AGA Institute Rapid Review and Recommendations on the Role of Pre-Procedure SARS-CoV-2 Testing and Endoscopy

Abstract

The genome of the severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2), the cause of coronavirus disease 2019 (COVID-19), was first identified on January 12, 2020. This was a critical first step that allowed for the development of molecular diagnostic tests to identify the presence of virus.1Lu R. Zhao X. Li J. et al.Genomic characterisation and epidemiology of 2019 novel coronavirus: implications for virus origins and receptor binding.Lancet. 2020; 395: 565-574Abstract Full Text Full Text PDF PubMed Scopus (7149) Google Scholar, 2Wenjie T. Xiang Z. Xuejun M. et al.A novel coronavirus genome identified in a cluster of pneumonia cases—Wuhan, China 2019−2020.China CDC Weekly. 2020; 2: 61-62Crossref Scopus (418) Google Scholar, 3Zhu N. Zhang D. Wang W. et al.A novel coronavirus from patients with pneumonia in China, 2019.N Engl J Med. 2020; 382: 727-733Crossref PubMed Scopus (16050) Google Scholar At the individual patient level, testing for SARS-CoV-2 infection in symptomatic patients helps to identify individuals who can be isolated to prevent the spread of disease and can inform treatment decisions aimed at reducing morbidity and mortality.4Hanson KE, Caliendo AM, Arias CA, et al. Infectious Diseases Society of America Guidelines on the diagnosis of COVID-19 [published online ahead of print June 20, 2020]. Clin Infect Dis https://doi.org/10.1093/cid/ciaa760.Google Scholar At the population level, widespread testing of individuals (symptomatic and asymptomatic) is critical to understanding the true prevalence of disease. This information can then inform local decisions regarding the economy and the provision of health care services, including the re-introduction of endoscopy across health care systems and ambulatory care centers.5Corral J.E. Hoogenboom S.A. Kroner P.T. et al.COVID-19 polymerase chain reaction testing before endoscopy: an economic analysis.Gastrointest Endosc. 2020; 92: 524-534.e6Abstract Full Text Full Text PDF PubMed Scopus (47) Google Scholar Tests fall under 2 broad categories: tests that detect virus and tests that detect the presence of antibodies associated with the virus (serology tests). Direct detection of viral RNA is most commonly performed via nucleic acid amplification testing of specific known targets in the genome of the virus using reverse transcription polymerase chain reaction (RT-PCR).6Centers for Disease Control and PreventionCDC’s diagnostic test for COVID-19 only and supplies.https://www.cdc.gov/coronavirus/2019-ncov/lab/virus-requests.htmlDate accessed: July 8, 2020Google Scholar The most common sample types (or sources) are swabs that are taken from the nasopharynx and/or oropharynx, lower respiratory tract, or saliva by a trained health care worker or self-collection. It is important to recognize that the quality of sample collection, as well as the source, influence test results. Development of an antibody response to SARS-CoV-2 infection through the identification of antibodies indicates recent or past infection. The predictive value of a test refers to the probability of having a condition or disease in an individual with a positive test result (positive predictive value) and the probability of not having a condition or disease in an individual with a negative test result (negative predictive value). A pretesting strategy in asymptomatic individuals before endoscopy can be informative in distinguishing people with SARS-CoV-2 infection and those without SARS-CoV-2 infection, but it is affected by the prevalence of the disease in asymptomatic individuals. This rapid review and rapid guideline address the role of implementing a SARS-CoV-2 pretesting strategy before endoscopy. An earlier American Gastroenterological Association (AGA) guideline examined the role of personal protective equipment (PPE) (including extended use and reuse of N95/N99 respirators or powered air purifying respirators [PAPRs] in resource-constrained settings) when testing was not readily available; the aim of this guideline was to determine the role of testing in endoscopy center reopening.7Sultan S. Lim J.K. Altayar O. et al.AGA Institute rapid recommendations for gastrointestinal procedures during the COVID-19 pandemic.Gastroenterology. 