ประเมินประสิทธิภาพชุดตรวจ SARS-CoV-2 Ag และชุดตรวจ POCT ชนิด real-time RT-PCR กับ วิธีมาตรฐาน real-time RT PCR ที่โรงพยาบาลสมเด็จพระสังฆราชองค์ที่ 17 จังหวัดสุพรรณบุรี ระหว่างโรคโควิด-19 ระบาดใหญ่ ปี 2022

Abstract

          In the outbreak of The COVID-19 outbreak caused by the SARS-CoV-2 virus is severe and spreading rapidly and with high severity. Diagnosing and separating infected people for quarantine, treatment, and disease control requires laboratory tests that must have the potential to detect pathogens accurately and quickly to support diagnosis.The standard method for detecting the SARS-CoV-2 virus is real-time RT-PCR. Although t has high sensitivity and specificity, but it takes a long time. The researcher studied the efficiency of the SARS-CoV-2 Antigen test kit and the POCT Standard RT-PCR for SARS-CoV-2 test kit were compared to the Standard real-time RT-PCR for SARS-CoV-2 test kit in nasopharyngeal swab and throat swab in viral transport media: VTM by cross-sectional descriptive research study in a sample group ofin 80 cases, during the COVID-19 outbreak from May to June 2022, which is the period with the highest. Cycle Threshold (CT) value of E gene 36.75.

          The result showed the efficiency of the coronavirus test kit by the SARS-CoV-2 Antigen test kit and the POCT Standard RT-PCR for SARS-CoV-2 test kit compared to the Standard real-time RT-PCR for SARS-CoV-2 test kit is more sensitivity of 85.66% , 91.66%, a specificity of 90.00, 100% and an accuracy of 87.50%, 93.75%, respectively. The group with CT of E gene not more than 30 had a sensitivity of 97.50%,100%, a specificity 95.00, 100% and an accuracy of 96.66%, 100%, respectively. For the group with CT of E gene exceeded 30 the sensitivity and an accuracy were 60.00% and 80.00%.

          In conclusion, the POCT Standard RT-PCR for SARS-CoV-2 test kit has sensitivity, specificity and accuracy better than testing with the SARS-CoV-2 Antigen assay, when compared to the standard real-time RT-PCR test kit in specimens with a CT value of E gene less than 30 but decreased sensitivity and accuracy when the CT value exceeds 30. Therefore, the POCT Standard RT-PCR for SARS-CoV-2 test kit is effective for SARS-CoV-2 infection to screening for isolate the infected person person in the initial stage and during the spread of infection. It also reduces waiting time from 6-12 hours to 45-60 minutes, making treatment faster. and promote disease control more effectively, but it is not suitable for selection to detect bacteria in late stages of infection.