Subanalysis of paired biliary brushings, biliary biopsies, distal bile duct strictures, primary sclerosing cholangitis (PSC) and repeat testing
| Parameter | Sensitivity, n (95% CI) | Specificity, n (95% CI) | PPV, n (95% CI) | NPV, n (95% CI) | AUC, n (95% CI) |
| Paired biliary brushings (n=132) | |||||
| Pathological evaluation | 35 (0.25 to 0.46) | 98 (0.88 to 1.00) | 97 (0.81 to 1.00) | 46 (0.36 to 0.56) | 0.66 (0.57 to 0.75) |
| BiliSeq testing | 71 (0.60 to 0.81) | 100 (0.91 to 1.00) | 100 (0.93 to 1.00) | 67 (0.54 to 0.77) | 0.86 (0.79 to0.92) |
| Pathological evaluation and BiliSeq testing | 81 (0.71 to 0.88) | 98 (0.88 to 1.00) | 99 (0.91 to 1.00) | 75 (0.62 to 0.84) | 0.89 (0.84 to 0.95) |
| Paired biliary biopsies (n=114) | |||||
| Pathological evaluation | 52 (0.41 to 0.62) | 100 (0.85 to 1.00) | 100 (0.90 to 1.00) | 38 (0.27 to 0.51) | 0.76 (0.68 to 0.85) |
| BiliSeq testing | 75 (0.65 to 0.84) | 100 (0.85 to 1.00) | 100 (0.93 to 1.00) | 55 (0.40 to 0.70) | 0.88 (0.82 to 0.94) |
| Pathological evaluation and BiliSeq testing | 84 (0.74 to 0.91) | 100 (0.84 to 1.00) | 100 (0.94 to 1.00) | 65 (0.48 to 0.79) | 0.92 (0.87 to 0.97) |
| Distal bile duct strictures (n=61) | |||||
| Pathological evaluation of biliary specimens | 59 (0.42 to 0.73) | 95 (0.73 to 1.00) | 96 (0.78 to 1.00) | 53 (0.36 to 0.69) | 0.68 (0.55 to 0.82) |
| EUS-FNA of biliary stricture | 58 (0.42 to 0.73) | 100 (0.80 to 1.00) | 100 (0.83 to 1.00) | 54 (0.37 to 0.70) | 0.79 (0.68 to 0.90) |
| BiliSeq testing | 76 (0.59 to 0.87) | 100 (0.80 to 1.00) | 100 (0.86 to 1.00) | 67 (0.47 to 0.82) | 0.88 (0.79 to 0.96) |
| Pathological evaluation (biliary specimens) and BiliSeq testing | 90 (0.76 to 0.97) | 95 (0.73 to 1.00) | 97 (0.85 to 1.00) | 83 (0.61 to 0.94) | 0.93 (0.85 to 1.00) |
| Pathological evaluation (biliary and EUS-FNA) and BiliSeq testing | 93 (0.79 to 0.98) | 95 (0.73 to 1.00) | 97 (0.85 to 1.00) | 86 (0.64 to 0.96) | 0.94 (0.87 to 1.00) |
| PSC patients (n=37) | |||||
| Elevated CA19-9 (n=37)* | 67 (0.35 to 0.89) | 84 (0.63 to 0.95) | 57 (0.30 to 0.81) | 83 (0.61 to 0.94) | 0.71 (0.53 to 0.90) |
| Pathological evaluation of biliary brushings/biopsies | 8 (0.01 to 0.40) | 100 (0.83 to 1.00) | 100 (0.06 to 1.00) | 69 (0.52 to 0.83) | 0.54 (0.34–0.75) |
| BiliSeq testing | 83 (0.51 to 0.98) | 100 (0.83 to 1.00) | 100 (0.66 to 1.00) | 93 (0.74 to 0.99) | 0.92 (0.79–1.00) |
| Elevated CA19-9* and BiliSeq testing | 92 (0.60 to 1.00) | 84 (0.63 to 0.95) | 65 (0.39 to 0.85) | 95 (0.73 to 1.00) | 0.84 (0.70–0.98) |
| Pathological evaluation and BiliSeq testing | 83 (0.51 to 0.98) | 100 (0.83 to 1.00) | 100 (0.66 to 1.00) | 93 (0.74 to 0.99) | 0.92 (0.79 to 1.00) |
| Elevated CA19-9*, pathological evaluation and BiliSeq testing | 92 (0.60 to 1.00) | 84 (0.63 to 0.95) | 65 (0.39 to 0.85) | 95 (0.73 to 1.00) | 0.84 (0.70 to 0.98) |
| Repeat ERCP and biomarker testing (n=220) | |||||
| Pathological evaluation of biliary brushings/biopsies | 51 (0.43 to 0.60) | 99 (0.91 to 1.00) | 99 (0.92 to 1.00) | 49 (0.40 to 0.57) | 0.75 (0.69 to 0.81) |
| BiliSeq testing | 75 (0.68 to 0.82) | 100 (0.94 to 1.00) | 100 (0.96 to 1.00) | 65 (0.56 to 0.74) | 0.88 (0.83 to 0.92) |
| Pathological evaluation and BiliSeq testing | 87 (0.80 to 0.92) | 99 (0.91 to 1.00) | 99 (0.95 to 1.00) | 78 (0.67 to 0.85) | 0.93 (0.89 to 0.96) |
*On the basis of cases where serum CA19-9 was performed concurrently where elevated CA19-9 was defined as >129 U/mL.
AUC, area under the curve; CA19-9, carbohydrate antigen 19–9; ERCP, endoscopic retrograde cholangiopancreatography; EUS-FNA, endoscopic ultrasound-fine needle aspiration; NPV, negative predictive value; PPV, positive predictive value; PSC, primary sclerosing cholangitis.