Noninferiority of Multiplex Polymerase Chain Reaction Compared to Standard Urine Culture for Urinary Tract Infection Diagnosis in Pediatric Patients at Hackensack Meridian Health Children’s Hospital Emergency Department DOI Creative Commons
Sejal M. Bhavsar,

Nisha Polavarapu,

Emery Haley

et al.

Pediatric Health Medicine and Therapeutics, Journal Year: 2024, Volume and Issue: Volume 15, P. 351 - 364

Published: Nov. 1, 2024

To establish the noninferiority of rapid and sensitive multiplex polymerase chain reaction (M-PCR) method versus standard urine culture (SUC) in pediatric urinary tract infection (UTI) diagnostic testing.

Language: Английский

Urine biomarkers individually and as a consensus model show high sensitivity and specificity for detecting UTIs DOI Creative Commons

Marzieh Akhlaghpour,

Emery Haley, Laura Parnell

et al.

BMC Infectious Diseases, Journal Year: 2024, Volume and Issue: 24(1)

Published: Jan. 31, 2024

Abstract Background Current diagnoses of urinary tract infection (UTI) by standard urine culture (SUC) has significant limitations in sensitivity, especially for fastidious organisms, and the ability to identify organisms polymicrobial infections. The rate both SUC “negative” or “mixed flora/contamination” results UTI cases high prevalence asymptomatic bacteriuria indicate need an accurate diagnostic test help true cases. This study aimed determine if infection-associated biomarkers can differentiate definitive from non-UTI controls. Methods Midstream clean-catch voided samples were collected volunteers symptomatic subjects ≥ 60 years old diagnosed with a urology specialty setting. Microbial identification density assessed using multiplex PCR/pooled antibiotic susceptibility (M-PCR/P-AST) SUC. Three [neutrophil gelatinase-associated lipocalin (NGAL), Interleukins 8 1β (IL-8, IL-1β)] also measured via enzyme-linked immunosorbent assay (ELISA). Definitive defined as diagnosis positive microorganism detection M-PCR, while volunteers. Results We observed strong correlation (R 2 > 0.90; p < 0.0001) between microbial NGAL, IL-8, IL-1β subjects. Biomarker consensus criteria two more had sensitivity 84.0%, specificity 91.2%, predictive value 93.7%, negative 78.8%, accuracy 86.9%, likelihood ratio 9.58, 0.17 differentiating cases, regardless non-zero density. showed elevation microbe compared without identification. exhibited distinguishing Conclusion demonstrated that IL-1β, and/or M-PCR was associated A criterion meeting positivity thresholds good balance (84.0%), (91.2%), (86.9%). Therefore, this biomarker is excellent supportive tool resolving presence active UTI, particularly disagree.

Language: Английский

Citations

14

The Prevalence and Association of Different Uropathogens Detected by M-PCR with Infection-Associated Urine Biomarkers in Urinary Tract Infections DOI Creative Commons
Emery Haley, Natalie Luke,

Mohit Mathur

et al.

Research and Reports in Urology, Journal Year: 2024, Volume and Issue: Volume 16, P. 19 - 29

Published: Jan. 1, 2024

Background: 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 associated with UTIs and truly cause inflammation. Objective: To determine if microbes detected M-PCR were likely causative of measuring inflammatory biomarkers the symptomatic patients. Design, Setting, Participants: Midstream voided was collected from subjects ≥ 60 years presenting to urology clinics symptoms (n = 1132) between 01/2023 05/2023. Microbe inflammation-associated biomarker (neutrophil gelatinase-associated lipocalin, interleukin 8, 1β) enzyme-linked immunosorbent assay. Biomarker positivity measured against individual groups organisms, E. coli non- cases, uropathogens, monomicrobial polymicrobial Outcome Measurements Statistical Analysis: Distributions compared using 2-sample Wilcoxon Rank Sum test 2-tailed p-values < 0.05 considered statistically significant. Results Limitations: positive 823 (72.7%) specimens 28 30 (93%) microorganisms/groups detected. Twenty-six twenty-eight had 2 > 66% Both cases significant (p 0.05). Limitations that a few low prevalence making inferences their significance difficult. Conclusion: The majority microorganisms active inflammation positivity, indicating they This includes frequently not standard culture. Plain Language Summary: assay is novel diagnostic for UTI. study found most included were:detected patients at least age presumptive diagnosisassociated infection Thus, assay:is clinically relevanthas likelihood false-positivity Keywords: testing, IL-8, IL-1β, M-PCR, NGAL,

