{"product_id":"ghm-hav-igm-rapid-test-us-qualitative-detection-of-hepatitis-a-virus-igm-antibodies-with-15-minute-results-whole-blood-serum-plasma-sample-compatibility-and-professional-point-of-care-use","title":"GHM HAV IgM Rapid Test US – Qualitative Detection of Hepatitis A Virus IgM Antibodies with 15-Minute Results, Whole Blood \/ Serum \/ Plasma 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 HAV IgM 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 HAV IgM Rapid Test US\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e is a lateral flow immunochromatographic assay designed for the qualitative detection of IgM antibodies to hepatitis A virus (HAV) in human whole blood, serum, or plasma specimens. The kit is intended for use by healthcare professionals as a screening test and as an aid in the diagnosis of acute or recent hepatitis A virus infection.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eHepatitis A is caused by infection with the hepatitis A virus (HAV), a positive-sense RNA virus belonging to the Picornaviridae family. Its transmission primarily depends on the fecal-oral route from person to person, and infection occurs mainly due to contaminated food or poor sanitary conditions. Globally, there were an estimated 159 million acute HAV infections in 2019, with 39,000 deaths from acute hepatitis A. The clinical presentation of hepatitis A is often indistinguishable from hepatitis B or C, making serological testing essential for accurate diagnosis. The presence of specific HAV IgM antibody in blood samples suggests acute or recent HAV infection. At the onset of symptoms, HAV IgM antibody becomes detectable, rapidly increases in titer over a period of 2–6 weeks, and then declines to non-detectable levels within 3–6 months in most patients. Because of the transient production of anti-HAV IgM, its presence in serum indicates ongoing or recent infection and is the most useful serological marker for diagnosing acute HAV infection.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe GHM HAV IgM Rapid Test US delivers qualitative results in just 15 minutes, supporting rapid clinical decision-making at the point of care. The test is compatible with whole blood, serum, and plasma specimens, providing flexible sample collection options suitable for a wide range of clinical settings.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe kit is intended for in vitro diagnostic use and professional use only, suitable for application scenarios including physician office laboratories, urgent care centers, hospital laboratories, public health 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.\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=\"\"\u003eColloidal Gold Immunochromatography – Reliable Qualitative Detection\u003c\/span\u003e\u003c\/h3\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe GHM HAV IgM Rapid Test US is based on lateral flow immunochromatography technology. The membrane is immobilized with anti-human IgM antibody on the test region. During the assay, the specimen reacts with gold particles coated with recombinant HAV antigen. As the specimen\/particle mixture migrates chromatographically on the membrane by capillary action, the complex is captured by the test band located in the result window, causing a visible line. The appearance of any color in the test region is considered positive for HAV IgM antibody. A colored line at the control region serves as a procedural control and always appears in the viewing window, confirming proper test performance.\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=\"\"\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=\"\"\u003eRecombinant HAV antigen-coated gold particles\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eTargeted detection of HAV IgM antibodies\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eAnti-human IgM capture antibody\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eSpecific and accurate detection\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\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eInternal procedural control\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eConfirms proper test performance\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 HAV IgM Rapid Test US provides qualitative results in just 15 minutes, supporting rapid clinical decision-making and efficient patient workflow in point-of-care settings.\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 physician office laboratories and urgent care centers\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 testing 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 \/ Serum \/ Plasma Compatibility – Flexible Sample Collection\u003c\/span\u003e\u003c\/h3\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe GHM HAV IgM Rapid Test US is compatible with whole blood (fingerstick or venipuncture), 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 pediatric and adult patient populations.\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 \/ serum \/ plasma\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eFlexible sample collection options\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eFingerstick or venipuncture whole blood\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eSuitable 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 pediatric and adult 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 Acute or Recent Hepatitis A Infection\u003c\/span\u003e\u003c\/h3\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe GHM HAV IgM Rapid Test US is intended for use as a screening test and as an aid in the diagnosis of acute or recent infection with hepatitis A virus. The test provides rapid serological diagnosis, enabling timely clinical decision-making and supporting patient management. Early and accurate diagnosis of HAV infection is essential for appropriate clinical management, including supportive care, identification of close contacts who may benefit from post-exposure prophylaxis, and implementation of infection control measures.