D-dimer test accuracy in a low-prevalence population
| Test result . | No. of results per 1000 patients tested (95% CI) . | No. of participants (studies) . | Certainty of the evidence (GRADE) . |
|---|---|---|---|
| Prevalence 5%*† in patients with suspected PE . | |||
| True positives | 49 (48-49) | 22 849 (34) | ⨁⨁⨁◯ MODERATE‡§ |
| False negatives | 1 (1-2) | ||
| True negatives | 389 (352-437) | 22 849 (34) | ⨁⨁⨁◯ MODERATE‡§ |
| False positives | 561 (513-608) | ||
| Inconclusive test results | 0 | 22 849 (34) | — |
| Complications arising from the diagnostic test | Not reported |
| Test result . | No. of results per 1000 patients tested (95% CI) . | No. of participants (studies) . | Certainty of the evidence (GRADE) . |
|---|---|---|---|
| Prevalence 5%*† in patients with suspected PE . | |||
| True positives | 49 (48-49) | 22 849 (34) | ⨁⨁⨁◯ MODERATE‡§ |
| False negatives | 1 (1-2) | ||
| True negatives | 389 (352-437) | 22 849 (34) | ⨁⨁⨁◯ MODERATE‡§ |
| False positives | 561 (513-608) | ||
| Inconclusive test results | 0 | 22 849 (34) | — |
| Complications arising from the diagnostic test | Not reported |
Patient or population: patients with suspected PE. Setting: inpatient and outpatient. Pooled sensitivity: 0.97 (95% CI, 0.96-0.98). Pooled specificity: 0.41 (95% CI, 0.36-0.46). An interactive summary of findings is available at https://gdt.gradepro.org/presentations/#/isof/isof_4a1a37bd-1b30-40b7-adea-d5214ffb73c2-1581444096033?_k=f5c4gy.
GRADE, Grading of Recommendations Assessment, Development and Evaluation.
Ceriani E, et al. J Thromb Haemost. 2010;8(5):957. Pooled prevalence of PE with low PTP in North American studies 6.5% (5% used in table).
Disease prevalence applies to the index test in each pathway. Prevalence applied to the accuracy of each subsequent test depends on the result of the previous test in the pathway.
Certainty of evidence not downgraded for risk of bias, although few studies had a combination of reference standards that were judged to be acceptable by a panel of clinical experts.
Although there was inconsistency noted for sensitivity, it was judged as not serious and we did not downgrade the certainty of evidence. Certainty of evidence was downgraded for serious unexplained inconsistency in specificity, with a range from 12.8% to 64%.