Table 2.
Diagnosis values of GPC1-positive exosomes, CTC detection by CellSearch®, and CTC quantification by RosetteSepTM, CA 19-9, and EUS-FNA.
| Test | Sensitivity (95% CI) | Specificity (95% CI) | Positive Predictive Value (95% CI) | Negative Predictive Value (95% CI) | Diagnosis Accuracy (95% CI) | |
|---|---|---|---|---|---|---|
| Conventional tools | ||||||
| CA19-9 | 37 (19–59) | 87 (72–95) | 63 (36–85) | 69 (54–82) | 68 (61–74) | |
| EUS FNA (n = 18; PDAC n = 15; IPMN n = 3) | 60 (36–81) | 100 (31–99) | 100 (60–99) | 33 (13–65) | 66 (59–73) | |
| Single biomarker based diagnosis method in liquid biopsy | ||||||
| CTCs | CellSearch® peripheral and/or portal vein (n = 30) | 32 (15–49) | 100 | 100 | 35 (18–52) | 50 (32–68) |
| RosetteSepTM portal vein (n = 30) | 46 (28–64) | 75 (59–90) | 84 (71–97) | 34 (17–51) | 54 (36–72) | |
| RosetteSepTM peripheral vein (n = 42) | 50 (35–65) | 90 (81–99) | 85 (74–96) | 63 (48–78) | 70 (56–84) | |
| RosetteSepTM peripheral and/or portal vein (n = 52) | 59 (46–72) | 87 (78–96) | 77 (66–88) | 75 (63–87) | 75 (63–87) | |
| EVs | EVs GPC1 portal vein | 46 (27–66) | 88 (53–99) | 91 (63–99) | 36 (20–59) | 57 (50–64) |
| EVs GPC1 peripheral vein | 50 (31–70) | 90 (77–99) | 79 (58–98) | 70 (54–82) | 72 (65–78) | |
| EVs GPC1 peripheral and/or portal vein | 64 (43–81) | 90 (73–97) | 83 (59–94) | 76 (59–88) | 78 (72–83) | |
| Combined diagnosis methods | ||||||
| CA19-9 and EUS-FNA | 50 (31–70) | 92 (78–99) | 86 (58–98) | 70 (55–83) | 74 (67–80) | |
| * CTC RosetteSepTM + EVs GPC1 | 96 (90–100) | 70 (55–83) | 70 (55–83) | 96 (90–100) | 81 (70–93) | |
| * CTC RosetteSepTM + CA19-9 + * EVs GPC1 | 96 (90–100) | 68 (54–83) | 68 (54–83) | 96 (90–100) | 79 (67–92) | |
| * CTC RosetteSepTM + * EVs GPC1 + EUS FNA | 96 (90–100) | 70 (55–83) | 70 (55–83) | 96 (90–100) | 81 (70–93) | |
| * CTC RosetteSepTM + CA19-9 + * EVs GPC1 + EUS FNA | 96 (90–100) | 68 (54–83) | 68 (54–83) | 96 (90–100) | 79 (67–92) | |
| * CTC CellSearch® + * CTC RosetteSepTM + * EVs GPC1 | 100 | 80 (68–93) | 85 (75–96) | 100 | 91 (83–99) | |
Abbreviations: CI, Confidence interval; CTC, circulating tumor cell; EVs, extracellular vescicles; PDAC, pancreatic ductal adenocarcinoma; IPMN, intraductal papillary and mucinous neoplasm; EUS-FNA endoscopic ultrasound-guided fine needle aspiration. * EVs GPC1, * RosetteSep, and * EVs GPC1, quantification in peripheral and portal vein.