2020; 159: 739-758.e4Abstract Full Text Full Text PDF PubMed Scopus (210) Google Scholar To inform the recommendations, a systematic review of the diagnostic performance of currently available tests for SARS-CoV-2 infection was conducted. A survey was conducted to gather information about the threshold of risk that endoscopists were willing to accept during endoscopy and an overview of strategies to estimate prevalence of infection among asymptomatic individuals is provided. Finally, the panel drafted recommendations for the role of a pretesting strategy for low-, intermediate-, and high-prevalence settings and a recommendation for serology testing (Table 1).Table 1Executive Summary of RecommendationsaThese recommendations assume that all patients are systematically screened for COVID-19 symptoms using the CDC screening checklist and are required to wear masks while in the endoscopy unit. The strength of a recommendation is expressed as strong or conditional and has the following interpretation: strong recommendation—for clinicians: most individuals should follow the recommended course of action, and only a small proportion should not; conditional recommendation—for clinicians: the majority of individuals in this situation would want the suggested course of action but many would not; different choices will be appropriate.What is the role of a pretesting strategy in asymptomatic individuals 48–72 h before endoscopy (including a self-quarantine between testing and endoscopy)? Benefits: Triage and PPE use to reduce the risk of infection. Downsides: Patient burden, limited testing capacity, testing logistics, and cost.RecommendationRemarksRecommendation 1For most endoscopy centers where the prevalence of asymptomatic SARS-CoV-2 infection is intermediate (0.5%–2%), the AGA suggests implementing a pretesting strategy using information about prevalence and test performance (sensitivity/specificity) in combination with considerations about the benefits and downsides of the strategy.Conditional recommendation, low certainty evidenceIn settings where testing is feasible and there is less perceived burden on patients, and when the benefits outweigh the downsides (eg, false positives do not significantly outnumber the true positives), an endoscopy center may reasonably choose to implement a pretesting strategy. Among individuals that test negative, endoscopists and staff should use surgical masksbAppropriate PPE includes a face shield over the surgical mask and face shield over the N95/N99 respirator (to allow for reuse/extended use in limited PPE availability settings).7 for all upper and lower endoscopies. Endoscopists and staff who are unwilling to accept the potential small risk of infection (from false negatives) may use N95/N99bAppropriate PPE includes a face shield over the surgical mask and face shield over the N95/N99 respirator (to allow for reuse/extended use in limited PPE availability settings).7 respirators or PAPRs for upper and/or lower endoscopies.In settings where the logistics of testing are challenging and the downsides outweigh the benefits (eg, the false positives outnumber the true positives) and endoscopy units are unwilling to accept the potential (albeit small) risk of infection then an endoscopy center may reasonably choose not to implement a pretesting strategy and proceed with using higher PPE (N95/N99 respirators or PAPRs) for all procedures.Recommendation 2For endoscopy centers where the prevalence of asymptomatic SARS-CoV-2 infection is low (<0.5%), the AGA suggests against implementing a pretesting strategy.Conditional recommendation, very low certainty evidenceIn low-prevalence settings, a pretesting strategy may not be informative for triage due to the high number of false positives, thus PPE availability may drive decision-making. If PPE is available, the majority of gastroenterologists may reasonably select to use N95/N99bAppropriate PPE includes a face shield over the surgical mask and face shield over the N95/N99 respirator (to allow for reuse/extended use in limited PPE availability settings).7 respirator or PAPRs. However, a small minority, with a low risk-aversion threshold, may reasonably choose to use surgical masks.bAppropriate PPE includes a face shield over the surgical mask and face shield over the N95/N99 respirator (to allow for reuse/extended use in limited PPE availability settings).7Recommendation 3For a small number of endoscopy centers in high-prevalence areas, the AGA suggests against implementing a pretesting strategy. In “hotspots,” endoscopy may be reserved for emergency or time-sensitive procedures with use of N95/N99bAppropriate PPE includes a face shield over the surgical mask and face shield over the N95/N99 respirator (to allow for reuse/extended use in limited PPE availability settings).7 respirators or PAPRs for all procedures.Conditional recommendation, very low certainty evidenceIn high-prevalence areas, a pretesting strategy may not be informative for decisions about PPE use because of