OraQuick HIV Self-Test – 1 Kit

Overview

The OraQuick HIV Self-Test is a single-use, over-the-counter test that looks for antibodies to HIV-1 and HIV-2 in oral fluid. OraSure Technologies states that it is FDA-approved for over-the-counter use by people aged 14 and older. It is the former OraQuick In-Home HIV Test under a new name and box; OraSure Technologies says only the packaging and branding changed, not the test.

The sample is taken with the flat pad on the test stick, swabbed once around the outer upper and lower gums. The pad then goes into the developer vial, which sits in the test stand, and the result appears as lines beside the letters C and T in the result window. It is read after 20 minutes and no later than 40 minutes: a line at C only reads as negative, while a line at C plus any line at T, even a faint one, reads as positive and needs a confirming test.

Key features

• Checks oral fluid for antibodies to HIV-1 and HIV-2
• Gum swab sample, with no blood and no needles
• Result read at 20 minutes, within a 20 to 40 minute window
• Single-use kit: test stick, developer vial and test stand
• Approved for people aged 14 and older
• OraSure phone line for questions, 7 days a week, 8 AM to 8 PM EST

Specifications

What’s in the box

• 1 × test stick with flat pad
• 1 × developer vial (test tube with fluid)
• 1 × test stand
• Instructions for Use and the “HIV, Testing & Me” booklet

Good for

• Private HIV testing at home
• People who prefer a gum swab to a finger-prick or blood draw
• Regular testing between appointments
• Getting a result in the same sitting, in about 20 minutes

Things to consider

• Window period: OraQuick says it can take up to 3 months after exposure for antibodies to reach a level this test can find, so a negative result within that time does not rule HIV out; OraQuick suggests repeating the test at least 3 months after a possible exposure.
• A positive or unclear result must be confirmed with additional testing in a medical setting.
• Do not eat, drink or use mouthwash, toothpaste or whitening strips for 30 minutes before testing, and have a timer ready; a result read before 20 or after 40 minutes is not valid.
• Not intended for people who already know they have HIV or take HIV medication, and HIV vaccine trial participants may get a positive result. Do not use a kit with a broken seal or past its expiry date.

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