Cepheid’s two HIV-1 tests obtain CE-IVD clearance
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Cepheid’s two HIV-1 tests obtain CE-IVD clearance

30 Jul 2021 (Last Updated July 30th, 2021 15:16)

Cepheid plans to start shipping the HIV test kits to CE mark-accepting countries by the end of the month.

Cepheid’s two HIV-1 tests obtain CE-IVD clearance
Scanning electron micrograph of HIV-1 budding (in green) from cultured lymphocyte. Credit: CDC/C Goldsmith on Wikimedia.

Cepheid has obtained CE-IVD clearance for two advanced, extended-coverage (XC) human immunodeficiency virus (HIV) tests, Xpert HIV-1 Viral Load XC and Xpert HIV-1 Qual XC.

Xpert HIV-1 Viral Load XC is indicated for analysing the viral load levels that are used for monitoring the antiretroviral treatment efficiency.

It adds a second target for the identification of HIV-1, offering expanded strain coverage to boost performance and alleviate the risk of false-negative results because of gene mutations or deletions.

Xpert HIV-1 Qual XC also adds a second target for quicker detection of HIV-1 infections, up to seven to ten days before seroconversion.

This test is intended to be used in both laboratory and near-patient testing environments for adults, adolescents and infants

As all reagents involved are in one completely integrated cartridge, Xpert HIV-1 Qual XC aids in the processing of dried blood spot (DBS) samples and facilitates a streamlined workflow.

Furthermore, as the test does not have guanidinium thiocyanate (GTC), the cartridge can be disposed of easily and is a more environment-friendly option.

Cepheid executive vice-president, chief medical and technology officer Dr David Persing said: “Xpert HIV-1 Viral Load XC and Xpert HIV-1 Qual XC leverage new dual-target technology to improve detection while maintaining the flexibility to be performed on-demand in as little as 90 minutes.

“The combination of peripartum determination of HIV viral load in mothers along with early qualitative HIV detection in newborns facilitates same-day treatment decisions, which will result in improved outcomes for babies, mothers and entire communities.”

Both the tests can be used on any of Cepheid’s GeneXpert Systems. The systems offer simple, reference laboratory-quality polymerase chain reaction testing at medical centres, hospitals, community health clinics and physician’s offices.

Cepheid will commence shipping of Xpert HIV-1 Viral Load XC and Xpert HIV-1 Qual XC test kits to regions accepting CE mark by the end of the month.

Both the tests will undergo the World Health Organisation pre-qualification assessment, anticipated next year.

In March last year, Cepheid received emergency use authorisation from the US Food and Drug Administration for its rapid molecular diagnostic test, Xpert Xpress SARS-CoV-2.