GHM Vitamin D Semi-Quantitative Rapid Test US – Semi-Quantitative Detection of 25-Hydroxyvitamin D with 10-Minute Results, Fingerstick Whole Blood Sample Compatibility, and Professional Point-of-Care Use

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SKU: GHM Vitamin D Semi-Quantitative Rapid Test US
Brand: Global Healthcare Medical

Product Overview

Global Healthcare Medical GHM Vitamin D Semi-Quantitative Rapid Test US is a lateral flow chromatographic immunoassay designed for the semi-quantitative detection of 25-hydroxyvitamin D (25(OH)D) in human fingerstick whole blood, serum, and plasma specimens. The kit is intended for use by healthcare professionals as a screening test and as an aid in the assessment of vitamin D status.

Vitamin D is a fat-soluble nutrient essential for bone development and maintenance, as it enhances calcium, magnesium, and phosphate absorption. Vitamin D deficiency affects an estimated one billion people worldwide and is linked to osteoporosis, immune dysfunction, and cardiometabolic disease. Approximately 40% of children and adults are vitamin D deficient, and 60% are deficient or insufficient globally. A circulating 25-hydroxyvitamin D level above 30 ng/mL is necessary to ensure adequate levels of the unmodified molecule, and deficiency can lead to various complications, most notably rickets in children and osteoporosis in adults. The evaluation of vitamin D deficiency involves measuring serum levels of the 25-hydroxy form, with values below 20 ng/mL indicating deficiency, levels between 20 and 30 ng/mL suggesting insufficiency, and levels above 30 ng/mL indicating sufficiency.

The GHM Vitamin D Semi-Quantitative Rapid Test US provides a practical, point-of-care screening solution for the rapid classification of vitamin D status, enabling timely clinical decision-making and supporting appropriate patient management. The test delivers semi-quantitative results in just 10 minutes, supporting rapid clinical assessment at the point of care. The test is compatible with fingerstick whole blood, serum, and plasma specimens, providing flexible sample collection options suitable for a wide range of clinical settings, including primary care clinics, endocrinology clinics, and clinical laboratories.

The kit is intended for in vitro diagnostic use and professional use only, suitable for application scenarios including primary care clinics, endocrinology clinics, hospital laboratories, and clinical laboratories. The VivaDiag product line is manufactured under an EN ISO 13485 certified quality management system covering in vitro diagnostic test kits and analyzers based on immunochromatography.

Key Features & Benefits

Colloidal Gold Immunochromatography – Reliable Semi-Quantitative Detection

The GHM Vitamin D Semi-Quantitative Rapid Test US is based on lateral flow chromatographic immunoassay technology. The test strip contains colloidal gold-conjugated antibodies specific to 25-hydroxyvitamin D, along with immobilized capture reagents on the test line. The test provides semi-quantitative results by comparing the intensity of the test line against a reference scale, enabling healthcare professionals to classify vitamin D status into three clinically important categories: deficiency (<20 ng/mL), insufficiency (20–30 ng/mL), and sufficiency (>30 ng/mL).

Feature	Benefit
Colloidal gold immunochromatography	Established and reliable detection method
Semi-quantitative analysis	Provides estimated 25(OH)D concentration for clinical decision-making
25(OH)D-specific antibodies	Targeted detection of 25-hydroxyvitamin D
Three-category classification	Distinguishes deficiency, insufficiency, and sufficiency
Internal procedural control	Confirms proper test performance

Fast Results – 10 Minutes

The GHM Vitamin D Semi-Quantitative Rapid Test US provides semi-quantitative results in just 10 minutes, supporting rapid clinical decision-making and efficient patient workflow in point-of-care settings. Traditional laboratory-based vitamin D testing relies on high-performance liquid chromatography (HPLC) or chemiluminescent assays—methods that are costly and time-consuming. Rapid point-of-care testing addresses these limitations by delivering actionable results within minutes.

