Worlds' Smallest Rapid Vitamin D Test Analyzer

Worlds' Smallest Rapid Vitamin D Test Analyzer

INTENDED USE

• SPARK Quantitative Vitamin D Test is an immunochromatography-based one stop in vitro test. It is designed for the quantitative determine of total 10-hydraxy Vitamin D (10-OH Vitamin D) in human finger-prick blood. This assay provides a preliminary diagnostic test result and can be used for screening of Vitamin D deficiency. The liquid chromatography with tandem mass spectrometry (LC_MS/MS) assays or other quantitative immunoassays are recommended to further confirm the diagnostics test results.

SUMMARY AND EXPLANATION

• Vitamin D is a steroid hormone responsible for enhancing intestinal absorption of calcium and the regulation of its homeostasis. The two common forms of Vitamin D are Vitamin D2 and Vitamin D3. Vitamin D3 is naturally produced in the human skin through the exposure to ultraviolet light and Vitamin D2 is mainly obtained from foods. Vitamin D is transported to the liver where it is metabolized to 25-hydroxy Vitamin D. In medicine, a 25-hydroxy Vitamin D blood test is used to determine Vitamin D concentration in the body. The blood concentration of 25-hydroxy Vitamin D is considered the best indicator of Vitamin D status.
• Vitamin D deficiency is now recognized as a global epidemic. Virtually every cell in our body has receptors for Vitamin D, meaning that they all require "Sufficient" Level of Vitamin D for adequate functioning. The health risks associated with Vitamin D deficiency are far more severe than previously thought. Vitamin D deficiency has been linked to various serious diseases: Osteoporosis, Osteomalacia, Multiple Sclerosis, Cardiovascular Diseases, Pregnancy Complications, Diabetes, Depression, Strokes, Autoimmune Diseases, Flu, Different Cancers, Infectious Diseases, Alzheimer, Obesity and Higher Mortality etc. Therefore, now detecting (25-OH) Vitamin D level is considered as "Medically Necessary Screening Test", and maintaining sufficient levels not just to improve bone health, but to improve overall health and well-being.
• Multiple guidelines for Vitamin D deficiency have been published by various health organizations; but a common recommendation remained to be established.
• Recent literature has suggested the following ranges for the classification of Vitamin D status:

TEST PRINCIPLE

• Quantitative Vitamin D Test utilizes the principle of Immunochromatography, a unique two-site "Sandwich" immunoassay on a membrane. The test employs a very "Exclusive" pair of anti-25-OH Vitamin D Monoclonal Antibodies; one conjugated with colloidal gold and another one immobilized on the solid phase. This will selectively detect Vitamin D with a high degree of sensitivity and specificity.
• As the test sample flows through the membrane assembly within the test device, the colored anti-25-OH Vitamin D-colloidal gold conjugate complexes with 25-OH Vitamin D from the sample. This complex moves further on the membrane by the capillary action to the test region (T) where it is immobilized by another anti-25-OH Vitamin D coated on the membrane, leading to formation of a pink/ purple colored band, which confirms a positive test results. The intensity of colored band in the test line region is 25-OH Vitamin D concentration-dependent, higher the concentration of 25-OH Vitamin D in the tested sample, the stronger the colored band is. A control line is present in the test window to work as procedural control. This colored band should always appear on the control line region (C) if the test device is stored in good condition and the test is performed appropriately.

Learn how to use our product : https://www.youtube.com/watch?v=9yIC0pExD_4&feature=emb_logo

Spark Diagnostics was conceived with a multi-year research inspired by the technology revolution bought by development of paper-based affordable diagnostics. We believe that mobile phone penetration across the globe provides a tremendous opportunity to revolutionize Diagnostics while providing data at the Fingertips of the customers. The company was hence started in 2016 with the mission to bring Simple, Affordable, and Portable Diagnostics to all its customers by leveraging the use of the mobile phones.

Mobile App Reader and Support:

• Mobile App available for iOS and Android Mobile phones.
• State of the Art Patent Pending App algorithm Quick Scan, and Results within 60 seconds.
• App provides the ability to Save & Print results and monitor trends.
• Customer support available in the regions.

Partnership and Collaboration:

• We offer collaborative partnership including Marketing Support to introduce the Mobile App Reader technology to your regions.