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.

As described in the kit insert, PerkinElmer’s RT-PCR assays target two specific genomic regions of SARS-CoV-2: the nucleocapsid (N) gene and ORF1ab. Thus mutations in spike protein, as seen in the B.1.1.7 and B.1.351 lineages, do not impact the safety and effectiveness of PerkinElmer’s assays.

  • 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)
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Products may not be licensed in accordance with the laws in all countries, such as the United States and Canada. Please check with your local representative for availability.
Multiplex assay for detection of SARS-COV-2, influenza A, influenza B, and RSV

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.
Automated viral RNA isolation from SARS-CoV-2, influenza, and RSV

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

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Products may not be licensed in accordance with the laws in all countries, such as the United States and Canada. Please check with your local representative for availability.