2019-Novel Coronavirus (2019-nCoV) RT-qPCR Detection Kit
Manufactured by Biobase Biodustry（Shandong） Co. Ltd., China - https://www.biobase.cc/
Device identification number
2900
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Lab-based, Manual
Physical Support
Microplate
Target type
Nucleic acid
Specimen
Nasopharyngeal swab, Oropharyngeal swab
Cross-reactivity (pathogens tested)
Coronaviruses (HCoV)
Lineages detected
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
This product is intended for the detection of 2019-Novel Coronavirus (2019-nCoV). The detection result of this product is only for clinical reference, and it should not be used as the only evidence for clinical diagnosis and treatment. It can be only used in professional institutions.
Assay Type
Nucleic acid-PCR
Reader Required
Yes
Subcategory
Calibrant / control sample
Method
RT-PCR
Measurement
Qualitative
Time
75 minutes
LOD
500 copies/ml
Positive control
Positive Control contains three targets, ORF 1ab gene、 N gene and internal control gene
Negative control
Negative control, not specified
Analytical Sensitivity
99.64 %
Analytical Specificity
99.29 %
Clinical Sensitivity
99.64 %
Clinical Specificity
99.29 %
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