Vitamin D3 tests are rapid chromatographic immunoassays designed for the semi-quantitative detection of 25-hydroxyvitamin D (25(OH)D) in whole blood from a fingerstick. The test is intended for in vitro diagnostics and can be performed independently at home. It allows for an initial assessment of vitamin D levels and the identification of vitamin D deficiency.

Measuring vitamin D levels is an important part of preventive healthcare and monitoring the body’s proper functioning. Vitamin D deficiency may be associated with osteoporosis, osteomalacia, cardiovascular diseases, diabetes, and other conditions. Regular monitoring of vitamin D levels helps detect abnormalities sooner and take appropriate preventive measures or consult a doctor.

The high accuracy of this test allows for reliable results as early as 10 minutes after applying the blood sample. The test’s measurement range is 0–100 ng/ml (0–250 nmol/l).

This product is intended for self-testing.
This is a medical device. Use it in accordance with the instructions for use or the label.

Features

• Sample type: whole blood from a finger prick
• Quick and easy testing
• Semi-quantitative measurement of vitamin D3 levels
• Results in approximately 10 minutes
• High-quality product
• Measurement range: 0–100 ng/ml (0–250 nmol/l)
• Single-use packaging
• Product intended for self-testing

Package contents

• 1 test cassette
• 1 buffer
• 1 lancet
• 1 alcohol swab
• 1 capillary pipette
• 1 color chart
• 1 user manual

How to perform the test?

1. Wash your hands with warm water and soap, then dry them thoroughly.
2. Open the package and prepare all the components of the kit.
3. Twist and remove the cap from the lancet.
4. Gently massage your hand from the wrist to the fingertips to increase blood flow.
5. Place the lancet against your fingertip and press firmly to draw a blood sample.
6. Draw a blood sample into the capillary tube up to the marked line.
7. Apply the blood sample to the test well marked with the symbol (S).
8. Add 2 drops of buffer to the well marked with the symbol (B).
9. Wait 10 minutes.
10. Compare the intensity of the T line with the color scale included in the kit and read the result.

The result should not be interpreted after 20 minutes.

Indications for testing

• suspected vitamin D deficiency
• weakness and chronic fatigue
• muscle and bone pain
• impaired immunity
• preventive monitoring of vitamin D levels
• monitoring of vitamin D supplementation
• risk of osteoporosis or osteomalacia
• limited sun exposure

Application

• Vitamin D Level Monitoring: The test allows for a quick check of 25-hydroxyvitamin D (25(OH)D) levels without the need to visit a laboratory, which can help assess the risk of vitamin D deficiency.
• Prevention of vitamin D deficiency: Regular testing can support the early detection of low vitamin D levels, as deficiency is associated with many conditions, including osteoporosis, osteomalacia, cardiovascular diseases, diabetes, and autoimmune diseases.
• Monitoring the effectiveness of supplementation: Individuals taking vitamin D supplements or making lifestyle changes can track the impact of these actions on their body’s vitamin D levels.
• Support during health checkups: The test can be helpful for people monitoring their vitamin D levels between doctor’s visits or during the diagnosis of deficiencies.
• Quick assessment at home: The product allows for convenient testing at home and provides a preliminary, semi-quantitative result in a short time.

What is vitamin D3 and what are the effects of its deficiency?

Vitamin D is a group of fat-soluble secosteroids responsible for increasing the intestinal absorption of calcium, iron, magnesium, phosphates, and zinc. In humans, the most important compounds in this group are vitamin D3 and vitamin D2. Vitamin D3 is naturally produced in human skin upon exposure to ultraviolet radiation, while vitamin D2 is obtained primarily from food.

Vitamin deficiency leads to various serious diseases:

• osteoporosis,
• osteomalacia,
• multiple sclerosis,
• cardiovascular diseases,
• pregnancy complications,
• diabetes,
• strokes,
• autoimmune diseases,
• the flu,
• various cancers,
• infectious diseases,
• Alzheimer’s disease,
• obesity,
• and higher mortality rates.

The medical tools presented here are self-test kits, meaning they can be used at home. It is advisable to take a vitamin D level test if you experience symptoms of deficiency, which include fatigue, weakness, muscle and joint pain, as well as frequent infections.

The Bisaf medical store also offers other diagnostic tests, including both tests for healthcare professionals (e.g., combo tests) and self-test kits.

How it works

The vitamin D level test is an immunoassay based on the principle of competitive binding. During the test, the mixture migrates upward along the chromatographic membrane due to capillary action. The membrane is pre-coated with 25(OH)D antigens in the test line area of the strip. During the test, the 25(OH)D present in the sample will compete with the 25(OH)D on the test line for a limited amount of anti-25(OH)D antibodies in the conjugate. The higher the concentration of 25(OH)D in the sample, the lighter the T line will be. The result is read according to the color chart included with the kit. As part of the procedural control, a red line will always appear in the control line (C) area, indicating whether the appropriate sample volume was added and whether the membrane was moistened.

More information in the package insert—available upon request.

EAN code: 6936983105101