the unacceptable number of false negatives and PPE availability may drive decision-making.If PPE is available, N95/N99bAppropriate PPE includes a face shield over the surgical mask and face shield over the N95/N99 respirator (to allow for reuse/extended use in limited PPE availability settings).7 respirators or PAPRs may be used for all upper and lower endoscopies, regardless of time sensitivity.A hotspot is defined by a surge in COVID-19 cases with an acute burden on hospital capacity. In hotspots, resumption of outpatient endoscopy may depend on availability of PPE.Recommendation 4For all endoscopy centers, the AGA recommends against serologic testing as part of a pretesting strategy for patients or endoscopy staff.Strong recommendation, low certainty evidenceSerology testing for the presence of antibodies indicates past infection and has no role in diagnosing SARS-CoV-2 infection in asymptomatic individuals before endoscopy.The evidence supporting the role of seroconversion for return to work or hospital staffing policies is also lacking.a These recommendations assume that all patients are systematically screened for COVID-19 symptoms using the CDC screening checklist and are required to wear masks while in the endoscopy unit. The strength of a recommendation is expressed as strong or conditional and has the following interpretation: strong recommendation—for clinicians: most individuals should follow the recommended course of action, and only a small proportion should not; conditional recommendation—for clinicians: the majority of individuals in this situation would want the suggested course of action but many would not; different choices will be appropriate.b Appropriate PPE includes a face shield over the surgical mask and face shield over the N95/N99 respirator (to allow for reuse/extended use in limited PPE availability settings).7Sultan S. Lim J.K. Altayar O. et al.AGA Institute rapid recommendations for gastrointestinal procedures during the COVID-19 pandemic.Gastroenterology. 2020; 159: 739-758.e4Abstract Full Text Full Text PDF PubMed Scopus (210) Google Scholar Open table in a new tab We sought to provide an overview of the considerations of diagnostic testing in the decision to reopen or expand endoscopy operations in the setting of a pandemic. We summarized the available data on the diagnostic test characteristics of tests for SARS-CoV-2 infection and provided evidence-based clinical guidance on the role of pretesting before endoscopic procedures. This rapid review and guideline was commissioned and approved by the AGA Governing Board to provide timely, methodologically rigorous guidance on a topic of high clinical importance to the AGA members and the public. The guideline panel included gastroenterologists, an infectious disease expert, a member of the Practice Management and Economics Committee, and guideline methodologists from the Clinical Guideline Committee and Clinical Practice Updates Committee. Panel members disclosed all potential conflicts of interest according to the AGA Institute policy. All members were required to disclose financial, intellectual, or other potential conflicts. The target audience for these guidelines includes gastroenterologists, advanced practice providers, nurses, and other health care professionals in academic centers and in private practice settings across various geographic locations. Patients as well as policy-makers can also benefit from these guidelines. These guidelines are not intended to impose a standard of care for individual institutions, health care systems, or countries. They provide the basis for rational informed decision-making for clinicians, patients, and other health care professionals in the setting of a pandemic. This rapid guideline is intended to help clinicians make decisions about pre-procedural testing before endoscopy; however, decisions may be constrained by local health system or state-level policies, as well as availability of resources, specifically RT-PCR tests and PPE. Recommendations are accompanied by qualifying remarks, which serve to facilitate more accurate implementation. They should never be omitted when recommendations from these guidelines are quoted or translated. A summary of the recommendations is provided in Table 1, with a more detailed rationale for each recommendation in the Discussion section. The Implementation Considerations section in this guideline will help clinicians implement these recommendations. This section includes a checklist for endoscopy center reopening, instructions for an online interactive tool, and a matrix to facilitate pretesting strategy considerations in low- and high-prevalence areas accounting for testing and PPE availability. The evidence base to support this recommendation included the following: a systematic review and meta-analysis of diagnostic test performance (sensitivity and specificity) of currently available tests in the United States; a survey of gastroenterologists to understand the acceptable threshold of risk; and available data on prevalence of infection among asymptomatic individuals. Recommendations were developed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) framework.8Sultan S. Falck-Ytter Y. Inadomi J.M. The AGA Institute process for developing clinical practice guidelines part one: grading the evidence.Clin Gastroenterol Hepatol. 