Description: INTENDED USE
This product is intended for the detection of 2019-Novel Coronavirus (2019-nCoV). The detection result of this product is only for clinical reference, and it should not be used as the only evidence for clinical diagnosis and treatment.
PRINCIPLE OF DETECTION
This product is a multiplex fluorescent probe-based Taqman® RT-qPCR assay system. The Taqman fluorescent probe is a specific oligonucleotide based on a reporter-quencher mechanism. For each probe, the 5’-end is labeled with a fluorophore, while the 3’-end was labeled with a quencher. When the probe is intact,the fluorescence emitted by the fluorophore is absorbed by the quencher, and no fluorescent signal is detected. However, during amplification of the template, the probe will be degraded due to the 5'-3’ exonuclease activity of Taq DNA polymerase, and the fluorescent reporter and the quencher are cleaved and separated, then a fluorescent signal can be detected. The generation of each molecular amplicon is accompanied by the generation of a fluorescent signal. Real-time monitoring of the entire PCR process can be assessed by monitoring the accumulation of fluorescent signals. 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 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.
1. The detection result of this product is only for clinical reference, and it should not be used as the only evidence for clinical diagnosis and treatment. The clinical management of patients should be considered in combination with their symptoms/signs, history, other laboratory tests and treatment responses. The detection results should not be directly used as the evidence for clinical diagnosis, and are only for the reference of clinicians.
2. The detection result can be affected by operations, including specimen collection, storage and transportation. False negative result may occur if there is any mistakes in the operation. Cross contamination during specimen treatment may lead to false positive result.
3. The detected target sequences of this products are the conservative region of 2019-nCoV’s ORF1ab gene and N gene. However, target sequence variations may lead to false negative result.
1. Detection limitation: 200copies/mL.
2. Precision: using precision reference CV1 and CV2 for within-batch and between-batch detection, the coefficient of variation (CV) of their Ct values is ≤5.0%.
3. Conformity rate of Negative Control: 100%
4. Conformity rate of Positive Control: 100%
5. Specificity: non-specific interference of Influenza A Virus (H1N1, H3N2, H7N9, H5N1), Influenza B Virus (Yamagata, Victoria), Respiratory Syncytial Virus (type B), Respiratory Adenovirus (type 3, type 7), Haemophilus influenzae, Staphylococcus aureus, Streptococcus Pneumoniae, etc.