Objective To evaluate the efficacy of homodimer neutrophil gelatinase-associated lipocalin(H-NGAL)rapid test kit in diagnosing peritoneal dialysis(PD)-associated peritonitis(PDAP).Methods It was a multicenter prospective observational study.The PD patients from the nephrology clinics or wards at four hospitals:the First Affiliated Hospital of Nanchang University,the Third Hospital of Hebei Medical University,Taian Central Hospital,and Weifang People's Hospital from December 27,2021,and July 18,2022 were enrolled.The patients were categorized into PDAP and non-PDAP groups based on whether PDAP occurred at the time of enrollment.PD effluent samples were collected,and H-NGAL test was performed.The patients or their families used cassette-type,strip-type,and pen-type H-NGAL test kits to detect H-NGAL.Healthcare professionals only used the cassette-type H-NGAL kit to detect H-NGAL.All participants completed a questionnaire regarding the instructions for use of H-NGAL kit before testing,and a summary of patient experience and evaluation questionnaires after testing.The sensitivity,specificity,compliance rate,and 95％confidence interval(CI)of H-NGAL rapid test kit for diagnosing PDAP were calculated using clinical diagnosis as the standard.Kappa test was used to assess the consistency between H-NGAL detection results and clinical diagnoses.Results A total of 221 PD patients were enrolled,with 42 PDAP patients and 179 non-PDAP patients.The sensitivity and specificity of H-NGAL rapid test kit for diagnosing PDAP were 100％(95％CI 91.62％-100％)and 99.44％(95％CI 96.90％-99.90％),respectively,with accuracy rate of 99.55％(95％CI 97.48％-99.92％).The positive agreement rate was 97.67％(95％CI 87.94％-99.59％),and the negative agreement rate was 100％(95％CI 97.89％-100％).The consistency evaluation results showed that kappa value was 0.985(95％CI 0.956-1.000).The results obtained by patients and their families using the H-NGAL rapid test kits were consistent across all three methods(cassette,strip,and pen-type H-NGAL test kits),and the results obtained by using the H-NGAL rapid test kits were also consistent between non-healthcare professionals and healthcare professionals.The kit instruction questionnaire and the experience and evaluation questionnaire showed that the overall satisfaction of patients with the H-NGAL rapid test kits was very good.Conclusions H-NGAL rapid test kit exhibits high sensitivity and specificity in diagnosing PDAP and can serve as a rapid diagnostic method for PDAP.
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