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. 2022 Jul 6;10(19):6456-6463.
doi: 10.12998/wjcc.v10.i19.6456.

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

Irena Tabain  1 , Djivo Cucevic  2 , Nikola Skreb  3 , Anna Mrzljak  3 , Ivana Ferencak  1 , Zeljka Hruskar  1 , Anita Misic  1 , Josipa Kuzle  1 , Ana Marija Skoda  1 , Hrvojka Jankovic  1 , Tatjana Vilibic-Cavlek  1
Affiliations

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

Irena Tabain et al. World J Clin Cases. .

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.

Keywords: Coronavirus disease 2019; Croatia; Rapid antigen test; Real-time reverse transcription-polymerase chain reaction; Severe acute respiratory syndrome coronavirus-2.

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Conflict of interest statement

Conflict-of-interest statement: The authors declare no conflict of interest.

Figures

Figure 1
Figure 1
Weekly number of symptomatic patients tested by rapid antigen-detection tests.
Figure 2
Figure 2
Ratio of positive rapid antigen-detection tests results by week. RAT: Rapid antigen.
Figure 3
Figure 3
Ratio of false-negative rapid antigen-detection tests results by week.
Figure 4
Figure 4
Number of rapid antigen-detection tests false-negative patients testing positive per each reverse transcription-polymerase chain reaction cycle. Ct: Reverse transcription-polymerase chain reaction cycle.
Figure 5
Figure 5
Correlation between reverse transcription-polymerase chain reaction cycle values and prevalence of false-negative results.
Figure 6
Figure 6
Predictive model of correlation between the total number of patients and the number of false negatives.
See this image and copyright information in PMC

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