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Quest Diagnostics launches Zika antibody test created by CDC
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Quest Diagnostics announced a new antibody test service — based on the Zika immunoglobulin M antibody capture enzyme-linked immunosorbent assay developed by the CDC — is available for the detection of infection associated with Zika virus, according to a news release.
The CDC licensed the test to Quest Diagnostics and other national reference laboratories to help combat Zika in the United States. Quest will offer access to Zika virus antibody and molecular laboratory test services through 2,300 service centers for people in the U.S., Puerto Rico and other U.S. territories.
“Quest now provides physicians and patients with access to a robust, complementary range of Zika test options for aiding diagnosis of Zika infection,” Rick L. Pesano, MD, PhD, Quest’s vice president of research and development, said in the release. “Quest’s national scale, diagnostic expertise and relationships with half the country’s physicians may be an increasingly important complement to public health response should the number of suspected Zika cases and demand for testing grow in the United States.”
The molecular real-time PCR test (Quest Diagnostics) identifies the presence of Zika virus RNA in a specimen, while antibody serology tests identify the presence of antibodies created by the body in response to infection, according to the release. Molecular RT-PCR testing is most useful up to 14 days after the onset of symptoms, depending on sample type and other factors, while IgM antibody testing is most effective 2 to 12 weeks after symptom onset. Pesano said the new test will be particularly helpful in Florida which, according to the CDC, has seen all of the locally acquired Zika virus cases in the U.S., as of Sept. 21.
“We are particularly gratified to provide these services in Florida, where the first local transmission has been documented and where Quest Diagnostics operates a significant service infrastructure,” Pesano said.
In April, Quest Diagnostics received FDA emergency use authorization for the first test for Zika virus; it developed a molecular test intended for the qualitative detection of RNA from Zika virus in human serum specimens. Then, on Sept. 6, Quest expanded its testing and introduced its Zika virus RNA qualitative RT-PCR test — designed to detect Zika virus RNA in human blood. The test is intended only for patients who qualify under CDC clinical or epidemiological criteria for Zika virus. Quest said its Focus Diagnostics laboratory in San Juan Capistrano, California, which developed and validated the test, currently will handle testing for the U.S. and Puerto Rico.
“Commercial labs such as Quest Diagnostics can play an essential role in public health response to emerging infectious diseases like Zika,” Scott Becker, executive director, Association of Public Health Laboratories, said in the release. “These organizations bring expertise, scale and logistics support, as well as access to health care providers and patients, that complement and extend the capabilities of our nation’s public health labs.”
The Zika tests provided by Quest Diagnostics and its Focus Diagnostics laboratory have not been FDA cleared or approved. Rather, they have been authorized by the FDA under emergency use authorizations and only are authorized for the duration of the declaration.
According to the CDC, as of Sept. 21, there are 23,135 confirmed cases of locally acquired and travel-associated Zika virus cases in the U.S. and its territories.
Disclosures: Pesano is employed by Quest Diagnostics. Becker is employed by the Association of Public Health Laboratories.