{"product_id":"ghm-rubella-igg-igm-rapid-test-us-dual-target-qualitative-detection-of-rubella-virus-igg-igm-antibodies-with-15-minute-results-whole-blood-serum-plasma-sample-compatibility-and-professional-point-of-care-use","title":"GHM Rubella IgG\/IgM Rapid Test US – Dual-Target Qualitative Detection of Rubella Virus IgG \u0026 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 Rubella IgG\/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 Rubella IgG\/IgM 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 IgG and IgM antibodies to rubella virus (RV) 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 rubella virus infection and immunity assessment.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eRubella is an acute respiratory infection caused by the rubella virus (RV), including congenital infection and acquired infection. Clinical features include short precursors, low fever, rash, and occipital lymph node enlargement. The general condition is mild, the course of the disease is short, and the prognosis is good\u003c\/span\u003e\u003ca href=\"https:\/\/imda.moh.gov.vn\/documents\/10182\/56381726\/upload_00031922_1721985421956.pdf?version=1.0\u0026amp;fileId=56408822#1#1\" rel=\"noreferrer\" target=\"_blank\"\u003e\u003c\/a\u003e\u003cspan class=\"\"\u003e. However, rubella is very easy to cause outbreaks, which can happen throughout the year, with many diseases in winter and spring. The susceptible age is mainly 1–5 years old, so the prevalence is prevalent in preschool children. Although the clinical symptoms are mild, the virus can infect the fetus through the fetal blood barrier. Both overt and non-dominant infection can lead to congenital rubella syndrome (CRS), such as congenital fetal malformation, stillbirth, premature birth, etc. Therefore, the early diagnosis and prevention of rubella are very important\u003c\/span\u003e\u003ca href=\"https:\/\/imda.moh.gov.vn\/documents\/10182\/56381726\/upload_00031922_1721985421956.pdf?version=1.0\u0026amp;fileId=56408822#1#1\" rel=\"noreferrer\" target=\"_blank\"\u003e\u003c\/a\u003e\u003cspan class=\"\"\u003e.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eRubella virus infection during early pregnancy can result in miscarriage, fetal death, stillbirth, or a constellation of birth defects. The estimated number of CRS births globally declined by approximately two-thirds during 2010–2019, from 100,000 (95% CI: 54,000–166,000) to 32,000 (95% CI: 22,000–48,000)\u003c\/span\u003e\u003cspan class=\"\"\u003e. By the end of 2023, 19 lower- and middle-income countries had not yet introduced rubella-containing vaccine (RCV). In 2019, an estimated 24,000 CRS cases occurred in these countries, representing 75% of the estimated 32,000 cases worldwide\u003c\/span\u003e\u003cspan class=\"\"\u003e. Following the COVID-19 pandemic, reported rubella case numbers increased from 10,021 cases in 2021 to 35,714 in 2023\u003c\/span\u003e\u003ca href=\"https:\/\/www.sciencedirect.com\/science\/article\/pii\/S1201971226006922?fr=RR-2\u0026amp;ref=pdf_download\u0026amp;rr=a35ff3e2f842481d#1\" rel=\"noreferrer\" target=\"_blank\"\u003e\u003c\/a\u003e\u003cspan class=\"\"\u003e.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe clinical presentation of rubella overlaps significantly with other exanthematous diseases, making laboratory confirmation essential for accurate diagnosis. Rubella-specific IgG and IgM antibodies are observed about 14–18 days after rubella infection, at about the time when the rash appears\u003c\/span\u003e\u003cspan class=\"\"\u003e. Rubella IgM antibodies are typically detectable between 4 and 30 days after rash onset in acute rubella infection and for up to six months after birth in CRS cases\u003c\/span\u003e\u003cspan class=\"\"\u003e. Rubella IgG antibodies become detectable by day four after rash onset and reach peak levels in the following one to two weeks\u003c\/span\u003e\u003cspan class=\"\"\u003e. Detection of specific IgM antibodies is widely used for acute case investigation, but also to confirm CRS cases in infants aged 6 months or younger\u003c\/span\u003e\u003ca href=\"https:\/\/www.sciencedirect.com\/science\/article\/pii\/S1201971226006922?fr=RR-2\u0026amp;ref=pdf_download\u0026amp;rr=a35ff3e2f842481d#1\" rel=\"noreferrer\" target=\"_blank\"\u003e\u003c\/a\u003e\u003cspan class=\"\"\u003e.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe GHM Rubella IgG\/IgM Rapid Test US delivers qualitative results in 15 minutes, supporting rapid clinical decision-making 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, including obstetric clinics, prenatal screening programs, infectious disease clinics, and clinical laboratories.\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 obstetric clinics, prenatal screening programs, infectious disease clinics, pediatric 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.