The COVID-19 Coronavirus Real-Time PCR Kit is an In Vitro Diagnostic (IVD) reagent that utilizes fluorescent real-time PCR technology, intended for the qualitative detection of the Open Reading Frame (ORF1a/b) gene region and the viral nucleocapsid (N) region of SARS-CoV-2 RNA in upper and lower respiratory tract samples.
Upper respiratory tract samples include throat swabs and nasopharyngeal swabs. Lower respiratory tract samples include sputum.
The product is intended for use in populations suspected of SARS-CoV-2 infection as an aid in the diagnosis of the disease and should be operated by professionals trained in RT-PCR.
Multiplex: Multiplex real-time PCR detects different specific targets of SARS-CoV-2.
Reliable: Internal control ensures the reliability of the entire process.
Accurate: Enhanced performance providing more precise results.
Efficient: 96 tests in 72 minutes (on a single instrument).
Compatible: Compatible with the most widely used instruments on the market.
Shelf Life: 12 months.
Parameters
| Targets |
ORF1a/b, N genes, and RNaseP as an internal control (IC). |
| Clinical Sensitivity: | 100% |
| Clinical Specificity: | 99.8% |
| Limit of Detection (LoD): | 350 copies/mL |
| Sample input volume | 5 μL |
| Sample Type: | Nasopharyngeal swab, oropharyngeal (throat) swab, anterior nasal swabs, mid-turbinate nasal swabs, nasal aspirates, nasal washes, bronchoalveolar lavage (BAL) fluid, and sputum samples. |
NMPA, CE, FDA-EUA, WHO-EUL, ANVISA, TGA, SAHPRA, SFDA
