COVID-19 – Rapid Test Performance
| COVID-19 RT-PCR Assay | COVID-19 IgG/IgM Test | ||
Positive | Negative | Total | |
| Positive | 227 | 12 | 239 |
| Negative | 0 | 30 | 30 |
| Total | 227 | 42 | 269 |
95% CI | |||
| Sensitivity | 235/239 | 98.3% | (85.3% – 99.3%) |
| Specificity | 30/30 | 100% | (76.8% – 100%) |
| Overall | 265/269 | 98.5% | (87.9% – 98.9%) |
PERFORMANCE CHARACTERISTICS
The COVID-19 lgG/lgM Rapid Test (Whole Blood/Serum/Plasma) has been evaluated with the 269 samples obtained from patients exhibiting pneumonia or respiratory symptoms. The results were compared to Fluorescent Real Time Polymerase Chain Reaction (RT-PCR) or clinical diagnosis (including chest Computed Tomography and clinical signs etc.) of “Diagnosis and treatment of novel coronavirus pneumonia”.
RT-PCR Method testing was included as clinical site method. Nucleic acid was detected by probe fluorescence PCR. This product contained primers and probes (ORF1ab gene and N gene strains of coronavirus) and internal controls (housekeeping gene beta Globin gene sequences) used in RT-PCR for the in vitro qualitative detection of SARS-CoV-2 RNA in nasopharyngeal swab specimens. The novel coronavirus2019-ncov specific probe was respectively labeled with FAM fluorescence and ROX fluorescence, and the internal standard gene was labeled with VIC fluorescence. The minimum detection limit of the fluorescent RT-PCR assay is 10 copies/reaction.
TEST OVERVIEW
- Utilizes human whole blood, serum, or plasma
- Used in rapid, qualitative and differential detection of IgG and IgM antibodies
- Delivers clinical results between 2 and 10 minutes at the point-of-care
- Visual interpretation of results
COVID-19 – Rapid Test Performance
- No special equipment needed