This first real-time PCR diagnostic test is expected to cost $300.
Quest Diagnostics Inc. has launched a lab testing kit to detect H1N1 virus that causes swine flu.
The swine flu test kit, which uses real-time polymerase chain reaction (PCR) test to aid in identifying Influenza A H1N1 Swine-origin (H1N1) flu virus, will be the first laboratory testing kit commercially available to identify swine flu virus in infected patients, Quest Diagnostics said in a press statement.
Real-time PCR is a highly sensitive testing technique that can detect the presence of a virus’ RNA from a patient’s nasal or nasopharyngeal specimen.
Focus Diagnostics, one of Quest’s regional laboratory, has validated its new influenza A H1N1 (Swine Flu) RNA Real-Time RT-PCR Test using clinical specimens submitted to its reference laboratory confirmed as positive for the novel H1N1 influenza virus by public health authorities.
Focus Diagnostics has a track record of being first to develop and market with new laboratory testing services for emerging infectious diseases, such as West Nile Virus, SARS, and chikungunya virus.
“Our new laboratory test will be an important tool to help health care professionals and public health authorities identify infected patients more quickly, promoting earlier diagnosis and treatment,” said Jon R. Cohen, MD, senior vice president and chief medical officer, Quest Diagnostics.
The new test kit could be particularly important if the novel H1N1 virus continued to spread in the U.S. or re-emerges this fall or winter, said Jon R Cohen.
The swine flu causing H1N1 virus is a subtype of Influenza virus Type A. The new Focus Diagnostics test simultaneously detects the presence of Influenza A virus RNA and specifically identifies the presence of the novel H1N1 virus, the company stated.
Focus Diagnostics will perform the Influenza A H1N1 (swine flu) RNA Real-Time RT-PCR laboratory test at its reference laboratory in Cypress, California.
Physicians, hospitals and other health care practitioners may order the laboratory test directly from Focus Diagnostics or through the Quest Diagnostics national laboratory network.
Physicians will be able to submit patient specimens that are found to be positive for Influenza virus type A through testing performed by a Quest Diagnostics’ regional laboratory or other private clinical laboratory to Focus Diagnostics’ reference laboratory for novel H1N1 laboratory testing.
If a patient is at high risk of novel H1N1 infection, the physician may order the new Focus Diagnostics test to aid the diagnosis of Influenza virus type A infection.
The test kits are expected to report back within 24 hours of receipt of specimen by the Focus Diagnostics laboratory.
Focus Diagnostics would also submit those test specimens found to be positive as well as the test results to the appropriate public health authorities, as required by local public health guidelines.
The swine flu test kit will cost approx. $300
In addition to the new Influenza A H1N1 (Swine Flu) RNA Real-Time RT-PCR Test, Quest Diagnostics’ regional laboratories, including the Focus Diagnostics reference laboratory, perform a broad range of testing services to detect Influenza viruses, including PCR, rapid cell culture, direct immunofluorescence (DFA) and enzyme immunoassay (EIA) techniques.
Quest laboratories can perform testing on different types of collected specimens, such as nasopharyngeal swabs, nasal secretions, nasal wash (lavage) and aspirations.
Focus Diagnostics has collaborated with the U.S. Centers for Disease Control and Prevention, the World Health Organization and other public health agencies to help identify and develop diagnostic tests for emerging infectious diseases. Focus Diagnostics was instrumental in developing the first laboratory developed test for West Nile Virus after it was identified in New York in 1999. Focus Diagnostics also introduced the first laboratory developed test for SARS and the first FDA-cleared serological test kit for Lyme disease.
Focus Diagnostics, Inc. is an infectious disease diagnostics company, providing infectious disease reference laboratory services to hospitals and laboratories nationwide, and manufacturing and distributing diagnostic products worldwide.
Focus Diagnostics develops innovative tests and products to assist physicians in diagnosing infectious diseases such as West Nile Virus and SARS. HerpeSelect type-specific HSV serology and West Nile Virus DxSelect are top-selling Focus Diagnostics products used in laboratories worldwide. Focus Diagnostics is a wholly owned subsidiary of Quest Diagnostics.
Quest Diagnostics is the world’s leading provider of diagnostic testing, information and services.