMANCE CHARACTERISTICS

Accuracy

A clinical evaluation was conducted comparing the results obtained using the Vitamin D Rapid Test to predicate Device (Vitamin D Rapid Test). The in-house clinical trial included 90 whole blood specimens. The results demonstrated with an overall accuracy of 94.4%.

This assay is intended to be used as a preliminary test only and repeatedly abnormal results should be discussed with doctor or medical professional.

  • Follow the indicated time strictly.
  • Use the test only once. Do not dismantle and touch the test window of the test cassette.
  • The kit must not be frozen or used after the expiration date printed on the package.
  • Keep out of the reach of children.
  • The used test should be discarded according to local regulations.
Manufacturer Manufacturer Tests per kit Tests per kit Do not reuse Do not reuse
In Vitro For In Vitro use only Use by Use by Catalogue # Catalogue #
Temperature Store between 2-30 degrees C Lot number Lot number Authorized representative in EU Authorized representative in EU
Package damaged Do not use if package is damaged Instructions for use Consult Instructions for use Caution Caution