By Kirell Lakhman
The FDA has given Quest Diagnostics’ Focus business an emergency-use authorization to offer its real-time PCR-based 2009 H1N1 influenza test to high-complexity labs in the US, Quest said today.
The lab-developed test differentiates the pandemic virus from seasonal human influenza A by targeting two separate regions of the hemagglutinin gene of the virus. Turnaround time for reporting results is typically within 24 hours of receipt of specimen.
It is the first to qualitatively detect RNA of the strain in nasal or nasopharyngeal specimens, and is the first commercially developed test to be given an FDA emergency-use authorization.
Public-health labs in the US may employ CDC's rRT-PCR test, which the FDA authorized for emergency use in April. Public health labs may also use the CDC test to determine if certain high-risk patients who test positive for influenza A virus by commercial tests happen to be infected with H1N1.
Focus Diagnostics in May launched the test to help “offload an expected backlog” of testing from public health lab. Its Cypress, Calif., lab is currently the only facility performing the test, though Quest is currently validating the assay at “a number” of its CLIA high-complexity labs in the US “capable of performing the test in compliance with the emergency use authorization.”
At Focus, “orders placed by physicians for patients suspected of being infected with the 2009 H1N1 influenza virus increased dramatically before peaking in late June,” Quest said in a statement. “While test volume has since declined, it remains more than 30 times higher than the company's typical rate of influenza virus testing in July.”
Of the samples tested positive for H1N1, approximately 75 percent came from patients aged five to 20 years, which suggests Quest’s data “are consistent with CDC data suggesting that this pandemic flu virus is disproportionately affecting children and young adults, as compared to older adults," Jay Lieberman, medical director, Focus Diagnostics, said in the statement.
The data also showed that 49 percent were seen in adults aged 21 to 40 years; 36 percent came from adults aged 41 to 60, and 14 percent came from those aged 61 to 80.
