
Introduction: The ongoing SARS-CoV-2 pandemic has led to shortages of laboratory-based testing kits and reagents worldwide and manufacturers have developed simple testing strategies for easy use and convenience. The Dry Swab-based Direct RT-PCR is a simple and quick method for SARS-COV2 detection which has been developed by Meril Diagnostics Pvt. Ltd. This method is a simple variation of the existing RT-PCR testing, making the extraction step easy and can expedite the testing capacity and reduces the turnaround time. Objectives: The aim of this study was to assess the diagnostic accuracy (sensitivity, specificity, positive predictive value and negative predictive value) of Meril extraction-free dry swab kit and compare its diagnostic performance with the usual RTPCR testing aided with extraction process using swabs collected in viral transport medium. Materials and Methods: This is a cross sectional (facility-based study) conducted at a tertiary care hospital in South India. The nasopharyngeal or oropharyngeal dry swab was taken under aseptic precautions, kept in a sterile collection tube and sent to the laboratory for further testing. The dry swab was processed as per the manufacturer’s instructions and proceeded with RTPCR testing as per the PCR kit protocol. The same individual’s VTM swab samples were also processed using the extraction kit and then proceeded with RTPCR protocol and the comparisons between the two test methods were done. Results: Among the 133 patients who were included in the study, RT-PCR testing with conventional extraction was positive for 19 individuals, with a prevalence of 14.29% and negative for 114 patients (85.71%). The Meril extraction free dry swab kit test was positive for 21 patients (15.79%) and negative for individuals112 (84.21%). The comparison analysis shows a Sensitivity of 94.7%, Specificity 97.4%Positive Predictive Value 85.7% And Negative Predictive Value 99.1%. Area under the Curve (AUC) indicates that the dry swab kit was able to distinguish between true positive and true negative very efficiently. Conclusion: Nasopharyngeal and oropharyngeal swabs stored in dry collection tubes area robust and inexpensive method for SARS-CoV-2 testing. The efficiency is almost equal to RTPCR testing. It can be deployed for large scale testing considering the advantages.
Introduction: The ongoing SARS-CoV-2 pandemic has led to shortages of laboratory-based testing kits and reagents worldwide and manufacturers have developed simple testing strategies for easy use and convenience. The Dry Swab-based Direct RT-PCR is a simple and quick method for SARS-COV2 detection which has been developed by Meril Diagnostics Pvt. Ltd. This method is a simple variation of the existing RT-PCR testing, making the extraction step easy and can expedite the testing capacity and reduces the turnaround time. Objectives: The aim of this study was to assess the diagnostic accuracy (sensitivity, specificity, positive predictive value and negative predictive value) of Meril extraction-free dry swab kit and compare its diagnostic performance with the usual RTPCR testing aided with extraction process using swabs collected in viral transport medium. Materials and Methods: This is a cross sectional (facility-based study) conducted at a tertiary care hospital in South India. The nasopharyngeal or oropharyngeal dry swab was taken under aseptic precautions, kept in a sterile collection tube and sent to the laboratory for further testing. The dry swab was processed as per the manufacturer’s instructions and proceeded with RTPCR testing as per the PCR kit protocol. The same individual’s VTM swab samples were also processed using the extraction kit and then proceeded with RTPCR protocol and the comparisons between the two test methods were done. Results: Among the 133 patients who were included in the study, RT-PCR testing with conventional extraction was positive for 19 individuals, with a prevalence of 14.29% and negative for 114 patients (85.71%). The Meril extraction free dry swab kit test was positive for 21 patients (15.79%) and negative for individuals112 (84.21%). The comparison analysis shows a Sensitivity of 94.7%, Specificity 97.4%Positive Predictive Value 85.7% And Negative Predictive Value 99.1%. Area under the Curve (AUC) indicates that the dry swab kit was able to distinguish between true positive and true negative very efficiently. Conclusion: Nasopharyngeal and oropharyngeal swabs stored in dry collection tubes area robust and inexpensive method for SARS-CoV-2 testing. The efficiency is almost equal to RTPCR testing. It can be deployed for large scale testing considering the advantages.
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