SARS-CoV-2 & Influenza A/B Nucleic Acid Detection Kit (PCR-Fluorescent Probe Method)
Manufactured by Zybio Inc., China - https://www.zybio.com/en/
Device identification number
2221
CE Marking
✓Yes
HSC common list (RAT)
×No
Target type
Nucleic acid
Specimen
Bronchoalveolar lavage fluid, Nasopharyngeal swab, Oropharyngeal swab, Sputum
Cross-reactivity (pathogens tested)
Influenza A, Influenza B, SARS-CoV
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
N/A
Assay Type
Nucleic acid-PCR
Rapid Diagnostic
Yes
Reader Required
No
Subcategory
Other ()
Method
RT-PCR
Measurement
Qualitative
Time
10 minutes
Detection Principle
Fluorescence
LOD
200 AU
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
0 % (SARS-CoV-2), 0(Influenza A), 0(Influenza B)
False negatives
0 % (SARS-CoV-2), 0(Influenza A), 0(Influenza B)
Precision
Evaluated
Accuracy
99.33 % ( (SARS-CoV-2), 100%(Influenza A), 100%(Influenza B))
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
97.62 % ((SARS-CoV-2), 100%(Influenza A), 100%(Influenza B))
Clinical Specificity
100 % ((SARS-CoV-2), 100%(Influenza A), 100%(Influenza B))
Type of antigen
Other
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