GHM Ferritin Semi-Quantitative Rapid Test US – Semi-Quantitative Detection of Human Ferritin with 5-Minute Results, Whole Blood / Serum / Plasma Sample Compatibility, and Professional Point-of-Care Use

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

Product Overview

Global Healthcare Medical GHM Ferritin Semi-Quantitative Rapid Test US is a lateral flow chromatographic immunoassay designed for the semi-quantitative detection of human ferritin in human whole blood, serum, or plasma specimens. The kit is intended for use by healthcare professionals as an aid in the diagnosis of iron deficiency anemia.

Iron deficiency (ID) is among the most common global hematologic disorders and a leading contributor to the global disease burden. Over one-third of individuals worldwide have iron deficiency anemia (IDA), with children and pregnant women living in low- and middle-income countries disproportionately impacted. In 2021, an estimated 24.3% of the global population had anemia, with iron deficiency recognized as the leading cause. Serum ferritin is the most specific routine test for diagnosing ID, with values reflective of body iron stores. A serum ferritin concentration of less than 30 μg/L has a high specificity and sensitivity for diagnosing iron deficiency in adults. However, the diagnosis of ID is frequently overlooked by clinicians, and access to timely testing remains a barrier in many settings.

The GHM Ferritin Semi-Quantitative Rapid Test US provides a practical, point-of-care screening solution for the rapid assessment of ferritin levels, enabling timely clinical decision-making and supporting appropriate patient management. The test delivers semi-quantitative results in just 5 minutes, supporting rapid clinical assessment at the point of care. The test is compatible with whole blood (venipuncture or fingerstick), serum, and plasma specimens, providing flexible sample collection options suitable for a wide range of clinical settings.

The kit is intended for in vitro diagnostic use and professional use only, suitable for application scenarios including primary care clinics, hematology clinics, prenatal screening programs, 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 Ferritin Semi-Quantitative Rapid Test US is based on lateral flow chromatographic immunoassay technology. The test strip contains colloidal gold-conjugated antibodies specific to human ferritin, along with immobilized capture antibodies 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 estimate ferritin concentrations and classify iron status using sex-specific cut-off values (30 ng/mL for males, 13 ng/mL for females).

Fast Results – 5 Minutes

The GHM Ferritin Semi-Quantitative Rapid Test US provides semi-quantitative results in just 5 minutes, supporting rapid clinical decision-making and efficient patient workflow in point-of-care settings. Traditional laboratory-based ferritin testing requires venous blood collection and laboratory processing, which can delay clinical decision-making. Rapid point-of-care testing addresses these limitations by delivering actionable results within minutes.

Whole Blood / Serum / Plasma Compatibility – Flexible Sample Collection

The GHM Ferritin Semi-Quantitative Rapid Test US is compatible with whole blood (venipuncture or fingerstick), serum, and plasma specimens, providing flexible sample collection options to accommodate different clinical protocols and patient needs. The test requires only a small sample volume, making it suitable for both clinic-based and field-based testing scenarios.

Clinical Utility – Aid for Diagnosis of Iron Deficiency Anemia

The GHM Ferritin Semi-Quantitative Rapid Test US is intended for use as an aid in the diagnosis of iron deficiency anemia. The test provides rapid semi-quantitative detection of ferritin, enabling timely clinical decision-making and supporting patient management.

The test is particularly valuable in settings where rapid identification of iron deficiency supports timely initiation of iron supplementation and prevention of associated complications. Serum ferritin is the most sensitive and specific test to diagnose iron deficiency, with values reflective of body iron stores. The test is also suitable for use in decentralized testing environments where laboratory infrastructure may be limited. Point-of-care ferritin testing may be a useful adjunct with good sensitivity to detect iron deficiency in appropriate clinical contexts.

High Accuracy – Trusted Clinical Performance

The GHM Ferritin Semi-Quantitative Rapid Test US is designed to deliver reliable clinical performance with high sensitivity and specificity. The product specifications report a sensitivity of 94.7%, specificity of 95.2%, and accuracy of 95.1%. Published evaluations of point-of-care ferritin assays have demonstrated high sensitivity for detecting iron deficiency, with one validation trial reporting 90% sensitivity and 96% specificity using the WHO cut-off of <30 ng/mL. A prospective cohort analysis reported high sensitivity (88.7%) for point-of-care ferritin in detecting iron deficiency (ferritin < 30 ng/mL) compared to laboratory serum ferritin.

Performance characteristics based on product specifications and published evaluations of rapid ferritin tests. A validation trial of a point-of-care ferritin system using capillary whole blood reported a sensitivity of 90% and specificity of 96% for diagnosing iron deficiency using the WHO cut-off of <30 ng/mL. A prospective cohort analysis of point-of-care ferritin testing reported high sensitivity (88.7%) but lower specificity (34.8%) compared to laboratory serum ferritin in detecting iron deficiency. 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 diagnosis of iron deficiency anemia. The test provides a preliminary result; laboratory-based quantitative 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.

CE Marked – European Conformity

The GHM Ferritin 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.

Product Specifications

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 the specimen to the cassette sample well according to the instructions, followed by the buffer.

• Results should be interpreted at 5 minutes. Do not interpret results after 10 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. Laboratory-based quantitative testing is recommended for confirmation and monitoring of ferritin levels.

• Serum ferritin should be interpreted in the correct clinical context, as ferritin is an acute-phase reactant and may be elevated in inflammatory conditions even when iron stores are low.

• A serum ferritin level <30 μg/L for an adult is diagnostic of iron deficiency; levels of 30–100 μg/L in an anemic adult may represent iron deficiency if there is coexisting inflammatory disease.

• Healthcare professionals should exercise clinical consideration and professional judgment with any test result.

Why Clinical Professionals Choose Global Healthcare Medical

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 Ferritin 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.