NEW YORK (GenomeWeb) – Altona Diagnostics announced today that it has received Emergency Use Authorization for its Zika virus assay from the US Food and Drug Administration.
The test can now be used as a molecular diagnostic for samples from individuals meeting the US Centers for Disease Control and Prevention's clinical or epidemiological criteria for potential Zika virus infection. It is the third molecular diagnostic test for the virus to be granted EUA since the emergency was declared in March; there is also an authorized immunoassay.
The RealStar Zika Virus RT-PCR kit detects Zika RNA in human serum and in matched urine specimens. The authorized workflow involves extraction with the Qiagen QIAamp Viral RNA Mini Kit. Altona has validated the test’s amplification and detection on systems from Qiagen, Applied Biosystems, Bio-Rad, Roche, and Corbett Research.
The Hamburg, Germany-based firm noted in a statement that the Zika test is intended for use only under EUA in CLIA-certified High Complexity labs in the US or similarly qualified non-US labs, and that the test is not FDA cleared or approved but rather authorized for use only during the duration of the emergency.
A research-use only version of the test was launched in January of this year. It had been used as part of a lab-developed test by a hospital in Houston — that LDT was later reviewed by the FDA to determine whether it required regulatory oversight.
This month the CDC updated its guidance to recommend Zika virus testing in urine specimens. The agency itself has two Zika assays that have been granted EUA by the FDA: an ELISA immunoassay and the Trioplex PCR-based assay for Zika, dengue, and chikungunya viruses. The latter can be used to test urine samples. Although many other firms such as Siemens and Ubiquitome are purportedly working on EUA for Zika tests, the only other commercial entity to have received it so far is Quest Diagnostics for a test authorized for use on human serum samples.