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    Diagnostics & Testing >  Infectious Disease Testing

    Infectious Disease Testing

    OraSure Technologies is a global leader in infectious disease diagnostics, and our unique infectious disease assays for HIV, HCV, COVID-19, Ebola, and influenza provide accurate and easy-to-administer testing methods to help healthcare practitioners easily identify infected people.

    Inteliswab® COVID-19 Rapid Test

    Inteliswab® COVID-19 Rapid Test

    OraSure has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for its COVID-19 rapid antigen tests, which the Company is branding as InteliSwab®. The FDA has authorized the InteliSwab® COVID-19 Rapid Test for Over-the-Counter (OTC) use without a prescription. FDA has also authorized the InteliSwab® COVID-19 Rapid Test Pro for professional use in point of care (POC) CLIA-waived settings, and InteliSwab® COVID-19 Rapid Test Rx for Prescription Home Use. These remarkably simple COVID-19 lateral flow tests use samples self-collected from the lower nostrils. InteliSwab's unique design incorporates a built-in swab fully integrated into the test stick. After users swab their lower nostrils, the test stick is swirled in a pre-measured buffer solution, and the result appears right on the test stick within 30 minutes, with no instruments, batteries, smartphone or laboratory analysis needed to see the result.

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    OraQuick® HCV Rapid Antibody Test

    OraQuick® HCV Rapid Antibody Test

    The first and only FDA approved and CLIA Waived point of care test for HCV that is also CE Marked. Our simple platform enables healthcare providers to deliver an accurate diagnosis in 20 minutes.

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    OraQuick® Self-Test

    OraQuick® HIV Self-Test

    The OraQuick® HIV Self-Test (HIVST) is a point-of-care rapid antibody test. It detects antibodies for both HIV-1 and HIV-2, enabling individuals to find out their HIV status with a simple oral swab in as little as 20 minutes. The simplicity of the product makes it ideal for testing in a range of locations, including in the privacy of one’s home, at the pharmacy, or at community-based testing events. This test is available for use in select geographic locations outside of the US.

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    Oraquick ADVANCE® HIV-1/2 Rapid Antibody Test

    Oraquick ADVANCE® HIV-1/2 Rapid Antibody Test

    The OraQuick ADVANCE® Rapid HIV‑1/2 Antibody Test is FDA‑approved for use with oral fluid, fingerstick or venous whole blood and plasma and delivers results with laboratory accuracy in 20 minutes. CDC guidelines call for routine testing in all healthcare settings to identify all HIV positive people and connect them to care. This simple test is ideal for screening programs in public health and outreach settings, emergency departments, labor and delivery, laboratories and physician offices.

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    OraQuick® In-Home HIV Test

    OraQuick® In-Home HIV Test

    The OraQuick® In-Home HIV Test is the first and only oral fluid rapid over‑the‑counter (OTC) HIV test approved in the U.S. It can detect antibodies to both HIV‑1 and HIV‑2 with an oral swab, providing a confidential in‑home testing option with results in as little as 20 minutes. The test kit comes with extensive resources and support, including access to a "live" toll‑free customer support center and comprehensive consumer website.

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    OraQuick® Ebola Rapid Antigen Test

    OraQuick® Ebola Rapid Antigen Test

    The OraQuick® Ebola Rapid Antigen Test is designed to detect viral antigens in fingerstick and venous whole blood from patients presenting with signs and symptoms of Ebola infection in conjunction with epidemiological risk factors. It is also intended for use with cadaveric oral fluid collected from recently deceased individuals with epidemiological risk factors who are suspected to have died of EVD.

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    OraSure® HIV-1 Oral Specimen Collection Device

    OraSure® HIV-1 Oral Specimen Collection Device

    OraSure® HIV-1 Oral Specimen Collection Device collects oral fluid, which contains antibodies. The simple 2-5 minute collection procedure is ideal for insurance testing and other non-medical settings. The OraSure® device is placed into a preservative and shipped to a lab where the sample will be screened for HIV-1 antibodies.

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    Objective Adherence Testing

    OraSure has partnered with Molecular Testing Labs to offer an objective adherence test that measures adherence to HIV medications, including pre-exposure prophylaxis (PrEP), the daily medication to prevent HIV. The adherence test is currently a lab-based dried blood spot test that measure long-term levels of the medication in the patient’s blood. Adherence testing is also available as a point of care urine test for research use only.

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