SIMULTANEOUS DETECTION OF SARS-COV-2, INFLUENZA A, INFLUENZA B, & RSV VIRUSES (CE-IVD)
The Omicron variant does not impact the performance of the PKamp™ Respiratory SARS-CoV-2 RT-PCR Panel assay based on in silico assessment against sequences published in the GISAID database.
PKamp™ Respiratory SARS-CoV-2 RT-PCR Panel Assay
Delivering Relevant, Accurate, & Actionable Results
The PKamp™ Respiratory SARS-CoV-2 RT-PCR Panel assay is a real-time RT-PCR multiplexed test intended for the:
- Simultaneous qualitative detection and differentiation of SARS-CoV-2, influenza A, influenza B, and respiratory syncytial virus (RSV) or
- Simultaneous qualitative detection and differentiation of SARS-CoV-2, influenza A, and influenza B or
- Qualitative detection of SARS-CoV-2 only
The PKamp™ Respiratory SARS-CoV-2 RT-PCR Panel assay is CE-IVD marked and intended for in vitro diagnostic use in Europe.
Building off the most sensitive COVID-19 test*
Efficient Processing: Resource conservation by allowing simultaneous detection of SARS-CoV-2, influenza A, influenza B, and RSV
- Automation Flexibility: Assay coupled with modular, scalable extraction and liquid handling options suitable to process a broad range of samples every day (a few 100 to over 100,000)
Based Off of the Commercially Available SARS-CoV-2 Kit With the Lowest LOD*
As can be seen in Table 2 on the SARS-CoV-2 Reference Panel Comparative Data reported by the FDA website, the PerkinElmer New Coronavirus Nucleic Acid Detection Kit, which this multiplex assay is based on, has the lowest LOD* of the commercially available COVID-19 kits tested.
* Lowest LOD, most sensitive reflect a comparison of analytical sensitivity between Emergency Use Authorized COVID test kits as reported in FDA SARS-CoV-2 Reference Panel on January, 13, 2021.

Rapid, High Quality RNA Extraction of Viral RNA for Respiratory RT-PCR Testing
PerkinElmer’s chemagic™ Viral DNA/ RNA 300 kit H96 and chemagic™ 360 instrument deliver fast, high quality RNA extraction from oropharyngeal, nasopharyngeal, and anterior nasal swabs. The samples can be used to prepare specimens for use with the PKamp™ Respiratory SARS-CoV-2 RT-PCR Panel assay.
COVID-19 Respiratory Panel RT-PCR Assay Primers
The oligonucleotide primers and probes for detection of SARS-CoV-2 were selected from the regions of the virus nucleocapsid (N) gene and ORF1ab gene. The primers and probes for detection of influenza A and RSV were selected from the regions of matrix protein. The primers and probes for detection of influenza B were selected from the regions of nuclear export protein (NEP) and nonstructural protein 1 (NS1) genes. An additional primer/probe set to detect the endogenous control gene RNase P is also included in the test. It is used for monitoring sample collection and extraction efficiency.
Probes for the amplicons of SARS-CoV-2, Influenza A, Influenza B, RSV and RNase P are labeled with FAM, ROX, Cy5, Cy5.5 and HEX/VIC fluorescent dyes respectively to generate target-specific signals.
The assay also uses a dUTP/UNG carryover prevention system to avoid contamination of PCR products and subsequent false positive results.
KIT CONTENTS
- nCoV Reagent A
- nCoV Resp Reagent B1
- nCoV Resp Reagent B2
- nCoV Enzyme Mix
- nCoV Resp Positive Control
- nCoV Negative Control
Each kit contains 96 or 384 tests. The shelf life of all reagents is 12 months when stored properly. Store the assay at -25℃ to -15℃.
Assay Citations
Yan, Y., Chang, L., Luo, w., Liu, J., Guo, F. and Wang, L. (2020) Comparison of Seven Commercial Severe Acute Respiratory Syndrome Coronavirus 2 Nucleic Acid Detection Reagents with Pseudovirus as Quality Control Material. J of Mol Diag. https://doi.org/10.1016/j.jmoldx.2020.12.002