Novel Coronavirus (2019-nCoV) Real-time RT-PCR Kit
Manufactured by Getein Biotech Inc., China - en.bio-gp.com.cn
Device identification number
189
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual
Target type
Nucleic acid
Specimen
Bronchoalveolar lavage fluid, Oropharyngeal swab
Cross-reactivity (pathogens tested)
Adenovirus, Adenovirus 3, Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus HKU1 (HCoV-HKU1), Beta Coronavirus OC43 (HCoV-OC43), 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
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
Novel Coronavirus (2019-nCoV) Real-time RT-PCR Kit is a real-time RT-PCR test intended for the qualitative detection of nucleic acid from the 2019-nCoV in oropharyngeal swabs and bronchoalveolar lavage fluid collected from individuals suspected of COVID-19 by their healthcare provider.
Assay Type
Nucleic acid-PCR
Rapid Diagnostic
No
Reader Required
Yes
Subcategory
Other ()
Method
RT-PCR
Measurement
Qualitative
Time
45 minutes
LOD
300 copies/ml
Positive control
In vitro transcription RNA containing target genes (ORF1ab, N genes) and internal standard gene
Negative control
DEPC Water
Analytical Sensitivity
97.35 %
Analytical Specificity
100 %
Clinical Sensitivity
97.35 %
Clinical Specificity
100 %
Notes
http://en.bio-gp.com.cn/index.php/product/plist/10/69.html
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