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Cepheid Qualitative HIV-1 Test Receives CE Mark

NEW YORK (GenomeWeb) – Cepheid announced today that its qualitative HIV-1 assay has achieved CE-IVD status. The assay, called Xpert HIV-1 Qual, runs on the firm's GeneXpert platform and detects nucleic acid of the virus from blood samples in around 90 minutes.

The test is designed for early diagnosis of HIV in high-risk individuals and infants, with the hope that faster sample-to-result time will reduce loss to follow-up. It detects HIV-1 total nucleic acid in either whole blood or dried blood spots, targets a single gene, includes two internal controls, and has a limit of detection of 40 viral copies/ml of plasma, as previously reported.

Cepheid has placed over 8,000 GeneXpert platforms worldwide, and Xpert HIV-1 Qual brings the total number of test cartridges to 22 outside the US, the firm said in a statement.

An HIV viral load monitoring cartridge for the GeneXpert platform was CE marked late last year, and the firm announced yesterday that it received CE-IVD status for an assay cartridge providing on-demand confirmation of infection and monitoring of hepatitis C virus.

The Xpert HIV-1 Qual test was developed in collaboration with the Foundation for Innovative New Diagnostics and will being shipping this month.