Asanté ® HIV-1/2 ORAL SELF-TEST
IN DEVELOPMENT

FOR THE QUALITATIVE DETECTION OF ANTIBODIES TO TYPE 1 AND TYPE 2 HIV IN ORAL FLUID SPECIMENS

Asanté ® HIV-1/2 Oral Self-Test

A rapid, visually read, in vitro immunoassay for the qualitative detection of antibodies to HIV-1 and HIV-2 in oral fluid specimens. Will be intended for use outside the United States.

Easy to Use

No needles or sharps containers required.

Easy to follow color reference guides in product insert.

Swipe the included swab along the gums and mix with Sample Buffer. Discard Swab and add Test Strip to begin the test.

Convenient

No laboratory infrastructure required.

Results in as soon as 20 minutes.

Flexible

Stored and transported at ambient temperatures.

Easily implemented in a variety of healthcare settings.

HIV-1-2-Oral-Self-Test-1

PRODUCT SPECIFICATIONS

HIV-1/2 Subtype Antibody Detection

Designed to detect antibodies to both HIV-1 and HIV-2.

Two Reaction Lines

Control Line signifies the specimen was properly added and the test functioned properly.

Test Line indicates a presumptive positive or negative result.

EXPECTED PRODUCT APPLICATIONS

May encourage wide-spread testing in all regions of the world.

Will enable at-risk users to continuously monitor HIV status.

FREQUENTLY ASKED QUESTIONS

Can this test be purchased?

The Asanté ® HIV-1/2 Oral-Self Test is in development and is not yet available for purchase. Contact customerservice@sediabio.com for more information.

The Asanté ® HIV-1/2 Oral-Self Test will only be used with oral fluid specimens.

The Oral Swab is inserted directly in the Sample Buffer Tube, and mixed by moving the Swab up and down at least 2 times. Once mixed, press the Swab against the Tube to expel excess fluid and discard the Swab with local, state, and federal regulations.

The “C” line is the Control Line which will indicate the test is functioning properly. The “T” line is the Test Line which is designed to indicate a positive result for HIV infection when present. Once available, if a positive result is obtained from the Asanté ® HIV-1/2 Oral Self-Test the user should go to a clinic and get re-tested to confirm the result.

If the “C” line does not appear, the test will be considered invalid. The test will be repeated using new Sample Buffer, Oral Swab, and Test Strip.

There no current regulatory approvals for the Asanté ® HIV-1/2 Oral Self-Test. Availability will be dependent upon regulatory approvals within each country prior to sale.

CONTACT US

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