Comparison of Two Real-time Polymerase Chain Reaction Assays for the Detection of Severe Acute Respiratory Syndrome-CoV-2 from Combined Nasopharyngeal-Throat Swabs

Autor: Nazia Nagi, Sanchita Tuteja, Sonal Saxena, Oves Siddiqui, Tanu Sagar, Abhishek Yadav, Vikas Manchanda
Rok vydání: 2020
Předmět:
0301 basic medicine
Microbiology (medical)
Pneumonia
Viral
real-time polymerase chain reaction
030106 microbiology
Immunology
lcsh:QR1-502
Context (language use)
Microbiology
lcsh:Microbiology
law.invention
molecular diagnostics
Betacoronavirus
Coronavirus Envelope Proteins
03 medical and health sciences
COVID-19 Testing
0302 clinical medicine
Viral Envelope Proteins
Immunology and Microbiology (miscellaneous)
law
Throat
test comparison
medicine
Humans
Immunology and Allergy
Viral rna
030212 general & internal medicine
Pathology
Molecular
Respiratory system
Pandemics
Polymerase chain reaction
General Immunology and Microbiology
Clinical Laboratory Techniques
SARS-CoV-2
business.industry
Gold standard (test)
Virology
Early Diagnosis
Infectious Diseases
medicine.anatomical_structure
Real-time polymerase chain reaction
covid-19
Viral Transport medium
RNA
Viral
Original Article
Reagent Kits
Diagnostic
severe acute respiratory syndrome-cov-2
Coronavirus Infections
business
Zdroj: Indian Journal of Medical Microbiology, Vol 38, Iss 3, Pp 385-389 (2020)
Indian Journal of Medical Microbiology
ISSN: 0255-0857
Popis: Context: In the absence of effective treatment or vaccine, the current strategy for the prevention of further transmission of severe acute respiratory syndrome (SARS) CoV-2 (COVID-19) infection is early diagnosis and isolation of cases. The diagnosis of SARS-CoV-2 is done by detecting viral RNA in the nasopharyngeal and throat swabs by real-time polymerase chain reaction (PCR). Many commercial assays are now available for performing the PCR assay. Aims: The aim was to evaluate the performance of the SD Biosensor nCoV real-time detection kit with the real-time PCR kit provided by the Indian Council of Medical Research-National Institute of Virology (ICMR-NIV), Pune (NIV Protocol). Subjects and Methods: A total of 253 pairs of nasopharyngeal-oropharyngeal swabs combined in a single viral transport medium were tested for viral RNA by both the protocols. The sensitivity and specificity of the SD Biosensor were calculated considering the ICMR-NIV kit as the gold standard. Matched pairs of recorded cycle threshold values (Ct values) were compared by Pearson’s correlation coefficient. Results: Concordant COVID-19 negative and positive PCR results were reported for 113 and 77 samples, respectively. The SD Biosensor kit additionally detected 62 cases, which were found negative by the NIV protocol. In all discordant positive results by the SD Biosensor kit, the average Ct values were higher than the concordant positive results. A total of forty samples tested positive for E gene by SD Biosensor and having Ct values 32 were all found negative by the NIV protocol. Conclusions: The results highlight the need for careful evaluation of commercial kits before being deployed for screening of COVID-19 infections.
Databáze: OpenAIRE
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