The Omicron variant does not impact the performance of the PerkinElmer New Coronavirus Nucleic Acid Detection Kit based on in silico assessment against sequences published in the GISAID database.
COMMERCIAL COVID-19 TEST KIT WITH LOWEST LOD*
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 individuals suspected of having COVID-19. 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.
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, 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 individuals
Reliable: Performance verified with case studies from outbreak’s point of origin
Automated: Options available to meet a broad range of sample throughput
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.
Rapid, High Quality RNA Extraction of SARS-CoV-2
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 for individuals suspected of having COVID-19 in the following sample types:
- Anterior nasal swab
- Oropharyngeal swab
- Nasopharyngeal swab
- Saliva (collected using the SalivaSecure™ Saliva Collection Kit)
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
- nCoV reagent A
- nCoV reagent B
- nCoV enzyme mixture
- nCoV internal standard
- nCoV positive control
- nCoV negative control
INSTRUCTIONS FOR USE
- Instructions for PerkinElmer® New Coronavirus Nucleic Acid Detection Kit
- Instructions for SalivaSecure™ Saliva Collection Kit
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.
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