Abstract
Since COVID-19 pandemic is a global crisis, tests with high sensitivity and specificity are crucial for the identification and management of COVID-19 patients. There is an urgent need for low-cost rapid antigen COVID-19 test with a good diagnostic performance. Although various antigen rapid detection tests are widely available, strong evidence of their usefulness in clinical practice are still limited. Therefore, our aim was to evaluate clinical performance of STANDARD Q COVID-19 Ag Test (SD Biosensor, Gyeonggi-do, South Korea). The performance of the STANDARD Q COVID-19 Ag Test for the detection of SARS-CoV-2 antigen was evaluated in comparison to RT-qPCR results in 120 symptomatic patients (median age 49, IQR 36-70) who presented to health care facility in Novi Sad, Vojvodina, Serbia. Twenty five out of 120 samples have been tested positive using STANDARD Q COVID-19 Ag Test, and all of them were also positive on RT-qPCR. Overall, the STANDARD Q COVID-19 Ag Test showed sensitivity of 58.1% (95% CI 42.1-73.0) but it was higher in the early days of disease, when the highest viral loads were detected. During the first five days after the symptom onset, the sensitivity ranged from 66.7% to 100% and the pooled accuracy and Kappa values were high (0.92 and 0.852). A strong agreement between performance of STANDARD Q COVID-19 Ag Test and RT-qPCR was observed during the first five days of illness, suggesting that this rapid antigenic test can be very useful for COVID-19 diagnosis in the early phase of disease.
Highlights
On January 20th, China’s “National Infectious Diseases Law” was amended to make 2019-novel coronavirus diseases (COVID-19) a Class B notifiable disease and its “Frontier Health and Quarantine Law” was revised to support the COVID-19 outbreak response effort [1]
The performance of the STANDARD Q COVID-19 Ag Test for the detection of SARS-CoV-2 antigen was evaluated in comparison to RT-qPCR results in 120 symptomatic patients who presented to health care facility in Novi Sad, Vojvodina, Serbia
Twenty five out of 120 samples have been tested positive using STANDARD Q COVID-19 Ag Test, and all of them were positive on RT-qPCR
Summary
On January 20th, China’s “National Infectious Diseases Law” was amended to make 2019-novel coronavirus diseases (COVID-19) a Class B notifiable disease and its “Frontier Health and Quarantine Law” was revised to support the COVID-19 outbreak response effort [1]. High diagnostic accuracy tests applied in the early phase of the illness would enable identification of COVID-19 patients and promptly implementation of control measures in order to reduce household and community transmission [2, 6, 7]. To this end, “point-of-care” or “near patient” antigen and molecular tests for detection of a current SARS-CoV-2 infection have the potential to allow fast laboratory confirmation and timely isolation of COVID-19 cases [6].
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