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Real Time Qualitative RT-PCR Detection of 2019-nCOV RNA / COVID-19 RNA

The test results for Mr. Abdul Saleem Shaikh, a 78-year-old male, showed that SARS-CoV-2 was not detected from his throat and nasal swab samples. The real-time RT-PCR test used kits that are recommended by ICMR and target the E and RdRP genes of SARS-CoV-2. Negative results do not rule out infection and clinical correlation is needed due to various factors that can affect test accuracy, such as inadequate sampling, improper handling, or mutations in the virus.

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0% found this document useful (0 votes)
105 views1 page

Real Time Qualitative RT-PCR Detection of 2019-nCOV RNA / COVID-19 RNA

The test results for Mr. Abdul Saleem Shaikh, a 78-year-old male, showed that SARS-CoV-2 was not detected from his throat and nasal swab samples. The real-time RT-PCR test used kits that are recommended by ICMR and target the E and RdRP genes of SARS-CoV-2. Negative results do not rule out infection and clinical correlation is needed due to various factors that can affect test accuracy, such as inadequate sampling, improper handling, or mutations in the virus.

Uploaded by

rubabshaikh
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© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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CID  2022129466  SID  177801848856  R 


Name  : MR.ABDUL SALEEM SHAIKH  Registered  : 08-Aug-2020 / 12:40  P 

Age  /  Gender  : 78 Years / Male  Collected  : 08-Aug-2020 / 17:13  R 
Dr.  : MAHENDRA KAWEDIA  Reported  : 09-Aug-2020 / 12:38  T 

Reg. Location  : 
:  Printed 

Real time Qualitative RT-PCR detection of 2019-nCOV RNA / COVID-19 RNA 
PARAMETER  RESULT 
Result 
SARS-CoV-2: Not Detected 
Kit Specification 
TRUPCR,Screening-E gene,Confirmatory-RdRP gene,CT cutoff-<35 

ICMR Registration No.SUBUR001 

Specimen: Throat swab + Nasal swab in VTM 
Method: Real time RT-PCR 

Note: 
•  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. 
•  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 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, Inproper 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. 
2.  Diagnostic detection of 2019-nCoV by real-time RT-PCR, Berlin Jan 17th, 2020. 
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 

Dr.HEENA SATAM.  Dr.SHWETA NAIK 
 Ph.D.  M.D D.N.B 
MOLECULAR BIOLOGIST  MICROBIOLOGIST 

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