2013; 11: 329-332Abstract Full Text Full Text PDF PubMed Scopus (62) Google Scholar We conducted a systematic literature search to identify all published and unpublished studies that could be considered eligible for our review, with no restrictions on languages. To capture relevant published articles, we electronically searched OVID Medline and EmBase from inception to May 16, 2020 using the Medical Subject Heading term developed for COVID-19. For additional unpublished or preprint studies, we searched medRxiv, LitCovid, Biorxiv, and SSRN on May 16, 2020 and May 17, 2020 (a Preferred Reporting Items for Systematic Reviews and Meta-Analyses Flow Diagram is provided in Supplementary Figure 1). Two reviewers were assigned to each database (S.M.S. and P.D. to SSRN; O.A. and J.F. to Medrxiv and Biorxiv; and S.S. and R.M. to LitCovid) and independently screened titles and abstracts, as well as eligible full-text studies. Disagreements were resolved by discussion to reach consensus. Studies were included if they reported data on diagnostic test accuracy (cohort studies, cross-sectional studies, and case-control studies). All studies compared an index test with a reference standard test. Reviewers extracted relevant information into a standardized data extraction form (Supplementary Table 1). Data extracted included study characteristics (authors, publication year, country, and study design), index test and reference standard, and sensitivity and specificity of the index test. In addition, studies that reported on prevalence of SARS-CoV-2 infection were also identified and reviewed. Risk of bias for studies on diagnostic test accuracy was assessed using the Quality Assessment of Diagnostic Accuracy Studies-2 revised tool.9Whiting P.F. Rutjes A.W. Westwood M.E. et al.QUADAS-2: a revised tool for the quality assessment of diagnostic accuracy studies.Ann Intern Med. 2011; 155: 529-536Crossref PubMed Scopus (7497) Google Scholar This tool assesses the risk of bias in the following domains: patient selection, index test, reference standard, and flow and timing of study. Studies were categorized as being higher quality if they had a cross-sectional or cohort design as opposed to case-control design; included a reference standard that is not a laboratory-developed test; and if there were 2 reference standards or at least 1 reference standard with a second test for discordant results. We used the bivariate normal model to pool sensitivity and specificity using the logit transformation.10Reitsma J.B. Glas A.S. Rutjes A.W. et al.Bivariate analysis of sensitivity and specificity produces informative summary measures in diagnostic reviews.J Clin Epidemiol. 2005; 58: 982-990Abstract Full Text Full Text PDF PubMed Scopus (2226) Google Scholar We performed sensitivity analyses by limiting the analysis to studies at low risk of bias based on the patient selection and reference test domains of the Quality Assessment of Diagnostic Accuracy Studies-2 tool. We used the package mada, version 0.5.8, in R software, version 3.6.3, to conduct the analysis and produce the forest plots.11Doebler P. mada: Meta-Analysis of Diagnostic Accuracy.2020Google Scholar,12R Core TeamR: A Language and Environment for Statistical Computing. R Foundation for Statistical Computing, Vienna, Austria2018Google Scholar The GRADE framework was used to assess overall certainty by evaluating the evidence for each outcome on the following domains: risk of bias, imprecision, inconsistency, indirectness, and publication bias.13Schunemann H.J. Mustafa R.A. Brozek J. et al.GRADE guidelines: 21 part 1. Study design, risk of bias, and indirectness in rating the certainty across a body of evidence for test accuracy.J Clin Epidemiol. 2020; 122: 129-141Abstract Full Text Full Text PDF PubMed Scopus (104) Google Scholar,14Schunemann H.J. Mustafa R.A. Brozek J. et al.GRADE guidelines: 21 part 2. Test accuracy: inconsistency, imprecision, publication bias, and other domains for rating the certainty of evidence and presenting it in evidence profiles and summary of findings tables.J Clin Epidemiol. 