GHM Sickle Cell Disease Rapid Test US – Qualitative Detection & Differentiation of Hemoglobin A, S, and C with 15-Minute Results, Whole Blood Sample Compatibility, and Professional Point-of-Care Use

SKU: GHM Sickle Cell Disease Rapid Test US
Brand: Global Healthcare Medical

Product Overview

Global Healthcare Medical GHM Sickle Cell Disease Rapid Test US is a lateral flow chromatographic immunoassay designed for the simultaneous detection and differentiation of hemoglobin A (HbA), hemoglobin S (HbS), and hemoglobin C (HbC) in human whole blood specimens. The kit is intended for use by healthcare professionals as a screening test and as an aid in the diagnosis of sickle cell disease (SCD) and hemoglobinopathy variants.

Sickle cell disease is a group of inherited red blood cell disorders caused by mutations in the beta-globin gene, resulting in the production of abnormal hemoglobin. The most common and severe form is sickle cell anemia (HbSS), in which red blood cells become rigid and crescent-shaped, leading to chronic hemolytic anemia, vaso-occlusive crises, and progressive organ damage. Sickle cell trait (HbAS) occurs when an individual inherits one sickle cell gene and one normal gene, generally causing no symptoms but carrying the potential to pass the trait to offspring. Hemoglobin C (HbC) is another clinically significant variant that can combine with HbS to produce HbSC disease, a form of sickle cell disease that can cause significant complications.

Globally, an estimated 7.74 million people were living with sickle cell disease in 2021, with 515,000 new births, primarily in sub-Saharan Africa, which accounts for nearly 80% of global cases. Sickle cell disease is prevalent among people whose ancestors originated from regions where malaria was or is still endemic, including sub-Saharan Africa, the Mediterranean, the Middle East, and India. Among African Americans, the prevalence of sickle cell trait is approximately 10%, resulting in approximately 1,100 infants with SCD born annually in the United States. Early diagnosis through newborn screening and confirmatory testing is critical for initiating prophylactic treatment, reducing mortality, and improving long-term outcomes.

The GHM Sickle Cell Disease Rapid Test US delivers qualitative results in just 15 minutes, supporting rapid clinical decision-making at the point of care. The test requires only a small volume of whole blood, collected by venipuncture or fingerstick, and provides simultaneous differentiation of HbA, HbS, and HbC in a single assay. The kit is intended for in vitro diagnostic use and professional use only, suitable for application scenarios including newborn screening programs, pediatric clinics, hematology clinics, genetic counseling services, 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 lateral flow immunochromatography.

Key Features & Benefits

3-in-1 Detection – Simultaneous Identification of HbA, HbS, and HbC

The GHM Sickle Cell Disease Rapid Test US utilizes a lateral flow chromatographic immunoassay capable of simultaneously detecting and differentiating hemoglobin A (HbA), hemoglobin S (HbS), and hemoglobin C (HbC) from a single patient sample. This triple-target design enables healthcare professionals to distinguish between normal hemoglobin (HbAA), sickle cell trait (HbAS), sickle cell disease (HbSS), and hemoglobin C variants (HbAC, HbCC, HbSC) in a single rapid test, supporting accurate diagnosis and appropriate clinical management.

Fast Results – 15 Minutes

The GHM Sickle Cell Disease Rapid Test US provides qualitative results in just 15 minutes, supporting rapid clinical decision-making and efficient patient workflow in point-of-care settings. Rapid diagnostic tests for sickle cell disease enable faster case identification and support timely clinical intervention, particularly in newborn screening and pediatric care settings where early diagnosis is critical.

Whole Blood Sample Compatibility – Simple and Efficient Collection

The GHM Sickle Cell Disease Rapid Test US is compatible with whole blood specimens collected by venipuncture or fingerstick, providing simple and efficient sample collection methods suitable for a wide range of clinical settings. The test requires only a small volume of whole blood (5 µL), making it practical for use in newborn screening programs and pediatric settings where sample volume may be limited.

Clinical Utility – Aid for Diagnosis of Sickle Cell Disease and Hemoglobinopathies

The GHM Sickle Cell Disease Rapid Test US is intended for use as a screening test and as an aid in the diagnosis of sickle cell disease and hemoglobinopathy variants. The test provides rapid hemoglobin typing, enabling timely clinical decision-making and supporting patient management. Early and accurate identification of sickle cell disease is essential for reducing SCD-related morbidity and mortality through prompt initiation of prophylactic treatment and comprehensive care.

The triple-target design provides comprehensive diagnostic value. Detection of HbAA indicates normal hemoglobin. Detection of HbAS indicates sickle cell trait, which is generally asymptomatic but carries reproductive implications. Detection of HbSS indicates sickle cell disease (sickle cell anemia), the most severe form. Detection of HbC patterns (HbAC, HbCC, HbSC) identifies hemoglobin C variants, which may have clinical significance depending on the specific genotype.

The test is particularly valuable in settings where rapid identification of sickle cell disease supports newborn screening and early intervention. The test is also suitable for use in decentralized testing environments where laboratory infrastructure may be limited.

High Accuracy – Trusted Clinical Performance

The GHM Sickle Cell Disease Rapid Test US is designed to deliver reliable clinical performance with high sensitivity and specificity across all three hemoglobin targets. Clinical evaluation against reference methods has demonstrated strong performance, making this assay a valuable tool for point-of-care diagnostics when correctly used.

Performance characteristics based on evaluations of rapid hemoglobinopathy tests. A systematic review and meta-analysis of point-of-care diagnostic tests in children and adolescents with sickle cell disease reported that when detecting homozygous SCD, the pooled sensitivity and specificity of included lateral flow immunoassays was 92% or higher in all individual meta-analyses. Sensitivities and specificities were also nearly 100% when detecting hemoglobin SC disease for these point-of-care tests. Field evaluations of rapid hemoglobinopathy tests have reported sensitivities ranging from 95.8% to 100% for sickle cell trait and disease detection, with specificities exceeding 96%.

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 Sickle Cell Disease 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

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 Sickle Cell Disease 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.