SENSITIVE CE-IVD RT-PCR ASSAY FOR COVID-19 DETECTION AND NOW SAMPLE POOLING 

PerkinElmer® SARS-CoV-2 Real-time RT-PCR Assay

NOW INCLUDES: Swab or Saliva Sample Types – Sample Pooling – Asymptomatic & Symptomatic Testing

The PerkinElmer® SARS-CoV-2 Real-time RT-PCR assay is CE-IVD marked and intended for in vitro diagnostic use in Europe. It is intended for the qualitative detection of nucleic acid from the SARS-CoV-2 virus in human oropharyngeal swab, nasopharyngeal swab, and saliva specimens collected by healthcare providers from individuals suspected of having COVID-19 or asymptomatic carriers.

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.

CONTACT US TO POOL YOUR SARS-COV-2 SAMPLES
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.
  • Specific: Detection of SARS-CoV-2 ORF1ab and N genes

  • Sensitive: Builds on the most sensitive SARS-CoV-2 test kit with the lowest limitation of detection in the market*

  • Flexible: Compatible with human oropharyngeal swab, nasopharyngeal swab, and saliva specimens collected from individuals suspected of having COVID-19 or asymptomatic carriers and can be used for pooling of up to 5 samples

  • Reliable: Performance verified with case studies from outbreak’s point of origin

  • Automated: Options available to meet a broad range of sample throughput

Compatible with Asymptomatic and Symptomatic Pooling 

The PerkinElmer® SARS-CoV-2 Real-time RT-PCR assay can be used for sample pooling with oropharyngeal swab, nasopharyngeal swab and saliva samples of either asymptomatic and symptomatic individuals. This test is also for the qualitative detection of nucleic acid from the SARS-CoV-2 virus in pooled specimens containing up to 5 individual specimens (nasopharyngeal swabs and saliva) on chemagic™ 360 instrument, where each specimen is collected under observation or by a healthcare provider using individual vials containing transport media.

Pooling is desirable because it allows labs to reduce costs and increase throughput, but it requires a sensitive assay. The PerkinElmer® SARS-CoV-2 Real-time RT-PCR assay builds on the most sensitive commercially available SARS-CoV-2 test kit with the lowest limitation of detection in the market, according to the FDA’s reference panel comparative data*. Easy-to-use automation solutions are available delivering pooling prior to viral RNA isolation.

The complete PerkinElmer® SARS-CoV-2 Real-time RT-PCR workflow delivers the sensitivity needed for:

  • back to work screening
  • back to school screening

FDA Reference Panel Comparative Data. Oct. 2, 2020.

Nucleic Acid Extraction Expertise

Nucleic acid quality is of major importance when conducting molecular analysis since factors causing degradation and the presence of impurities and enzymatic inhibitors can have a significant impact on the quality of data. PerkinElmer’s chemagen™ technology addresses the challenges associated with extraction while offering high recovery of clean nucleic acids suitable for demanding downstream applications.

The PerkinElmer chemagic Viral DNA/ RNA 300 Kit H96 (cat # CMG-1033-S) and the chemagic 360 instrument is recommended for the isolation of nucleic acids for use with the PerkinElmer® SARS-CoV-2 Real-time RT-PCR assay.

Accurate RT-PCR Detection
of SARS-CoV-2 ORF1ab and N Genes

The PerkinElmer® SARS-CoV-2 Real-time RT-PCR Assay does not show cross reactivity with common respiratory tract pathogens and blood stream pathogens including:

