PerkinElmer – Test Kit – New Coronavirus Nucleic Acid Detection Kit
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.
Technical Specifications
Package | 45 Tests/Kit | |
Test Gene Region | ORF1ab & N | |
---|---|---|
Sample Type | oropharyngeal swab, nasopharyngeal swab, bronchoalveolar lavage (BAL), sputum, plasma and serum | |
Sample Volume | 400 µL | |
Limit of Detection | 20 copies/mL (400 µL) | |
Specify: No cross-reactivity with common respiratory tract pathogens and blood stream pathogens. Whole system solution (extraction and PCR kits) for blood bank has been tested in Wuhan blood bank | PCR kits have been tested in Beijing CDC and Guangdong CDC. |
Key Features
- 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
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