NOW YOU CAN POOL SAMPLES WITH THE REAL-TIME RT-PCR ASSAY FOR COVID-19 TESTING WITH THE LOWEST LOD* ON THE MARKET
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.
VUI 202012/01 does not affect PerkinElmer RT-PCR assay’s ability to accurately detect SARS-CoV-2. All of PerkinElmer’s SARS-CoV-2 RT-PCR assays were designed to identify SARS-CoV-2 ORF1ab and N genes. Read our blog post to learn more about the UK variant.
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
Efficient: Pooling of multiple samples increases throughput and decreases costs
Sample Pooling for COVID-19 Testing
Multiple samples can be pooled prior to RNA isolation in the SARS-CoV-2 workflow using the PerkinElmer New Coronavirus Nucleic Acid Detection kit. This increases testing throughput and decreases cost allowing more people to be tested while using fewer testing resources.
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 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.
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.
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.
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
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
FACT SHEETS
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.
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
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).
* FDA Reference Panel Comparative Data. Oct. 2, 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.