Novel Coronavirus (2019-nCoV) RT-PCR Detection Kit (Lyophilized)
Manufactured by Guangzhou Biokey Health Technologies Co. Ltd., China - http : // biokeyhealth.com
Device identification number
3070
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Lab-based
Target type
Nucleic acid
Targets
nucleocapsid protein/gene, ORF1ab polyprotein/gene
Specimen
Nasal swab, Throat swab
Cross-reactivity (pathogens tested)
Adenovirus, Adenovirus 3, Adenovirus 7, Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus HKU1 (HCoV-HKU1), Beta Coronavirus OC43 (HCoV-OC43), Bordetella Pertussis, Chlamydia Pneumoniae, Coronaviruses (HCoV), Cytomegalovirus (CMV), Enterovirus A71 (EV-A71), Epstein-Barr Virus (EBV), Influenza A, Influenza A H1N1, Influenza A H3N2, Influenza A H5N1, Influenza B, Influenza B Victoria, Influenza B Yamagata, MERS-CoV, Mumps Virus (MuV), Mycobacterium Tuberculosis, Mycoplasma Pneumoniae, Parainfluenza Virus Type 1, Parainfluenza Virus Type 2, Parainfluenza Virus Type 3, Parainfluenza Virus Type 4, Respiratory Syncytial V (RSV), Respiratory Syncytial V (RSV) Type A, Respiratory Syncytial V (RSV) Type B, Rhinovirus, Rhinovirus A, Rhinovirus B, SARS-CoV, Varicella Zoster Virus (VZV)
Lineages detected
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
Other pathogens tested for cross-reactivity: Influenza A H7N9 ; Measles virus
Assay Type
Nucleic acid-PCR
Self Test
No
Reader Required
Yes
Subcategory
Validity test kit
Method
RT-PCR
Measurement
Qualitative
Time
90 minutes
LOD
500 cpu
Positive control
ORF1ab, N and RdRp gene plasmid
Negative control
DEPC DW
Clinical Sensitivity
98.81 %
Clinical Specificity
99.14 %
Throughput
96 samples per run
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