\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 HAV infection supports timely clinical management and public health intervention. Because symptomatic hepatitis A viral infections cannot be clinically distinguished from hepatitis B or C viral infections, serological testing is important for proper diagnosis. The detection of HAV IgM antibody in blood samples suggests acute or recent HAV infection (usually within the past 6 months).\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=\"\"\u003eAcute\/recent infection detection aid\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eSupports identification of acute or recent HAV infection\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eScreening 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=\"\"\u003eDifferential diagnosis support\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eHelps distinguish HAV from hepatitis B and C infections\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eInfection control support\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eEnables prompt identification of cases and close contacts\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 physician offices, urgent care, and public health screening 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 HAV IgM Rapid Test US is designed to deliver reliable clinical performance with high sensitivity and specificity. Clinical evaluation against ELISA methods has demonstrated strong performance across multiple independent studies, making this assay a reliable 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=\"\"\u003eParameter\u003c\/span\u003e\u003c\/th\u003e\n\u003cth\u003e\u003cspan class=\"\"\u003eSpecification\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=\"\"\u003eSensitivity\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003e95.7%\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eSpecificity\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003e99.1%\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eReference Method\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eELISA\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 clinical evaluation of 377 specimens (96 HAV IgM positive and 281 HAV IgM negative, confirmed by ELISA with clinical symptoms or asymptomatic) using commercial ELISA as the reference method. In an additional evaluation of 151 specimens (50 positive and 101 negative) using another rapid test as the reference method, the assay also demonstrated high relative sensitivity and specificity. Published studies of rapid HAV IgM assays report sensitivities ranging from 66–100% and specificities ranging from 97.7–\u0026gt;99.9%, depending on the product and population evaluated.\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 HAV IgM 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 HAV IgM Rapid Test US\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eProduct Code\u003c\/span\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eIHA-402\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=\"\"\u003eHAV IgM 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 of IgM antibodies to hepatitis A virus (HAV) in human whole blood, serum, or plasma specimens; used as a screening test and as an aid in the diagnosis of acute or recent HAV infection\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 immunochromatography; colloidal gold immunoassay\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eTarget Antibody\u003c\/span\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eIgM antibodies to hepatitis A virus (HAV)\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 \/ Serum \/ Plasma\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=\"\"\u003e95.7%\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=\"\"\u003e99.1%\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eReference Method\u003c\/span\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eELISA\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=\"\"\u003ePhysician office laboratory, urgent care center, hospital laboratory, public health screening program, 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 Sizes\u003c\/span\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003e25 tests\/kit; 50 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=\"\"\u003eHAV IgM Test Cassette, Sample Buffer, Disposable Droppers, Sterile Lancet (optional), 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 HAV IgM 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=\"\"\u003eColloidal gold immunochromatography\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eEstablished and reliable detection technology\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 \/ serum \/ plasma compatibility\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eFlexible and convenient sampling options\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eHAV IgM-specific detection\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eTargeted detection of HAV IgM antibodies\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=\"\"\u003e95.7% sensitivity and 99.1% specificity\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eELISA-validated performance\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eValidated against ELISA methods in clinical studies\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eAcute\/recent infection detection aid\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eSupports identification of acute or recent HAV infection\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eDifferential diagnosis support\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eHelps distinguish HAV from hepatitis B and C infections\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 physician offices, urgent care, and public health screening 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 HAV IgM 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":46236180381740,"sku":null,"price":0.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0629\/9756\/1388\/files\/ghm-v6-8558952284204-01-2048.png?v=1790270864","url":"https:\/\/www.globalhealthcaremedical.com\/products\/ghm-hav-igm-rapid-test-us-qualitative-detection-of-hepatitis-a-virus-igm-antibodies-with-15-minute-results-whole-blood-serum-plasma-sample-compatibility-and-professional-point-of-care-use","provider":"Global Healthcare Medical","version":"1.0","type":"link"}