Field evaluation of COVID-19 rapid antigen test: Are rapid antigen tests less reliable among the elderly?

Abstract

BACKGROUND The global outbreak of coronavirus disease 2019 (COVID-19) leads to the development of accessible and cost-effective rapid antigen-detection tests (RATs), as quick and accurate diagnosis is crucial to curb the pandemic. AIM To evaluate the Humasis COVID-19 Ag Test (Humasis Co., Ltd., Gyeonggi-do, Republic of Korea) in the diagnosis of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2). METHODS This retrospective study was carried out at the Croatian Institute of Public Health and included patients with clinical symptoms of COVID-19 lasting no longer than 5 d prior to testing, whose nasopharyngeal swabs were primarily tested with RAT. Negative RAT samples underwent confirmatory real-time reverse transcription-polymerase chain reaction (RT-PCR). Diagnostic efficacy was determined compared to RT-PCR. The patients were divided into three age groups (< 18, 19-65, > 65 years). Statistical analysis was performed with the significance level set at P < 0.05. RESULTS In total, 2490 symptomatic patients were tested; 953 samples were positive on RAT, and 1537 were negative. All negative RAT samples were subjected to RT-PCR; 266 samples were positive and marked as false-negative results on RAT. The calculated negative predictive value as a measure of RAT efficacy was 82.69%. The χ 2 test and Kruskal-Wallis test showed a significant difference in the proportion of false negatives ( P < 0.001) and RT-PCR cycle (Ct) values for false-negative RATs ( P = 0.012) among the age groups. The young age group was significantly less likely to be false negative, whereas the false negatives from the elderly group experienced significantly lower Ct values than the other two age groups. CONCLUSION Evaluated RAT demonstrated satisfactory performance with more reliable results in younger patients. Humasis COVID-19 Ag RAT is potentially a valuable tool in areas where access to molecular methods is limited; however, RT-PCR remains a gold standard for SARS-CoV-2 detection.

Evaluation of COVID-19 rapid antigen test against polymerase chain reaction test in immunocompromised patients

“…Table 3 indicates that the group with highest false-negative results was in the age group 41–50 years old. In another report by Tabain et al, false negative results were compared between different age groups, the highest false negative result was in the age group older than 65 years old [ 10 ]. Mostly, this can be attributed to Ct values distribution in different age groups in each study, and false negative results are not directly related to age groups.…”

Rapid Antigen Tests during the COVID-19 Era in Korea and Their Implementation as a Detection Tool for Other Infectious Diseases

“…Among the RAT negative results, 266 samples were confirmed to be false negatives by RT-PCR. Thus, the overall efficacy of the Humasis COVID-19 Ag Test according to this study was 82.69% [ 49 ]. In addition, on-field performance evaluation of 10 commercially available SARS-CoV-2 RATs, including the Humasis COVID-19 Ag Test, found the sensitivity and specificity of this RAT to be 80% and 79%, respectively [ 50 ].…”

Effect of gender on the reliability of COVID-19 rapid antigen test among elderly

“…With interest, we read Tabain et al [ 1 ] study that was published in World J Clin Cases 2022 and how the elderly population experienced a meaningfully lower cycle threshold (Ct) value than younger groups; thus, increasing false negative rapid antigen test (RTA) tests results[ 1 ].…”