Laboratory Corporation of America Holdings (LabCorp) has announced the nationwide availability of testing for Zika virus using the RealStar Zika Virus RT-PCR Kit U.S. from altona Diagnostics GmbH.
The test has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration for the qualitative detection of Zika virus RNA in serum or urine (collected alongside a patient-matched serum specimen). It is intended to be used to aid in the diagnosis of Zika virus infection in individuals meeting clinical and/or epidemiological criteria for infection risk established by the Centers for Disease Control and Prevention.
“The Zika virus is a serious public health threat, and many people are concerned about the risk it presents to them and their families,” David P. King, LabCorp’s chairman and CEO, said in a statement. “Offering this new Zika virus test aligns with LabCorp’s strategy to deliver world-class diagnostics that provide physicians and patients with information they need to achieve better health outcomes.”
CDC clinical criteria for Zika virus infection testing include signs and symptoms associated with Zika virus infection. CDC epidemiological criteria for Zika virus infection testing include a recent history of residence in or travel to a geographic region with active Zika virus transmission at the time of travel, including for male sexual partners with such residence or travel history.
Zika virus, which is primarily spread through mosquito bites and can also be spread through certain sexual contact, has been identified in 618 individuals in the U.S. as of June 1, 2016. All of those cases have been associated with travel to areas with ongoing transmission of Zika virus, such as many South and Central American countries where Zika virus has been active since 2015. According to U.S. public health officials, there is a significant threat that local transmission of Zika virus will begin in the U.S. in 2016.
“Public health officials anticipate that the U.S. will become an area of active Zika virus transmission this year,” Marcia Eisenberg, Ph.D., chief scientific officer for LabCorp Diagnostics, said.
Most cases of Zika virus are relatively minor, and those infected may exhibit no symptoms or mild symptoms such as fever, joint pain, rash or redness of the eyes. However, Zika virus infection during pregnancy may cause birth defects, including fetal microcephaly, and may also contribute to poor pregnancy outcomes including stillbirth or miscarriage.
Women who are exposed to Zika virus or diagnosed with Zika virus during pregnancy, or who become pregnant from a partner who has been exposed or diagnosed, should monitor their pregnancy closely with their healthcare provider.
RT-PCR testing, such as the RealStar Zika Virus RT-PCR Kit U.S., is only clinically appropriate in symptomatic individuals during approximately the first seven days after the onset of symptoms. In addition, serum and urine samples need to be tested concurrently to help ensure maximum diagnostic accuracy.
Because individual responses to Zika virus may vary, additional serological testing may be considered within 2-12 weeks after symptom onset to further evaluate the likelihood of Zika virus infection. LabCorp plans to offer serological testing for Zika virus when there is an FDA approved for emergency use product available to commercial labs.
This test has not been FDA cleared or approved. This test has been authorized by FDA under an EUA for use by CLIA High Complexity Laboratories and similarly qualified non-U.S. laboratories and is only authorized for the duration of the declaration that circumstances exist justifying the EUA. It is only authorized for the detection of RNA from Zika Virus and the diagnosis of Zika Virus infection, and not for any other viruses or pathogens.
As required by FDA, LabCorp will report positive results of this test to CDC and other public health authorities, as may be appropriate. LabCorp will also report to altona Diagnostics any suspected occurrence of false positive or false negative results of which it becomes aware.