Language: Английский

Citations

9

Novel technologies for the diagnosis of urinary tract infections DOI Creative Commons
Tomas A. Bermudez, Jonathan E. Schmitz,

Malcolm Boswell

et al.

Journal of Clinical Microbiology, Journal Year: 2025, Volume and Issue: unknown

Published: Jan. 6, 2025

ABSTRACT Urinary tract infections (UTIs) impose a substantial burden on patient quality of life and urine testing accounts for the majority workload in many clinical microbiology laboratories. Traditional UTI diagnosis relies symptoms, urinalysis, culture which are interpreted based historical guidelines. This approach, while foundational, presents limitations, particularly complex cases. Low-level bacteriuria presence fastidious organisms often overlooked or entirely missed standard culture, stressing need novel diagnostic methods technologies. mini-review summarizes existing state diagnostics 2024 covers current upcoming technologies including rapid molecular-based pathogen identification, next-generation sequencing, advanced antimicrobial susceptibility testing. However, these represent unique challenges, as they implemented, will require field to adapt new concepts avoid misdiagnosis overtreatment.

Language: Английский

Citations

1

Pooled Antibiotic Susceptibility Testing for Polymicrobial UTI Performs Within CLSI Validation Standards DOI Creative Commons

Richard A. Festa,

F. R. Cockerill,

Rick L. Pesano

et al.

Antibiotics, Journal Year: 2025, Volume and Issue: 14(2), P. 143 - 143

Published: Feb. 1, 2025

Background/Objectives: Urinary tract infections (UTIs) pose an increasing risk of antimicrobial resistance, and novel diagnostic tests have been developed to address the limitations standard urine culture in these cases. It is important that be validated for agreement error rates against antibiotic susceptibility testing (AST) methods. Methods: Polymicrobial (≥two non-fastidious microorganisms) consecutive clinical specimens submitted UTI were included this analysis. Specimens tested with Pooled Antibiotic Susceptibility Testing (P-AST) broth microdilution/disk diffusion (BMD/DD) parallel. Performance characteristics, such as essential (EA%), very major errors (VMEs), (MEs), assessed using Clinical Laboratory Standards Institute (CLSI) standards. P-AST-resistant BMD/DD consensus-sensitive results heteroresistance. Real-world sample data used assess associations between organism counts average “sensitive” count per sample. Results: The P-AST isolate AST was ≥90%, VMEs <2.0%, MEs <3.0%, meeting CLSI guidelines verification validation studies. When heteroresistance accounted for, overall both <1.5%. presence additional organisms dropped number antibiotics from 9.8 one 2.5 five or more organisms. fastidious did not any meaningful impact. Conclusions: P-AST, a component Guidance® assay (Pathnostics, Irvine, CA, USA), performed within standards polymicrobial specimens.

Language: Английский

Citations

1

Comparison Shows that Multiplex Polymerase Chain Reaction Identifies Infection-associated Urinary Biomarker–positive Urinary Tract Infections That Are Missed by Standard Urine Culture DOI Creative Commons
Emery Haley, Natalie Luke,

Mohit Mathur

et al.

