Corona Virus Disease 2019 (COVID-19) Nucleic Acid Detection Kit
Manufactured by OACP IE Ltd., China - www.oacp.it
Device identification number
2442
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Automated, Manual, Semi-automated
Physical Support
Microplate, Strip
Specimen
Anterior nasal swab, Bronchoalveolar lavage fluid, Deep (cough) sputum, Nasal swab, Nasopharyngeal swab, Oropharyngeal swab, Saliva, Sputum, Throat swab
Cross-reactivity (pathogens tested)
Coronaviruses (HCoV)
Commercial Status
Commercialised
Last Update
2022-12-02 09:22:17 CET
Comments
Product provided to the Italian Government in 2020 pandemic outbreak
Assay Type
Unknown
Reader Required
Yes
Subcategory
Other ()
Method
RT-PCR
Measurement
Quantitative
Time
75 minutes
LOD
5 cpm
Positive control
yes
Negative control
yes
Analytical Sensitivity
100 %
Analytical Specificity
100 %
Clinical Sensitivity
100 %
Clinical Specificity
100 %
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