Launch of the GSD NovaPrime® SARS-CoV-2 Direct RT-PCR

The GSD NovaPrime® SARS-CoV-2 Direct RT-PCR is intended for the qualitative detection of SARS-CoV-2 from human nasopharyngeal swabs, eluted directly into deionised water without an additional RNA extraction process (extraction-free).

Increase of global SARS-CoV-2 testing worldwide has posed new challenges to laboratories in nearly all countries. More than ever, there is a critical need for rapid molecular solutions to increase testing capacity, and provide accurate and faster results. Removing the RNA extraction step helps to meet this challenge, by increasing the number of laboratories that can perform these tests, allowing more tests to be performed and reducing the cost, labour, and time required to carry out very sensitive PCR tests.

The GSD NovaPrime® SARS-CoV-2 Direct RT-PCR is CE marked and has been validated as an extraction-free method. This new workflow shortens the complete turnaround time of the test, providing results in approximately one hour from sample to result without compromising the high accuracy of PCR testing, and allowing for a higher processing capacity.

Saliva and pharynx gargle samples validation for the GSD NovaPrime® SARS-CoV-2 (COVID-19)

The GSD NovaPrime® SARS-CoV-2 (COVID-19) has now been successfully validated for pharynx gargle and saliva samples. These new matrices constitute an easy-to-use sampling method that is particularly useful for self-sampling applications and are suitable for children.

This test is a highly sensitive multiplex real-time PCR assay intended for the qualitative determination of SARS-CoV-2 genomic RNA in respiratory samples. The assay simultaneously detects two target sequences in the N gene.

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These tests are not for sale outside of Europe at the moment.