NEW YORK – Cepheid announced Wednesday that it has received prequalification status from the World Health Organization for a point-of-care HIV-1 PCR assay with extended coverage. The test, which can be used to detect HIV infection in infants and people who were recently infected, will now be included on a list of tests that meet WHO's standards for global use.
Cepheid's Xpert HIV-1 Qual XC test runs on the GeneXpert system and provides results in approximately 90 minutes. It detects HIV-1 nucleic acids directly from dried blood spots and from capillary or venous whole blood and can be used at the point of care and in laboratories. The test provides extended coverage through the inclusion of two gene targets for HIV-1 strains. This approach allows infections to be detected up to 10 days before seroconversion, Cepheid said in a statement.
Point-of-care testing is projected to deliver results on the same day, enabling improved linkage to care and therapy initiation compared to centralized lab testing.
Using the test, expectant mothers can be tested prior to delivery, and babies can be tested when they are born, according to Cepheid, a subsidiary of Danaher.
"When accurate and sensitive test results are provided to clinicians quickly, they can immediately initiate the highly effective therapies that are now available to babies with HIV," said Devasena Gnanashanmugam, VP of medical affairs at Cepheid. Without treatment, half of babies born with HIV infections due to mother-to-child transmission will die before the age of 2.
Prequalification is intended in part to fill an oversight gap in countries that don't have designated regulatory agencies. It was originally a mechanism to prevent ineffective drugs from being sold in low- and middle-income countries, but the WHO also branched into prequalifying in vitro diagnostics in 2010.
Diagnostic tests are evaluated to demonstrate performance, quality, safety, and reliability prior to WHO prequalification. The prequalification status enables assays to be procured using large caches of donor funding earmarked for PQ tests, as well as to be purchased in certain countries where PQ is mandated.
A Cepheid HIV-1 test called Xpert HIV-1 Qual was CE-marked in 2012 and obtained WHO prequalification in 2016.
Other WHO prequalified Cepheid Xpert tests available internationally include tests for viral load in HIV-1, hepatitis B virus, hepatitis C virus, and human papillomavirus. Cepheid's Xpert HCV VL Fingerstick test has also obtained PQ, and its tuberculosis tests Xpert MTB/RIF Ultra and Xpert MTB/XDR were endorsed by the WHO in 2010.