{"product_id":"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","title":"GHM Sickle Cell Disease Rapid Test US – Qualitative Detection \u0026 Differentiation of Hemoglobin A, S, and C with 15-Minute Results, Whole Blood Sample Compatibility, and Professional Point-of-Care Use","description":"\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eSKU:\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e GHM Sickle Cell Disease Rapid Test US\u003c\/span\u003e\u003cbr\u003e\u003cspan class=\"\"\u003e\u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eBrand:\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e Global Healthcare Medical\u003c\/span\u003e\u003c\/p\u003e\n\u003ch2\u003e\u003cspan class=\"\"\u003eProduct Overview\u003c\/span\u003e\u003c\/h2\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eGlobal Healthcare Medical GHM Sickle Cell Disease Rapid Test US\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e 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.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eSickle 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.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eGlobally, 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\u003c\/span\u003e\u003cspan class=\"\"\u003e. 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\u003c\/span\u003e\u003cspan class=\"\"\u003e. 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\u003c\/span\u003e\u003cspan class=\"\"\u003e. Early diagnosis through newborn screening and confirmatory testing is critical for initiating prophylactic treatment, reducing mortality, and improving long-term outcomes.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe 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.\u003c\/span\u003e\u003c\/p\u003e\n\u003ch2\u003e\u003cspan class=\"\"\u003eKey Features \u0026amp; Benefits\u003c\/span\u003e\u003c\/h2\u003e\n\u003ch3\u003e\u003cspan class=\"\"\u003e3-in-1 Detection – Simultaneous Identification of HbA, HbS, and HbC\u003c\/span\u003e\u003c\/h3\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe 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.\u003c\/span\u003e\u003c\/p\u003e\n\u003cdiv class=\"ds-scroll-area ds-scroll-area--show-on-focus-within ds-scroll-area--enabled _1210dd7 c03cafe9\"\u003e\n\u003cdiv class=\"ds-scroll-area__gutters\"\u003e\n\u003cdiv class=\"ds-scroll-area__horizontal-gutter\"\u003e\u003cbr\u003e\u003c\/div\u003e\n\u003cdiv class=\"ds-scroll-area__vertical-gutter\"\u003e\u003cbr\u003e\u003c\/div\u003e\n\u003c\/div\u003e\n\u003ctable\u003e\n\u003cthead\u003e\n\u003ctr\u003e\n\u003cth\u003e\u003cspan class=\"\"\u003eFeature\u003c\/span\u003e\u003c\/th\u003e\n\u003cth\u003e\u003cspan class=\"\"\u003eBenefit\u003c\/span\u003e\u003c\/th\u003e\n\u003c\/tr\u003e\n\u003c\/thead\u003e\n\u003ctbody\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e3-in-1 hemoglobin detection\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eSimultaneously detects and differentiates HbA, HbS, and HbC in one test\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eDistinguishes trait from disease\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eDifferentiates sickle cell trait (HbAS) from sickle cell disease (HbSS)\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eDetects hemoglobin C variants\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eIdentifies HbC and HbSC variants alongside HbS\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eColloidal gold immunochromatography\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eEstablished and reliable detection method\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eSingle-sample workflow\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eReduces the need for multiple specimen collections and separate tests\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eQualitative visual result\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eClear and interpretable test outcome\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003c\/tbody\u003e\n\u003c\/table\u003e\n\u003c\/div\u003e\n\u003ch3\u003e\u003cspan class=\"\"\u003eFast Results – 15 Minutes\u003c\/span\u003e\u003c\/h3\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe 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.