GSD NovaPrime® Plus SARS-CoV-2
Manufactured by NovaTec Immundiagnostica GmbH, Germany - https://www.goldstandarddiagnostics.com/home/products/covid-19-elisa-assays/gsd-sars-cov-2-elisa/gsd-sars-cov-2-elisa-igg/
Device identification number
2321
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Lab-based, Manual, Semi-automated
Physical Support
Microtiter plate
Specimen
Nasal swab, Nasopharyngeal swab, Oropharyngeal swab
Cross-reactivity (pathogens tested)
Adenovirus, Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus HKU1 (HCoV-HKU1), Beta Coronavirus OC43 (HCoV-OC43), Bordetella Pertussis, Chlamydia Pneumoniae, Enterovirus A71 (EV-A71), Hemophilus Influenzae, Human Metapneumovirus (HMPV), Influenza A, Influenza B, MERS-CoV, Mycobacterium Tuberculosis, Mycoplasma Pneumoniae, Parainfluenza Virus Type 1, Parainfluenza Virus Type 2, Parainfluenza Virus Type 3, Parainfluenza Virus Type 4, Respiratory Syncytial V (RSV), Rhinovirus, SARS-CoV
Lineages detected
B.1.1.7 (Alpha), B.1.351 (Beta), P.1 (Gamma)
Commercial Status
Commercialised
Last Update
2022-12-02 09:22:17 CET
Comments
The qualitative detection of specific RNA is performed in one-step real-time RT-PCR format, i.e. reverse transcription (RT) and the subsequent PCR take place in one reaction vessel. The isolated RNA is transcribed into cDNA. The specific gene fragments from SARS-CoV-2 E, N and S genes are subsequently amplified by real-time PCR sequence specific primers. Hydrolysis probes, which are connected at one end to a quencher and at the other end with a reporter fluorescent dye (fluorophore) anneal with the amplified DNA. During the extension, the exonuclease activity of the Taq polymerase degrades the hydrolysis probe and separates the fluorophore from the quencher. After excitation, the reporter emits a fluorescent signal that is detected by the optical unit of a real-time PCR instrument. The fluorescence signal increases with the number of amplicons formed. Primers and probes targeting a fragment of the human RNase P gene are included as an internal process control. Detection of the human RNase P gene serves as an internal positive control for monitoring sample quality, RNA extraction, and detection of inhibitors of the PCR reaction.
Assay Type
Nucleic acid-PCR
Reader Required
Yes
Method
RT-PCR
Measurement
Qualitative
Time
60 minutes
LOD
3 AU
Positive control
Yes, will be provided within the kit.
The database contains publicly available In Vitro Diagnostic Medical Devices for COVID-19 and it is being updated periodically. Please note that additional performance (as retrieved from manufacturers web pages) is provided only for devices commercially available with CE-IVD mark. Acknowledgements