Copyright
©The Author(s) 2022. Published by Baishideng Publishing Group Inc. All rights reserved.
Field evaluation of COVID-19 rapid antigen test: Are rapid antigen tests less reliable among the elderly?
Irena Tabain, Djivo Cucevic, Nikola Skreb, Anna Mrzljak, Ivana Ferencak, Zeljka Hruskar, Anita Misic, Josipa Kuzle, Ana Marija Skoda, Hrvojka Jankovic, Tatjana Vilibic-Cavlek
Irena Tabain, Ivana Ferencak, Zeljka Hruskar, Anita Misic, Josipa Kuzle, Ana Marija Skoda, Hrvojka Jankovic, Tatjana Vilibic-Cavlek, Department of Virology, Croatian Institute of Public Health, Zagreb 10000, Croatia
Djivo Cucevic, Department of Emergency Medicine, Institute of Emergency Medicine of the City of Zagreb, Zagreb 10000, Croatia
Nikola Skreb, Anna Mrzljak, Tatjana Vilibic-Cavlek, School of Medicine, University of Zagreb, Zagreb 10000, Croatia
Anna Mrzljak, Department of Gastroenterology and Hepatology, University Clinical Hospital Zagreb, Zagreb 10000, Croatia
Author contributions: Tabain I made contributions to the conception and design of the study, and was involved in drafting and revising the manuscript; Cucevic D, Skreb N, Ferencak I, Hruskar Z, Misic A, Kuzle J, Skoda AM, and Jankovic H were involved in collecting data and drafting the manuscript; Mrzljak A and Vilibic-Cavlek T revised the manuscript critically; All authors have read and approved the final manuscript.
Institutional review board statement: The study was conducted according to the guidelines of the Declaration of Helsinki and approved by the Ethics Committee of the Croatian Institute of Public Health (protocol code 030-02/20-05/1, approved on May 7th, 2020).
Informed consent statement: Patients were not required to give informed consent to the study because the analysis used anonymous clinical data that were obtained after each patient agreed to treatment by written consent.
Conflict-of-interest statement: The authors declare no conflict of interest.
Data sharing statement: No additional data are available.
Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See:
https://creativecommons.org/Licenses/by-nc/4.0/ Corresponding author: Anna Mrzljak, PhD, Adjunct Associate Professor, Department of Gastroenterology and Hepatology, University Clinical Hospital Zagreb, Kispaticeva 12, Zagreb 10000, Croatia. anna.mrzljak@gmail.com
Received: March 14, 2022
Peer-review started: March 14, 2022
First decision: March 24, 2022
Revised: April 5, 2022
Accepted: May 17, 2022
Article in press: May 17, 2022
Published online: July 6, 2022
ARTICLE HIGHLIGHTS
Research background
One of the strategic objectives in response to the coronavirus disease 2019 (COVID-19) pandemic was the early identification of infected individuals. Compared to the reverse transcription-polymerase chain reaction (RT-PCR), antigen-detection rapid diagnostic tests (RATs) are less expensive, easier to use, and provide results faster.
Research motivation
The sensitivity and specificity of different severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) RAT vary.
Research objectives
To evaluate the value of Humasis COVID-19 Ag Test in the diagnosis of SARS-CoV-2 infection.
Research methods
A commercial immunochromatographic assay for the qualitative detection of SARS-CoV-2 nucleocapsid and receptor binding domain antigens (Humasis COVID-19 Ag Test Kit; Humasis Co., Ltd., Gyeonggi-do, Republic of Korea) was used to detect SARS-CoV-2 antigen in the nasopharyngeal swab samples. Negative samples were subjected to confirmatory RT-PCR testing.
Research results
A total of 2490 RAT were performed on nasopharyngeal swabs obtained from patients with a history of SARS-CoV-2 infection in the last 5 d prior to sampling. The overall positive RAT prevalence was 37.90% (953 positive samples) while the calculated negative RAT predictive value was 82.69%. A significant difference in the prevalence of false negatives was observed (7.19%, 19.26% and 31.37%, respectively) between the youngest group (< 18 years of age) and the adult (19-65 years of age) or elderly group (> 65 years of age) (P < 0.0001). In addition, a significant difference in mean Ct value between all three age groups was found (26.58, 25.89, and 23.86, respectively; P = 0.012).
Research conclusions
RAT is an acceptable tool in COVID-19 diagnostics in samples with a high viral load (Ct < 25), but caution is needed. The results seem to be more reliable in younger patients.
Research perspectives
Further studies including different RAT are needed to confirm this observation.
