Roche's Zika screening test secured approval from FDA

Roche's cobas Zika test to detect RNA of the Zika virus in human plasma samples has been approved by the US Food and Drug Administration (FDA).

The test is to detect RNA of the Zika virus in human plasma samples.

Prepared for the screening of blood and plasma donations in the country, the test is approved for use on the firm’s cobas 6800 / 8800 systems.

The cobas Zika test has been designed as a qualitative in-vitro nucleic acid screening indication to directly detect the virus’ RNA in plasma samples of individual blood donors.

Initially deployed under the IND protocol in April last year for the screening of blood donations in Puerto Rico, the test was expanded by the end of the year to support donor screening efforts in the US.

The cobas Zika test is intended to ensure that potentially infected units are not used for blood transfusion, with the cobas 6800 / 8800 systems performing automated data management, it carries out automated sample preparation and PCR amplification and detection and assigns a result as non-reactive, reactive or invalid.