High Sensitivity：5×102 copies/ml (10 copies/rxn)
The confirmatory LOD for SARS-CoV-2 is 500 copies/ml for the IdPath™ COVID-19 Real-Time RT-PCR Kit when analyzed in Bio-Rad CFX96, ABI StepOnePlus, ABI 7500 Fast, Roche LC480, Roche LC96, as well as in Qiagen Rotor Gene Q qPCR instruments.
High Inclusivity ：>99% of currently available complete virus genomes for SARS-CoV-2 including Omicron variant
Based upon BLAST analysis, the IdPath™ COVID-19 Real-Time RT-PCR Kit maps with >99.1% homology of known SARS-CoV-2 isolates in GenBank databases. Results confirmed the perfect matches to SARS-CoV-2 and inclusivity for 5 variants of concern are more than 99% in the database.
*Percentage of primer/probe matches with the sequences of SARS-CoV-2 (exhibiting ≤ 1 mismatch)
The IdPath™ COVID-19 Real-Time RT-PCR Kit is stable at 37°C and 25°C for at least 2 weeks, and at 4°C for 24 weeks. The kit is also stable during 10 times of freeze-thaw cycles.
High Accuracy：Clinical validation with 100% accuracy
Clinical studies using contrived specimens
The data showed 100% agreement with the expected results in the RNA spiked specimens and 100% agreement with the expected results in the negative specimens. The results demonstrated that the IdPath™ COVID-19 Real-Time RT-PCR Kit has 100% sensitivity, 100% specificity and 100% accuracy.
Clinical validation using patient specimens
The results of 60 positive (Ct < 30: 30 samples and Ct 30-35: 30 samples) and 30 negative samples from the patient specimens were compared to the FDA-authorized comparator real-time RT-PCR assay (CDC 2019-Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel). The data showed that the IdPath™ COVID-19 Real-Time RT-PCR Kit has 100% sensitivity, 100% specificity and 100% accuracy.
No Cross-Reactivity in Silico Analysis
An in silico analysis was performed to assess the potential of 47 organisms for interference with SARS-CoV-2 detection. The reference sequence (RefSeqs) in the NCBI Virus database or whole genome in the taxonomy database were used. No significant homology was observed between the SARS-CoV-2 primers/probes and other coronaviruses (except SARS-CoV) or human microflora.