OraSure Technologies empowers the global community to improve health and wellness by providing access to accurate, essential information. Together with its wholly owned subsidiaries, DNA Genotek, Diversigen, and Novosanis, OraSure provides its customers with end-to-end solutions that encompass tools, services and diagnostics.
The OraSure family of companies is a leader in the development, manufacture, and distribution of rapid diagnostic tests, sample collection and stabilization devices, and molecular services solutions 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, pharma, commercial entities, and direct to consumers.
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 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 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
Based in Bethlehem, PA, OraSure leads the way in creating, manufacturing, and distributing point-of-care diagnostic tools and collection technologies for identifying critical medical conditions. Their groundbreaking products include rapid tests for COVID-19, HIV, hepatitis C, syphilis, Ebola, and substance use. Bethlehem hosts OraSure's largest workforce and an advanced manufacturing facility.
OraSure also owns DNA Genotek, Inc., located in Ottawa, Canada, which specializes in developing cutting-edge sample collection solutions. Their product range includes systems that preserve various types of DNA and RNA samples at room temperature for extended periods. Designed for self-collection, these products enable testing across saliva, gut, oral, fecal, vaginal, and skin samples, driving advancements in genomics research, diagnostic labs, pharmaceuticals, animal genetics, and personalized genomics. Additionally, their first-void urine collection device supports the detection of specific urological cancers and sexually transmitted infections and is available for research purposes and select global markets.
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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.