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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail



Promotor SARS-CoV-2 RT-PCR Test Kit

Manufactured by Acon Biotech (Hangzhou) Co., Ltd, China - https://www.aconbio.com/ 

Device identification number
1376
CE Marking
Yes
HSC common list (RAT)
×No
Format
Lab-based
Target type
Nucleic acid
Commercial Status
Commercialised
Last Update
2022-03-14 09:42:40 CET
Comments
https://www.aconlabs.com.cn/en/MolecularDiagnosis/656.html https://www.aconlabs.com.cn/en/ACON/685.html
Assay Type
Nucleic acid-PCR
Method
RT-PCR
Time
90 minutes
LOD
500 copies/ml
Positive control
1 AU
Negative control
1 AU
Analytical Sensitivity
99.91 %
Analytical Specificity
94.72 %
Accuracy
97.93 %
Clinical Sensitivity
97.46 %
Clinical Specificity
98.26 %
Throughput
96 samples/run
Notes
The Promotor SARS-CoV-2 RT-PCR Test Kit is a real-time reverse transcription polymerase chain reaction; (rRT-PCR) test intended for the qualitative detection of nucleic acid from SARS-CoV-2 in oropharyngeal swab, nasopharyngeal swab and deep cough sputum specimens collected from individuals suspected of SARS-CoV-2 by their healthcare provider; triple target assay: high conserved regions within N, E, ORF1ab genes

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