GSD NovaPrime® SARS-CoV-2 Direct RT-PCR (4x96 reactions)

GSD NovaPrime® SARS-CoV-2 Direct RT-PCR (4x96 reactions)

GSD NovaPrime® SARS-CoV-2 (COVID-19) RT-PCR (2x384)

GSD NovaPrime® SARS-CoV-2 (COVID-19) RT-PCR (2x384)

GSD NovaPrime® SARS-CoV-2 (COVID-19) RT-PCR (1x384)

GSD NovaPrime® SARS-CoV-2 (COVID-19) RT-PCR is a highly sensitive Multiplex Real-Time PCR with CE-IVD marking for the direct qualitative pathogen detection of SARS-CoV-2 genomic RNA in respiratory samples. The assay simultaneously detects two target sequences in the N gene.
It can also be used on saliva and pharynx gargling 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 product is not available for online purchase for customers located in the US.


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

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.

It is also validated on saliva and pharynx gargling samples. Gargling is a non-invasive, easy-to-use sampling method that is less uncomfortable for the patient and particularly useful for self-sampling applications and the testing of children.

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 hour. An extraction/inhibition control and 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
SKU PCOV6036
No. of tests 384
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

▪ Exicycler™ 96 Real-Time Quantitative Thermal Block (Bioneer)

Further validation in progress.

Test Instructions