INSTI HIV Antibody Self Test Kit | Health Canada Approved

The INSTI HIV Antibody Self Test Kit is a rapid, single-use HIV self-test designed to detect HIV-1 and HIV-2 antibodies from a small fingerstick blood sample.

Health Canada licensed the INSTI HIV Self Test in Canada in 2020. The Health Canada listing identifies it as a Class 4 test kit manufactured by bioLytical Laboratories Inc.

The test is intended for untrained lay users aged 18 years and older. It provides a convenient option for people who prefer private, at-home HIV screening.

Key Features

• HIV-1 and HIV-2 antibody self-test
• Fingerstick whole blood sample
• Single-use test
• At-home testing format
• Results in approximately 1 minute
• Simple three-step testing process
• Built-in control indicator
• Includes sterile lancet
• Includes test device
• Includes three pre-filled solution bottles
• Includes instructions for use
• No external equipment required
• Designed for users 18 years and older
• Health Canada licensed in Canada

How the INSTI HIV Self Test Works

The test uses a flow-through immunoassay to detect antibodies to HIV-1 and HIV-2.

First, the user collects a small blood drop using the included lancet. The blood sample is added to Bottle 1.

The user then shakes and pours the solutions into the test device in sequence. Each solution must be allowed to absorb before the next step.

The result appears on the test device. The manufacturer states that results can be available in approximately 60 seconds.

Kit Contents

The INSTI HIV Self Test kit includes:

• Test device
• Sterile single-use lancet
• Bottle 1 sample diluent
• Bottle 2 color developer
• Bottle 3 clarifying solution
• Adhesive bandage
• Instructions for use

Understanding the Result

A control dot indicates that the test procedure worked correctly.

A result showing the control dot without a test dot is interpreted as negative according to the manufacturer's instructions.

Two visible dots indicate a preliminary positive result. A positive self-test result must be followed by confirmatory laboratory testing through a healthcare professional.

If the control dot does not appear, the result is invalid and the test should be repeated.

Window Period

HIV antibody tests have a window period. After exposure, it can take 3 to 12 weeks for enough antibodies to develop for detection.

A negative result soon after a possible exposure may not rule out HIV infection. The manufacturer recommends repeat testing when appropriate after the window period.

Important Use Information

The INSTI HIV Self Test is intended for single use only. Do not reuse the test device or lancet.

The manufacturer advises against using the test for people under 18 years. It is also not suitable for people with bleeding disorders or those taking antiretroviral therapy.

Follow the included instructions carefully. Proper hand washing, blood collection, solution handling, and result timing are important.

Storage

Store the test in its original packaging at 2–30°C. Do not freeze the kit.

Keep the test away from excessive heat and direct sunlight. Perform testing at the recommended room temperature.

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