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
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