{"id":39324,"key":"Global_Health_Medical_Device_Compendium/SURE_CHECK_HIV_1/2_Assay","title":"Global Health Medical Device Compendium/SURE CHECK HIV 1/2 Assay","latest":{"id":1267712,"timestamp":"2026-09-10T14:16:13Z"},"content_model":"wikitext","license":{"url":"https://www.appropedia.org/Appropedia:Copyrights","title":"CC-BY-SA-4.0"},"source":"[[File:Surecheck assay.jpg|thumb]]\n\n{{GHMDC device data\n| health-topic = HIV/AIDS\n| classification = Diagnosis\n| scope = Commercialized\n| manufacturer-location = New York, United States\n}}\n\nRapid diagnostic kits, which have emerged over the past few years as a result of advancing technology, help detect HIV infection quickly.\n\n== Detailed description of the solution ==\n\nSURE CHECK® HIV 1 / 2, HIV 1/ 2 STAT-PAK® and HIV 1/ 2 STAT-PAK® Dipstick tests are easy-to-perform, single-use diagnostic tests for the rapid, visual detection of antibodies to HIV1 and HIV2. All of these devices are produced by ChemBio Diagnostic Systems, Inc.\n\n== Designed by ==\n\n* Designed by: ChemBio Diagnostic Systems Inc.\n* Manufacturing: New York, USA\n\n== When and where it was tested/implemented ==\n\nDue to its inexpensive price and wide distribution, it is available globally. It has been tested and referred to in WHO reports.\n\n== References ==\n\n=== Peer-reviewed publication ===\n\nDelaney, Kevin P. et al. (2010). Evaluation of the Performance Characteristics of 6 Rapid HIV Antibody Tests. Oxford Journals. Medicine. Clinical Infectious Diseases Volume 52, Issue 2, pp. 257-263.\nLink available [http://cid.oxfordjournals.org/content/52/2/257.full here].\n\n=== Other internally generated reports ===\n\nA PDF of use and instructions is available [http://web.archive.org/web/20090105162757/http://www.chembio.com/pdfs/6174%20HIV%20Sure%20Check%20EXP%20Prod%20Insert%20Rev%203.pdf here].\n\n=== Approval by regulatory bodies or standards boards ===\n\nThis device received FDA approval in May 2006. Link available [http://www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/PremarketApprovalsPMAs/ucm091240.htm here].\n\n{{Page data\n| sdg = SDG03 Good health and well-being\n| license = CC-BY-SA-3.0\n| language = en\n}}"}