CHICAGO Quest Diagnostics Inc has developed the first commercially available test to identify U.S. patients infected with the new H1N1 flu virus, the medical testing provider said on Tuesday.
Quest said its Focus Diagnostics infectious disease reference laboratory validated the test using specimens confirmed as positive for the new virus by public health authorities. The test does not need to be approved by the U.S. Food and Drug Administration, the company said.
The virus, commonly referred to as swine flu, is a subtype of Influenza virus Type A. The Focus Diagnostics test detects the presence of Influenza A virus RNA and specifically identifies the presence of the novel H1N1 virus, Quest said.
The test can detect the presenHHce of a virus' RNA from a patient's nasal or nasopharyngeal specimen. Quest said Focus Diagnostics will perform the new test at its reference laboratory in Cypress, California.
"The public health laboratories don't have the capacity to do all the testing that is being requested. Now, clinicians and hospitals have another way to potentially identify this novel virus from patients by sending tests to us," said Dr. Jay Lieberman, medical director of Focus Diagnostics.
"We are very confident that the test will accurately identify this novel H1N1 strain," Lieberman told Reuters.
The tests, which list for $300, can be ordered directly from Focus Diagnostics or through the Quest Diagnostics national laboratory network, Quest said.
The Focus Diagnosics laboratory is expected to report back on the test results within 24 hours of receiving a specimen.
Quest said it also would submit positive specimens and test results to the appropriate public health authorities, as required by local public health guidelines.
(Reporting by Susan Kelly, editing by Leslie Gevirtz)