SENSITIVE NUCLEIC ACID BASED-DETECTION OF SARS-COV-2 AUTHORIZED UNDER FDA EMERGENCY USE AUTHORIZATION

by May 21, 2020COVID-19

PerkinElmer New Coronavirus Nucleic Acid Detection Kit
Authorized Under FDA EUA

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 and nasopharyngeal 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.

  • Specific: Detection of SARS-CoV-2 ORF1ab and N genes
  • Sensitive: Limit of detection 
  • Reliable: Performance verified with case studies from outbreak’s point of origin
  • Automated: Options available to meet a broad range of sample throughput

Sensitive & Specific Nucleic Acid-based Detection of 2019-nCoV 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)
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
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 and nasopharyngeal 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

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

AVAILABLE ON GSA THROUGH GOVERNMENT SCIENTIFIC SOURCE

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