Quest Diagnostics, the world's leading provider of diagnostic information services, announced the availability of a new antibody test service that aids the diagnosis of infection with the Zika virus. The service is based on the Zika Immunoglobulin M (IgM) Antibody Capture Enzyme-Linked Immunosorbent Assay (Zika MAC-ELISA), developed by the Centers for Disease Control and Prevention (CDC) and authorized for emergency use by the US Food and Drug Administration (FDA). The CDC has licensed the test to Quest Diagnostics and other select national reference laboratories to aid the response to the Zika emergency in the United States.
With the new service, Quest Diagnostics now provides access to Zika virus antibody and molecular laboratory test services for people in the United States as well as Puerto Rico and other US territories. Healthcare providers in other countries may also refer specimens for Zika testing to Quest. Quest Diagnostics was the first commercial laboratory to receive FDA emergency use authorization for a Zika test, on April 28, 2016. That molecular test is intended for the qualitative detection of RNA from Zika virus in human serum specimens. On September 6, Quest expanded its molecular Zika test capabilities with the introduction of an RT-PCR Zika test service for the qualitative detection of RNA from Zika virus in serum and paired urine specimens.
Molecular RT-PCR tests identify 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. 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 useful two to 12 weeks following the onset of symptoms.
"Quest now provides physicians and patients with access to a robust, complementary range of Zika test options for aiding diagnosis of Zika infection," said Rick L. Pesano, M.D., Ph.D., vice president, research and development, Quest Diagnostics. "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.
"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," Dr. Pesano added.
Quest operates approximately 2,300 patient service centers across the United States, more than any other commercial laboratory provider. Approximately 260 of these centers are in Florida, the first state to document cases of local transmission. Patients can provide specimens for testing at any one of these centers with a physician test order.
In addition, many healthcare providers can also collect patient specimens in their offices for testing by Quest Diagnostics. Quest Diagnostics serves half the physicians and hospitals in the United States each year.
"Commercial labs such as Quest Diagnostics can play an essential role in public health response to emerging infectious diseases like Zika," said Scott Becker, executive director, Association of Public Health Laboratories. "These organizations bring expertise, scale and logistics support, as well as access to healthcare providers and patients, that complement and extend the capabilities of our nation's public health labs."
Quest Diagnostics performs testing for its proprietary Zika RT-PCR test as well as the CDC-based Zika MAC-ELISA test at its Focus Diagnostics laboratory, a reference laboratory business of Quest Diagnostics in San Juan Capistrano, Calif. Quest performs the molecular RT-PCR Zika test for use on serum and paired urine specimens at its advanced laboratory in Chantilly, Virginia.
Zika is an infectious disease spread through the bite of infected mosquitoes, from mother to fetus during pregnancy, and through sexual transmission. Symptoms include fever, rash, joint pain, and red eyes (conjunctivitis). Zika infection during pregnancy may cause microcephaly and other birth defects. In February 2016, the World Health Organization declared an international public health emergency and the US Department of Health and Human Services declared significant potential for a public health emergency due to Zika.
According to the CDC, there were 20,870 confirmed cases of locally acquired and travel-associated Zika virus disease cases in the United States and US territories as of September 14, 2016; 3,176 of these are in the United States. Among the 50 states, the largest number of identified cases (639) is in Florida, with 43 of those cases locally acquired.
Quest Diagnostics is a leader in infectious disease testing services, with a broad menu of molecular, antibody, and other test services to aid diagnosis, treatment and monitoring. Quest offers a comprehensive range of testing services for the flaviviruses dengue fever and Chikungunya as well as Zika.
The Zika tests provided by Quest Diagnostics and its Focus Diagnostics laboratory business have not been FDA cleared or approved. These tests have been authorized by FDA under emergency use authorizations and are only authorized for the duration of the declaration.
The Zika tests are intended for patients meeting CDC's Zika virus clinical criteria (e.g., clinical signs and symptoms associated with Zika virus infection) and/or CDC Zika virus epidemiological criteria (e.g., history of residence in or travel to a geographic region with active Zika transmission at the time of travel, or other epidemiologic criteria for which Zika virus testing may be indicated). The diagnosis of Zika virus infection must be made based on history, signs, symptoms, exposure likelihood, and other laboratory evidence in addition to the identification of Zika virus. The tests should not be used as the sole basis for patient management decisions. Within the United States, all positive and negative results of these tests are reported as required to State and local Public Health authorities.