[IP2000] IdPath™ COVID-19 Real-Time RT-PCR Kit, 100 RXN

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Description

The IdPath™ COVID-19 Real-Time RT-PCR Kit is a real-time RT-PCR test intended for the detection of SARS-CoV-2 virus RNA which might be extracted from the respiratory tract specimens. The Kit provides reagents for multiplex real-time RT-PCR to detect SARS-CoV-2 by one-step reaction, specifically targeting the E (Envelope), RdRP (RNA-dependent RNA polymerase) and N (Nucleocapsid protein) gene for SARS-CoV-2 virus.

The Kit contains the RT enzyme mix and qPCR master mix for reverse transcription and real-time PCR of virus RNA. The COVID-19 Control (positive control) and ddWater (negative control) are used as indicators to avoid false negative/positive results across all experimental procedures. The Primers/probes Mix contains multiplex primers and TaqMan probes specific to the N, E/RdRP genes of SARS-CoV-2 and RNase P gene of human, detected by FAM, VIC and ROX channels, respectively.

For Research Use Only

Features

High Sensitivity：5×102 copies/ml (10 copies/rxn)
High Inclusivity : >99% of currently available complete virus genomes for SARS-CoV-2 including Omicron variant
High Accuracy : Clinical validation with 100% accuracy
High Stability : 37/25°C for 2 weeks ; 4°C for 24 weeks ; 10 times of freeze-thaw cycles
High Compatibility : Suitable for most laboratory qPCR machines
Operation Control : Including internal control for quality control of total process
Convenience : Multiplex (E/RdRP and N) detection by one-step reaction

Storage

Aliquot to avoid multiple freeze-thaw cycles

Protect fluorogenic probes from light

-20°C for 12 months

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)

High Stability

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.