2020; 122: 142-152Abstract Full Text Full Text PDF PubMed Scopus (105) Google Scholar The GRADE interactive summary of findings table was generated using the GRADEpro Guideline Development Tool.15GRADEpro GDT: GRADEpro Guideline Development Tool [software]McMaster University, 2015 (developed by Evidence Prime, Inc.).gradepro.orgGoogle Scholar In developing recommendations, the panel considered the certainty of evidence, the balance between the desirable and undesirable effects (ie, the benefits and downsides of a pretesting strategy), and additional domains were acknowledged where applicable (eg, feasibility, resource use, and acceptability). For all recommendations, the expert panelists reached consensus. As per GRADE methodology, recommendations are labeled as “strong” or “conditional” (Supplementary Tables 2 and 3). The phrase we recommend indicates strong recommendations and we suggest indicates conditional recommendations. Guideline panels often conduct internal surveys among panel members to determine values and preferences of providers. In order to gain a better understanding of a broader population of endoscopists, the panel developed a survey open to all AGA members. The goal was to understand the endoscopists’ threshold to accept risks associated with pretesting to inform PPE use (surgical mask vs N95/N99 or PAPR). We developed a short online survey that was piloted and modified before dissemination. Earlier data have shown that endoscopy centers in North America are adopting pretesting strategies.16Kushnir V.M. Berzin T.M. Elmunzer B.J. et al.Plans to reactivate gastroenterology practices following the COVID-19 pandemic: a survey of North American centers.Clin Gastroenterol Hepatol. 2020; 18: 2287-2294.e1Abstract Full Text Full Text PDF PubMed Scopus (18) Google Scholar The purpose of our survey was to better understand risk-aversion thresholds based on false-negative results, which drive decision-making for triage and PPE. A false-negative result can provide false reassurance to an individual who has SARS-CoV-2 infection, could be shedding virus, and may transmit the infection to others. The survey presented a clinical scenario of an asymptomatic patient undergoing elective endoscopy who tested negative for SARS-CoV-2 72 hours before the endoscopy. Respondents were given 5 options for acceptable levels of risk of transmission of SARS-CoV-2. The first option was 1 in 1000, with a comment stating that selecting this option would indicate willingness to open the endoscopy center using a surgical mask only. The last option was 1 in 40,000, with a comment stating that selecting that option would indicate willingness to open the endoscopy center only once N95s are available, despite a negative test result. The range of options were based on the following assumptions: local prevalence of 1% (intermediate), baseline risk of SARS-CoV-2 transmission without PPE of 50%, and reduction of risk of COVID-19 transmission with PPE to 20% with surgical mask and 5% with N95 respirators. We collected responses from US-based gastroenterologists using the “AGA Community” platform. The “AGA Community” is a nonpublic community for members of the AGA through which gastroenterologists connect with colleagues and have conversations about relevant issues in their field. A pretesting strategy in asymptomatic individuals before endoscopy can be informative in distinguishing people with SARS-CoV-2 infection and those without, but it is affected by the prevalence of the disease in asymptomatic individuals. To identify sources of data that provide information about the prevalence of infection in asymptomatic individuals, we searched the published and unpublished literature and also reviewed public health websites. We also queried panel members regarding data from their local institutions. We identified 12 studies that provided information for 31 comparisons about test accuracy for the various nucleic acid amplification testing tests.17Craney A.R. Velu P. Satlin M.J. et al.Comparison of two high-throughput reverse transcription-polymerase chain reaction systems for the detection of severe acute respiratory syndrome coronavirus 2.J Clin Microbiol. 2020; 58 (e00890-20)Crossref Scopus (41) Google Scholar, 18Loeffelholz M.J. Alland D. 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Richards M. et al.Comparing the analytical performance of three SARS-CoV-2 molecular diagnostic assays.J Clin Virol. 2020; 127: 104384Crossref PubMed Scopus (84) Google Scholar, 27Zhen W. Smith E. Manji R. et al.Clinical evaluation of three sample-to-answer platforms for the detection of SARS-CoV-2.J Clin Microbiol. 