Product Overview
OraQuick® HIV Self-Test is a single-use, qualitative oral-fluid test intended for over-the-counter use by individuals ages 14 and older. The test works by detecting antibodies produced by the body in response to HIV-1 or HIV-2 infection.
The easy three-step process includes swabbing the upper and lower gums, placing the test device into the provided developer vial, and reading results after 20 minutes.
- Oral-fluid HIV antibody test
- Detects antibodies to HIV-1 and HIV-2
- No blood draw or fingerstick required
- Results available in 20 minutes
- Single-use, self-administered test
- FDA-approved for OTC consumer use
- Intended for individuals ages 14 and older
Simple Testing in 3 Steps
Accuracy & Important Testing Information
OraQuick® HIV Self-Test is a highly accurate HIV screening test when used according to the Instructions for Use. It detects HIV antibodies in oral fluid and is designed to identify HIV-1 and HIV-2 infection.
In clinical studies, OraQuick detected HIV infection in more than 99% of individuals who were infected and correctly identified 99.8% of individuals who were not infected.
Because OraQuick is an HIV antibody test, it may not detect a recent exposure immediately. Following exposure, it can take up to three months for the body to produce enough antibodies for detection.
Important:
- A reactive (positive) result is preliminary and must be followed by confirmatory testing in a medical setting.
- A negative result does not rule out HIV if exposure may have occurred within the previous three months.
- Individuals with recent potential exposure should consult a healthcare provider regarding appropriate follow-up testing.
- Always follow the Instructions for Use included with the kit.
Features & Benefits
- Needle-Free Oral Swab — Uses oral fluid collected by swabbing the gums, offering a comfortable, non-invasive alternative to blood-based testing.
- Results in 20 Minutes — Provides fast, easy-to-read results during the same testing session, without waiting days for laboratory results.
- Private At-Home Testing — Allows individuals to test discreetly at home or another confidential setting, without appointments, travel, or waiting rooms.
- FDA-Approved OTC HIV Self-Test — Provides a trusted, accessible HIV screening option available without a prescription.
- Detects HIV-1 & HIV-2 Antibodies — Screens for antibodies to both HIV-1 and HIV-2, helping individuals take an important first step toward understanding their HIV status.
- Easy Three-Step Process — Simply swab, insert, and read results, making self-testing approachable and convenient.
- Support & Guidance Available — Offers access to bilingual English/Spanish support representatives who can assist with product questions, result interpretation, and referrals for follow-up resources and care.
- Helps Expand Access to Testing — Supports community outreach, partner-testing programs, and individuals who may not seek testing in a traditional healthcare setting.
- Encourages Linkage to Care — Helps connect individuals with confirmatory testing, counseling, and appropriate follow-up care when needed.
