Vitamin D Semi-Quantitative Diagnostic Rapid Test

• Type: IVD Reagent, Vitamin D Self Test
• Certification: CE, ISO13485
• Classification: Ivd Reagent
• Group: All Groups
• Accuracy: 93.8%
• Sensitivity: 10-30-100ng/Ml
• Model NO.: SV-028
• Specimen: Whool Blood
• Format: Cassettes
• Product: Vitamin D Self Testing
• Quality Certification: CE
• Transport Package: Carton
• Specification: OEM
• Trademark: SD
• Origin: Hangzhou
• HS Code: 3822190090
• Production Capacity: 300000PCS/Day

Product Description

Vitamin D Semi-quantitative diagnostic Rapid test

Principle:

The Vitamin D Rapid Test is for the semi-quantitative detection of 25-hydroxyvitamin D (25 (OH) D) in human fingerstick Whole blood at a cut-off concentration of 30 ± 4ng/mL. This assay provides a preliminary diagnostic test result and can be used to screening for Vitamin D deficiency.

 

Produt name	blood Self testing Vitamin D Rapid Test Kit
Sensitivity	10-30-100ng/mL
Accuracy	More than 93.8%
Shelf time	24-36 month
OEM time	20 days
Certificate	CE/ISO13485
Specimen	Whool blood
Format	Cassette
Size	Cassette :4mm
Usage	Read results within 5 minutes

Feature:
Fast results
Easy visually interpretation
Simple operation, no equipment required
High accuracy
 

Why do I need a vitamin D test?

You need a Vitamin D test if you have signs or symptoms of a bone condition that may be related to a vitamin D deficiency (very low levels of vitamin D), such as:

• Bone pain
• Muscle weakness or aches
• Soft bones
• Deformed bones
• Weak bones and fractures (broken bones)
• Low bone density (osteoporosis or osteopenia)

Picture Display:

TEST 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 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 of 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 colored line(s) to appear. Read results at 10 minutes. Compare the T line intensity with "Vitamin D Color 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
(Please refer to the illustration and compare the T line intensity with "Vitamin D Color card" provided with the kit.)

Interpreting results:

Please refer to the illustration and compare the T line intensity with " Vitamin D Color card" Provided with the kit

 

Package:
 

Product Name	Specimen	Format	Package Size
Vitamin D self testing	whool blood	Cassette	1Test/foil pouch, 1Test/ or 10 Tests/box

FAQ:

1. How does the Vitamin D test work?
In medicine, a 25-hydroxy Vitamin D is the main storage form of vitamin D in the body. Therefore, the overall status of vitamin D can be determined by detecting the content of 25-hydroxy Vitamin D. 25-hydroxy Vitamin D level less than 30 ng/mL in case of a positive result, indicates Vitamin D Deficiency or Insufficiency. Vitamin D supplements can be recommended in these cases.
2. When should the test be used?
The clinical application of 25-hydroxy Vitamin D is mainly for diagnosis, treatment and monitoring of rickets (children), osteomalacia, postmenopausal osteoporosis and renal osteopathy. Vitamin D deficiency is also associated with many other diseases, including cancer, cardiovascular disease, autoimmune diseases, diabetes and depression. Monitor your vitamin D levels to determine whether to take vitamin D supplements. The Vitamin D Rapid Test can be used any time of the day.
3. Can the result be incorrect?
The results are accurate as far as the instructions are carefully respected. Nevertheless, the result can be incorrect if the Vitamin D Rapid Test cassette gets wet before test performing or if the quantity of blood dispensed in the sample well is not sufficient, or if the number of buffer drops are less than 2 or more than 3. The capillary dropper provided in the box allows making sure the collected blood volume is correct. Besides, due to immunological principles involved, there exist the chances of false results in rare cases. A consultation with the doctor is always recommended for such tests based on immunological principles.
4. How to interpret the test if the color and the intensity of the lines are different?
Please refer to the illustration and compare the T line intensity with "Vitamin D Color card" provided with the kit.
5. If I read the result after 20 minutes, will the result be reliable?
No. The result should be read at 10 minutes after adding the buffer. The result is unreliable after 20 minutes.
6. What do I have to do if the result is deficient or insufficient?
If the result is deficient or insufficient, it means that the Vitamin D level in blood is less than 30 ng/mL and that you should consult a physician to show the test result. The physician will decide whether additional analysis should be performed.
7. What do I have to do if the result is sufficient?
If the result is sufficient, it means that the Vitamin D level is higher than or equal to 30 ng/mL and is within the normal range. A case of Vitamin D toxicity (hypercalcemia), though rare, but cannot be excluded based on such test results. However, if the symptoms persist, it is recommended to consult a physician.




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