Quick test to confirm swine flu Diatherix H1N1-09 approved for emergency use in USA

Diatherix H1N1-09 Influenza Test can accurately confirm the H1N1 virus in six hours or less

Diatherix H1N1-09 Influenza Test for quick detection swine flu has been granted emergency use authorization (EUA) from the US Food and Drug Administration.

Diatherix H1N1-09 Influenza Test utilizes Diatherix’ proprietary molecular technology, known as Target Enriched Multiplex Polymerase Chain Reaction (Tem-PCR), which is used for the detection of the H1N1-09 influenza viral RNA.

Diatherix H1N1-09 Influenza Test is the first clinically available test that can definitively diagnose the current strain of H1N1 virus, also known as the swine flu, in six hours or less, the company said.

Currently, it takes several days to confirm a suspected H1N1 patient due to the numerous rounds of testing needed to make a definitive diagnosis. Diatherix’s advanced technology can identify multiple pathogens at one time, allowing them to detect and differentiate between the current strains of the H1N1 virus and other respiratory infections in one fast, accurate test.

“Due to the highly mutative nature of the H1N1 strains, it can be very difficult to diagnose the H1N1 virus with many of the current testing methods,” stated Jian Han, MD, PhD, laboratory director at Diatherix and faculty investigator of the HudsonAlpha Institute for Biotechnology.

Diatherix H1N1-09 Influenza Test uses Tem-PCR technology which enables the test for multiple genetic targets at one time.

Diatherix H1N1-09 Influenza Test is the only rapid molecular test that, from a nasal swab, can detect and differentiate multiple influenza strains and nine other respiratory viruses in a single test, Jian Han.

Diatherix H1N1-09 Influenza Test allows clinicians to quickly and definitively identify H1N1-09 patients, differentiating from those who have similar symptoms.

Once H1N1 infection is accurately identified, infected patients can be provided proper antiviral therapy in a timely manner.

Diatherix H1N1-09 Influenza Test enables confirmation of the infection and appropriate treatment of H1N1-09 patients as early as possible. This can mitigate many of the negative economic and social impacts associated with a pandemic influenza outbreak, Diatherix stated in a press release.

With Diatherix H1N1-09 Influenza Test’s turnaround time of 24-hours from sample receipt, clinics, hospitals, physician offices, urgent care centers and public health departments are able to treat and contain patients who test positive for the H1N1-09 pandemic flu virus.

Diatherix H1N1-09 Influenza Test is intended to be used on nasopharyngeal swabs, nasal swabs, throat swabs and nasal aspirates from patients with signs and symptoms of respiratory infection in conjunction with clinical risk factors.

Diatherix H1N1-09 Influenza Test is meant only to be used in for emergency use.

US FDA is yet to clear Diatherix H1N1-09 Influenza Test for approval test. Under the Emergency Use Approval, the US FDA has authorized use of Diatherix H1N1-09 Influenza Test only for the duration of the declaration of emergency.

Diatherix Laboratories, Inc is located in the HudsonAlpha Institute for Biotechnology in Huntsville, Ala. Diatherix operates as an independent CLIA-certified clinical laboratory providing advanced multiplex molecular diagnostic services to assist healthcare providers in the detection of infectious disease.