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.
|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.