\u003c\/span\u003e\u003c\/p\u003e\n\u003cdiv class=\"ds-scroll-area ds-scroll-area--show-on-focus-within ds-scroll-area--enabled _1210dd7 c03cafe9\"\u003e\n\u003cdiv class=\"ds-scroll-area__gutters\"\u003e\n\u003cdiv class=\"ds-scroll-area__horizontal-gutter\"\u003e\u003cbr\u003e\u003c\/div\u003e\n\u003cdiv class=\"ds-scroll-area__vertical-gutter\"\u003e\u003cbr\u003e\u003c\/div\u003e\n\u003c\/div\u003e\n\u003ctable\u003e\n\u003cthead\u003e\n\u003ctr\u003e\n\u003cth\u003e\u003cspan class=\"\"\u003eFeature\u003c\/span\u003e\u003c\/th\u003e\n\u003cth\u003e\u003cspan class=\"\"\u003eBenefit\u003c\/span\u003e\u003c\/th\u003e\n\u003c\/tr\u003e\n\u003c\/thead\u003e\n\u003ctbody\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e15-minute test time\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eRapid turnaround for timely clinical decisions\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003ePoint-of-care compatibility\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eSuitable for newborn screening programs and pediatric clinics\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eEfficient workflow\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eEnables immediate patient assessment\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eQuick sample-to-result\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eSupports high-throughput screening environments\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003c\/tbody\u003e\n\u003c\/table\u003e\n\u003c\/div\u003e\n\u003ch3\u003e\u003cspan class=\"\"\u003eWhole Blood Sample Compatibility – Simple and Efficient Collection\u003c\/span\u003e\u003c\/h3\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe 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.\u003c\/span\u003e\u003c\/p\u003e\n\u003cdiv class=\"ds-scroll-area ds-scroll-area--show-on-focus-within ds-scroll-area--enabled _1210dd7 c03cafe9\"\u003e\n\u003cdiv class=\"ds-scroll-area__gutters\"\u003e\n\u003cdiv class=\"ds-scroll-area__horizontal-gutter\"\u003e\u003cbr\u003e\u003c\/div\u003e\n\u003cdiv class=\"ds-scroll-area__vertical-gutter\"\u003e\u003cbr\u003e\u003c\/div\u003e\n\u003c\/div\u003e\n\u003ctable\u003e\n\u003cthead\u003e\n\u003ctr\u003e\n\u003cth\u003e\u003cspan class=\"\"\u003eFeature\u003c\/span\u003e\u003c\/th\u003e\n\u003cth\u003e\u003cspan class=\"\"\u003eBenefit\u003c\/span\u003e\u003c\/th\u003e\n\u003c\/tr\u003e\n\u003c\/thead\u003e\n\u003ctbody\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eWhole blood specimen\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eSimple and efficient sample collection\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eVenipuncture or fingerstick\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eFlexible collection options for different clinical settings\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eSmall sample volume required\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003ePractical for newborn and pediatric patients\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eNo special equipment required\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eStreamlined workflow in clinical settings\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003c\/tbody\u003e\n\u003c\/table\u003e\n\u003c\/div\u003e\n\u003ch3\u003e\u003cspan class=\"\"\u003eClinical Utility – Aid for Diagnosis of Sickle Cell Disease and Hemoglobinopathies\u003c\/span\u003e\u003c\/h3\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe 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.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe 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.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe 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.\u003c\/span\u003e\u003c\/p\u003e\n\u003cdiv class=\"ds-scroll-area ds-scroll-area--show-on-focus-within ds-scroll-area--enabled _1210dd7 c03cafe9\"\u003e\n\u003cdiv class=\"ds-scroll-area__gutters\"\u003e\n\u003cdiv class=\"ds-scroll-area__horizontal-gutter\"\u003e\u003cbr\u003e\u003c\/div\u003e\n\u003cdiv class=\"ds-scroll-area__vertical-gutter\"\u003e\u003cbr\u003e\u003c\/div\u003e\n\u003c\/div\u003e\n\u003ctable\u003e\n\u003cthead\u003e\n\u003ctr\u003e\n\u003cth\u003e\u003cspan class=\"\"\u003eFeature\u003c\/span\u003e\u003c\/th\u003e\n\u003cth\u003e\u003cspan class=\"\"\u003eBenefit\u003c\/span\u003e\u003c\/th\u003e\n\u003c\/tr\u003e\n\u003c\/thead\u003e\n\u003ctbody\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eScreening test utility\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eSuitable for use as a screening test in clinical and public health settings\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eNewborn screening support\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eValuable for early identification of SCD in newborns\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eTrait identification\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eIdentifies sickle cell trait carriers for genetic counseling\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eHemoglobin C variant detection\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eIdentifies