The Vitamin D Rapid Test Kit (Mono Pack) is a professional in-vitro diagnostic (IVD) rapid immunochromatographic assay designed for the qualitative or semi-quantitative screening of 25-Hydroxy Vitamin D [25(OH)D] in human whole blood obtained from a fingerstick or venous sample, depending on the manufacturer's instructions.
Vitamin D plays an essential role in maintaining bone health, calcium absorption, muscle function, immune system support, and overall wellbeing. Low Vitamin D levels are common worldwide and may be associated with reduced bone mineralization and other health conditions. This rapid test provides healthcare professionals with a convenient point-of-care screening tool to assist in identifying individuals who may require further clinical evaluation or laboratory confirmation.
The Mono Pack contains a single test device, making it suitable for clinics, hospitals, physician practices, wellness centres, health screening camps, occupational health programmes, and diagnostic laboratories.
Microsidd supplies genuine diagnostic products with secure packaging, fast dispatch, and delivery across India.
Product Name: Vitamin D Rapid Test Kit (Mono Pack)
Test Type: Rapid Immunochromatographic Assay
Analyte: 25-Hydroxy Vitamin D [25(OH)D]
Result Type: Qualitative / Semi-Quantitative (Refer Manufacturer Instructions)
Sample Type: Fingerstick Whole Blood or Venous Whole Blood (Refer IFU)
Pack Size: Mono Pack (Single Test)
Intended Use: Professional In-Vitro Diagnostic (IVD)
Ideal For: Hospitals, Clinics, Diagnostic Laboratories, Wellness Centres and Healthcare Professionals
The Vitamin D Rapid Test Kit is a rapid diagnostic assay designed to screen for 25-Hydroxy Vitamin D [25(OH)D], the primary circulating form of Vitamin D commonly measured to evaluate Vitamin D status.
Vitamin D is important for calcium metabolism, healthy bones, teeth, muscles, and normal immune function. Individuals with low Vitamin D levels may require additional clinical assessment and laboratory investigations as recommended by their healthcare provider.
This rapid test provides an initial screening result that can support healthcare professionals during routine health assessments and preventive health programmes.
The Vitamin D Rapid Test Kit may be used for:
Vitamin D deficiency screening
Preventive health check-ups
Routine wellness assessments
Hospital and clinic screening programmes
Physician office testing
Occupational health screening
Community health camps
Diagnostic laboratory support
Nutritional assessment programmes
Rapid screening for 25-Hydroxy Vitamin D [25(OH)D]
Professional point-of-care diagnostic solution
Convenient Mono Pack for single-patient testing
Simple immunochromatographic testing method
Suitable for preventive health programmes
Easy specimen collection using approved sample types
Compact and convenient test format
Supports timely clinical assessment
Genuine diagnostic product supplied by Microsidd
Vitamin D is essential for maintaining healthy bones and supporting normal calcium and phosphorus metabolism. Healthcare professionals may recommend Vitamin D testing for individuals who have risk factors for deficiency, symptoms consistent with low Vitamin D, or as part of routine health assessments.
People who may benefit from screening include:
Older adults
Individuals with limited sun exposure
People with nutritional deficiencies
Individuals with osteoporosis or reduced bone density
Patients with certain gastrointestinal disorders affecting nutrient absorption
People undergoing routine preventive health screening
Testing decisions should always be made by a qualified healthcare professional.
The Vitamin D Rapid Test Kit uses immunochromatographic lateral flow technology to detect 25-Hydroxy Vitamin D [25(OH)D] in the collected blood specimen.
After the appropriate sample and buffer are added according to the manufacturer's instructions, the specimen migrates across the membrane where specific antibodies react with the target analyte. The appearance of visible lines is interpreted according to the supplied instructions for use.
Results should always be interpreted together with the patient's clinical history, symptoms, physical examination, and, when appropriate, confirmatory laboratory testing.
This product is intended for professional use by:
Physicians
Clinical Pathologists
Hospital Laboratories
Diagnostic Laboratories
Wellness Clinics
Preventive Health Centres
Occupational Health Teams
Qualified Healthcare Professionals
This product is not intended for self-testing unless specifically approved by the manufacturer.
Each Mono Pack generally contains:
1 Vitamin D Rapid Test Device
Sample Collection Device (where supplied)
Buffer Solution
Manufacturer's Instructions for Use (IFU)
Please refer to the product packaging for the exact kit contents.
Bring the test kit and specimen to room temperature.
Collect the required blood specimen according to the manufacturer's instructions.
Apply the recommended volume of sample to the test device.
Add the supplied buffer if required.
Allow the test to develop for the specified time.
Read the result only within the recommended interpretation period.
Dispose of all used materials according to biomedical waste regulations.
Always follow the manufacturer's Instructions for Use (IFU).
| Feature | Details |
|---|---|
| Product Name | Vitamin D Rapid Test Kit |
| Pack Size | Mono Pack |
| Target Analyte | 25-Hydroxy Vitamin D [25(OH)D] |
| Test Method | Immunochromatographic Assay |
| Sample Type | Fingerstick or Venous Whole Blood (Refer IFU) |
| Result Type | Qualitative / Semi-Quantitative |
| Intended Use | Professional IVD |
| Usage | Single Use |
| Application | Vitamin D Screening |
| Specification | Details |
|---|---|
| Product Category | Vitamin D Rapid Test |
| Detection Target | 25-Hydroxy Vitamin D [25(OH)D] |
| Method | Immunochromatographic Lateral Flow Assay |
| Sample | Whole Blood (Refer IFU) |
| Intended User | Healthcare Professionals |
| Usage | Single Use |
| Storage | Store according to manufacturer instructions |
Store according to the manufacturer's recommended storage conditions.
