ExProbe SARS-CoV-2 Testing Kit
Manufactured by TBG Biotechnology Corp., Australia - www.tbgbio.com/en
Device identification number
1335
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual
Target type
Nucleic acid
Targets
envelope protein/gene, non-structural protein/gene NSP12, non-structural protein/gene NSP7, non-structural protein/gene NSP8, nucleocapsid protein/gene
Specimen
Nasopharyngeal swab, Sputum
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Assay Type
Nucleic acid-PCR
Method
RT-PCR
Time
80 minutes
LOD
50 copies/reaction
Positive control
Virus-like Particles(VLPs) containing target sequence for each target gene(RdRP,E, N)and internal standard gene fragments (RNase P)
Negative control
Virus-like Particles(VLPs)containing internal standard gene fragments (RNase P)
Type of antigen
RdRP, N and E genes of SARS-CoV-2
Notes
http://www.tbgbio.com/files/instruction_manuals/1.5%20IFU_COVID19_qPCR_CE_v1.5.pdf
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