European Urology Open Science, Journal Year: 2023, Volume and Issue: 58, P. 73 - 81

Published: Nov. 8, 2023

Multiplex polymerase chain reaction (M-PCR) has increased sensitivity for microbial detection compared with standard urine culture (SUC) in cases diagnosed as urinary tract infections (UTIs), leading to questions whether detected microbes are likely causative of UTIs or incidental findings. To compare infection-associated biomarker levels against M-PCR and SUC results symptomatic a presumptive diagnosis UTI by urologist. Participants were ≥60 yr old presented urology clinics between January April 2023 symptoms (n = 583). Urine was SUC. Three biomarkers (neutrophil gelatinase-associated lipocalin, interleukin-8, interleukin-1β) measured enzyme-linked immunosorbent assay. Symptomatic elevated biomarkers, uropathogens, specialist clinical considered definitive cases. Distributions using two-sample Wilcoxon rank sum test, two-tailed p values <0.05 statistically significant. In M-PCR–positive/SUC-negative 80), all median significantly higher (p < 0.0001) than M-PCR–negative/SUC-negative 107). Two more positive 76% specimens. Limitation an inability examine associations each individual organism inflammation. A significant number had infection-related especially when infection caused organisms other Escherichia coli. This is strong indication that M-PCR, which would be missed SUC, associated UTIs. We patients (UTIs) the microorganisms multiplex (M-PCR). found most markers inflammation, indicating these

Language: Английский

Citations

13

Emerging and Fastidious Uropathogens Were Detected by M-PCR with Similar Prevalence and Cell Density in Catheter and Midstream Voided Urine Indicating the Importance of These Microbes in Causing UTIs DOI Creative Commons
Dakun Wang, Emery Haley, Natalie Luke

et al.

Infection and Drug Resistance, Journal Year: 2023, Volume and Issue: Volume 16, P. 7775 - 7795

Published: Dec. 1, 2023

Introduction: This study compared microbial compositions of midstream and catheter urine specimens from patients with suspected complicated urinary tract infections to determine if emerging fastidious uropathogens are infecting the bladder or contaminants. Methods: Urine was collected by in-and-out (n = 1000) voiding 2000 adult (≥ 60 years age) at 17 DispatchHealth sites across 11 states. The two groups were matched age (mean 81 years), sex (62.1% female, 37.9% male), ICD-10-CM codes. Microbial detection performed multiplex polymerase chain reaction (M-PCR) a threshold for "positive detection" ≥ 10,000 cells/mL bacteria any yeast. Results divided sex. Results: In females, 28 30 microorganisms/groups found both collection methods, while in males 26 both. There significant overlaps densities classical including Escherichia coli, Enterococcus faecalis , Klebsiella pneumoniae as well Actinotignum schaalii Aerococcus urinae . rates slightly higher voided catheter-collected (p 0.0005) samples, showed opposite trend < 0.0001). More polymicrobial detected samples (64.4% vs 45.7%, p 0.0001) females but (35.6% 47.0%, 0.002). Discussion: In-and-out shared similarities detections M-PCR, some differences small subset organisms between sexes. Conclusion: Non-invasive identification cases presumed UTI does not result significantly more contamination specimens. Additionally, long regarded contaminants should be reconsidered potential uropathogens. Keywords: infection, standard culture, diagnostic testing, reaction, catheter,

Language: Английский

Citations

7

The Impact of Polymerase Chain Reaction Urine Testing on Clinical Decision-Making in the Management of Complex Urinary Tract Infections DOI Open Access

Julia Elia,

Jason Hafron,

Mara Holton

et al.

International Journal of Molecular Sciences, Journal Year: 2024, Volume and Issue: 25(12), P. 6616 - 6616

Published: June 16, 2024

While urinary polymerase chain reaction (PCR) testing is effective in organism identification patients with complex tract infections (cUTI), limited data exists on the clinical usefulness of this test. We serially surveyed physicians treating symptomatic cUTI both at presentation and after PCR, urine culture (UC) results were available to ascertain how test modified therapy. A total 96 unique surveys completed by 21 providers included analysis. The mean age for female male was 69.4 ± 15.5 71.6 12.7 years, respectively. positivity line–item concordance UC PCR consistent prior reports. or confirmed treatment 59/96 (61.5%) 25/96 (26.0%) cases, respectively, 12/29 (41.4%) 47/67 (70.1%) having negative positive results, resulting change (difference 28.7%, p < 0.01). Of these, 55/59 (57.3%) alterations antibiotic regimen. use modify similar across not statistically different when stratified patient age, gender, empiric In 31/59 (52.5%) where would not; conversely, have 3/37 (8.1%) cases did 44.4%, find that are used clinicians managing cUTI, provides an opportunity improve stewardship difficult-to-treat subset patients.

