Original from: Sedia Biosciences Corporation
Sedia Biosciences Corporation, a leading developer of innovative diagnostic tests for infectious diseases, today announced that its Asant¨¦® HIV-1/2 Oral Fluid Test has received Pre-Qualification (PQ) status from the World Health Organization (WHO). This significant achievement enables global procurement and widespread use of this rapid diagnostic test.
The Asant¨¦® HIV-1/2 Oral Fluid Test is a single-use, qualitative immunoassay designed for the rapid detection of antibodies to Human Immunodeficiency Virus Type 1 (HIV-1) and Type 2 (HIV-2) in oral fluid specimens. It is intended for use by medical professionals at the point-of-care as a non-invasive, simple, and rapid aid in the diagnosis of HIV infection in resource constrained settings.
Enhancing Global Access and Convenience
WHO Pre-Qualification signifies that the Asant¨¦® test meets the organization¡¯s stringent standards for quality, safety, efficacy, and performance, making it eligible for use and purchase by UN agencies (such as UNAIDS, UNICEF, and UNDP) and other major global procurement organizations for the detection and diagnosis of HIV infections.
¡°Receiving WHO Pre-Qualification is a testament to the quality and reliability of our Asant¨¦®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.¡±
Key Benefits of the Asante™ HIV-1/2 Oral Fluid Test:
- Non-Invasive Sample Collection:Uses an oral fluid specimen, eliminating the need for phlebotomy or sharps, improving patient comfort and safety for both users and healthcare workers.
- Rapid Results:Provides results in as soon as 20 minutes, enabling immediate counselling and linkage to care.
- Point-of-Care Suitability:Can be performed with limited training and does not require complex laboratory infrastructure, making it ideal for decentralized testing programs.
- High Performance:Clinical performance evaluations demonstrated high sensitivity and specificity, critical for reliable HIV diagnosis.
The WHO Pre-Qualification of the Asant¨¦® HIV-1/2 Oral Fluid Test marks a major step in Sedia Biosciences¡¯ mission to develop and deliver innovative, accessible diagnostic solutions for global health challenges.
Source: Sedia Biosciences Receives WHO Pre-Qualification for its Asant¨¦® HIV-1/2 Oral Fluid Test