\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=\"\"\u003e2-in-1 Detection – IgG and IgM in One Test\u003c\/span\u003e\u003c\/h3\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe GHM Rubella IgG\/IgM Rapid Test US utilizes a lateral flow chromatographic immunoassay capable of simultaneously detecting and differentiating rubella virus IgG and IgM antibodies from a single patient sample. The test incorporates two separate test lines: the IgG line is coated with antibody for the detection of IgG anti-RV, and the IgM line is coated with antibody for the detection of IgM anti-RV, enabling clear differentiation between recent\/acute infection and past infection or immunity in a single assay\u003c\/span\u003e\u003ca href=\"https:\/\/imda.moh.gov.vn\/documents\/10182\/56381726\/upload_00031922_1721985421956.pdf?version=1.0\u0026amp;fileId=56408822#1#1\" rel=\"noreferrer\" target=\"_blank\"\u003e\u003c\/a\u003e\u003cspan class=\"\"\u003e. This dual-target design provides a comprehensive diagnostic picture that supports appropriate clinical decision-making, particularly in pregnant women and in assessing immune status before or during pregnancy.\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=\"\"\u003e2-in-1 detection\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eSimultaneously detects rubella IgG and IgM antibodies in one test\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eTwo separate test lines (IgG \u0026amp; IgM)\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eClear differentiation between recent\/acute infection and past infection\/immunity\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=\"\"\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=\"\"\u003eRV recombinant envelope antigen-coated particles\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eTargeted detection of rubella virus antibodies\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 Rubella IgG\/IgM Rapid Test US provides qualitative results in 15 minutes, supporting rapid clinical decision-making and efficient patient workflow in point-of-care settings. Rapid results enable immediate clinical assessment, which is particularly valuable in prenatal screening settings where timely identification of seronegative pregnant women allows for appropriate preventive counseling and serological monitoring during pregnancy. The standard test to detect IgM antibodies is enzyme immunoassay (EIA), which requires laboratory and staff capacity, appropriate sample transport to the laboratory, and a turnaround time of several hours\u003c\/span\u003e\u003ca href=\"https:\/\/www.sciencedirect.com\/science\/article\/pii\/S1201971226006922?fr=RR-2\u0026amp;ref=pdf_download\u0026amp;rr=a35ff3e2f842481d#1\" rel=\"noreferrer\" target=\"_blank\"\u003e\u003c\/a\u003e\u003cspan class=\"\"\u003e. Decentralized testing with easy-to-use point-of-care diagnostic assays such as rapid diagnostic tests (RDTs) could improve rubella surveillance and enable faster clinical decision-making\u003c\/span\u003e\u003ca href=\"https:\/\/www.sciencedirect.com\/science\/article\/pii\/S1201971226006922?fr=RR-2\u0026amp;ref=pdf_download\u0026amp;rr=a35ff3e2f842481d#1\" rel=\"noreferrer\" target=\"_blank\"\u003e\u003c\/a\u003e\u003cspan class=\"\"\u003e.\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 obstetric clinics and prenatal screening programs\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 \/ Serum \/ Plasma Compatibility – Flexible Sample Collection\u003c\/span\u003e\u003c\/h3\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe GHM Rubella IgG\/IgM 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.\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 field and decentralized testing\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 Rubella Virus Infection and Immunity Assessment\u003c\/span\u003e\u003c\/h3\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe GHM Rubella IgG\/IgM Rapid Test US is intended for use as a screening test and as an aid in the diagnosis of rubella virus infection and immunity assessment. The test provides rapid serological diagnosis, enabling timely clinical decision-making and supporting patient management.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe dual-target design provides comprehensive diagnostic value:\u003c\/span\u003e\u003c\/p\u003e\n\u003cul\u003e\n\u003cli\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eIgG Positive, IgM Negative\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e: Indicates past exposure to rubella virus or vaccination, suggesting immunity. This is particularly valuable for identifying seropositive women who have protection against rubella infection during pregnancy.\u003c\/span\u003e\u003c\/p\u003e\n\u003c\/li\u003e\n\u003cli\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eIgM Positive\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e: Indicates a recent or acute rubella virus infection. The immunocomplex is captured by the reagent coated on the IgM line, forming a colored IgM line, indicating a fresh infection\u003c\/span\u003e\u003ca href=\"https:\/\/imda.moh.gov.vn\/documents\/10182\/56381726\/upload_00031922_1721985421956.pdf?version=1.0\u0026amp;fileId=56408822#1#1\" rel=\"noreferrer\" target=\"_blank\"\u003e\u003c\/a\u003e\u003cspan class=\"\"\u003e.\u003c\/span\u003e\u003c\/p\u003e\n\u003c\/li\u003e\n\u003cli\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eIgG \u0026amp; IgM Positive\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e: Suggests a current or ongoing infection, with both early and late-stage antibodies present. The immunocomplex is then captured by the reagent pre-coated on the IgG line, forming a colored IgG line, indicating a positive test result and suggesting a recent or repeat infection\u003c\/span\u003e\u003ca href=\"https:\/\/imda.moh.gov.vn\/documents\/10182\/56381726\/upload_00031922_1721985421956.pdf?version=1.0\u0026amp;fileId=56408822#1#1\" rel=\"noreferrer\" target=\"_blank\"\u003e\u003c\/a\u003e\u003cspan class=\"\"\u003e.