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.

Go deeper with GlobalData

Data Insights

The gold standard of business intelligence.

Find out more

Related Company Profiles

View all

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.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

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.