Meso Scale Diagnostics LLC (MSD) confirmed today that its investigational influenza test was used in detecting the first identified case of infection with the 2009 A(H1N1) swine flu.
The MSD® Point of Care Influenza Test, which is being developed under a contract with the Centers for Disease Control and Prevention (CDC), is the investigational device referred to in the CDC’s Morbidity and Mortality Weekly Report (MMWR) Dispatch dated April 21, 2009.
As described in the MMWR Dispatch, Patient A visited an outpatient clinic in San Diego with influenza-like symptoms and participated in an ongoing clinical study of the MSD Point of Care Influenza Test, coordinated at that site by the Naval Health Research Center. A nasal swab taken from the patient tested positive for Influenza A on the MSD test, but the specific subtype could not be determined by the test, suggesting the possible presence of a novel influenza strain.
Per protocols established for conducting the clinical trial, this result prompted further testing at a reference laboratory that confirmed that the virus was not a common seasonal strain. The virus was ultimately identified by the CDC as a novel strain that included components having swine influenza lineage.
MSD’s Point of Care Influenza Test has been in development since 2006 under a contract with CDC, supported by the Biomedical Advanced Research and Development Authority (BARDA), an office under the Assistant Secretary for Preparedness and Response (ASPR) within the U.S. Department of Health & Human Services (HHS).
MSD’s test supports BARDA’s goal of advancing rapid point-of-care diagnostic tests for novel influenza viruses. Currently-available point of care influenza tests are designed to detect influenza A and B infections. The MSD Point of Care Influenza Test is designed to additionally identify influenza A infections by subtype, differentiating between common human A(H1N1), common human A(H3N2) and avian A(H5N1) influenza strains.
The MSD Point of Care Influenza Test has been granted an investigational device exemption by the U.S. Food and Drug Administration and is currently undergoing evaluation in a multi-site clinical trial. The test, which consists of a portable instrument and disposable test cartridges, reports results from a nasal swab sample within 15 minutes. The early identification of the 2009 A(H1N1) swine flu infection as a result of the use of MSD’s test highlights the need, identified by BARDA and the CDC, for point-of-care tests with the ability to differentiate between common and novel strains of influenza.
Source: Meso Scale Diagnostics