EUA AUTHORIZATION FOR THE SIMULTANEOUS DETECTION OF SARS-COV-2, INFLUENZA A, INFLUENZA B, & RSV VIRUSES

The Omicron variant does not impact the performance of the PKamp™ Respiratory SARS-CoV-2 RT-PCR Panel 1 based on in silico assessment against sequences published in the GISAID database.

PKamp™ Respiratory SARS-CoV-2 RT-PCR Panel 1

Conserve Time & Reagents While Delivering Relevant, Accurate, & Actionable Results 

The FDA EUA authorized PKamp™ Respiratory SARS-CoV-2 RT-PCR Panel 1 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) from nasopharyngeal swabs, anterior nasal swabs, and mid-turbinate swabs, collected from individuals suspected by a healthcare provider of having respiratory viral infection consistent with COVID-19. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high complexity tests, or by similarly qualified non-U.S. laboratories.

As described in the kit insert, this RT-PCR assay targets two specific genomic regions of SARS-CoV-2: the nucleocapsid (N) gene and ORF1ab. Thus mutations in spike protein, as seen in many Variants of Concern, do not significantly impact the safety or effectiveness of our assays.

  • Efficient Processing: Resource conservation by allowing simultaneous detection of SARS-CoV-2, influenza A, influenza B, and RSV

  • Scalable Workflows: Allow laboratories to scale their testing up or down

CONTACT US TO MULTIPLEX YOUR RESPIRATORY TESTING
For emergency use authorization only. Products may not be licensed in accordance with the laws in all countries. Please check with your local representative for availability.

The CDC is encouraging laboratories to consider adoption of a multiplexed method that can facilitate detection and differentiation of SARS-CoV-2 and influenza viruses1, such as the PKamp™ Respiratory SARS-CoV-2 RT-PCR Panel 1, as it can save both time and resources as we head into influenza season.

chemagic 360 instrument for sars-cov-2 testing

Rapid, High Quality RNA Extraction of Viral RNA for Respiratory RT-PCR Testing

The chemagic™ Viral DNA/ RNA 300 kit H96 and chemagic™ 360 instrument deliver fast, high quality RNA extraction from  nasopharyngeal, anterior nasal swabs, and mid-turbinate swabs. The samples can be used to prepare specimens for use with the PKamp™ Respiratory SARS-CoV-2 RT-PCR Panel 1.

PKamp™ Respiratory SARS-CoV-2 RT-PCR Panel 1 Primers and Controls

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 human biological material 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. Additionally, this kit includes positive, negative, and internal controls to prevent the reporting of incorrect 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 (SDX-56390) or 384 (SDX-56391) tests. Store the assay at -25℃ to -15℃.

ASK HOW YOU CAN START MULTIPLEXING YOUR TESTING THIS FLU SEASON

For emergency use authorization only. Products may not be licensed in accordance with the laws in all countries. Please check with your local representative for availability.

References:

  1. CDC. Alert: Changes to CDC RT-PCR for SARS-CoV-2 Testing. Sept 13, 2021