Research and Reports in Urology (Jan 2024)
The Prevalence and Association of Different Uropathogens Detected by M-PCR with Infection-Associated Urine Biomarkers in Urinary Tract Infections
Abstract
Emery Haley,1 Natalie Luke,1 Mohit Mathur,2 Richard A Festa,3 Jimin Wang,4 Yan Jiang,4 Lori A Anderson,5 David Baunoch3 1Department of Clinical Research, Pathnostics, Irvine, CA, USA; 2Department of Medical Affairs, Pathnostics, Irvine, CA, USA; 3Department of Research and Development, Pathnostics, Irvine, CA, USA; 4Department of Statistical Analysis, Stat4Ward, Pittsburgh, PA, USA; 5L.Anderson Diagnostic Market Access Consulting, San Diego, CA, USACorrespondence: David Baunoch, Pathnostics, 15545 Sand Canyon Suite 100, Irvine, CA, 92618, USA, Tel +1-714-966-1221, Fax +1-714-966-1231, Email [email protected]: Many emerging uropathogens are currently identified by multiplex polymerase chain reaction (M-PCR) in suspected UTI cases. Standard urine culture (SUC) has significantly lower detection rates, raising questions about whether these organisms are associated with UTIs and truly cause inflammation.Objective: To determine if microbes detected by M-PCR were likely causative of UTI by measuring inflammatory biomarkers in the urine of symptomatic patients.Design, Setting, and Participants: Midstream voided urine was collected from subjects ≥ 60 years presenting to urology clinics with symptoms of UTI (n = 1132) between 01/2023 and 05/2023. Microbe detection was by M-PCR and inflammation-associated biomarker (neutrophil gelatinase-associated lipocalin, interleukin 8, and interleukin 1β) was by enzyme-linked immunosorbent assay. Biomarker positivity was measured against individual and groups of organisms, E. coli and non-E. coli cases, emerging uropathogens, monomicrobial and polymicrobial cases.Outcome Measurements and Statistical Analysis: Distributions were compared using 2-sample Wilcoxon Rank Sum test with 2-tailed p-values 66% of cases. Both non-E. coli cases and E. coli cases had significant biomarker positivity (p < 0.05). Limitations were that a few organisms had low prevalence making inferences about their individual significance difficult.Conclusion: The majority of microorganisms identified by M-PCR were associated with active inflammation measured by biomarker positivity, indicating they are likely causative of UTIs in symptomatic patients. This includes emerging uropathogens frequently not detected by standard urine culture.Plain Language Summary: The M-PCR assay is a novel diagnostic assay for UTI.This study found that most organisms included in the M-PCR assay were:detected in the urine of patients at least 60 years of age with a presumptive UTI diagnosisassociated with biomarkers of infection and inflammationThus, the M-PCR assay:is clinically relevanthas a low likelihood of false-positivity for UTIKeywords: diagnostic testing, IL-8, IL-1β, M-PCR, NGAL, UTI
