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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

Scientific literature on COVID-19 Test Methods and Devices - detail

A Novel Amplification-free SARS-CoV-2 Point-of-care Nucleic Acid Detection System based on Hybrid Capture Fluorescence Immunoassay

Detection Principle
NucleicAcid-Others
Target
ORF1ab, N, E
Testing Method Category
 
Testing Method
hybrid capture fluorescence immunoassay (HC-FIA)
Testing Method - Additional Info
Performance evaluation vs RT-PCR
Reported Performance
Sensitivity: 88.61% (all samples), 87.69% (throat swabs), 91.94% (sputum), 100% (HC-FIA and RT-PCR all samples); Specificity: 94.92%(all samples), 95.01% (throat swabs), 92.41% (sputum), 98.18% (HC-FIA and RT-PCR all samples).
Sample Size
734 samples from 670 subjects
Peer-reviewed
No

The database contains available information from scientific literature that is being updated periodically. Please note that the provided information (as retrieved from analysed papers) is provided only for devices commercially available with CE-IVD mark. Acknowledgements