SARS-CoV-2 Nucleic Acid Detection Kit (PCR-Fluorescent Probe Method)
Manufactured by Zybio Inc., China - https://www.zybio.com/en/
Device identification number
2204
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Semi-automated
Physical Support
Strip
Target type
Nucleic acid
Specimen
Bronchoalveolar lavage fluid, Nasal swab, Throat swab
Cross-reactivity (pathogens tested)
SARS-CoV
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Assay Type
Nucleic acid-PCR
Reader Required
Yes
Subcategory
Other ()
Method
RT-PCR
Measurement
Qualitative
Time
70 minutes
Detection Principle
Fluorescence
LOD
200 AU
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
1.05 %
False negatives
1.5 %
Precision
Evaluated
Accuracy
99.08 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
98.78 %
Clinical Specificity
100 %
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