POC Oral Fluid Test Diagnoses HIV Infection in 20 Minutes

Conventional blood-based tests, such as ELISA, can take days or even weeks to return results, delaying counselling, treatment initiation, and linkage to care. Blood collection also introduces barriers related to safety, biohazard waste, and patient discomfort. Now, a rapid, non-invasive oral fluid test allows individuals to receive reliable HIV test results shortly after sample collection at the point of care.

Sedia Biosciences’ (Portland, OR, USA) Asanté HIV-1/2 Oral Fluid Test is a single-use, qualitative immunoassay that detects antibodies to HIV-1 and HIV-2 using oral fluid rather than blood. By eliminating the need for phlebotomy, sharps, and cold-chain storage, the test is suited for decentralized testing programs. It can be administered with limited training, generates little to no biohazard waste, and is easily transported and stored in remote regions.

The test works by collecting an oral fluid specimen and analyzing it for the presence of antibodies associated with HIV infection. Results are available in as little as 20 minutes, enabling same-visit counselling and referral. This rapid turnaround addresses one of the key limitations of traditional laboratory-based testing. Oral fluid testing also improves patient acceptance and safety for healthcare workers, while maintaining high diagnostic reliability, making it suitable for community-based and outreach testing initiatives.

Clinical performance evaluations of the Asanté HIV-1/2 Oral Fluid Test demonstrated high sensitivity and specificity, which are essential for accurate HIV diagnosis. These findings supported its assessment against international quality and performance benchmarks. Based on these results, the test has received World Health Organization (WHO) Pre-Qualification, confirming that it meets stringent standards for quality, safety, efficacy, and performance required for global public health use.

WHO pre-qualification enables the test to be procured by UN agencies and major global health organizations, supporting large-scale deployment in HIV testing programs worldwide. Its non-invasive design and point-of-care suitability make it particularly valuable for expanding access to testing in underserved populations. The approval is expected to support earlier diagnosis, faster linkage to care, and stronger progress toward global HIV elimination goals, especially in regions where traditional laboratory testing remains impractical.

“Receiving WHO Pre-Qualification is a testament to the quality and reliability of our Asanté HIV-1/2 Oral Fluid Test,” said Roger Gale, CEO and President of Sedia Biosciences. “This approval is a game-changer for expanding global HIV testing efforts. The non-invasive nature of oral fluid testing, combined with its high accuracy and ease of use, addresses critical barriers to testing in many regions, moving us closer to achieving the global goal of eliminating HIV as a public health threat.”

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