First “cobas” test for screening Zika virus in blood donations – FDA

The U.S. Food and Drug Administration today approved the cobas Zika test, a qualitative nucleic acid test for the detection of Zika virus RNA in individual plasma specimens obtained from volunteer donors of whole blood and blood components, and from living organ donors. It is intended for use by blood collection establishments to detect Zika virus in blood donations, not for the individual diagnosis of Zika virus infection.

“Today’s action represents the first approval of a Zika virus detection test for use with screening the nation’s blood supply,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. “Screening blood donations for the Zika virus is critical to preventing infected donations from entering the U.S. blood supply. Today’s approval is the result of a commitment by the manufacturer to work rapidly and collaboratively with the FDA and the blood collection industry to respond to a public health crisis and ensure the safety of blood in the U.S. and its territories.”

In August 2016, the FDA issued a final guidance document recommending that all states and territories screen individual units of whole blood and blood components with an investigational blood screening test available under an investigational new drug (IND) application, or a licensed (approved) test when available.

Before today, several blood collection establishments used the cobas Zika test under IND in order to follow the recommendations in the FDA’s 2016 guidance document. The data collected from this testing, and from additional studies performed by the manufacturer, demonstrated that the cobas Zika test is an effective test to screen blood donors for Zika virus infection. The test’s clinical specificity was evaluated by testing individual samples from blood donations at five external laboratory sites, resulting in the clinical specificity of more than 99 percent.

The Zika virus is transmitted primarily by mosquitos (Aedes aegypti), but it can also be spread through blood transfusion and sexual contact. Although most people infected with Zika virus do not develop symptoms, when symptoms do occur they may include fever, arthralgia (joint pain), maculopapular rash (red area with small bumps), and conjunctivitis (red, irritated eyes). In addition, Zika virus infection can cause a serious neurological disease in adults, and infection during pregnancy can cause serious birth defects.

The cobas Zika test is intended for use on the fully automated cobas 6800 and cobas 8800 systems. The cobas Zika test, cobas 6800, and cobas 8800 systems are manufactured by Roche Molecular Systems, Inc.
More Information about Cobas Test from
Roche Molecular Systems, Inc

The cobas® MRSA/SA assay for use on the cobas® Liat® System allows healthcare professionals to take control of methicillin-resistant Staphylococcus aureus (MRSA) and Staphylococcus aureus (SA) infections. Fast, accurate identification, suitable for use in ER, ICU and STAT lab settings, enable rapid response for time-sensitive decolonization and unnecessary isolation of suspected MRSA/SA cases.

Active surveillance to identify carriers with speed and accuracy, using a single nasal swab specimen, brings time-saving efficiencies and life-saving answers.

Simplified workflow with less than 1-minute hands-on time; no vortex step, no precision pipetting, no result interpretation required
High sensitivity and specificity with expanded strain inclusivity for MRSA and SA to detect new and emerging SCCmec subtypes including mecC

Intended Use

The cobas® MRSA/SA Nucleic acid test for use on the cobas® Liat® System is an automated, real-time PCR assay for the rapid in vitro qualitative detection of methicillin-resistant Staphylococcus aureus (MRSA) and Staphylococcus aureus (SA) DNA from nasal swabs to aid in the identification and control of MRSA and SA infections in healthcare settings. The cobas®MRSA/SA Test is not intended to diagnose, guide or monitor treatment for MRSA or SA infections, or provide results of susceptibility to methicillin. A negative result does not preclude MRSA/SA nasal colonization. Concomitant cultures are necessary to recover organisms for epidemiology typing or for further susceptibility testing.

This product is not registered as an in vitro diagnostic (IVD) in all countries; additional information may be available from your Roche sales representative.