CLSI M40-A2
CLSI M40-A2
Test the Performance of Your Viral Transport System
CLSI M40-A2 provides a standardised method for evaluating the performance of microbiological specimen collection and transport devices, including those intended for viral specimens.
For viral transport systems, the test assesses the ability of the device and transport medium to preserve virus viability during transport and storage, ensuring that infectious virus can be successfully recovered for subsequent analysis.
CLSI M40-A2
Our Approach
To perform a CLSI M40-A2 test, a defined concentration of virus is introduced into the test viral transport medium and maintained under specified temperature and storage conditions.
The testing approach depends on the intended application of the viral transport medium. For transport media intended for viral culture, we assess the ability of the viral transport medium to preserve viral infectivity over time. At defined time points, the virus is recovered and used to infect susceptible cultured host cells. Viral infectivity is assessed by fluorescent antibody staining combined with high-content imaging.
For viral transport media intended for molecular testing, we assess the ability of the transport medium to preserve viral genome integrity during storage. Viral nucleic acid is recovered at defined time points and analysed by quantitative PCR (qPCR).
Results are compared with the appropriate initial and/or reference controls to determine the ability of the viral transport medium to preserve either viral infectivity or viral genome integrity, according to its intended use.
As part of the standard, testing is performed across different viruses, viral transport medium production lots, storage temperatures and defined time points to evaluate the performance and consistency of the transport system under the conditions relevant to its intended use.
Subscribe