OraSure Technologies, Inc. transforms health through actionable insight and powers the shift that connects people to healthcare wherever they are. OraSure improves access, quality, and value of healthcare with innovation in effortless tests and sample management solutions.
OraSure, together with its wholly-owned subsidiaries, DNA Genotek Inc. and Sherlock Biosciences, is a leader in the development, manufacture, and distribution of rapid diagnostic tests and sample collection and stabilization devices designed to discover and detect critical medical conditions.
OraSure's portfolio of products is sold globally to clinical laboratories, hospitals, physician's offices, clinics, public health and community-based organizations, research institutions, government agencies, pharmaceutical companies, and direct to consumers.
The Diagnostics Direct Syphilis Health Check™ offers a rapid and reliable solution for syphilis testing, delivering results in just 10 minutes. This CLIA-waived test is designed for fingerstick whole blood samples and is suitable for both clinical and non-clinical settings, including outreach programs and mobile clinics. With an accuracy of 98.0% sensitivity and 97.2% specificity, it effectively detects IgM and IgG antibodies. The simple, easy-to-read format requires no additional equipment, streamlining the testing process and allowing more patients to be tested efficiently. This test is accessible for individuals aged 13 and older and has been proven to detect syphilis at all stages of infection, including latent stages, making it an essential tool for early diagnosis and prompt connection to care.
Diagnostics Direct Syphilis Health Check™
The OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test offers healthcare providers a fast and reliable method for detecting HIV-1 and HIV-2 antibodies, delivering results in just 20 minutes. With over 99% accuracy, this CLIA-waived test can be used with oral fluid, plasma, fingerstick, or venipuncture whole blood specimens, making it ideal for both clinical and non-clinical settings. Its simple and flexible design allows for easy integration into various testing environments, including outreach programs and mobile clinics. By providing pain-free, needle-free testing, the OraQuick ADVANCE® enables more individuals to be screened and promptly connected to care, enhancing the overall effectiveness of HIV prevention and treatment efforts.
Oraquick ADVANCE®HIV-1/2 Rapid Antibody Test
The OraQuick® In-Home HIV Test is a groundbreaking solution, being the first and only FDA-approved oral fluid rapid HIV test available over-the-counter in the U.S. This innovative test allows individuals to detect both HIV-1 and HIV-2 antibodies with a simple oral swab, delivering results in just 20 minutes. Designed for privacy and ease, the OraQuick® test offers a convenient at-home testing option, complete with extensive support resources. Users benefit from access to a dedicated toll-free customer support center and a comprehensive online platform, ensuring they have the guidance needed throughout the testing process.
OraQuick® In-Home HIV Test
The OraQuick® HCV Test is the first FDA-approved, CLIA-waived rapid test for detecting HCV antibodies using fingerstick and venipuncture whole blood samples. This test offers healthcare providers a quick and accurate diagnosis within 20 minutes, boasting over 98% accuracy. Ideal for use in various settings such as public health facilities, physician's offices, community health clinics, laboratories, and emergency rooms, the OraQuick® HCV Test ensures reliable, point-of-care results. Its easy-to-use platform and ability to test for multiple HCV genotypes make it a valuable tool for efficient and effective hepatitis C screening.
OraQuick® HCV Rapid Antibody Test
The InteliSwab® COVID-19 Rapid Test provides a quick and efficient solution for COVID-19 detection, now available with Emergency Use Authorization from the FDA. Designed for professional use in point-of-care CLIA-waived settings, the InteliSwab® test is incredibly simple, utilizing a built-in swab that integrates directly into the test stick. After self-collecting a sample from the lower nostrils, users swirl the test stick in a pre-measured buffer solution, and results appear on the test stick within 30 minutes. This rapid antigen test requires no additional instruments, batteries, or laboratory analysis, making it an ideal choice for healthcare providers seeking reliable and immediate COVID-19 testing.
Inteliswab® COVID-19 Rapid Test
Headquartered in Bethlehem, PA, OraSure is a leader in the development, production, and distribution of point-of-care diagnostic and collection devices, and other technologies designed to detect or diagnose critical medical conditions. Bethlehem is home to OraSure's employee base and state-of-the-art manufacturing facility.
OraSure is also the parent company of DNA Genotek, Inc., in Ottawa, Canada, and Sherlock Biosciences, which has locations in Newton, Mass., as well as the United Kingdom. OraSure's portfolio of sample collection solutions includes innovation to stabilize multiple types of DNA and RNA samples for years at ambient temperature. The self-collection products for saliva, gut, oral, fecal, vaginal, and skin samples are designed to maximize reach and access to testing, enabling breakthroughs in genomics research, diagnostics laboratories, the pharmaceutical industry, animal genomics, and personal genomics. OraSure also has a collection device for first-void urine samples that is used to detect certain urological cancers and sexually transmitted infections, currently available in some global geographies and for research use.
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OraQuick, OraQuick ADVANCE, and InteliSwab are registered trademarks of OraSure Technologies, Inc. Syphilis Health Check is a trademark of Diagnostics Direct LLC, used under license by OraSure Technologies, Inc. Syphilis Health Check products are manufactured by Diagnostics Direct, LLC, and distributed by OraSure Technologies, Inc., © OraSure Technologies, Inc., all rights reserved.