an7O0 UMA cD 12312716015 Name :MS.SAILEE UBHARE Age / Gender: 31 Years / Female Consulting Dr. Collected : 29-Dec-2023 / 14:41 Reg. Location _: Vashi (Main Centre) Reported : 30-Dec-2023 / 00:50 Real time Qualitative RT-PCR detection of SARS -COV 2 RNA / COVID-19 RNA PARAMETER RESULT SARS-CoV-2 SARS-CoV-2 : Not Detected (Negative) Kit description-€ gene as screening and ORFtab/ReRp or N gene as target gene,Cutoff:<35 Reference Range: Not Detected CMR Registration No: SDRL, Vidyavihar-Mumbal- SUBURBNDGN Specimen: Nasopharyngeal & Orepharyngeal swab in VTM Method: Real time RT-PCR Note Ct value indicates the infectivity and not severity of infection. * ICR recommended kits are used for reporting. Al the positive cases willbe notified to ICMR for further surveillance. * Clinical correlation with patient history, racology findings and co-infection with other virus infection is necessary to be: setermined especially in cases with Bordertine postive Ct valves. Borderline positive cases (Ct Value >30) may give variable results on repeat testing, The possible reasons could be the variations in its ane Instruments used, Limitations: * Optimum specimen types and timing of peak viral levels during Infections caused by SARS-COV-2 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 aelitional testing if required. (other respiratory pathogens) Negative results do not preclude SARS - CoV - 2 infection ané should not be used asthe Sale basis for patient management decisions. * This test isa qualitative assay and does not quantify vial load. Various host factors, viral factors, variility 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 Clinical Significance: Diagnosis of infection due Lo SARS-COV2 Virus Result Interpretation: Detected: indicates that RNA of SARS COV2 was present in the specimen. Not Detected: Indicates tat RNA of SARS COV? was not present in the specimen or was below the detection limit of the test Analytical Sensitivity: The analytical sensitiviy of the method is 10 copies/ul of target nucleic acid detection sequence of SARS COV2 Factors leading to false negative RT-PCR report: ‘Inadequate specimen collection, Poor qualty of sample and non-representative sample. ‘Technical reasons- PCR Inhibiter, analytical sensitivity of kit used * Aetive recombination &/ mutations in target genes used for detection of SARS-CoV-virs. References: ‘Diagnostic detection of 2019-nCoY by real-time RT-PCR, Bertin Jan 17th, 2020 Labcorp COVID-19 RT-PCR test EUA Summary / COVID-19 RT-PCR test (‘aboratory corporation of America) * sample processed at Molecular Diagnostics Laboratory, CPL, Andheri West End OF Report eee TM ene Emcee Se Reva ee aT