Summary of findings'. 'Serum amylase and lipase and urinary trypsinogen and amylase for diagnosis of acute pancreatitis.
Population | People with abdominal pain seen in emergency care | ||||||||||
Setting | Secondary care in various countries | ||||||||||
Target condition | Acute pancreatitis | ||||||||||
Reference standard |
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Pre‐test probability (prevalence of acute pancreatitis) | 22.6% | ||||||||||
Index test | Sensitivity | Specificity | Post‐test probability of a positive test1 | Post‐test probability of a negative test1 | Number of false positives per 100 people having a positive test | Number of false negatives per 100 people having a negative test | Number of studies | Number of participants | Risk of bias | Applicability concerns | Inconsistency |
Serum amylase (threshold: > 3 times normal) (on admission)2 | 0.72 (95% CI 0.59 to 0.82) | 0.93 (95% CI 0.66 to 0.99) | 74.0% (95% CI 33.4% to 94.1%) | 8.1% (95% CI 5.4% to 12.1%) | 26 (95% CI 6 to 67) | 8 (95% CI 5 to 12) | 3 | 605 | Unclear | Low | Moderate |
Serum lipase (threshold: > 3 times normal) (on admission)2 | 0.79 (95% CI 0.54 to 0.92) | 0.89 (95% CI 0.46 to 0.99) | 68.1% (95% CI 21.4% to 94.3%) | 6.6% (95% CI 2.7% to 15.1%) | 32 (95% CI 6 to 79) | 7 (95% CI 3 to 15) | 4 | 678 | Unclear | Low | Moderate |
Urinary trypsinogen‐2 (threshold: Actim Pancreatitis ‐ all studies; > 50 ng/mL) (on admission) | 0.72 (95% CI 0.56 to 0.84) | 0.90 (95% CI 0.85 to 0.93) | 67.2% (95% CI 57.3% to 75.7%) | 8.4% (95% CI 5.2% to 13.3%) | 33 (95% CI 24 to 43) | 8 (95% CI 5 to 13) | 5 | 841 | High | Unclear | Moderate |
Urinary trypsinogen‐2 (quantitative) (threshold: > 50 ng/mL) (on admission) | 0.71 (95% CI 0.63 to 0.78) | 0.89 (95% CI 0.84 to 0.92) | 65.6% (95% CI 57.0% to 73.3%) | 8.7% (95% CI 6.9% to 10.9%) | 34 (95% CI 27 to 43) | 9 (95% CI 7 to 11) | 1 | 412 | High | Low | Not applicable |
Urinary trypsinogen‐2 (threshold: only + or most positive ‐ the threshold for this was not available) (on admission) | 0.60 (95% CI 0.51 to 0.67) | 0.92 (95% CI 0.88 to 0.95) | 69.1% (95% CI 59.0% to 77.6%) | 11.4% (95% CI 9.6% to 13.5%) | 31 (95% CI 22 to 41) | 11 (95% CI 10 to 13) | 1 | 412 | High | Low | Not applicable |
Urinary amylase (quantitative) (threshold: above normal) (on admission) | 0.83 (95% CI 0.65 to 0.94) | 0.86 (95% CI 0.77 to 0.91) | 62.8% (95% CI 50.8% to 73.5%) | 5.4% (95% CI 2.5% to 11.3%) | 37 (95% CI 27 to 49) | 5 (95% CI 2 to 11) | 1 | 134 | Unclear | Unclear | Not applicable |
Urinary amylase (qualitative) (threshold: 1 plus) (on admission) | 0.66 (95% CI 0.49 to 0.79) | 0.94 (95% CI 0.90 to 0.97) | 77.3% (95% CI 64.2% to 86.6%) | 9.6% (95% CI 6.5% to 14.0%) | 23 (95% CI 13 to 36) | 10 (95% CI 6 to 14) | 1 | 218 | High | High | Not applicable |
Urinary amylase (qualitative) (threshold: 2 plus) (on admission) | 0.44 (95% CI 0.29 to 0.60) | 0.99 (95% CI 0.96 to 1.00) | 95.8% (95% CI 75.8% to 99.4%) | 14.2% (95% CI 11.2% to 17.8%) | 4 (95% CI 1 to 24) | 14 (95% CI 11 to 18) | 1 | 218 | High | High | Not applicable |
CI: confidence interval
1The post‐test probabilities were calculated at the median pre‐test probability. At the lower quartile of pre‐test probability of 16.3%, the post‐test probabilities of positive test for serum amylase (more than three times normal), serum lipase (more than three times normal), and urinary trypsinogen (more than 50 ng/mL) were 65.5% (95% CI 25.1% to 91.5%); 58.7% (95% CI 15.4% to 91.7%); and 57.7% (95% CI 47.2% to 67.5%), respectively. At the same pre‐test probability of 16.3%, the post‐test probabilities of negative test for serum amylase (more than three times normal), serum lipase (more than three times normal), and urinary trypsinogen (more than 50 ng/mL) were 5.6% (95% CI 3.7% to 8.4%); 4.5% (95% CI 1.8% to 10.6%); and 5.8% (95% CI 3.5% to 9.3%), respectively. At the upper quartile of pre‐test probability of 47.3%, the post‐test probabilities of positive test for serum amylase (more than three times normal), serum lipase (more than three times normal), and urinary trypsinogen (more than 50 ng/mL) were 89.7% (95% CI 60.7% to 98.0%); 86.7% (95% CI 45.6% to 98.1%); and 86.3% (95% CI 80.5% to 90.6%), respectively. At the same pre‐test probability of 47.3%, the post‐test probabilities of negative test for serum amylase (more than three times normal), serum lipase (more than three times normal), and urinary trypsinogen (more than 50 ng/mL) were 21.4% (95% CI 14.9% to 29.7%); 17.8% (95% CI 7.9% to 35.4%); and 22.0% (95% CI 14.4% to 32.0%), respectively. 2The results do not include one study for which there was high concern about applicability.