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CDC interim guidance requires samples suspected of containing SARS-CoV-2 to be handled under proper containment.  Inactivated samples do not require containment.  PrimeStore MTM is the only FDA cleared microbial nucleic acid storage and stabilization device that inactivates the sample to include SARS-CoV-2.

 

 

LHNVD is working closely with the US FDA, States, Hospital Groups, and laboratories to ensure that the US has adequate, high quality sample collection capability.  Further capacity is being added for foreign Governments.

PrimeStore MTM should not be used with the Hologic Panther System due to a disinfecting step involving bleach that is specific to that platform.  PrimeStore MTM, like most lysis buffers and nucleic acid purification reagents, contains Guanidine.  Bleach and guanidine create cyanide gas which is why most molecular lab protocols use ethanol based decontamination and cleaning solutions rather than bleach.    To take advantage of the microbial inactivation and RNA stabilization qualities of PrimeStore MTM, users can safely test on a wide variety of high throughput platforms from Roche, Thermo Fisher, Abbott, Siemens, Luminex, BioRad, PSS, Promega, and BioMerieux, as well as the Cepheid GeneXpert point of care platform.

Early Rt-PCR testing challenges in China were likely due to degraded RNA in samples.  Accurate diagnostic requires the RNA in the sample is intact.

 

The outbreak of severe and sometimes deadly pneumonia Worldwide has been determined to be caused by a coronavirus.  Like SARS and MERS, coronaviruses can be spread from animals to people and occasionally from people to people.  

As the current strain of coronavirus continues to spread, safe specimen handling and highly sensitive screening of both symptomatic and asymptomatic high risk individuals is needed.

PrimeStore MTM has been demonstrated to rapidly (within seconds) fully inactivate viruses and stabilize the RNA/ DNA for molecular testing and characterization. Inactivating the virus allows for testing to take place outside of containment facilities opening up more testing laboratories.

Published paper on coronavirus transported in PrimeStore MTM:

Clinical Infectious Diseases:

 

A “One-Health” approach for diagnosis and molecular characterization of SARS-CoV-2 in Italy

 

Burden and Risk Factors for Coronavirus Infections in Infants in Rural Nepal  

Lancent:

Aetiology of childhood pneumonia in a well vaccinated South African birth cohort: a nested case-control study of the Drakenstein Child Health Study

ICID Poster

Microbiology of the Nasopharynx in Children Hospitalized with Suspected Pulmonary Tuberculosis 

Microbial Aetiology of Community Acquired Pneumonia at a Tertiary Hospital