HbC and HbSC variants\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eField-friendly testing\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eNo instrumentation required, suitable for decentralized settings\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eClinical versatility\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eUseful across newborn screening programs, pediatric clinics, and hematology settings\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003c\/tbody\u003e\n\u003c\/table\u003e\n\u003c\/div\u003e\n\u003ch3\u003e\u003cspan class=\"\"\u003eHigh Accuracy – Trusted Clinical Performance\u003c\/span\u003e\u003c\/h3\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe 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.\u003c\/span\u003e\u003c\/p\u003e\n\u003cdiv class=\"ds-scroll-area ds-scroll-area--show-on-focus-within ds-scroll-area--enabled _1210dd7 c03cafe9\"\u003e\n\u003cdiv class=\"ds-scroll-area__gutters\"\u003e\n\u003cdiv class=\"ds-scroll-area__horizontal-gutter\"\u003e\u003cbr\u003e\u003c\/div\u003e\n\u003cdiv class=\"ds-scroll-area__vertical-gutter\"\u003e\u003cbr\u003e\u003c\/div\u003e\n\u003c\/div\u003e\n\u003ctable\u003e\n\u003cthead\u003e\n\u003ctr\u003e\n\u003cth\u003e\u003cspan class=\"\"\u003eTarget\u003c\/span\u003e\u003c\/th\u003e\n\u003cth\u003e\u003cspan class=\"\"\u003eSensitivity\u003c\/span\u003e\u003c\/th\u003e\n\u003cth\u003e\u003cspan class=\"\"\u003eSpecificity\u003c\/span\u003e\u003c\/th\u003e\n\u003c\/tr\u003e\n\u003c\/thead\u003e\n\u003ctbody\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eHemoglobin A (HbA)\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003e99.67%\u003c\/span\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003e98.04%\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eHemoglobin S (HbS)\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003e97.66%\u003c\/span\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003e99.49%\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eHemoglobin C (HbC)\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003e99%\u003c\/span\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003e99%\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003c\/tbody\u003e\n\u003c\/table\u003e\n\u003c\/div\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cem\u003e\u003cspan class=\"\"\u003ePerformance 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\u003c\/span\u003e\u003cspan class=\"\"\u003e. Sensitivities and specificities were also nearly 100% when detecting hemoglobin SC disease for these point-of-care tests\u003c\/span\u003e\u003cspan class=\"\"\u003e. 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%\u003c\/span\u003e\u003cspan class=\"\"\u003e.\u003c\/span\u003e\u003c\/em\u003e\u003c\/p\u003e\n\u003ch3\u003e\u003cspan class=\"\"\u003eISO 13485 Certified – Quality and Safety Compliance\u003c\/span\u003e\u003c\/h3\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe 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.\u003c\/span\u003e\u003c\/p\u003e\n\u003cdiv class=\"ds-scroll-area ds-scroll-area--show-on-focus-within ds-scroll-area--enabled _1210dd7 c03cafe9\"\u003e\n\u003cdiv class=\"ds-scroll-area__gutters\"\u003e\n\u003cdiv class=\"ds-scroll-area__horizontal-gutter\"\u003e\u003cbr\u003e\u003c\/div\u003e\n\u003cdiv class=\"ds-scroll-area__vertical-gutter\"\u003e\u003cbr\u003e\u003c\/div\u003e\n\u003c\/div\u003e\n\u003ctable\u003e\n\u003cthead\u003e\n\u003ctr\u003e\n\u003cth\u003e\u003cspan class=\"\"\u003eFeature\u003c\/span\u003e\u003c\/th\u003e\n\u003cth\u003e\u003cspan class=\"\"\u003eBenefit\u003c\/span\u003e\u003c\/th\u003e\n\u003c\/tr\u003e\n\u003c\/thead\u003e\n\u003ctbody\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eEN ISO 13485 certification\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eQuality management system compliance\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eIVD scope\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eCertified for in vitro diagnostic test kits\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eQuality assurance\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eMeets high standards of quality and safety\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eProfessional-grade\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eDesigned for healthcare professional use\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003c\/tbody\u003e\n\u003c\/table\u003e\n\u003c\/div\u003e\n\u003ch3\u003e\u003cspan class=\"\"\u003eCE Marked – European Conformity\u003c\/span\u003e\u003c\/h3\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe 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.