Feature	Benefit
10-minute test time	Rapid turnaround for timely clinical decisions
Point-of-care compatibility	Suitable for primary care clinics and endocrinology clinics
Efficient workflow	Enables immediate patient assessment
Quick sample-to-result	Supports high-throughput screening environments

Fingerstick Whole Blood Compatibility – Simple and Non-Invasive Collection

The GHM Vitamin D Semi-Quantitative Rapid Test US is compatible with fingerstick whole blood specimens, providing a simple and minimally invasive sample collection method. The test requires only 20 µL of fingerstick whole blood, making it practical for use in both clinic-based and field-based testing scenarios. Serum and plasma specimens may also be used. Cross-platform testing between serum and capillary samples has confirmed a 100% classification agreement rate and an overall diagnostic accuracy of 95.5%.

Feature	Benefit
Fingerstick whole blood	Simple and minimally invasive sample collection
Serum and plasma compatibility	Flexible specimen options for different clinical protocols
Small sample volume required	Practical for pediatric and adult patients
No special equipment required	Streamlined workflow in clinical settings

Clinical Utility – Aid for Assessment of Vitamin D Status

The GHM Vitamin D Semi-Quantitative Rapid Test US is intended for use as a screening test and as an aid in the assessment of vitamin D status. The test provides rapid semi-quantitative detection of 25(OH)D, enabling timely clinical decision-making and supporting patient management.

The test is particularly valuable in settings where rapid identification of vitamin D deficiency supports timely initiation of supplementation and prevention of associated complications. The 2024 Endocrine Society Clinical Practice Guideline recommends against routine 25(OH)D testing in healthy individuals without specific risk factors, and testing should be reserved for patients with clinical indications such as hypocalcemia, osteoporosis, malabsorption syndromes, chronic kidney disease, and other conditions associated with hypovitaminosis D. The test is also suitable for use in decentralized testing environments where laboratory infrastructure may be limited.

Feature	Benefit
Vitamin D deficiency detection aid	Supports identification of vitamin D deficiency and insufficiency
Risk stratification support	Helps identify patients requiring supplementation
Screening test utility	Suitable for use as a screening test in clinical settings
Field-friendly testing	No instrumentation required, suitable for decentralized settings
Clinical versatility	Useful across primary care clinics, endocrinology clinics, and clinical laboratories

High Accuracy – Trusted Clinical Performance

The GHM Vitamin D Semi-Quantitative Rapid Test US is designed to deliver reliable clinical performance with high sensitivity and specificity. The product specifications report a sensitivity of 94.6%, specificity of 93.3%, and accuracy of 94.4%. A clinical performance evaluation of the Vitamin D Rapid Test Cassette demonstrated that the test correctly classified vitamin D status in all ten HPLC-verified samples, achieving 100% categorical agreement, and achieved 94.4% overall agreement in a larger in-house cohort of 90 clinical specimens.

Parameter	Specification
Sensitivity	94.6%
Specificity	93.3%
Accuracy	94.4%
Cut-off Values	10, 30, 100 ng/mL
Detection Range	5–100 ng/mL
Specimen	Fingerstick Whole Blood / Serum / Plasma
Time to Result	10 minutes
Storage Temperature	2–30°C (35.6–86°F)
Shelf Life	24 months

Performance characteristics based on product specifications and published evaluations of rapid vitamin D tests. A clinical performance evaluation of the Vitamin D Rapid Test Cassette (OVD-402H) demonstrated 100% categorical agreement with HPLC in ten fingerstick whole-blood samples spanning deficient, insufficient, and sufficient ranges, and 94.4% overall agreement in a larger in-house cohort of 90 archived clinical specimens benchmarked against a predicate quantitative assay. A smartphone-integrated sandwich-type LFA for 25(OH)D achieved a detection range of 5–100 ng/mL, with little interference and cross-reactivity for endogenous substances or structurally similar vitamin D derivatives, and demonstrated 97.0% category consensus (κ = 0.951) compared with the Atellica IM 1600 analyzer. Detection is optimal when specimens are collected and processed according to the manufacturer's instructions, and the test is best suited for use as an aid in the assessment of vitamin D status in at-risk patients. The test provides a preliminary result; quantitative laboratory testing is recommended for confirmation and monitoring.

ISO 13485 Certified – Quality and Safety Compliance

The VivaDiag product line is manufactured under an EN ISO 13485 certified quality management system, demonstrating compliance with stringent international standards for the design, development, manufacture, and distribution of in vitro diagnostic test kits and analyzers.