2020; 58 (e01187-20)Crossref Scopus (164) Google Scholar, 28Smith E. Zhen W. Manji R. et al.Analytical and clinical comparison of three nucleic acid amplification tests for SARS-CoV-2 detection.J Clin Microbiol. 2020; 58 (e01134-20)Crossref Scopus (43) Google Scholar The risk of bias was rated using the Quality Assessment of Diagnostic Accuracy Studies-2 (Supplementary Table 4). The pooled sensitivity was 0.941 (95% confidence interval [CI], 0.908–0.963) and pooled specificity was 0.971 (95% CI, 0.958–0.980) (Figure 1). We performed a sensitivity analysis for studies with low risk of bias and found similar results: pooled sensitivity of 0.929 (95% CI, 0.847–0.968) and pooled specificity of 0.968 (95% CI, 0.942–0.983) (Supplementary Figure 2). An important caveat of these studies is that tests were validated in samples from symptomatic individuals, and it is likely that in asymptomatic individuals the tests may not perform as well and would have lower sensitivity and specificity. We received 74 responses to the survey (Table 2). There was a wide distribution of answer selections: 37.8% (28 of 74) selected willingness to accept a risk of 1 in 40,000, indicating that they would not be willing to open their endoscopy center unless N95s are available for all cases, including those with a negative SARS-CoV-2 test. On the other hand, 19 of 74 (25.7%) selected 1 in 1000, indicating that they were willing to open their endoscopy units and use surgical masks regardless of testing. The remainder of the participants (27 of 74 [36.5%]) were willing to accept risks between 1 in 2500 and 1 in 10,000. Survey respondents included gastroenterologists practicing in academic institutions (23 of 74 [31.1%]), in nonacademic hospitals (15 of 74 [20.3%]), in independent practice (34 of 74 [45.9%]), and in other institutions (2 of 74 [2.8%]). Gastroenterologists performing procedures in private practice ambulatory centers were willing to accept higher infection risk compared with gastroenterologists in academic centers and nonacademic hospitals. Of 19 participants choosing the 1 in 1000 risk, 12 (63.2%) were in private practice.Table 2Survey Respondent Characteristics by Risk-Aversion ThresholdCharacteristicAll respondentsCharacteristics by response selection1 in 10001 in 25001 in 50001 in 10,0001 in 40,000Total, n74191010728Sex, male, n (%)51 (68.9)12 (63.2)9 (90.0)10 (100.0)5 (71.4)15 (53.6)Settings, n (%) Academic medical center23 (31.1)4 (21.1)5 (50.0)1 (10.0)4 (57.1)9 (32.1) Independent practice34 (45.9)12 (63.2)3 (30.0)4 (40.0)3 (42.9)12 (42.9) Nonacademic hospital15 (20.3)2 (10.5)1 (10.0)5 (50.0)0 (0.0)7 (25.0) Other1 (1.4)0 (0.0)1 (10.0)0 (0.0)0 (0.0)0 (0.0) Veterans Affairs hospital1 (1.4)1 (5.3)0 (0.0)0 (0.0)0 (0.0)0 (0.0)Group size, median (IQR)7.0 (4.0–20.0)9.0 (5.0–24.0)8.5 (4.5–18.8)4.0 (4.0–8.3)8.0 (5.5–37.0)8.0 (4.0–14.5)Clinical experience Procedures per year, median (IQR)500 (300–1000)493 (213–1075)400 (263–1000)800 (325–950)450 (325–500)500 (300–1000) Years of practice, median (IQR)20 (12–30)22.5 (15.5–30)17.5 (6.5–25.5)31 (30–33.5)20 (9–25)17.5 (11.3–27.5) Open table in a new tab For diagnostic tests to inform decision-making, it is essential to determine the pretest probability (eg, prevalence) of disease in asymptomatic individuals. We searched for studies that evaluated the prevalence of SARS-CoV-2 among asymptomatic individuals, but only identified studies reporting on seroprevalence, which were noninformative. Public websites reporting on numbers of positive cases (predominantly in symptomatic patients) and deaths were reviewed but, due to limitations of nonrandom testing; variability in availability of testing; and delays in reporting, these estimates cannot directly inform prevalence estimates in asymptomatic individuals. Acknowledging the limited publicly available evidence for accurate estimates of prevalence of SARS-CoV-2 infection in asymptomatic individuals, we relied on information from panel members’ experiences within their health systems (based on rates of positive cases in asymptomatic individuals undergoing testing before any elective procedure) and modeling studies trying to estimate prevalence of SARS-CoV-2 infection in the general population. We defined low-prevalence areas as areas where the prevalence of asymptomatic infection is <0.5%, intermediate prevalence areas as areas where the prevalence is between 0.5 and 2%, and high prevalence as areas where the prevalence is >2%. We defined hotspots as areas where there is a sudden surge in the number of daily cases with an acute burden on hospital capacity. The prevalence of exclusively