What is the role of rapid diagnostic tests for COVID-19 IgM/IgG in the pre-operative period of cosmetic plastic surgery?
Qual o papel dos testes rápidos de diagnóstico de COVID-19 IgM/IgG no pré-operatório de cirurgia plástica estética?

INTRODUCTION

Coronavirus disease 2019 (COVID-19) emerged in China and spread globally with sustained human-to-human transmission¹. Due to its highly contagious nature, unprecedented global spread, aggressive clinical presentation, and the lack of effective treatment, the acute coronavirus 2 (SARS-CoV-2) respiratory infection syndrome is causing the loss of thousands of lives and repercussions unmatched in health systems worldwide².

The infection caused by COVID-19 is a highly transmissible disease that presents a significant risk for both patients and health professionals³. Recently, it was demonstrated that high levels of the virus are present in respiratory secretions during the pre-symptomatic period, which can last from days to weeks before the characteristic symptoms of COVID-19⁴. The virus’s ability to be transmitted by people without symptoms is one of the main reasons for the pandemic⁵.

The diagnosis of COVID-19 is made using clinical, laboratory, and radiological characteristics⁶. As the signs and radiological findings of COVID-19 are nonspecific, infection with SARS-CoV-2 must be confirmed by laboratory tests. Polymerase chain reaction tests with reverse transcriptase (RT-PCR) are the gold standard for the diagnosis of COVID-19. However, it is challenging to collect tests, and its results are not immediately available⁷. The rapid diagnostic tests for COVID-19 IgM / IgG were developed using lateral flow technology to find antigens from the SARS-CoV-2 virus and detect antibodies produced by patients infected with COVID-19⁸.

Screening tests are widely used to assess the probability of members of a defined population having a specific disease; with few exceptions, screening tests do not diagnose the disease⁹. The rapid serological diagnostic test performed at the time of admission, before elective surgery, is among the most widely used pre-operative screening methods for COVID-19^10-18.

OBJECTIVES

The aim of this study is to evaluate the role of rapid tests for COVID-19 antibodies in outpatients being admitted for aesthetic plastic surgery.

METHODS

A systematic review of the literature was performed using the search engines in PubMed, Web of Science, and SciELO journals, for studies with animals and humans published from December 2019 to July 30, 2020. We consider specific terms about COVID-19 or SARS- CoV-2 and plastic surgery. The following descriptors were used: “plastic surgery”, “elective surgery”, “COVID-19”, “COVID-19 diagnostic test”, “COVID-19 blood antibody test”, “SARS-CoV-2 test”. Many terms and words were displayed similarly when searching for articles. Words like “pre-operative,” “surgical,” and “surgery” showed similar results. The results of the words and phrases investigated were analyzed by quantity and quality. Documents written in English, Spanish, French, Italian, and Portuguese were included. Videos, posters, and letters to the editor were disregarded. Two researchers independently selected the relevant articles through the evaluation of titles and abstracts. The third researcher reviewed relevant articles. Data on the level of evidence, sensitivity, specificity, and predictive values ​​of rapid diagnostic tests were collected.

This study follows Helsinki’s declaration and does not need to be evaluated by an ethics committee since it does not directly involve collecting data or tissues from human beings, only research conducted exclusively with scientific texts.

RESULTS

Using our active search strategy, the database review found 409 articles (Figure 1). A total of 357 studies were duplicated or considered not relevant to our research question. Among the remaining articles, 28 were studies without information on the accuracy of rapid diagnostic tests, and 24 were studies describing measures of accuracy^7,8,19-40.

Figure 1 - Algorithm of a systematic review.

Figure 1 - Algorithm of a systematic review.

The level of evidence varied from V to III. The sensitivity varied from 18.4 to 100%, the specificity varied from 94 to 100%, the positive predictive value varied between 19.7 and 100%, and the negative predictive value was between 20 and 100%.

DISCUSSION

The limited experience accumulated during the COVID-19 pandemic has shown that the management of all medical conditions, including elective surgeries, has undergone some degree of change². We all want to go back to work without the COVID-19 spectrum. During the extraordinary conditions of the COVID-19 pandemic, the ideal strategies for treating aesthetic patients individually are unknown. There is no consensus in the literature regarding pre-operative care, except that all patients should be screened for symptoms before being presented to the operating room, and those who report symptoms of COVID-19 should be referred for further evaluation.

The rapid diagnostic test can be produced quickly and cheaply. This qualitative test is small and portable, usually similar to a pregnancy test, showing to the user colored lines to indicate positive or negative results⁸. Rapid diagnostic tests do not measure the number of antibodies in the patient’s serum or whether these antibodies can protect against future infections. However, they do have the ability to detect exposure and can identify asymptomatic people and people who have cleared the virus. Many of the rapid diagnostic tests available so far lack analytical performance concerning sensitivity and specificity and need to be better validated before being used preoperatively²¹.

