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Roche gets FDA approval to screen blood samples with cobas Zika assay

MDBR Staff Writer Published 31 March 2016

Roche has received approval from the US Food and Drug Administration (FDA) to start collection and testing of blood samples for screening with the cobas Zika assay under an investigational new drug application (IND) protocol.

Zika

The cobas Zika test for use with the cobas 6800/8800 systems is a qualitative in vitro nucleic acid screening test will identify Zika virus RNA in plasma specimens from individual human blood donors.

Roche Diagnostics COO Roland Diggelmann said: "The cobas Zika test has been specifically designed utilising the generic cobas omni Utility Channel on the cobas 6800/8800 systems.

"These fully-automated high-volume systems provide solutions for blood services to detect the virus and ensure that potentially infected blood units are not made available for transfusion."

Roche will initially deploy the cobas Zika test to screen blood donations collected locally in Puerto Rico.

The testing will allow the reinstatement of the blood services in the country and decrease the reliance of blood importation from other areas in the US.

Roche said the second stage of deployment for the cobas Zika test will be to prepare for screening of blood donations collected by blood services in the southern US.

The cobas Zika test is based on fully automated sample preparation followed by PCR amplification and detection.

The cobas 6800/8800 systems include sample supply module, transfer module, processing module and analytic module.

Automated data management will be carried out by the cobas 6800/8800 software, which attributes test results for all tests as non-reactive, reactive, or invalid.


Image: Electron micrograph of the Zika virus. Photo: courtesy of CDC/ Cynthia Goldsmith.