NEW YORK (GenomeWeb) – Laboratory scientists at Houston Methodist Hospital and Texas Children's Hospital have begun using a lab-developed test for the Zika virus that they claim is the first hospital-based rapid assay for the virus in the US.
PCR-based testing is currently provided by the US Centers for Disease Control and Prevention. And state and local labs that are qualified to run the CDC West Nile assay or have passed a proficiency panel can also perform the CDC's Zika test.
Houston Methodist's Chair of Pathology and Genomic Medicine James Musser told GenomeWeb that the hospitals felt it was imperative to have a faster option. "We are the flagship hospitals in the Texas medical center, and for that matter in the state of Texas. So to best care for our patients we felt a substantial need to have this test in house with a very rapid turnaround time, which currently is not possible with any other available testing nationally," he said, adding that testing by the CDC currently takes several weeks. "We have always taken the position that we must be 100 percent prepared to rapidly diagnose any entity, regardless of whether its Zika virus, or Ebola before that, or whatever virus will emerge next year."
Texas Children's also has a focus on neglected tropical diseases — Peter Hotez, dean of the National School of Tropical Medicine at Baylor, holds the hospital's endowed chair in tropical pediatrics.
However, Musser said, a focus on tropical disease or the presence of arbovirus vector species in the local area were not necessarily the inspiration to bring the Zika test on board. Rather, the globally diverse nature of Houston's population and the fact that the city is a transportation hub motivated the focus on viral diagnostics. The city is also on track to become third largest in the US, with a population of 6 million people.
"We have a huge international population with huge travel, both to Africa and to the Caribbean and Central and South America, and honestly, we have to be prepared simply because of that," Musser said.
Further, the hospitals, which are located adjacent to each other, received philanthropic support about a year ago to create the L.E. and Virginia Simmons Collaborative in Virus Detection and Surveillance. "We really put a lot of effort into developing this [test] in a very rapid fashion through these generous funds," Musser said. "Just to begin with, yesterday we already tested four patients, I don't know how many are downstairs now in the laboratory that we'll do today, tomorrow, and so forth, but there will absolutely be a need for this here."
The test, which is PCR-based, was developed and validated extensively in a matter of weeks. "The test that we're using is based on a kit that's sold through a company in Germany called Altona; it's the same group that we've used for other viral diagnostics," Musser said. "[Altona supplies], in essence, the great majority of a kit, and then we validate and so forth in house."
An Altona representative confirmed that Houston Methodist Hospital's lab was the first in the US to work with its test, but noted that it is not the only lab to do so. The assay is CE-IVD marked but is research-use only in the US.
The Altona test kit was launched in Europe in late January, and is not approved by the US Food and Drug Administration. "At present, and due to regulatory reasons in the US market, we sell the research-use only version of the RealStar Zika Virus RT-PCR Kit," the company spokesperson noted.
The firm is distributing the kit in Europe as well, and is establishing sales partnerships in various regions while also aiming for local registrations, particularly in South and Central America. "Regarding North America, we are following the activities of the FDA [and] as soon as there is an announcement for Emergency Use Authorization [EUA], we will apply for the authorization of the RealStar Zika Virus RT-PCR Kit 1.0," the representative said.
Altona previously received EUA from the FDA for RealStar kits to detect Ebola virus and Middle East Respiratory Syndrome Coronavirus. The firm also recently submitted the RealStar Zika Virus RT-PCR Kit 1.0 to the World Health Organization for assessment under the Emergency Use Assessment and Listing (EUAL) procedure.