Diagnostic Study to Assess the Performance of a New Urinary Antigen Test-A National Study in Three Referral University Hospitals in Austria during 2014-2017.

Background: We evaluated the performance of a rapid diagnostic antigen test (Coris) as an index test versus the urinary Antigen ELISA (Bartels) as the reference test.

Methods: Prospective diagnostic accuracy study (2014-2017) at three university hospitals in Austria.

Results: A total of 996 patients were included in the study. Legionellosis was diagnosed in 49/996 (4.9%) using the reference test. The sensitivity and specificity of the Coris test were 75.5% (95% CI 61.1-86.7%) and 100% (95%CI 99.6-100%), respectively. The PPV was 100% and when using the lower 95% CI limit of the estimate for sensitivity, the resulting PPV was 61.1%. The NPV was 98.7% and the accuracy was 98.8%. The index test showed a PPV > 97% during the period of summer and autumn (May through November) and ≥88% during winter (December through February). The NPV was >97% during all of the periods. The median of the monthly incidence in the general population was 0.1 per 100,000 (IQR 0.1; 0.3).

Conclusion: The new rapid test gave a high level of diagnostic accuracy in a rapid fashion. The test can be applied at the bedside by non-laboratory staff.