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Infectious Disease

Substance Abuse

Sample Management

Infectious Disease Testing

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.

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.

View Oraquick ADVANCE HIV-1/2 Rapid Antibody Test »
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.

View OraQuick HIV Self-Test Website »
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.

View OraQuick In-Home HIV Test Website »
Diagnostics Direct Syphilis Health Check

Diagnostics Direct Syphilis Health Check™

The Diagnostics Direct Syphilis Health Check™ rapid test is FDA cleared and CLIA Waived for use with fingerstick whole blood and delivers results with laboratory accuracy in 10 minutes. With more than 6 million tests already sold in the US, studies have verified the test’s accuracy at all stages of infection, which provides the ability to detect infection in pregnant people for the identification of potential congenital syphilis at every trimester.

This simple test is ideal for screening programs in public health and outreach settings, emergency departments, labor and delivery, laboratories and physician offices. Please note, this test is not intended for use in screening blood or plasma donors.

View Diagnostics Direct Syphilis Health Check Test »
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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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.

View InteliSwab® COVID-19 Rapid Test Website »
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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SureQuick HBV

SureQuick™ HBsAG Rapid Test Cassette

SureQuick™ HBsAg Rapid Test is a qualitative, solid phase, two-site sandwich immunoassay for the detection of Hepatitis B Surface Antigen in human whole blood, serum or plasma. The test uses just 3 drops of whole blood, serum or plasma to deliver accurate results in just 15 minutes.

View SureQuick HBsAG Rapid Test Cassette »
SureQuick HCV

SureQuick™ HCV Rapid Test Cassette

SureQuick™ HCV Rapid Test is a membrane-based immunoassay for the qualitative detection of antibodies to Hepatitis C Virus in human whole blood, serum or plasma. The test uses just 2 drops of blood or 1 drop of serum or plasma to deliver accurate results in just 10 minutes.

View SureQuick HCV Rapid Test Cassette »
SureQuick Syphilis

SureQuick™ Syphilis Rapid Test Cassette

SureQuick™ Syphilis Rapid Test is a qualitative, membrane-based immunoassay for the detection of antibodies (IgG and IgM) to Treponema Pallidum in whole blood, serum or plasma. This Treponemal (TP) point of care screening test uses just 2 drops of blood, or 1 drop of plasma or serum to deliver accurate results in just 5 minutes.

View SureQuick Syphilis Rapid Test Cassette »
SureQuick HIV

SureQuick™ HIV Rapid Test Cassette

SureQuick™ HIV 1.2 Rapid Test is a qualitative, membrane-based immunoassay for the detection of antibodies to HIV 1.2 in whole blood, serum or plasma. The membrane is pre-coated with recombinant HIV antigens. This point of care test uses just 2 drops of blood, or 1 drop of plasma or serum to deliver accurate results in just 10 minutes. SureQuick™ is a trusted partner that delivers reliability and value where it matters most.

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Substance Abuse Testing

OraSure Technologies is a global leader in oral fluid substance abuse testing products. Our unique assays provide accurate and easy-to-administer testing methods to help determine the presence or absence of drugs or alcohol in a person's system. Oral fluid-based testing products provide a simplified collection process, faster results, and cost savings, with minimal risk of tampering and dramatically reduced risk of adulteration.

Intercept® Oral Fluid Drug Test & Assays

Intercept® Oral Fluid Drug Test & Assays

The Intercept® Oral Fluid Drug Test is an FDA-cleared laboratory-based oral fluid drug testing system that enables accurate testing for drugs of abuse including marijuana, cocaine, PCP, amphetamines and opiates. With a fast and easy-to-administer collection process, Intercept® is ideal for workplace, criminal justice, drug treatment centers, and clinical setting screening programs, among others.

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Intercept i2 Oral Fluid Test

Intercept i2™ Oral Fluid Collection Device & Assays

As the leader in oral fluid specimen collection and testing, we proudly present our latest advancement in oral fluid collection with the Intercept®i2 ™ Oral Fluid Collection Device.

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Intercept i2he Oral Fluid Test

Intercept i2he® Oral Fluid Collection Device & Assays

As the leader in oral fluid specimen collection and testing, we proudly present our latest advancement in oral fluid collection with the Intercept i2he® Oral Fluid Collection Device.

