Self-test for vitamin d deficiency

Product Description

Rapid immunochromatographic test for the semi-quantitative detection of 25-hydroxyvitamin D in human blood by fingerstick.

Indications

The Vitamin D Self-Test by Munus Medical is able to provide a preliminary diagnostic result and can be used in screening for vitamin D deficiency. During the test, 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 (T) region of the test strip. During the test, the 25(OH)D present in the sample will compete with the 25(OH)D present on the test line (T) due to the limited amount of anti-25OH vitamin D antibodies present in the conjugate. The higher the concentration of 25(OH)D in the sample, the higher the concentration of 25(OH)D in the test line (T). the T line will be slight. The result can be interpreted according to the color chart provided with this kit. With the procedural control feature, a colored line will always appear in the control line area (C), indicating that sufficient specimen volume has been added and the membrane has been saturated.

Directions for Use and Dosage

• Wash your hands with soap and rinse with clean, warm water.
• Bring the package to room temperature before opening.
• Open the package, remove the test and place it on a clean, flat surface.
• Perform the test within one hour of opening. Best results will be obtained by performing the test immediately after opening the foil package.
• Remove the dropper, swab vial, sterile lancet and alcohol wipe and place them near the test.
• Gently pull to remove the protective cap from the lancet.
• Use the alcohol wipe to clean the pad of your middle or ring finger, where you will prick.
• Wait until the affected area is dry again.
• Press the lancet on the side where the cap was removed; the tip retracts automatically and safely after use.
• Massage your hand towards the pad of the middle or ring finger that was pricked (without touching the puncture site) to obtain a drop of blood.
• Touch the capillary dropper with the blood, without squeezing the bulb.
• The blood will migrate into the capillary dropper until it reaches the line indicated on the dropper.
• You can massage your finger again to obtain more blood. blood if the fill line has not been reached.
• As far as possible, try to avoid the formation of air bubbles.
• Pour the collected blood into the sample well (S) on the device by pressing the dropper bulb.
• Wait until all the blood has flowed into the well. Unscrew the cap of the swab vial and add 2 drops of buffer to the swab well (B) on the device and start the timer.
• Wait for the colored line(s) to appear. Read the results after 10 minutes.
• Compare the intensity of the T-line with the “Vitamin D Color Card” provided in the kit to interpret the vitamin D level in the blood.
• Do not interpret the result after 20 minutes.

Reading the results

• Deficient: Two distinct colored lines appear. One line is 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 10 ng/mL line shown on the color deficiency card provided in the kit.
• Insufficient: Two colored lines appear. One line is 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 30 ng/mL line and darker than the 30 ng/mL line. The result is a clearer than the 10 ng/mL line, both of which are shown on the color card provided with the kit.
• Sufficient: Two colored 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 30 ng/mL line shown on the color card.
• Excessive: One colored line appears in the control region (C). No colored line appears in the test region (T). If the result is a Vitamin D excess, it is recommended to consult your healthcare provider.
• Invalid: The control line does not appear. The most likely reasons for the control line not appearing are insufficient sample volume or improper procedural techniques. Review the procedure and repeat the test with a new kit. If the problem persists, discontinue use of the kit immediately and contact your local distributor.

Warnings

Please read all information in this package insert before performing the test. For in vitro self-diagnostic use only. Do not eat, drink, or smoke in the area where the specimens or kits are handled. Please do not use the test if the sealed package is damaged or opened. 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 indicated timing. Use the test only once. Do not disassemble or touch the test window on the holder. The kit should not be frozen or used beyond the expiration date printed on the package. Keep out of reach of children. Once used, the test must be disposed of according to local regulations. The Vitamin D Deficiency 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 interfering substances in the blood sample, may cause erroneous results. As with all diagnostic tests, all results must be evaluated in conjunction with other clinical data available to your doctor. In the event of a questionable result, clinical testing with additional analytical methods is necessary.

Storage

Store packaged at room temperature or refrigerated (2-30°C). Do not freeze. The test is stable until the expiration date printed on the sealed package or unopened box. The test must remain in the sealed package until use. Do not use beyond the expiration date. Shelf life with intact packaging: 24 months.

Format

The package contains: test, dropper, swab, alcohol wipe, lancets, package leaflet and color card.