Infectious Diseases Society of America Guidelines on the Diagnosis of Coronavirus Disease 2019 (COVID-19): Serologic Testing

Abstract

Background The availability of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) serologic testing has rapidly increased. Current assays use a variety of technologies, measure different classes of immunoglobulin or immunoglobulin combinations and detect antibodies directed against different portions of the virus. The overall accuracy of these tests, however, has not been well-defined. The Infectious Diseases Society of America (IDSA) convened an expert panel to perform a systematic review of the coronavirus disease 2019 (COVID-19) serology literature and construct best practice guidance related to SARS-CoV-2 serologic testing. This guideline is the fourth in a series of rapid, frequently updated COVID-19 guidelines developed by IDSA. Objective IDSA’s goal was to develop evidence-based recommendations that assist clinicians, clinical laboratories, patients and policymakers in decisions related to the optimal use of SARS-CoV-2 serologic tests in a variety of settings. We also highlight important unmet research needs pertaining to the use of anti-SARS-CoV-2 antibody tests for diagnosis, public health surveillance, vaccine development and the selection of convalescent plasma donors. Methods A multidisciplinary panel of infectious diseases clinicians, clinical microbiologists and experts in systematic literature review identified and prioritized clinical questions related to the use of SARS-CoV-2 serologic tests. Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology was used to assess the certainty of evidence and make testing recommendations. Results The panel agreed on eight diagnostic recommendations. Conclusions Information on the clinical performance and utility of SARS-CoV-2 serologic tests are rapidly emerging. Based on available evidence, detection of anti-SARS-CoV-2 antibodies may be useful for confirming the presence of current or past infection in selected situations. The panel identified three potential indications for serologic testing including: 1) evaluation of patients with a high clinical suspicion for COVID-19 when molecular diagnostic testing is negative and at least two weeks have passed since symptom onset; 2) assessment of multisystem inflammatory syndrome in children; and 3) for conducting serosurveillance studies. The certainty of available evidence supporting the use of serology for either diagnosis or epidemiology was, however, graded as very low to moderate.

Recommendations for SARS-CoV-2/COVID-19 testing: a scoping review of current guidance

“…71 78 In addition, two documents do not recommend the use of imaging (unclear which test) for the assessment of asymptomatic individuals. 43 63 We identified three areas of agreement among developers, supported by two documents with Domain 3/AGREE II tool score ≥50%, 44 63 regarding the role of RT-PCR assays and antigen-based tests (in favour) and chest imaging (against) in this setting ( table 2 ).…”

“… 37 44 58 One document developed by a scientific society recommends against the use of RT-PCR in asymptomatic patients with a low probability of being infected. 44 Two documents recently published by global health agencies suggest the use of COVID-19 rapid antigen tests in cases of known exposure, even if individuals are asymptomatic. 71 78 In addition, two documents do not recommend the use of imaging (unclear which test) for the assessment of asymptomatic individuals.…”

Occupational hazards in anaesthesiology during the COVID-19 pandemic

“…However, this is a conditional recommendation with very low certainty of evidence. Among the upper respiratory tract samples, nasopharyngeal and mid-turbinate swabs are indicated, as characterised by the highest sensitivity: 97% (95% cI: 92-100%) and 100% (95% cI: 93-100%), respectively [23].…”

Diagnosis of SARS-CoV-2 infection in the setting of the cytokine release syndrome

“…As a general rule, deeper specimens yield greater sensitivity. Nucleic acid testing on nasopharyngeal specimens is overall more sensitive than for other URT specimens with midturbinate, anterior nasal and oropharyngeal specimens being incrementally less sensitive [77]. The data are mixed, however with some studies showing mid-turbinate swab specimens to be equally sensitive to nasopharyngeal specimens [78].…”