Cost–Utility analysis for rapid severe acute respiratory syndrome-coronavirus-2 antigen detection assay in comparison versus real-time reverse transcription-polymerase chain reaction assay for laboratory diagnosis of coronavirus disease -2019

Rujittika Mungmunpuntipantip; Viroj Wiwanitkit

doi:10.4103/bbrj.bbrj_301_22

BRIEF COMMUNICATION

Year : 2023 | Volume : 7 | Issue : 1 | Page : 123-125

Cost–Utility analysis for rapid severe acute respiratory syndrome-coronavirus-2 antigen detection assay in comparison versus real-time reverse transcription-polymerase chain reaction assay for laboratory diagnosis of coronavirus disease -2019

Rujittika Mungmunpuntipantip¹, Viroj Wiwanitkit²
¹ Private Academic Consultant, Bangkok, Thailand
² Depatment of Community Medicine, Dr. DY Patil Vidyapeeth, Pune, Maharashtra, India

Date of Submission	25-Oct-2022
Date of Decision	01-Nov-2022
Date of Acceptance	01-Jan-2023
Date of Web Publication	14-Mar-2023

Correspondence Address:
Rujittika Mungmunpuntipantip
Private Academic Consultant, 111 Bangkok 122, Bangkok 103300
Thailand

Source of Support: None, Conflict of Interest: None

DOI: 10.4103/bbrj.bbrj_301_22

Abstract

Background: The global pandemic of coronavirus disease-2019 (COVID-19) is still spreading. As a result, rapid, simple, and accurate diagnostics to diagnose severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2) infection are urgently needed. For the diagnosis of COVID-19 cases, the performance characteristics of the quick SARS-CoV-2 antigen detection test should be investigated and compared to the gold standard real-time reverse transcription-polymerase chain reaction (RT-PCR) test. The utility of the antigen detection test is reported from field evaluation. However, an interesting concern is on the utility of the test. Methods: Here, the authors perform a cost utility analysis to appraise rapid SARS-CoV-2 antigen detection assay in comparison versus real-time RT-PCR assay for laboratory diagnosis of COVID-19. Results: According to the analysis, the cost per utility of rapid SARS-CoV-2 antigen detection assay is 3.24 times less than that of comparison versus real-time RT-PCR assay. Conclusion: Hence, it can conclude that rapid SARS-CoV-2 antigen detection assay is appropriate for using for diagnosis of COVID-19 in term of cost–utility.

Keywords: Antigen, cost, coronavirus disease-2019, diagnosis, reverse transcription-polymerase chain reaction, utility

How to cite this article:
Mungmunpuntipantip R, Wiwanitkit V. Cost–Utility analysis for rapid severe acute respiratory syndrome-coronavirus-2 antigen detection assay in comparison versus real-time reverse transcription-polymerase chain reaction assay for laboratory diagnosis of coronavirus disease -2019. Biomed Biotechnol Res J 2023;7:123-5

How to cite this URL:
Mungmunpuntipantip R, Wiwanitkit V. Cost–Utility analysis for rapid severe acute respiratory syndrome-coronavirus-2 antigen detection assay in comparison versus real-time reverse transcription-polymerase chain reaction assay for laboratory diagnosis of coronavirus disease -2019. Biomed Biotechnol Res J [serial online] 2023 [cited 2023 Jun 10];7:123-5. Available from: https://www.bmbtrj.org/text.asp?2023/7/1/123/371692

Introduction

The severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2)-caused coronavirus disease-2019 (COVID-19) pandemic has spread around the globe since the city of Wuhan in China first reported a case in December 2019.^[1] Despite the availability of the COVID-19 vaccination, there is currently no effective disease control for COVID-19.^[1]

For COVID-19 to be effectively controlled, an early diagnosis is still required. Real-time reverse transcription-polymerase chain reaction (RT-PCR), the current gold standard test for the laboratory diagnosis of SARS-CoV-2 infection, requires at least 4 h of operation by qualified people. To prevent and control disease, it is essential to do prompt and accurate SARS-CoV-2 screening tests as well as screening during preoperative care for invasive procedures.^[2],[3],[4] As an alternate technique to aid in quick diagnosis, the new rapid SARS-CoV-2 antigen detection assay is presented. They can be employed as complementary screening tests if the precision of lateral flow immunoassays using monoclonal anti-SARS-CoV-2 antibodies, which target SARS-CoV-2 antigens, is similar to that of real-time RT-PCR assays.^{[5],[6],[7],[8]} The new quick SARS-CoV-2 antigen detection assay has been demonstrated to be useful for diagnostic systems in a recent publication from Thailand. In that study, the sensitivity, specificity, false positive, and false negative rates were 98.33%, 98.73%, 1.27%, and 1.67%, respectively, when compared to the standard RT-PCR test.^[9]

The price, viability, and usefulness of the new alternative technique should all be taken into account when putting the new diagnostic technique into practice. For the purpose of COVID-19 laboratory diagnosis, the authors of this study compare the cost–utility of a quick SARS-CoV-2 antigen detection assay to a real-time RT-PCR technique.