  • Human coronavirus (229E, OC43)
  • SARS coronavirus (plasmid)
  • MERS coronavirus (plasmid)
  • Adenovirus (3, 2, 31, 37, 51 types)
  • Enterovirus (A, D)
  • Rhinovirus (A, B)
  • Influenza A virus
  • Influenza B virus
  • Influenza A H1N1 virus (2009)
  • Seasonal influenza virus (H1N1)
  • Seasonal influenza virus (H3N2)
  • Respiratory syncytial virus
  • Parainfluenza virus
  • Measles virus
  • Mumps virus
  • Human cytomegalovirus
  • Chlamydia pneumoniae
  • Mycoplasma pneumoniae
  • Haemophilus influenzae
  • Staphylococcus aureus
  • Streptococcus pyogenes
  • Streptococcus saliva
  • Hepatitis A virus
  • Hepatitis B virus
  • Hepatitis C virus
  • EB virus
  • Herpes simplex virus type I
  • Herpes simplex virus type II
  • Human immunodeficiency virus type I (HIV-1)
  • Human immunodeficiency virus type II (HIV-2)

The PerkinElmer® SARS-CoV-2 Real-time RT-PCR assay includes both positive and negative internal controls to prevent the reporting of incorrect results.

Saliva Samples Simplify COVID-19 Testing Sample Collection

Saliva is a desirable as a specimen type for SARS-CoV-2 testing because collecting saliva is much easier and less invasive than collecting other sample types.  Not only is saliva collection easier, it is also faster, more scalable than swab collection, and also reduces health care workers’ exposure to sick patients. Note that saliva samples need to be collected under observation or by a healthcare provider.

A complete automated workflow is also available for testing of saliva samples.

Flexible Sample Types Can Be Used to Detect SARS-CoV-2

This assay can be used to identify SARS-CoV-2 ORF1ab and N genes in the following sample types:

  • Oropharyngeal swab
  • Nasopharyngeal swab
  • Saliva

The Following Instruments Are Included in the Instructions for Use:

  • Applied Biosystems™ QuantStudio™ 5 Real-Time PCR System
  • Applied Biosystems® 7500 Fast Dx Real-Time PCR System
  • Applied Biosystems® QuantStudio™ 3 Real-Time PCR System
  • Applied Biosystems® QuantStudio™ Dx Real-Time PCR System
  • Analytik Jena® Tower3/qTower3 G 96 Real-Time PCR System
  • Analytik Jena® qTower3 84/qTower3 84 G Real-Time PCR System
  • Applied Biosystems® 7500 Real-Time PCR System
  • BioRad® CFX384™ Real-Time PCR Detection System
  • BioRad® CFX96™ Real-Time PCR Detection System

SEE HOW OUR SOLUTIONS ARE HELPING LABS OVERCOME THEIR SARS-COV-2 TESTING CHALLENGES

KIT CONTENTS

  • nCoV reagent A
  • nCoV reagent B
  • nCoV enzyme mix
  • nCoV internal control
  • nCoV positive control
  • nCoV negative control

CITATIONS REFERENCING PERKINELMER’S SARS-CoV-2 REAL-TIME RT-PCR ASSAY

Klussmeier, A., Behrens, G. A., Lange, V. (2020) Etablierung der PCR-basierten SARSCoV-2-Testung im Hochdurchsatz. BioSpektrum. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7474486/pdf/12268_2020_Article_1431.pdf

Sahajpal, N. S., Mondal, A. K., Ananth, S., Njau, A., Ahluwalia, P., Chaubey, A., . . . Kolhe, R. (2020). SalivaAll: Clinical validation of a sensitive test for saliva collected in healthcare and community settings with pooling utility for SARS-CoV-2 mass surveillance. doi:10.1­­­101/2020.08.26.20182816.

Sahajpal, N., S., et Al. (2020) SalivaSTAT: Direct-PCR and pooling of saliva samples collected in healthcare and community setting for SARS-CoV-2 mass surveillance. medRxiv 2020.11.23.20236901; doi: https://doi.org/10.1101/2020.11.23.20236901.

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

Each kit contains 48 tests. The shelf life of all reagents is 24 months when stored properly. Store the assay at -25℃ to -15℃.

Contact Us to Pool Your SARS-CoV-2 Samples

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.