\u003c\/span\u003e\u003c\/p\u003e\n\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe test is particularly valuable in prenatal screening programs, where determining maternal serostatus is essential for identifying seronegative women who require preventive counseling and serological monitoring during pregnancy. If a woman's immune status is unknown, her blood should be tested for rubella antibodies within 7 days of exposure\u003c\/span\u003e\u003cspan class=\"\"\u003e. A prenatal diagnosis of congenital infection is recommended when a maternal infection is diagnosed and is based on the detection of RV-specific IgM antibodies\u003c\/span\u003e\u003cspan class=\"\"\u003e. In congenital rubella, IgM becomes positive within one month of birth and is usually negative by twelve months\u003c\/span\u003e\u003cspan class=\"\"\u003e.\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 recent or acute rubella infection via IgM detection\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eImmunity assessment support\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eDetermines past infection or vaccination status via IgG detection\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003ePrenatal screening support\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eValuable for identifying seronegative pregnant women requiring monitoring\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eCongenital rubella surveillance support\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eUseful for confirming CRS cases in infants\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\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=\"\"\u003eClinical versatility\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eUseful across obstetric clinics, pediatric clinics, and clinical laboratories\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 Rubella IgG\/IgM Rapid Test US is designed to deliver reliable clinical performance with high sensitivity and specificity. Published evaluations of rapid rubella antibody tests have demonstrated strong performance across multiple independent studies.\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\u003cth\u003e\u003cspan class=\"\"\u003eAccuracy\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=\"\"\u003eRubella IgG Antibody\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003e98.01%\u003c\/span\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003e99.01%\u003c\/span\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003e98.5%\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eRubella IgM Antibody\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003e93.4%\u003c\/span\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003e99.0%\u003c\/span\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003e98.1%\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003c\/tbody\u003e\n\u003c\/table\u003e\n\u003c\/div\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=\"\"\u003eSpecimen\u003c\/span\u003e\u003c\/strong\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\u003cstrong\u003e\u003cspan class=\"\"\u003eTime to Result\u003c\/span\u003e\u003c\/strong\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\u003cstrong\u003e\u003cspan class=\"\"\u003eStorage Temperature\u003c\/span\u003e\u003c\/strong\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\u003cstrong\u003e\u003cspan class=\"\"\u003eShelf Life\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003e24 months\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 published evaluations of rapid rubella antibody tests. An evaluation of the RapidFor Rubella IgG\/IgM Rapid Test Kit reported sensitivity of 98.01% and specificity of 99.01% for rubella IgG compared with ELISA methods. Independent evaluations of rubella IgG\/IgM rapid tests have reported sensitivities of 93.4% for IgM and 91.8% for IgG, with specificities of 99.0% for IgM and 98.7% for IgG, and accuracies of 98.1% for IgM and 97.6% for IgG. A systematic assessment of commercial lateral flow immunoassays for rubella IgM detection noted that most RDTs showed substantially lower analytical sensitivity than EIAs, detecting IgM only at higher antibody concentrations, and that results should be interpreted cautiously and confirmed by EIA, particularly in elimination settings. Detection is optimal in specimens collected at appropriate time points during infection, and the test is best suited for use as an aid in the diagnosis of rubella virus infection in symptomatic patients and for immunity assessment. The test provides a preliminary result; confirmatory testing with reference laboratory methods is recommended.