GSD NovaPrime® SARS-CoV-2 (COVID-19) RT-PCR (1x96)

GSD NovaPrime® SARS-CoV-2 (COVID-19) RT-PCR (1x96)

GSD NovaPrime® SARS-CoV-2 (COVID-19) RT-PCR (4x96)

GSD NovaPrime® SARS-CoV-2 (COVID-19) RT-PCR  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.

This product is not available for online purchase for customers located in the US or in Germany.

US Customers: please contact 
Gold Standard Diagnostics directly
e-mail or phone: +1 530 759 8000

German customers: please contact VIROTECH Diagnostics directly
via e-mail or phone: +49 6142 69090

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 1 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.

More Information
No. of tests 4x96
Time to Result Approximately 1 hour
PCR cycler platforms Extraction systems:

▪ Eurofins GeneScan Technologies: GSD NovaPrime® RNA Extraction AE1 and AE2

▪ bioMérieux: NUCLISENS® easyMAG® or EMAG®

Real-Time PCR Cyclers:

▪ Agilent Technologies: AriaDxTM, AriaMxTM

▪ Applied BiosystemsTM: ABI Prism® 7500 SDS, 7500 Fast SDS, Quantstudio™ 5

▪ Bio-Rad: CFX96 Touch®

▪ Roche Diagnostics: LightCycler® 480 Instrument II

Further validation in progress.