ABSTRACT
Aim: Currently, there is lack of data regarding rapid antigen detection (RAD) kits to detect SARS-CoV-2 B.1.617.2 virus. Objective: The purpose of this evaluation is to assess analytical sensitivity of 12 RAD kits against SARS-CoV-2 B.1.617.2. Study design: Analytical sensitivity was determined by limit of detection (LOD). A serial tenfold dilution set from a respiratory specimen collected from a COVID-19 patient infected by SARS-CoV-2 B.1.617.2 was used. RT-PCR was used as a reference method. Results: The LOD results showed that 11 and one RAD kits were 100- and 1000-fold less sensitive than RT-PCR respectively. Conclusion: The results showed that the RAD kits evaluated in this study may be used for first-line screening of the SARS-CoV-2 B.1.617.2 variant.
ABSTRACT
BACKGROUND: Numerous rapid antigen detection (RAD) kits for diagnosing COVID-19 patients are available in the market recently. OBJECTIVE: To compare analytical sensitivity and clinical sensitivity for the three commercially available RAD kits. STUDY DESIGN: Analytical sensitivity for the detection of SARS-CoV-2 virus was determined by limit of detection (LOD) using RT-PCR as a reference method. Clinical sensitivity was evaluated by using respiratory specimens collected from confirmed COVID-19 patients. RESULTS: The LOD results showed that the three RAD kits varied from 102-105 fold less sensitive than RT-PCR. Clinical sensitivity of RAD kits ranged from 22.9 %-71.4 % for detecting specimens from COVID-19 patients. CONCLUSIONS: Although RAD kits were less sensitive than RT-PCR, understanding the clinical characteristics of different RAD kits can guide us to obtain suitable specimens for testing. The likelihood of positive results for RAD kits will be higher.
Subject(s)
Antigens, Viral/analysis , COVID-19 Serological Testing/methods , COVID-19/diagnosis , Nasopharynx/virology , COVID-19 Nucleic Acid Testing , Humans , Limit of Detection , Reagent Kits, Diagnostic , SARS-CoV-2/isolation & purification , Sensitivity and Specificity , Time FactorsABSTRACT
BACKGROUND: The rapid diagnosis of Coronavirus Disease 2019 (COVID-19) patients is essential to reduce the disease spread. Rapid antigen detection (RAD) tests are available, however, there is scanty data on the performance of RAD tests. OBJECTIVE: To evaluate the performance of the commercially available BIOCREDIT COVID-19 Ag test and compare it with RT-PCR for detecting Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) virus. Analytical sensitivity for the detection of SARS-CoV-2 virus was determined for the RAD test using viral culture and RT-PCR as reference methods. The RAD test was further evaluated using respiratory samples collected from confirmed COVID-19 patients. The results were compared with RT-PCR test. RESULTS: The detection limits between RAD test, viral culture and RT-PCR varied hugely. RAD was 103 fold less sensitive than viral culture while RAD was 105 fold less sensitive than RT-PCR. The RAD test detected between 11.1 % and 45.7 % of RT-PCR-positive samples from COVID-19 patients. CONCLUSIONS: This study demonstrated that the RAD test serves only as adjunct to RT-PCR test because of potential for false-negative results.