\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 Rubella IgG\/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 Rubella IgG\/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=\"\"\u003eIRGM-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=\"\"\u003eRubella IgG\/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 and differentiation of IgG and IgM antibodies to rubella virus in human whole blood, serum, or plasma specimens; used as a screening test and as an aid in the diagnosis of rubella virus infection and immunity assessment\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 Antibodies\u003c\/span\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eRubella virus IgG and IgM antibodies\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) \/ 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 (do not interpret after 30 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=\"\"\u003eIgG: 98.01%; IgM: 93.4%\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=\"\"\u003eIgG: 99.01%; IgM: 99.0%\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eAccuracy\u003c\/span\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eIgG: 98.5%; IgM: 98.1%\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=\"\"\u003eObstetric clinic, prenatal screening program, infectious disease clinic, pediatric clinic, hospital laboratory, 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; 40 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=\"\"\u003eRubella IgG\/IgM Test Cassette, Sample Diluent, Disposable Droppers, 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\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eImportant Testing Notes:\u003c\/span\u003e\u003c\/strong\u003e\u003c\/p\u003e\n\u003cul\u003e\n\u003cli\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eAllow the test kit and sample to reach room temperature (18–30°C) prior to testing.\u003c\/span\u003e\u003c\/p\u003e\n\u003c\/li\u003e\n\u003cli\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eFor fingerstick whole blood, clean the fingertip with an alcohol swab and allow it to dry; collect blood using a sterile lancet.\u003c\/span\u003e\u003c\/p\u003e\n\u003c\/li\u003e\n\u003cli\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eAny visible shade of color in the Test line (IgG or IgM) indicates a positive result, as intensity varies with antibody concentration.\u003c\/span\u003e\u003c\/p\u003e\n\u003c\/li\u003e\n\u003cli\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eA negative result does not rule out rubella virus infection, particularly during the early window period before antibodies become detectable, or if the specimen was collected too late after infection when IgM levels have declined.\u003c\/span\u003e\u003c\/p\u003e\n\u003c\/li\u003e\n\u003cli\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eIn pregnant women with both IgG and IgM positive, additional testing such as IgG avidity testing should be requested to further evaluate the timing of infection.\u003c\/span\u003e\u003c\/p\u003e\n\u003c\/li\u003e\n\u003cli\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eConfirmatory testing at a reference laboratory with expertise in rubella diagnosis is recommended for any reactive specimen before clinical intervention.\u003c\/span\u003e\u003c\/p\u003e\n\u003c\/li\u003e\n\u003cli\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eIgM may remain detectable for up to 6 months after acute infection and may occasionally be detected for months and even years after vaccination\u003c\/span\u003e\u003cspan class=\"\"\u003e.\u003c\/span\u003e\u003c\/p\u003e\n\u003c\/li\u003e\n\u003c\/ul\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 Rubella IgG\/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=\"\"\u003e2-in-1 detection\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eSimultaneous detection and differentiation of rubella IgG and IgM antibodies\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=\"\"\u003eTwo separate test lines (IgG \u0026amp; IgM)\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eClear differentiation between recent\/acute infection and past infection\/immunity\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=\"\"\u003eIgG: 98.01% sensitivity and 99.01% specificity; IgM: 93.4% sensitivity and 99.0% specificity\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e98.5% and 98.1% overall accuracy\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eStrong concordance with reference methods for IgG and IgM respectively\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003ePrenatal screening support\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eValuable for identifying seronegative pregnant women requiring monitoring\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eCongenital rubella surveillance support\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eUseful for confirming CRS cases in infants\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\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=\"\"\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 obstetric clinics, pediatric clinics, and clinical laboratories\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 Rubella IgG\/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":46238983290924,"sku":null,"price":0.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0629\/9756\/1388\/files\/ghm-v6-8559598174252-01-2048.png?v=1790270030","url":"https:\/\/www.globalhealthcaremedical.com\/products\/ghm-rubella-igg-igm-rapid-test-us-dual-target-qualitative-detection-of-rubella-virus-igg-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"}