(RTTNews) - CerTest Biotec, along with medical technology company Becton, Dickinson and Co. or BD (BDX) announced Tuesday that the VIASURE SARS-CoV-2 Real Time PCR Detection Kit adapted for the BD MAX System has been CE marked to the IVD Directive (98/79/CE).
The molecular test for detection of COVID-19 is available to clinical laboratories in countries recognizing the CE mark.
CerTest developed the kit, which is expected to bring rapid COVID-19 diagnostic capabilities to many laboratories across Europe to satisfy the desperate need for the ability to quickly identify COVID-19 patients.
The test is a real-time reverse transcriptase polymerase chain reaction (PCR) assay for use on the fully automated BD MAXSystem. It detects SARS-CoV-2 in clinical samples by amplification of a fragment of the S gene of the virus.
As with all CerTest tests, the VIASURE SARS-CoV-2 Real Time PCR Detection Kit for the BD MAX System is offered in a lyophilized format.
The BD MAX System is a fully-integrated, automated platform that performs nucleic acid extraction and real-time PCR providing results for up to 24 samples across multiple syndromes in less than three hours.
However, the VIASURE SARS-CoV-2 Real Time PCR Detection Kit for the BD MAX System, sold through BD's network, is not available for sale in the United States.
CerTest Biotec is a European company established in 2002 for the development and manufacturing of in vitro diagnostic medical devices.
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