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This document summarizes the results of an RT-PCR test for Ms. Sailee Ubhare, a 30-year-old female, to detect the presence of SARS-CoV-2. The test resulted in SARS-CoV-2 being not detected, indicating a negative result. The test used real-time RT-PCR technology targeting the E gene, ORF1ab/RdRp, or N gene of SARS-CoV-2 from a nasopharyngeal and oropharyngeal swab sample. Several notes on the limitations and clinical significance of the test are also provided.

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32 views1 page

Data

This document summarizes the results of an RT-PCR test for Ms. Sailee Ubhare, a 30-year-old female, to detect the presence of SARS-CoV-2. The test resulted in SARS-CoV-2 being not detected, indicating a negative result. The test used real-time RT-PCR technology targeting the E gene, ORF1ab/RdRp, or N gene of SARS-CoV-2 from a nasopharyngeal and oropharyngeal swab sample. Several notes on the limitations and clinical significance of the test are also provided.

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APTEKA Pharmaceutical
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© © All Rights Reserved
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CID : 2204716005

Name : MS.SAILEE UBHARE


Age / Gender : 30 Years / Female
Consulting Dr. :- Collected : 16-Feb-2022 / 14:41
Reg. Location : Vashi (Main Centre) Reported : 17-Feb-2022 / 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-E gene as screening and ORF1ab/RdRp or N gene as target gene,Cutoff:<35

Reference Range: Not Detected


ICMR Registration No: SDRL,Vidyavihar-Mumbai- SUBURBNDGN
Specimen: Nasopharyngeal & Oropharyngeal swab in VTM
Method: Real time RT-PCR
Note:
* Ct value indicates the infectivity and not severity of infection.
* ICMR recommended kits are used for reporting. All the positive cases will be notified to ICMR for further surveillance.
* Clinical correlation with patient history, radiology findings and co-infection with other virus infection is necessary to be
determined especially in cases with Borderline positive Ct values.
Borderline positive cases (Ct Value >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 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 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.
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 that RNA of SARS COV2 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 quality of sample and non-representative sample.
* Technical reasons- PCR Inhibitor, analytical sensitivity of kit used.
* Active recombination &/ mutations in target genes used for detection of SARS-CoV-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).
* Sample processed at Molecular Diagnostics Laboratory, CPL, Andheri West
*** End Of Report ***

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