Language: Английский

Citations

2

Rapid and accurate testing for urinary tract infection: new clothes for the emperor DOI
Robert B. Moreland, Linda Brubaker,

Lana Tinawi

et al.

Clinical Microbiology Reviews, Journal Year: 2024, Volume and Issue: unknown

Published: Dec. 6, 2024

SUMMARY Urinary tract infection (UTI) is among the most common infections in clinical practice. In some cases, if left untreated, it can lead to pyelonephritis and urosepsis. other UTI resolves without treatment. Clinical diagnosis typically based on patient symptoms and/or urinalysis, including urine dipsticks. The standard culture method sometimes employed identify suspected urinary pathogen (uropathogen) guide antimicrobial choice, but results are rarely available before 24 h. also misses fastidious, anaerobic, slow-growing uropathogens reports polymicrobial infections. unexplained combination of negative cultures with persistent distressing both patients clinicians. Given broad appreciation advantages provided by rapid testing (e.g., for COVID-19 or influenza A), a rapid, accurate diagnostic test needed deliver timely treatment seeking care that optimizes antibiotic stewardship. Herein, we discuss progress being made toward an accessible, (i.e., within hours), assay clinically useful treating clinician timeframe growth rate pathogen(s)). New emerging often overlooked current techniques reviewed.

Language: Английский

Citations

2

Pooled Antibiotic Susceptibility Testing Performs Within CLSI Standards for Validation When Measured Against Broth Microdilution and Disk Diffusion Antibiotic Susceptibility Testing of Cultured Isolates DOI Creative Commons
Emery Haley,

F. R. Cockerill,

Rick L. Pesano

et al.

Antibiotics, Journal Year: 2024, Volume and Issue: 13(12), P. 1214 - 1214

Published: Dec. 14, 2024

Background/Objectives: While new methods for measuring antimicrobial susceptibility have been associated with improved patient outcomes, they should also be validated using standard protocols error rates and other test metrics. The objective of this study was to validate a novel assay complicated recurrent urinary tract infections (UTIs): pooled antibiotic testing (P-AST). This compared broth microdilution (BMD) disk diffusion (DD), following Clinical Laboratory Standards Institute (CLSI) guidelines assessment agreement. Methods: analyzed consecutive fresh clinical urine specimens submitted UTI diagnostic testing. Upon receipt, the samples were subjected in parallel culture multiplex polymerase chain reaction (M-PCR) microbial identification quantification. Specimens same monomicrobial non-fastidious bacteria detected by both M-PCR (SUC) underwent (AST) P-AST Analysis undertaken assess presence heteroresistance P-AST-resistant BMD/DD consensus-susceptible results. Results: performance measures without correction showed essential agreement (EA%) ≥90%, very major errors (VMEs) <1.5%, (MEs) <3.0% P-AST, all meeting threshold established CLSI AST. categorical (CA%) met acceptable criteria (>88%), as majority minor (mEs) decreased <1.0% when accounted for. Conclusions: methodology is within parameters criteria.

Language: Английский

Citations

2

Comparing Prescribing Behaviors and Clinician Experiences Between Multiplex PCR/Pooled Antibiotic Susceptibility Testing and Standard Urine Culture in Complicated UTI Cases DOI Open Access
Emery Haley, Natalie Luke,

Howard Korman

et al.

Journal of Clinical Medicine, Journal Year: 2024, Volume and Issue: 13(23), P. 7453 - 7453

Published: Dec. 7, 2024

We aimed to compare the prescribing behavior and clinical experience of urology providers when using combined multiplex polymerase chain reaction (M-PCR)/Pooled Antibiotic Susceptibility Testing (P-AST) diagnostic test versus standard urine culture (SUC) in same set patients previously reported have improved outcomes with M-PCR/P-AST.

Language: Английский

Citations

0