Real time Qualitative RT-PCR detection of 2019-nCOV RNA / COVID-19 RNA PARAMETER RESULT Result SARS-CoV-2: Not Detected (Negative) Kit Specification Genestore SARS-CoV-2,Target gene (N1 & N2), Cutoff 30) may give variable results on repeat testing. The possible reasons could be the variations in kits and instruments used. Limitations: ‡ Optimum specimen types and timing of peak viral levels during infections caused by 2019-nCOV have not been determined. Collection of multiple specimens (Types & Time points) may be necessary in view of suspected clinical history. The repeat specimen may be considered after a gap of 2-4 days after the collection of first specimen for additional testing if required. (other respiratory pathogens) ‡ Negative results do not preclude SARS - CoV - 2 infection and should not be used as the sole basis for patient management decisions. ‡ This test is a qualitative assay and does not quantify viral load. Various host factors, viral factors, variability in sample collection / site and techniques used by the laboratories can affect Ct values. Therefore, Ct values are not an absolute indication of viral load and should be interpreted with caution. Factors leading to false negative RT-PCR report: ‡ Inadequate specimen collection, Poor quality of sample and non-representative sample. ‡ Sample collected too early or too late in the infection, Improper sample handling and shipment. ‡ Technical reasons- PCR Inhibitor, analytical sensitivity of kit used. ‡ Active recombination &/ mutations in target genes used for detection of SARS-CoV-2 virus. References: 1. Diagnostic detection of 2019-nCoV by real-time RT-PCR, Berlin Jan 17th, 2020. 2. Labcorp COVID-19 RT-PCR test EUA Summary / COVID-19 RT-PCR test (laboratory corporation of America).