Performance characteristics of a prototype dialysate turbidity monitoring system to detect peritonitis in patients receiving peritoneal dialysis

Author:

Briggs Benjamin12,Garcia-Garcia Guillermo3,Ibarra-Hernandez Margarita3,Alcantar-Vallin Luz3,Walker Gary4ORCID,Yu Eric4,ElBadry Aly4,Fisher Brian4,Williamson Don4,Chertow Glenn M5ORCID

Affiliation:

1. Department of Pediatrics, University of Rochester Medical Center, Rochester, NY, USA

2. CosmosID, Germantown, MD, USA

3. Hospital Civil de Guadalajara Fray Antonio Alcalde, University of Guadalajara Health Sciences Center, Mexico

4. CloudCath, San Francisco, CA, USA

5. Department of Medicine, Stanford University School of Medicine, San Francisco, CA, USA

Abstract

Background: The risk of peritonitis has limited wider adoption of peritoneal dialysis (PD) in the United States. We developed a prototype bedside dialysate turbidity monitoring system, aiming to improve diagnostic accuracy relative to conventional approaches which depend on visual inspection and reporting of insensitive and non-specific symptoms. Methods: The prototype system was tested in a single-centre, proof-of-principle clinical study in patients receiving intermittent PD. We obtained multiple effluent dialysate samples from each consenting participant. We compared turbidity measurements with diagnostic criteria endorsed by the International Society of Peritoneal Dialysis (ISPD). Results: Overall, we analysed 983 specimens from 65 patients, including 105 samples from patients with peritonitis and 878 samples from patients without peritonitis. An operating point derived from a previous in vitro study yielded an unadjusted sensitivity and specificity of 95.2% and 91.5%, respectively. The majority of samples that did not meet ISPD diagnostic criteria were either cases detected before criteria were met or were related to active peritonitis treatment and resolution. Conclusion: This proof-of-principle study demonstrates the feasibility and diagnostic accuracy of a prototype dialysate turbidity monitoring system for peritonitis surveillance.

Funder

CloudCath

Publisher

SAGE Publications

Subject

Nephrology,General Medicine

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