Feature	Benefit
EN ISO 13485 certification	Quality management system compliance
IVD scope	Certified for in vitro diagnostic test kits
Quality assurance	Meets high standards of quality and safety
Professional-grade	Designed for healthcare professional use

CE Marked – European Conformity

The GHM Vitamin D Semi-Quantitative Rapid Test US is CE marked for professional in vitro diagnostic use, demonstrating conformity with applicable European regulatory requirements for diagnostic medical devices.

Feature	Benefit
CE marking	Regulatory compliance for professional use
Professional IVD use	Designed for trained healthcare personnel
Quality compliance	Meets European regulatory standards

Product Specifications

Specification	Detail
Model / SKU	GHM Vitamin D Semi-Quantitative Rapid Test US
Product Code	OVD-402H
Product Type	Vitamin D Semi-Quantitative Rapid Test (Colloidal Gold)
Intended Use	Semi-quantitative detection of 25-hydroxyvitamin D (25(OH)D) in human fingerstick whole blood, serum, or plasma specimens; used as a screening test and as an aid in the assessment of vitamin D status
Detection Principle	Lateral flow chromatographic immunoassay; colloidal gold
Target Analyte	25-hydroxyvitamin D (25(OH)D)
Specimen	Fingerstick Whole Blood / Serum / Plasma
Sample Volume	20 µL fingerstick whole blood
Time to Result	10 minutes
Sensitivity	94.6%
Specificity	93.3%
Accuracy	94.4%
Cut-off Values	10, 30, 100 ng/mL
Detection Range	5–100 ng/mL
Storage Temperature	2–30°C (35.6–86°F)
Shelf Life	24 months
Application Scenario	Primary care clinic, endocrinology clinic, hospital laboratory, clinical laboratory, point-of-care
Regulatory Status	Manufactured under EN ISO 13485 certified quality management system; CE marked
Intended User	Professional healthcare use only
Kit Sizes	25 tests/kit; 40 tests/kit
Kit Contents	Test Cassette, Buffer, Disposable Droppers, Instructions for Use

Important Testing Notes:

Allow the test kit and sample to reach room temperature (18–30°C) prior to testing.
For fingerstick whole blood, clean the fingertip with an alcohol swab and allow it to dry; collect blood using a sterile lancet.
Apply 20 µL of fingerstick whole blood to the cassette sample well, followed by two drops of buffer.
Results should be interpreted at 10 minutes. Do not interpret results after 20 minutes.
The test provides semi-quantitative results by comparing test line intensity against the reference scale.
The test is intended for screening and preliminary assessment. Quantitative laboratory testing is recommended for confirmation and monitoring of vitamin D status.
The 2024 Endocrine Society Clinical Practice Guideline recommends against routine 25(OH)D testing in healthy individuals without specific risk factors; testing should be reserved for patients with clinical indications.
Healthcare professionals should exercise clinical consideration and professional judgment with any test result.

Why Clinical Professionals Choose Global Healthcare Medical

Consideration	GHM Vitamin D Semi-Quantitative Rapid Test US
Colloidal gold immunochromatography	Established and reliable detection technology
10-minute test time	Rapid turnaround for timely clinical decisions
Fingerstick whole blood compatibility	Simple and minimally invasive sample collection
Semi-quantitative detection	Provides estimated 25(OH)D concentration for clinical decision-making
High sensitivity and specificity	94.6% sensitivity, 93.3% specificity, and 94.4% accuracy
100% categorical agreement with HPLC	Strong concordance with reference methods
Three-category classification	Distinguishes deficiency, insufficiency, and sufficiency
Screening test utility	Suitable for use as a screening test in clinical settings
ISO 13485 certified	Quality management system compliance
CE marked	Regulatory compliance for professional use
Point-of-care compatible	Suitable for primary care clinics, endocrinology clinics, and clinical laboratories

About Global Healthcare Medical

Global Healthcare Medical is dedicated to connecting healthcare providers, retailers, and distributors with high-quality medical devices designed for reliable performance. The GHM Vitamin D Semi-Quantitative Rapid Test US is part of our professional diagnostic line, developed to support accurate, efficient, and accessible point-of-care testing in clinical environments.

Our focus is on dependable performance, clear documentation, and responsive support for professional healthcare settings.