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Additional file 1.

Additional file1: Table S1. Characteristics of the included studies (detailed). Table S2. Baseline characteristics of participants with CD. Table S3. Baseline characteristics of participants with UC. Figure S1. Forest plots showing the proportion of patients with Crohn’s disease achieving a CDAI-70 response during the induction phase with infliximab (upper plot) or vedolizumab (lower plot). Figure S2. Forest plots showing the proportion of with Crohn’s disease achieving a CDAI-100 response during the induction phase with infliximab (upper plot) or vedolizumab (lower plot). Figure S3. Forest plots showing the proportion of patients with Crohn’s disease achieving a CDAI-70 response during the maintenance phase with infliximab. Figure S4. Forest plots showing the proportion of patients with Crohn’s disease achieving a CDAI-100 response during the maintenance phase with infliximab (upper plot) or vedolizumab (lower plot). Figure S5. Forest plots showing the proportion of patients with Crohn’s disease experiencing any adverse event with infliximab (upper plot) or vedolizumab (lower plot). Figure S6. Forest plots showing the proportion of patients with Crohn’s disease experiencing any serious adverse event with infliximab (upper plot) or vedolizumab (lower plot). Figure S7. Forest plots showing the proportion of patients with Crohn’s disease experiencing any infection with infliximab (upper plot) or vedolizumab (lower plot). Figure S8. Forest plots showing the proportion of patients with Crohn’s disease experiencing any serious infection with infliximab (upper plot) or vedolizumab (lower plot). Figure S9. Forest plots showing the proportion of patients with Crohn’s disease who discontinued due to adverse events in the infliximab (upper plot) or vedolizumab (lower plot) treatment arms. Figure S10. Forest plots showing the proportion of patients with Crohn’s disease who discontinued due to lack of efficacy in the infliximab treatment arm. Figure S11. Forest plots showing the proportion of patients with ulcerative colitis achieving a clinical response during the induction phase with infliximab (upper plot) or vedolizumab (lower plot). Figure S12. Forest plot showing the proportion of patients with ulcerative colitis achieving mucosal healing during the induction phase with infliximab. Figure S13. Forest plots showing the proportion of patients with ulcerative colitis achieving a clinical response during the maintenance phase with infliximab (upper plot) or vedolizumab (lower plot). Figure S14. Forest plots showing the proportion of patients with ulcerative colitis achieving mucosal healing during the maintenance phase with infliximab (upper plot) or vedolizumab (lower plot). Figure S15. Forest plots showing the proportion of patients with ulcerative colitis experiencing any adverse event with infliximab (upper plot) or vedolizumab (lower plot). Figure S16. Forest plots showing the proportion of patients with ulcerative colitis experiencing any serious adverse event with infliximab (upper plot) or vedolizumab (lower plot). Figure S17. Forest plots showing the proportion of patients with ulcerative colitis experiencing any infection with infliximab (upper plot) or vedolizumab (lower plot). Figure S18. Forest plots showing the proportion of patients with ulcerative colitis experiencing any serious infection with infliximab (upper plot) or vedolizumab (lower plot). Figure S19. Forest plots showing the proportion of patients with ulcerative colitis who discontinued due to adverse events with infliximab (upper plot) or vedolizumab (lower plot). Figure S20. Forest plots showing the proportion of patients with ulcerative colitis who discontinued due to lack of efficacy with vedolizumab.

Background Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic control will require widespread access to accurate diagnostics. Salivary sampling circumvents swab supply chain bottlenecks, is amenable to self-collection, and is less likely to create an aerosol during collection compared with the nasopharyngeal swab. Methods We compared real-time reverse-transcription polymerase chain reaction Abbott m2000 results from matched salivary oral fluid (gingival crevicular fluid collected in an Oracol device) and nasal-oropharyngeal (OP) self-collected specimens in viral transport media from a nonhospitalized, ambulatory cohort of coronavirus disease 2019 (COVID-19) patients at multiple time points. These 2 sentences should be at the beginning of the results. Results There were 171 matched specimen pairs. Compared with nasal-OP swabs, 41.6% of the oral fluid samples were positive. Adding spit to the oral fluid percent collection device increased the percent positive agreement from 37.2% (16 of 43) to 44.6% (29 of 65). The positive percent agreement was highest in the first 5 days after symptoms and decreased thereafter. All of the infectious nasal-OP samples (culture positive on VeroE6 TMPRSS2 cells) had a matched SARS-CoV-2 positive oral fluid sample. Conclusions In this study of nonhospitalized SARS-CoV-2-infected persons, we demonstrate lower diagnostic sensitivity of self-collected oral fluid compared with nasal-OP specimens, a difference that was especially prominent more than 5 days from symptom onset. These data do not justify the routine use of oral fluid collection for diagnosis of SARS-CoV-2 despite the greater ease of collection. It also underscores the importance of considering the method of saliva specimen collection and the time from symptom onset especially in outpatient populations.