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OraQuick® In-Home HIV Test

Q.E.D.® Saliva Alcohol Test

Q.E.D.® Saliva Alcohol Test is a CLIA-waived and DOT-approved, on-site, rapid, low-cost alternative to breath or blood testing. Q.E.D.® is easy to administer and provides quantitative results comparable to a blood test. Q.E.D.® is ideal for use in workplace, criminal justice, drug and alcohol treatment centers and clinical setting screening programs, among others.

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OraQuick® Ebola Rapid Antigen Test

OralTox® Rapid Oral Fluid Drug Test

Oral fluid drug testing offers a minimally-invasive, observed collection to detect recent drug use. Using oral fluid, the collector can oversee a donor as he or she collects their own oral fluid specimens, reducing the likelihood of tampering or cheating as well as a donor challenge later in the drug testing process. When speed is a high priority, OralTox offers flexibility for hiring events, job fairs, and on-site collections.

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OraSure QuickFlu™ Rapid Flu A+B Test

OraSure® Oral Specimen Collection Device & Assays

OraSure Technologies offers collection devices and products to meet the needs of health and wellness programs within workplace environments. The collection is conducted directly by the agent through a simple two-to-five-minute collection procedure making it ideal for insurance testing and other non-medical applications.

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SWABTEK Surface Testing for Drugs

SwabTek’s reagents are dry-powder and set on paper, users will never need to pour, mix, or crush packets full of liquid chemicals for an easy testing process.

SwabTek® test kits are the first law enforcement-grade presumptive field tests available [to the general public/outside of law enforcement].They are simple, discreet and non-invasive, making them the perfect tool for schools, workplaces, and environments like construction, manufacturing, oil and gas, retail, hospitality and long-term care clinics. Request product samples »

SwabTek Cannabis Test

Cannabis Test Kit

The SwabTek® Cannabis Test Kit is a single-use spot test designed for use in screening for cannabis compounds in any sample type or on any surface. The test is capable of identifying the presumed presence of cannabinoids in very small quantities, with a level of detection as little as 6 μg in mass.

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SwabTek Fentanyl+ Test

Fentanyl+ Test Kit

The SwabTek® Fentanyl+ Test Kit is a single-use spot test designed as a multi-drug screen for fentanyl, a number of major fentanyl analogues and other major narcotics, including select opioids, amphetamines and other cyclic amines. SwabTek’s unique form factor makes it simple and safe to screen for narcotics in any sample type or on any surface.

The test is capable of identifying the presumed presence of fentanyl and other narcotics in very small quantities, with a level of detection as little as 3 μg in mass for certain fentanyl compounds.

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SwabTek Cocaine Test

Cocaine Test Kit

The SwabTek® Cocaine Test Kit is a single-use spot test designed for use in screening for cocaine derivatives in any sample type or on any surface. The test is capable of identifying the presumed presence of cocaine in very small quantities, with a level of detection as little as 500 µg in mass.

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SwabTek General Narcotics Test

General Narcotics Test Kit

The SwabTek® General Narcotics Test Kit is designed to screen for a broad spectrum of narcotics. Since this test screens for a wide array of targets, it can be used as a preliminary screen in conjunction with more targeted field tests (i.e., amphetamines, cocaine) or as a standalone test.

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SwabTek Heroin Test

Heroin Test Kit

The SwabTek® Heroin Test Kit is a single-use spot-test designed for use in screening for heroin and a number of major opiates in any sample type or on any surface. The test is capable of identifying the presumed presence of opiates in very small quantities, with a level of detection as little as 400 μg in mass.

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SwabTek THC Test

THC Test Kit

The SwabTek® THC Test Kit is a single-use spot test used to identify the presence of THC in any liquid or solid sample. The test is designed to provide a presumptive indication of total THC concentration, with a particular focus on the 0.3% threshold that designates the difference between marijuana and hemp under federal guidelines.

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Sample Management Collection

DNA Genotek, develops products that optimize ease of collection and provide superior samples and proven performance for those requiring high-quality biological samples for nucleic acid testing. High-quality samples that are easily collected from target populations enable our customers to focus on translating their analysis and testing into significant worldwide advancements in health and science. DNA Genotek's success is based on our strong relationship with our valued customers, our innovative environment and our passion for quality.

Today, DNA Genotek products are marketed worldwide and support thousands of customers as they achieve breakthroughs in genomic research, in diagnostics laboratories, in the pharmaceutical industry, in livestock and animal genomics, and in personal genomics. Consequently, our products provide our customers with the ability to focus on solving disease, disease prevention and treatment by translating their testing into worldwide health improvements.

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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.

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