SENSITIVE NUCLEIC ACID BASED-DETECTION OF SARS-COV-2 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

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 of 20 copies/mL using a 400 µL sample

  • Flexible: Compatible with a variety of sample types

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

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

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.

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 using a 400 µL sample. 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 both positive and negative 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 400 µL of the following sample types:

  • Oropharyngeal swab
  • Nasopharyngeal swab

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 shelf life of all reagents is 6 months when stored properly. The assay ships on wet ice.

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.