Materials

Study design

To diagnose COVID-19 in a laboratory setting, this study compares the cost-utility of a quick SARS-CoV-2 antigen detection assay to a real-time RT-PCR technique. The scene is in an Asian developing nation. The study strengthens earlier test validation.^[9] The real-time RT-PCR is from the Allplex™ 2019-nCoV Assay, and the studied quick SARS-CoV-2 antigen detection assay is from the standard Q COVID-19 Ag test (SD Biosensor^®, Chungcheongbuk-do, Republic of Korea) (Seegene, Korea).^[9] Real-time RT-PCR is considered the gold standard and has no false positives or false negatives, which is the main assumption.

Sampling and reasons for selection

There is no sampling in the present medial economical analysis. No inclusion and exclusion criteria are applicable.

Cost–utility analysis

Each test's price is determined by publicly available data from the local Ministry of Public Health and Center for Disease Control. The cost of each test for the diagnosis of COVID-19 was evaluated by the authors using a standard medical economics method for cost–utility analysis. The main information from a source that is open to the public is utilized. As noted earlier, the reported diagnostic test is used for cost allocation, and for cost–utility analysis, the accurate rate of diagnosis (calculated by 1-false positive-false negative) is assigned as utility.^[9] Each diagnostic test's cost per utility is determined, and the test's cost utility value is compared.

Results

Cost and utility

As demonstrated in [Table 1], there are differences between real-time RT-PCR and the quick SARS-CoV-2 antigen detection assay in terms of cost and utility.

Table 1: Cost-utility analysis of the diagnostic tests

Click here to view

Cost–utility analysis

Comparing the price per unit utility of the rapid SARS-CoV-2 antigen detection assay to the real-time RT-PCR assay for COVID-19 laboratory diagnosis is shown in [Table 1]. Rapid SARS-CoV-2 antigen detection assays are less expensive per unit than real-time RT-PCR assays.

Ethical approval and patient consent

This is not a study on human or animal subjects but it is a medical economics study. The ethical approval is not applicable. The informed consent is not applicable.

Discussion

A coronavirus called COVID-19 produces severe acute respiratory illness (SARS-CoV-2). Over 5 million individuals have died as a result of this devastating disease, which has affected nearly 200 million people. In addition, the illness has significantly impacted the global economy and used up a lot of medical resources. Molecular testing is used to confirm SARS-CoV-2 infection; RT-PCR techniques are frequently used in COVID-19 diagnostic centers to identify SARS-CoV-2 RNA in clinical material. The key to outbreak containment is early diagnosis and timely management. A reliable diagnostic test is necessary to identify COVID-19.

A molecular diagnostic test is necessary as the gold standard for diagnosis. The test is complicated although alternate methods like the quick antigen test have been created. The fast antigen test was suggested in a prior research for its benefit. More sensitive and specific than this lateral flow immunoassay, the nucleic acid test for SARS-CoV-2 gene detection is still utilized to diagnose COVID-19.^[9] Despite its shortcomings, the fast SARS-CoV-2 antigen test can assist all medical personnel in managing sick patients more quickly and effectively, particularly in rural and outbreak areas. The challenge in managing the current outbreak situation include the fast diagnosis of the disease at early stage of infection, which can further result in a prompt treatment of the patients and disease control.^{[10],[11],[12],[13],[14]} Therefore, an effective fast antigen test may be useful.

It is anticipated that the quick rapid test based on immunochromatography will be straightforward and may even be self-performed. The test's viability is verified.^{[9],[15],[16]} The price of the test should be taken into account in light of medical economics. According to a recent study, the antigen proved helpful for screening SARS-CoV-2 since it enables speedy results and mass testing.^[16] Regarding the price and utility, there is still some uncertainty. The quick SARS-CoV-2 antigen detection assay is still appropriate in terms of cost–utility, according to the study that was done for the current report.

Conclusion

According to the study, the fast SARS-CoV-2 antigen detection assay has a 3.24 times lower cost per utility than the comparison versus real-time RT-PCR method. As a result, the rapid SARS-CoV-2 antigen detection assay is suitable for the use in the diagnosis of COVID-19 from a cost–utility perspective.

Limitation of study

This study is a medical economic study. It is a kind of retrospective study. The basic limitation is according to the inability to control the confounding factor for the primary data. In addition, the retrospective reflects the past situation and there might be a change during the changing situation of the disease outbreak.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.

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