\u003c\/span\u003e\u003c\/p\u003e\n\u003cdiv class=\"ds-scroll-area ds-scroll-area--show-on-focus-within ds-scroll-area--enabled _1210dd7 c03cafe9\"\u003e\n\u003cdiv class=\"ds-scroll-area__gutters\"\u003e\n\u003cdiv class=\"ds-scroll-area__horizontal-gutter\"\u003e\u003cbr\u003e\u003c\/div\u003e\n\u003cdiv class=\"ds-scroll-area__vertical-gutter\"\u003e\u003cbr\u003e\u003c\/div\u003e\n\u003c\/div\u003e\n\u003ctable\u003e\n\u003cthead\u003e\n\u003ctr\u003e\n\u003cth\u003e\u003cspan class=\"\"\u003eFeature\u003c\/span\u003e\u003c\/th\u003e\n\u003cth\u003e\u003cspan class=\"\"\u003eBenefit\u003c\/span\u003e\u003c\/th\u003e\n\u003c\/tr\u003e\n\u003c\/thead\u003e\n\u003ctbody\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eCE marking\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eRegulatory compliance for professional use\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eProfessional IVD use\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eDesigned for trained healthcare personnel\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eQuality compliance\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eMeets European regulatory standards\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003c\/tbody\u003e\n\u003c\/table\u003e\n\u003c\/div\u003e\n\u003ch2\u003e\u003cspan class=\"\"\u003eProduct Specifications\u003c\/span\u003e\u003c\/h2\u003e\n\u003cdiv class=\"ds-scroll-area ds-scroll-area--show-on-focus-within ds-scroll-area--enabled _1210dd7 c03cafe9\"\u003e\n\u003cdiv class=\"ds-scroll-area__gutters\"\u003e\n\u003cdiv class=\"ds-scroll-area__horizontal-gutter\"\u003e\u003cbr\u003e\u003c\/div\u003e\n\u003cdiv class=\"ds-scroll-area__vertical-gutter\"\u003e\u003cbr\u003e\u003c\/div\u003e\n\u003c\/div\u003e\n\u003ctable\u003e\n\u003cthead\u003e\n\u003ctr\u003e\n\u003cth\u003e\u003cspan class=\"\"\u003eSpecification\u003c\/span\u003e\u003c\/th\u003e\n\u003cth\u003e\u003cspan class=\"\"\u003eDetail\u003c\/span\u003e\u003c\/th\u003e\n\u003c\/tr\u003e\n\u003c\/thead\u003e\n\u003ctbody\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eModel \/ SKU\u003c\/span\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eGHM Sickle Cell Disease Rapid Test US\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eProduct Type\u003c\/span\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eSickle Cell Disease Rapid Test (Colloidal Gold)\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eIntended Use\u003c\/span\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eQualitative detection and differentiation of hemoglobin A (HbA), hemoglobin S (HbS), and hemoglobin C (HbC) in human whole blood specimens; used as a screening test and as an aid in the diagnosis of sickle cell disease and hemoglobinopathy variants\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eDetection Principle\u003c\/span\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eLateral flow chromatographic immunoassay; colloidal gold\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eTarget Analytes\u003c\/span\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eHemoglobin A (HbA); Hemoglobin S (HbS); Hemoglobin C (HbC)\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eSpecimen\u003c\/span\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eWhole Blood (venipuncture or fingerstick)\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eSample Volume\u003c\/span\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003e5 µL whole blood\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eTime to Result\u003c\/span\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003e15 minutes\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eSensitivity\u003c\/span\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eHbA: 99.67%; HbS: 97.66%; HbC: 99%\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eSpecificity\u003c\/span\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eHbA: 98.04%; HbS: 99.49%; HbC: 99%\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eStorage Temperature\u003c\/span\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003e2–30°C (35.6–86°F)\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eShelf Life\u003c\/span\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003e24 months\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eApplication Scenario\u003c\/span\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eNewborn screening program, pediatric clinic, hematology clinic, genetic counseling service, clinical laboratory, point-of-care\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eRegulatory Status\u003c\/span\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eManufactured under EN ISO 13485 certified quality management system; CE