Testing Services

H1N1 (GLP Compliant)

Microbac's Microbiotest Division has introduced a virucidal efficacy offering to test against the pandemic H1N1 strain of influenza virus (“swine influenza virus”). This test, which is GLP-compliant, is a significant addition to Microbac’s service portfolio and will benefit customers who seek to verify their products’ antimicrobial effectiveness or to make an agency-approved antiviral claim and provide further assistance to the ongoing global fight against the serious outbreak of this disease.

Microbac’s Microbiotest Division has recently obtained the pandemic H1N1 virus and has successfully established a highly-efficient cell culture-based infectivity assay and real time PCR-based viral quantitation assay, available immediately, to serve the various efficacy testing needs of clients. The global spread of H1N1 has raised a vast demand on pharmaceutical and consumer products that can help with treatment and prevention of the disease such as hand rubs/washes, surface cleaners, disinfectants, and face masks, etc.  These products, along with general public health awareness and practice, have been important in ensuring successful disease prevention and control.

The efficacy and safety of these products must be adequately tested, following scientifically sound and regulatory-recognized methods.  Microbac’s use of the H1N1 influenza virus culture to serve as the challenge organism for testing, ensures the highest level of efficacy assurance.  Other surrogate viruses such as the generic Influenza A or the non-pandemic swine influenza isolates may be similar to the 2009 H1N1 in certain ways, yet they are different in their clinical, biological, and physico-chemical properties and therefore, must be used with caution when making an H1N1 efficacy claim. Additionally, with access to the pandemic H1N1 influenza virus as a positive control, Microbac can support confirmatory testing of both clinical specimen and environmental materials.

The newly-emerged H1N1 influenza virus has caused a global health crisis.  As of December 2, 2009, the disease has spread to over 200 countries and territories.  There have been more than 500,000 reported H1N1 cases, including at least 6,000 deaths worldwide.  In light of the rapid spread of the virus, the World Health Organization (WHO) has announced a Phase 6 (the highest level) pandemic alert for H1N1 influenza.  To date, the number of infections and deaths are still growing, and clinicians around the globe are closely monitoring any signs of virus mutation. Microbac is pleased to offer H1N1 efficacy testing and confirmatory clinical and environmental sample testing services.