Novel Coronavirus 2019-nCOV Nucleic Acid Typing Test Kit (Real-Time PCR Method)
Manufactured by OACP IE Ltd., China - www.oacp.it
Device identification number
2443
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Automated, Manual, Semi-automated
Physical Support
Microplate, Strip
Target type
Nucleic acid
Specimen
Anterior nasal swab, Bronchoalveolar lavage fluid, Nasal swab, Nasopharyngeal swab, Oropharyngeal swab, Other biological fluids, Saliva, Sputum, Throat secretion, Throat swab
Cross-reactivity (pathogens tested)
SARS-CoV
Lineages detected
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
Product sold and validated at the Sicilian Regional Quality center for Covid Emergency
Assay Type
Unknown
Reader Required
Yes
Subcategory
Other ()
Method
RT-PCR
Measurement
Quantitative
Time
45 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