marked\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eIntended User\u003c\/span\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eProfessional healthcare use only\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eKit Size\u003c\/span\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003e25 tests\/kit\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eKit Contents\u003c\/span\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eSickle Cell Disease Rapid Test Cassette, Buffer, Dropper, Instructions for Use\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003c\/tbody\u003e\n\u003c\/table\u003e\n\u003c\/div\u003e\n\u003ch2\u003e\u003cspan class=\"\"\u003eWhy Clinical Professionals Choose Global Healthcare Medical\u003c\/span\u003e\u003c\/h2\u003e\n\u003cdiv class=\"ds-scroll-area ds-scroll-area--show-on-focus-within ds-scroll-area--enabled _1210dd7 c03cafe9\"\u003e\n\u003cdiv class=\"ds-scroll-area__gutters\"\u003e\n\u003cdiv class=\"ds-scroll-area__horizontal-gutter\"\u003e\u003cbr\u003e\u003c\/div\u003e\n\u003cdiv class=\"ds-scroll-area__vertical-gutter\"\u003e\u003cbr\u003e\u003c\/div\u003e\n\u003c\/div\u003e\n\u003ctable\u003e\n\u003cthead\u003e\n\u003ctr\u003e\n\u003cth\u003e\u003cspan class=\"\"\u003eConsideration\u003c\/span\u003e\u003c\/th\u003e\n\u003cth\u003e\u003cspan class=\"\"\u003eGHM Sickle Cell Disease Rapid Test US\u003c\/span\u003e\u003c\/th\u003e\n\u003c\/tr\u003e\n\u003c\/thead\u003e\n\u003ctbody\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e3-in-1 hemoglobin detection\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eSimultaneous detection and differentiation of HbA, HbS, and HbC\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e15-minute test time\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eRapid turnaround for timely clinical decisions\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eWhole blood sample compatibility\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eSimple and efficient sample collection\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eDistinguishes trait from disease\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eDifferentiates sickle cell trait (HbAS) from sickle cell disease (HbSS)\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eHigh sensitivity and specificity\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eHbA: 99.67% sensitivity and 98.04% specificity; HbS: 97.66% sensitivity and 99.49% specificity; HbC: 99% sensitivity and 99% specificity\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eNewborn screening support\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eValuable for early identification of SCD in newborns\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eTrait identification\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eIdentifies sickle cell trait carriers for genetic counseling\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eHemoglobin C variant detection\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eIdentifies HbC and HbSC variants\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eField-friendly testing\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eNo instrumentation required, suitable for decentralized settings\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eISO 13485 certified\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eQuality management system compliance\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eCE marked\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eRegulatory compliance for professional use\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003ePoint-of-care compatible\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eSuitable for newborn screening programs, pediatric clinics, and hematology settings\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003c\/tbody\u003e\n\u003c\/table\u003e\n\u003c\/div\u003e\n\u003ch2\u003e\u003cspan class=\"\"\u003eAbout Global Healthcare Medical\u003c\/span\u003e\u003c\/h2\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eGlobal 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.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eOur focus is on dependable performance, clear documentation, and responsive support for professional healthcare settings.\u003c\/span\u003e\u003c\/p\u003e","brand":"Global Healthcare Medical","offers":[{"title":"Default Title","offer_id":46236992765996,"sku":null,"price":0.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0629\/9756\/1388\/files\/ghm-v6-8559114190892-01-2048.png?v=1790270596","url":"https:\/\/www.globalhealthcaremedical.com\/products\/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","provider":"Global Healthcare Medical","version":"1.0","type":"link"}