Rapid HSV-2 Test Sets New Standard in STI Diagnostics

With an estimated 65 million Americans living with genital herpes and around 90% of those undiagnosed, there is an urgent need for faster, more efficient, accurate, and accessible testing methods. Existing diagnostics, such as ELISA tests, commonly yield 17–22% equivocal results, resulting in misdiagnosis and delays in care. Specificity can be as low as 39.8% for certain index values, underscoring the inadequacy of current diagnostic tools. Such limitations often lead to uncertainty, distress, and postponed treatment, worsening patient outcomes. Now, a new rapid test for herpes simplex virus type 2 (HSV-2) addresses the limitations in STI diagnostics with its improved speed, accuracy, and accessibility.

Bio-Diagnostics Ltd.’s (Worcestershire, UK) HSV-2 BioCard test detects circulating antibodies to HSV-2 in the blood, indicating an active or past infection. Unlike HSV-1, which typically causes cold sores but can also lead to genital sores, HSV-2 is the primary cause of genital herpes, making accurate differentiation essential for treatment and limiting transmission. Bio-Diagnostics initially developed the BioCard HSV-2 testing technology as an accessible screening method to detect undiagnosed infections of genital HSV-2, but was later recommended by healthcare protection agencies to confirm around 20% of results that are left unclear by standard methods. The BioCard platform is also modular, supporting other diagnostic applications such as infectious diseases, autoimmune markers, toxins, and food safety.

Image: The HSV-2 Biocard Rapid Test Kit (Photo courtesy of Bio-Diagnostics Ltd)

The technology has been validated using blinded panels from UKHSA and MHRA NIBSC, demonstrating up to 100% sensitivity and 99.5% specificity for COVID-19 immunity tracking—further proving the reliability of the BioCard platform. It is the only technology to correctly identify every single UK NEQAS sample since its launch. Use of testing technologies by following the CDC guidelines resolves the compound effects of misdiagnosis, distress, and delayed care. The BioCard HSV-2 Rapid Test bridges this critical gap with point-of-care accuracy, simplicity, and global scalability. The BioCard HSV-2 test is typically administered in clinical settings or testing facilities by healthcare professionals, ensuring accurate diagnosis alongside access to supportive care. Bio-Diagnostics is now seeking new distribution partners and technology licensing collaborators to expand access across clinical, public health, and remote care settings.

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