cD 12312716005 Name :MS.SAILEE UBHARE Age / Gender :31 Years / Female Consulting Dr. Collected : 28-Dec-2023 / 1 Reg. Location —_: Vashi (Main Centre) Reported :29-Dec-2023 / 10:50 Real time Qualitative RT-PCR detection of SARS -COV 2 RNA / COVID-19 RNA PARAMETER RESULT SARS-CoV-2 SARS-CoV-2 : Detected (Positive) Kit description-£ gene as screening and ORF1ab/RdRp or N gene as target gene,Cutoff:<35 Reference Range: Detected CMR Registration No: SDR, Vidyavihar-Mumbat- SUBURBNDGN Specimen: Nasopharyngeal & Orepharyngeal swab in VT Method: Realtime 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, radiology findings and co-infection with other virus infection is necessary to be setermined especially in cases with Bordertine postive Ct values. Borderline positive cases (Ct Value >30) may give variable results on repeat testing. The possible reasons could be the variations in kits 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 Fepeat specimen may be considered after a gap of 2-4 days after the collection of first specimen for aditional testing if required. (other respiratory pathogens) Negative results do not preclude SARS - CoV - 2 infection and should not be Used asthe Sole basis for patient management decisions. * This testis a qualitative assay and does not quantify vial lead. Various hast 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 Clinical Significance: Diagnosis of infection due to 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 oF 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 COV Factors leading to false negative RT-PCR report: ‘Inadequate specimen collection, Poor quality of sample and non-representatve sample. ‘Technical reasons- PCR Inibiter, analytical sensitivity of kit used. * Aetive recombination &/ mutations in target genes used for detection of SARS-CoV-virus References: ‘Diagnostic detection of 2019-nCoV by real-time RT-PCR, Bertin Jan 17th, 2020 2\Labeorp 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