SENSITIVE REAL-TIME RT-PCR DETECTION OF COVID-19 AUTHORIZED UNDER FDA EMERGENCY USE AUTHORIZATION

To address growing supply constraints worldwide, PerkinElmer has expanded the production capacity of its extraction and RT-PCR tests at its global facilities and has the capability to ship millions of these solutions to its customers. 

PerkinElmer New Coronavirus Nucleic Acid Detection Kit authorized under FDA EUA for COVID-19 Testing

The PerkinElmer New Coronavirus Nucleic Acid Detection Kit is a real-time RT-PCR test intended for the qualitative detection of nucleic acid from SARS-CoV-2 in human oropharyngeal, nasopharyngeal, and anterior nasal swab samples. 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.

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

  • Sensitive: Limit of detection of 7.14 to 27.24 copies/mL

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

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

Sensitive limits of detection (LoD) are of critical importance because each 10-fold increase in the LoD of a COVID-19 viral diagnostic test is expected to increase the false negative rate by 13% (Arnaout, R., 2020). In the recent Nature publication (Mackey, et al., 2020) report, PerkinElmer New Coronavirus Nucleic Acid Detection kit was stated to have the lowest limit of detection (LoD) described in the IFU for FDA EUA authorized tests reported in copies/μL. To date there have been 5.76 million COVID cases detected in the US alone. If all 5.76 million COVID cases were performed with the kits listed in Table 1, many more samples would be reported as false negatives. These false negatives could be avoided by testing with the most sensitive kit available.

FDA’s Performance Comparison of Nucleic Acid-based SARS-CoV-2 Assays

The FDA developed an experiment to precisely compare the performance of the nucleic acid-based SARS-CoV-2 assays which have received EUA authorization and published a comparative performance analysis. This assessment used the FDA SARS-CoV-2 Reference Panel which allowed a consistent determination of the relative sensitivity of these tests and their cross-reactivity with the MERS-CoV virus. As can be seen in Table 2 on the FDA website, the PerkinElmer New Coronavirus Nucleic Acid Detection Kit had the lowest LOD of the assays tested.

Table 1. Shows the increase in false negative results that would be reported in the US alone if all 5.76 million positive COVID tests were performed using the products listed using the percentages of false negatives expected as reported by Arnaout, et al (2020). These false negatives could be avoided by using the PerkinElmer New Coronavirus Nucleic Acid Detection which has the lowest reported LOD (in copies/μL) for an FDA EUA authorized kit as reported in Nature Biotechnology (Mackey, et al., 2020)

Sensitive & Specific Nucleic Acid-based Detection
of COVID-19 ORF1ab and N Genes

The PerkinElmer New Coronavirus Nucleic Acid Detection kit has a limit of detection 20 copies/mL for the SARS-CoV-2 ORF1ab and N genes. It 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 New Coronavirus Nucleic Acid Detection kit includes positive, negative, and internal controls to prevent the reporting of incorrect results.

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
  • Anterior nasal swab
chemagic 360 instrument

Rapid, High Quality RNA Extraction of SARS-CoV-2

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. They are authorized to prepare specimens for use with the PerkinElmer New Coronavirus Nucleic Acid Detection kit EUA.

KIT CONTENTS

  • nCoV reagent A
  • nCoV reagent B
  • nCoV enzyme mixture
  • nCoV internal standard
  • nCoV positive control
  • nCoV negative control

Each kit contains 48 tests. The assay ships on wet ice.

Citations:

Arnaout R. et al. SARS-CoV2 testing: the limit of detection matters. Preprint at bioRxiv https://doi.org/10.1101/2020.06.02.131144 (2020).

Mackay, M. J., Hooker, A. C., Afshinnekoo, E., Salit, M., Kelly, J., Feldstein, J. V., Haft, N., Schenkel, D., Nambi, S., Cai, Y., Zhang, F., Church, G., Dai, J., Wang, C. L., Levy, S., Huber, J., Ji, H. P., Kriegel, A., Wyllie, A. L. Mason, C. E. (2020). The COVID-19 XPRIZE and the need for scalable, fast, and widespread testing. Nature Biotechnology. doi:10.1038/s41587-020-0655-4.

Contact Us to Accelerate Your SARS-CoV-2 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.