Keep the test device sealed until use.
Protect from moisture, excessive heat, and direct sunlight.
Do not freeze unless specified by the manufacturer.
Do not use after the expiry date.
Do not reuse the test device.
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Trusted by hospitals, clinics, laboratories, pharmacies, and healthcare professionals
The test is designed to detect 25-Hydroxy Vitamin D [25(OH)D], the primary marker used to assess Vitamin D status.
The test is intended for qualified healthcare professionals in hospitals, clinics, diagnostic laboratories, and wellness centres.
Unless specifically stated by the professional, this product is intended for professional in-vitro diagnostic use.
Refer to the manufacturer's Instructions for Use for approved specimen types, which may include fingerstick or venous whole blood.
This rapid test is intended as a screening tool. Results should be interpreted together with the patient's clinical assessment and may require confirmation using laboratory methods where appropriate.
Vitamin D plays an important role in bone health, calcium absorption, muscle function, and immune system support. Healthcare professionals may recommend testing when deficiency is suspected or during preventive health assessments.
No. The Mono Pack contains a single-use disposable test device.
Store according to the manufacturer's recommendations and do not use beyond the expiry date.
Microsidd supplies genuine diagnostic products, offers secure ordering, fast dispatch, reliable customer support, and delivery throughout India.
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The Vitamin D Rapid Test Kit (Mono Pack) is an in-vitro diagnostic medical device intended for professional use. Test results should always be interpreted by qualified healthcare professionals together with the patient's medical history, clinical findings, and, where appropriate, confirmatory laboratory testing. This product is not intended to replace professional medical advice, diagnosis, or treatment.
Vitamin D Rapid Test Kit is a rapid and convenient immunochromatographic assay for the semi quantitative detection of 25-hydroxy vitamin D (25-OH
vitamin D) in human Whole Blood. The device is designed for over-the- counter use as well as professional use. This assay provides only a preliminary result.
Clinical consideration and professional judgment should be applied to Vitamin D deficiency test results. Particularly in evaluating a preliminary positive result,
a more specific chemical method is advised
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 deficiency has been linked to various serious diseases: Osteoporosis, Osteoma Acia, Multiple Sclerosis, Cardiovascular Diseases, Pregnancy
Complications, Diabetes, Depression, Strokes, Autoimmune Diseases, Flu, Different Cancers, Infectious Diseases, Alzheimer, Obesity and Higher Mortality
etc. Therefore, the detection of 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
SUMMARY AND PRINCIPLE OF THE ASSAY
Vitamin D is a group of fat-soluble ketosteroids responsible for increasing intestinal absorption of calcium, magnesium, zinc, iron etc. The most essential
compounds in this group are Vitamin D2 and D3, D2 is mainly Obtained from food, and D3 is naturally produced in human skin through the exposure to
ultraviolet light. Vitamin D is transported to the liver where it is metabolized to 25 - hydroxy Vitamin D (25-OH vitamin D). In clinical, a 25-OH vitamin D whole
blood test is used to determine Vitamin D concentration in the body. The whole blood concentration of 25-OH vitamin D (including D2 and D3) is considered
the best indicator of Vitamin D status:
Deficiency: < 12 ng/ml (30 nM)
Insufficient: 12-20 ng/ml (30-50 nM)
Insufficient: 20-50 ng/ml (50-125 nM) Insufficient: > 50 ng/ml (> 125 nM)
Deficient (< 12 ng/ml):
One red band appears in the control region (C). No or a faint red band appears at the test region (T). The red band intensity in the test region (T) is weaker
than the 12 -20 ng/mL color band depicted on the reference card. It is recommended to consult a physician for a deficient result.
Insufficient (12-20 ng/ml):
Two red bands appear. One is in the control region (C), another one is in the test region (T). The red band intensity in the test region (T) is weaker than the
20-50 ng/mL color band depicted on the reference card
Sufficient (20-50 ng/ml):
Two red bands appear. One is in the control region (C), another one is in the test region (T). The red band intensity in the test region (T) is darker than
12-20 ng/mL color band and lighter than > 50 ng/mL color band depicted on the reference card.
Excess (> 50 ng/ml):
Two red bonds appear. One is in the control region (C), another one is in the test region (T). The red band intensity in the test region (T) is darker than the
20-50 ng/mL color band depicted on the reference card.
Invalid:
No visible band appears at the control region (C). Repeat with a new test kit. If the test still fails, please contact the distributor with the lot number
For in vitro diagnostic use only.
· Do not reuse.
· Do not use if the pouch seal or its packaging is compromised.
· Do not use after the expiration date shown on the pouch.
· Do not mix and interchange different specimens.
· Wear protective clothing such as laboratory coats, disposable gloves and eye protection while
handling potentially infectious materials or performing the assay.
· Wash hands thoroughly after finishing the tests.
· Do not eat, drink, or smoke in the area where the specimens or kits are being handled.
· Clean up spills thoroughly with appropriate disinfectants.
· Handle all specimens as if they contain infectious agents. Observe established precautions
against microbiological hazards throughout testing procedures.
· Dispose of all specimens and used devices in a proper bio-hazard container. The handling
and disposal of hazardous materials should follow local, national or regional regulations.
· Keep out of children's reach.
| Specification name | Specification Value |
|---|---|
| Test method | Point-of-care test, RDT, Lab analysis, At-home test (self-administered) |
| Test sample | Blood |
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