COMMERCIAL COVID-19 TEST KIT WITH LOWEST LOD*  

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 oropharyngeal, nasopharyngeal, anterior nasal swab taken from either individuals suspected of having COVID-19 or asymptomatic individuals. This test is also for use with saliva samples collected using the SalivaSecure™ Saliva Collection Kit either by an HCP or self collected under the supervision of an HCP in a healthcare setting from individuals suspected of COVID-19. This assay has been shown to exhibit the highest sensitivity for the commercially available kits when tested with the FDA reference panel*. 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, 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 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

  • Sample Types: Sample types include anterior nasal, oropharyngeal, and nasopharyngeal swabs for samples from asymptomatic individuals and individuals suspected of having COVID-19 or asymptomatic individuals and saliva samples collected using the SalivaSecure™ Saliva Collection Kit from individuals suspected of having COVID-19.

  • Flexible: Authorized for use with oropharyngeal, nasopharyngeal and anterior nasal swab specimens collected from symptomatic or asymptomatic individuals 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

  • Efficient: Pooling of multiple samples increases throughput and decreases costs

Compatible with Asymptomatic and Symptomatic Pooling

The PerkinElmer®  New Coronavirus Nucleic Acid Detection kit can be used for sample pooling for 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 oropharyngeal, nasopharyngeal, or anterior nasal swab specimens on the chemagic™ 360 instrument.

Pooling is desirable because it allows labs to reduce costs and increase throughput, but it requires a sensitive assay. The PerkinElmer® New Coronavirus Nucleic Acid Detection kit is the most sensitive commercially available SARS-CoV-2 test kit with the lowest limit of detection in the market, according to the FDA’s reference panel comparative data*. As one of the few kits authorized for asymptomatic testing and pooling, the complete PerkinElmer® SARS-CoV-2 detection workflow delivers the sensitivity needed to test travelers, students, workforce and others.

* lowest limit of detection, most sensitive, and highest sensitivity reflect a comparison of analytical sensitivity between Emergency Use Authorized COVID test kits as reported in FDA SARS-CoV-2 Reference Panel on January, 13, 2021.

REVIEW OF PERFORMANCE COMPARISONS OF COVID-19 WORKFLOWS

Why False Negatives Should be Avoided

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 PerkinElmer New Coronavirus Nucleic Acid Detection Kit, the most sensitive kit commercially available*.

False Negatives

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

The FDA developed an experiment to precisely compare the analytical 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 commercially available kits tested.

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.

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 using the SalivaSecure™ Saliva Collection Kit under observation or by a healthcare provider.

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

Automated Biobanking

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, anterior nasal swabs and saliva samples collected using the SalivaSecure™ Saliva Collection Kit. They are authorized to prepare specimens for use with the PerkinElmer New Coronavirus Nucleic Acid Detection kit EUA.

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:

  • Anterior nasal swab (for individuals suspected of having COVID-19 or asymptomatic individuals)
  • Oropharyngeal swab (for individuals suspected of having COVID-19 or asymptomatic individuals)
  • Nasopharyngeal swab (for individuals suspected of having COVID-19 or asymptomatic individuals)
  • Saliva (collected using the SalivaSecure™ Saliva Collection Kit for individuals suspected of having COVID-19 only)

The Following Instruments Are Included in the Instructions for Use:

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

KIT CONTENTS

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

CITATIONS

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

Li, L., Yang, R., Wang, J., Lv, Q., Ren, M., Zhao, L., . . . Liu, Z. (2020). Feasibility of a pilot program for COVID ‐19 convalescent plasma collection in Wuhan, China. Transfusion, 60(8), 1773-1777. doi:10.1111/trf.15921.

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.

Mostafa, H. H., Luo, C. H., Morris, C. P., Li, M., Swanson, N. J., Amadi, A., Gallagher, N., & Pekosz, A. (2021). SARS-CoV-2 Infections in mRNA Vaccinated Individuals are Biased for Viruses Encoding Spike E484K and Associated with Reduced Infectious Virus Loads that Correlate with Respiratory Antiviral IgG levels. medRxiv : the preprint server for health sciences, 2021.07.05.21259105. https://doi.org/10.1101/2021.07.05.21259105.

Ravi, N., Cortade, D. L., Ng, E., & Wang, S. X. (2020). Diagnostics for SARS-CoV-2 detection: A comprehensive review of the FDA-EUA COVID-19 testing landscape. Biosensors and Bioelectronics, 165, 112454. doi:10.1016/j.bios.2020.112454.

Sahajpal, N. S., Mondal, A. K., Njau, A., Ananth, S., Jones, K., Ahluwalia, P. K., . . . Kolhe, R. (2020). Proposal of RT-PCR–Based Mass Population Screening for Severe Acute Respiratory Syndrome Coronavirus 2 (Coronavirus Disease 2019). The Journal of Molecular Diagnostics, 22(10), 1294-1299. doi:10.1016/j.jmoldx.2020.07.001.

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 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).

Lowest limit of detection, most sensitive, and highest sensitivity reflect a comparison of analytical sensitivity between Emergency Use Authorized COVID test kits as reported in FDA SARS-CoV-2 Reference Panel on January, 13, 2021.

* 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.

Sahahjpal, N. S., Hon, E. C., Dallaire, S., Williams, C., Ananth, S., Mondal, A. K., . . . Kolhe, R. (2021). COVID-19 RT-PCR diagnostic assay sensitivity and Sars-cov-2 transmission: A missing link? doi:10.1101/2021.03.24.21254271

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.