GSD NovaPrime SARS-CoV-2 Real-Time PCR

GSD NovaPrime® SARS-CoV-2 (COVID-19) Real-Time PCR (96 reactions)

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GSD NovaPrime® SARS-CoV-2 (COVID-19) is a Multiplex Real-Time PCR with CE-IVD marking for the direct qualitative pathogen detection of the novel Coronavirus (SARS-CoV-2). Particularly in the early phase of a virus infection, the direct diagnostic of the pathogen is key.

The GSD NovaPrime® SARS-CoV-2 (COVID-19) RT-PCR is intended for the qualitative determination of SARS-CoV-2 (Severe acute respiratory syndrome coronavirus 2) genomic RNA extracted from human respiratory (nasal wash/swab, nasopharyngeal wash/swab, oropharyngeal swab and bronchoalveolar lavage) specimen types.

The assay simultaneously detects two target sequences inside the N gene. The multiplex PCR allows a streamlined workflow in one reaction and provides results in approximately 2 hours. An extraction/inhibition control and a positive control is included in the reagents.

The PCR assay demonstrates excellent performance with a 100 % Negative and Positive Percent Agreement (NPA, PPA) for all tested samples and no cross-reactivity with other common widely spread coronaviruses. The analytic sensitivity shows a limit of detection of 3.75 copies/reaction.

SKU PCOV6033
No. of Reactions 96
Time to Result Approximately 2 hours
PCR cycler platforms

▪ ABI Prism® 7500 SDS (Applied BiosystemsTM)
▪ ABI Prism® 7500 Fast SDS (Applied BiosystemsTM)
▪ LC480 II (Roche)
▪ CFX96 Touch (Bio-Rad)
▪ AriaMxTM and AriaDx (Agilent Technologies)
Currently not validated in the U.S.