PRINCIPLE OF DETECTION
This product provides triplex-detections in a single tube, including two independent genes of 2019-nCoV and an internal control which targets the human RNAse P (RNP) gene to assess specimen quality. Specific primers and probes were designed for the detection of conserved region of 2019-nCoV’s ORF1ab gene (RdRP region) and N gene, respectively, avoiding non-specific interference of SARS2003 and BatSARS-like virus strains. Internal control (RNAse P gene) provides a nucleic acid extraction procedural control and a secondary negative control. Positive control (2019-nCoV-pseudoviruse) provides a nucleic acid extraction and a reverse transcription control to validate the entire procedure and reagent integrity.
|Detection Buffer||900 μl × 3 Tubes||Buffer, dNTPs, Primers, Probes.|
|Enzyme Mix||400 μl × 1 Tube||RNase Inhibitor, UDG, Reverse Transcriptase, Taq DNA polymerase.|
|Positive Control||250 μl × 1 Tube||RNA pseudovirus containing target gene.|
|Negative Control||250 μl × 1 Tube||DEPC-Treated Water.|
SAMPLING & HANDLING
- Suitable specimen type: upper respiratory specimen (including nasal swabs, nasopharyngeal swabs / aspirates / washes, and sputum) and lower respiratory specimen (including respiratory aspirates, bronchial washes, bronchoalveolar lavage fluids, and lung biopsy specimens).
- For detailed methods of specimen collection, please refer to the protocol in the “Microbiology Specimen Collection Manual”.
- The collected specimen should be used for detection within the same day. Otherwise, please store the specimen as follows:
– Store at 2°C – 8°C for no more than 24 hours;
– Store at < -20°C for no more than 10 days;
– Store at < -70°C for long-term, avoiding repeated freeze-thaw cycles.
- The specimen should be transported using sealed foam box with dry ice.