GSD NovaPrime® SARS-CoV-2 (COVID-19) RT-PCR (1x96)
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.
Not available in the US.
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.
|No. of tests||96|
|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.|