For a medical diagnosis, the test’s sensitivity is its ability to correctly identify those with the disease (true positive rate), while the test’s specificity is its ability to accurately identify those without the disease (true negative rate). In this research, sensitivity ranged from 18.4 to 100%, reflecting a potential inability to identify people who have antibodies to COVID-19 correctly. Specificity varied between 94 and 100%, demonstrating a high ability to identify all patients who do not have COVID-19 antibodies.

The negative predictive value is the probability that patients with a negative result in a rapid diagnostic test do not have COVID-19 antibodies; in our research, their values ​​were between 20 and 100%, we can say that, in some circumstances, 80% of individuals with a negative test may have COVID-19 antibodies. Positive predictive value is the likelihood that individuals with a rapid positive diagnostic screening test will have the disease; in our research, its variation was between 60 and 100%. Consequently, we can affirm that, in some circumstances, 40% of the individuals with positive rapid tests may not have antibodies to COVID- 19. Therefore, the rapid test results seem to be scientifically unreliable, and the recommendation to perform this testing in a generalized way by patients or hospital institutions seems inadequate.

It is estimated that SARS-CoV-2 IgM antibodies can be detected in a blood sample after three days and IgG antibodies eight days after the onset of symptoms⁷. The seroconversion rate for IgM and IgG was described as 82.7% and 64.7%, respectively⁵. To date, we do not know whether everyone who has recovered from COVID-19 has developed antibodies, and we do not know to what extent these antibodies protect patients from reinfection. The antibody tests do not detect an active infection but look for signs that a person has been previously infected, as shown by the antibodies his immune system has produced to fight the coronavirus. With other diseases, the presence of antibodies usually means acquired immunity for at least some period, but this is not yet known in the case of COVID-19⁴.

Patients should be screened only if a positive test results in mandatory action. This is not the case for rapid diagnostic tests for COVID-19 before cosmetic surgery because the procedure will be performed regardless of antibody detection status. In the case of the new COVID-19 virus and the SARS-CoV-2 disease it causes in humans, the objective of pre-operative testing would be straightforward: to identify infected patients and isolate them by postponing their surgeries, trying to reduce the morbidities of the procedure and thus reducing the risk of infection for health professionals⁸. Nevertheless, without a perfect test, false positives and false negatives can lead to significantly worse outcomes.

Both false positives and false negatives pose their own unique dangers wherever testing occurs, but false negatives are particularly dangerous for COVID-19. Two weeks after surgery, some patients may be positive for COVID-19; despite the negative pre-operative result, important medico-legal implications may arise. Was the infection contracted during hospitalization? Did the surgeon or his team contaminate the patient during outpatient postoperative follow-up? Did seroconversion occur because of the surgery-induced immunosuppression? A negative result in a rapid diagnostic test for COVID-19 performed preoperatively can be dangerous medico-legal evidence for surgeons and hospital entities.

Antibody tests are versatile: these serological tests are of critical importance to determine seroprevalence, prior exposure and to identify highly reactive human donors for the generation of therapeutic convalescent serum⁴. They will also support contact screening and screening for healthcare professionals to identify those who are already immune.

It is plausible that several limitations may have influenced the results obtained in this research. The exclusion of articles in Asian languages ​​is one of them since much of the knowledge about COVID-19 comes from this geographic area. However, there was none among the researchers with knowledge of these languages ​​, and we consider that electronic translators are not reliable. However, many of these studies would provide information with limited external validity for patients in the Americas since COVID-19 mutations are frequent, and most of the rapid diagnostic tests used there are not available on our continent. A well-designed systematic review benefits the evolution of knowledge, identifying a lack of scientific information and providing a synopsis of the available evidence. The credibility of systematic reviews can be compromised by reporting bias, which arises when the results’ nature influences the dissemination of published articles. Our findings are based on a limited number of articles; therefore, the results of such analysis should be treated with utmost caution.

Controlled clinical trials are lacking, and future studies should examine the safety and efficacy of rapid diagnostic tests for COVID-19 to obtain more consistent results and establish recommendations for their appropriate use.

CONCLUSION

The COVID-19 IgM / IgG rapid diagnostic tests appear to be inaccurate. We found no evidence to support COVID-19 or SARS-CoV-2 antibodies’ rapid testing to screen outpatients for cosmetic plastic surgery. Future studies on the subject are needed to validate different laboratory diagnostic tests.