The experimental blood test detects Zika virus RNA in plasma samples from individual human donors.
The Food and Drug Administration (FDA) say in a statement released on Wednesday that:
"The screening test may be used under an investigational new drug application (IND) for screening donated blood in areas with active mosquito-borne transmission of Zika virus."
IND status does not mean that the FDA have cleared or approved the Zika test. It means the federal regulator has authorized its use under a specific protocol by US blood screening laboratories.
As the test is still experimental, all testing laboratories have to be enrolled and contracted into the clinical trial and agree to the terms set out by the FDA Center for Biologics Evaluation and Research (CBER).
Dr. Peter Marks, director of the CBER, says having such a test is important to protect the nation's blood supply, especially for US territories - like Puerto Rico - that are already experiencing active transmission of Zika.
The announcement follows guidance issued by the FDA in February recommending that blood centers situated in areas where Zika transmission is active source their blood and blood products from areas where Zika is not active.
That guidance meant Puerto Rico had to suspend its local collection of blood from donors, and instead, obtain it from shipments of blood collected in mainland US that the Department of Health and Human Services started sending to the island in early March.
Test ensures blood collection can continue in areas affected by Zika
Thus, once it has set up testing labs in line with the CBER protocol, Puerto Rico should be able to collect blood locally again and screen it for Zika. This should reduce the island's dependence on blood imported from elsewhere in the US. Dr. Marks also notes that:
"In the future, should Zika virus transmission occur in other areas, blood collection establishments will be able to continue to collect blood and use the investigational screening test, minimizing disruption to the blood supply."
The FDA collaborated with the manufacturer Roche Molecular Diagnostics in the development of the test, which detects Zika virus RNA in plasma samples from individual human donors.
The test equipment comprises four modules: sample supply module, the transfer module, the processing module and the analytic module.
According to the manufacturer, the test is "based on fully automated sample preparation (nucleic acid extraction and purification) followed by PCR amplification and detection," and automatically produces either a non-reactive, reactive, or invalid result.
Meanwhile, Medical News Today recently learned the FDA have also issued recommendations for reducing Zika transmission by human cell and tissue products.