Fluoro-CheckTM COVID-19 Antigen Test is a time-resolved fluorescent, rapid immunoassay for the qualitative detection of SARS-CoV-2 nucleoprotein antigen as an aid to the clinical diagnosis of patients with suspected SARS-CoV-2 infection. For prescription use only. For in vitro diagnostic use only.
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Product Specification
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Comparison between Fluoro-CheckTM COVID-19 Antigen Test and RT-PCR
| Fluoro-CheckTM COVID-19 Antigen Test | Comparator RT-PCR | Total | Performance (95% CI) | |
| Positive | Negative | |||
| Positive | 36 | 0 | 36 | PPA 90.0% (76.9 – 96.0%) |
| Negative | 4 | 50 | 54 | NPA 100.0% (92.9 – 100.0%) |
| Total | 40 | 50 | 90 | OPA 95.6% (89.1 – 98.3%) |