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OraSure Technologies is a global leader in infectious disease diagnostics, and our unique infectious disease assays for HIV, Syphilis, HCV, COVID-19, Ebola, and influenza provide accurate and easy-to-administer testing methods to help healthcare practitioners easily identify infected people.
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.
View Oraquick ADVANCE HIV-1/2 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.
View OraQuick HCV Rapid Antibody 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.
View InteliSwab® COVID-19 Rapid 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.
View OraQuick Ebola Rapid Antigen Test »
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.
View OraSure HIV-1 Oral Specimen Collection Device »Genetic testing requires high-quality DNA samples determined by yield and purity. Oragene™ saliva kits are ideal for any clinical diagnostics requiring DNA, offering an all-in-one device for saliva collection, DNA stabilization and transportation of biological samples.
OrageneTM•Dx saliva collection kits and ORAcollectTM•Dx saliva collection kits are FDA cleared devices. They are proven saliva sample collection devices for DNA stabilization, transportation and storage.
OraSure provides information regarding reimbursement (including, in some instances, potentially applicable CPT, HCPCS and/or analogous state or local codes or designations) for background purposes only. It does not constitute legal advice or a recommendation regarding clinical practice. Information provided is gathered from third-party sources and is subject to change without notice. The provider has the responsibility to determine medical necessity and to submit appropriate codes and charges for care provided. Any decision regarding specific coding is at the discretion of the healthcare professional, and provision of this information does not guarantee or facilitate reimbursement. OraSure makes no guarantee that the use of this information will prevent differences of opinion or disputes with Medicare or other payers as to the correct form of billing or the amount that will be paid to providers of service. Please contact your Medicare contractor, insurance provider, other payers, reimbursement specialists and/or legal counsel for interpretation of coding, coverage and payment policies or specific billing questions or concerns. Nothing herein is intended to promote or facilitate the purchase or use of products outside of their approved or cleared indications, and appropriate use of products should be based on the healthcare professional’s medical judgment.
