Intended purpose |
SARS-CoV-2 real-time PCR detection |
Number of tests |
96 tests |
Technology |
Reverse transcription polymerase chain reaction (RT-PCR) with real-time fluorescence detection; Qualitative assay |
Equipment |
CFX-96 (Bio-Rad), QuantStudio 5 (Thermo Fisher Scientific), Rotor Gene 3000, 6000 (Corbett Research), Rotor-Gene Q (QIAGEN), DTlight 4S1, DTprime, DT-96 (DNA-Technology), or analogous |
Compatible DNA/RNA isolation kits |
ExtraMag 1 kit, ExtraMag 2 kit, ExtraMag 3 kit гиперссылки |
Clinical material |
Nasopharyngeal swab, oropharyngeal swab, sputum |
Analytical specificity |
The potentially interfering substances do not interfere with the assay result* |
Analytical sensitivity |
5*102 copies of virus RNA (viral particles) per ml* |
Diagnostic specificity |
100% (95% CI: 86.3 ~ 100.0) * |
Diagnostic sensitivity |
100% (95% CI: 86.3 ~ 100.0) * |
Reproducibility |
The coefficient of variation does not exceed 2%* |
Storage conditions |
2–8 ºC |
Transportation conditions |
2–8 ºC* |
Shelf life |
12 months |
* See the user manual for the details |
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