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TEST INFORMATION
METHODOLOGY: The Novel Coronavirus (2019-nCoV) Nucleic Acid Diagnostic Kit PCR test is performed for the
qualitative detection of ORF-1ab, N, or E gene of SARS-CoV-2. This test adopts PCR-
Fluorescence Probing system technology to detect the COVID-19 genes in real time PCR
assay.
LIMITATION/S: The detection of a mutation is dependent on the number of copies present in the specimen
that can be detected, and may be affected by sample integrity, amout of isolated RNA, the
presence of interfering substances or inhibitors, and processing. The limit of detection for this
assay is 200 viral copies/ml.
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