Evidence map›Paper›PMID 42793286›Full record

ArticleCurrent issues in molecular biology2026

Species-Level Reconfiguration and Retrospective Bridging Assessment of a Multiplex PCR Panel for Complicated and Recurrent Urinary Tract Infections.

Moustafa Kardjadj, Itoe P Priestly, Roel Chavez, Thomas K Huard

Registry-linked trialAbstract read
In one paragraph

Article in Current issues in molecular biology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06996301 (Clinical Validity and Utility of PCR Compared to Conventional Culture and Sensitivity Testing for the Management of Complicated Urinary Tract Infections in Adults.), which is not on this map. Not yet cited in PubMed.

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1 · What the graph read from it

What it found

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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT06996301 nacompletednot on this map

Clinical Validity and Utility of PCR Compared to Conventional Culture and Sensitivity Testing for the Management of Complicated Urinary Tract Infections in Adults.

TypeinterventionalSponsorDoc Lab IncRan2023 to 2024Enrolled773ConditionsUrinary Tract Infection Complicated, Urinary Tract Infection (cUTI), Urinary Tract Infection (Diagnosis)ArmsTreatment guided by the PCR results, Treatment guided by the C&S results
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

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5 · Who and what money

Authors and funding

4 authors.

Moustafa KardjadjMED-US Consulting, LLC., Austin, TX 78734, USA.ORCID 0000-0002-9537-2274
Itoe P PriestlySoft Cell Laboratories, Hillsboro, OR 97006, USA.
Roel ChavezSoft Cell Laboratories, Hillsboro, OR 97006, USA.
Thomas K HuardMED-US Consulting, LLC., Austin, TX 78734, USA.

Funding

Doc Lab Inc.
6 · The paper itself

Abstract

backgroundComplicated and recurrent urinary tract infections (cUTI/rUTI) remain diagnostically challenging, particularly after antimicrobial exposure and in polymicrobial or fastidious infections. Multiplex PCR may address some limitations of culture, but panel composition requires periodic refinement as epidemiological, resistance, and clinical evidence evolves. This study describes the transition of the DocLab UTM™ multiplex PCR assay from the prospectively evaluated V2 configuration to the redesigned V5 configuration.

methodsV2 pathogen-level agreement with quantitative urine culture and molecular AMR target-phenotypic AST agreement were characterized using 773 baseline specimens from the prospective multicenter NCT06996301 study. V2-to-V5 panel reconfiguration incorporated US epidemiological and AMR evidence, clinical and antimicrobial-stewardship considerations, and species-level reporting value. V5 was assessed retrospectively using 743 evaluable archived specimens from the same NCT06996301 cohort. Pathogen and AMR agreement were evaluated against the original parent-study quantitative culture and phenotypic AST comparators, and directly shared V2-V5 targets were compared within the common paired cohort using McNemar testing with Holm adjustment for multiple target-specific comparisons. Six newly introduced pathogen targets and one internal process-control target underwent limited contrived-urine feasibility testing.

resultsV2 showed high agreement for most established pathogen and AMR targets, although lower negative percent agreement was observed for selected composite pathogen groups. V5 separated several composite targets into species-level outputs and modified selected AMR reporting, principally the

conclusionsV5 increased species-level reporting resolution while retaining generally high retrospective pathogen and AMR agreement with the original parent-study comparators. Paired analyses did not identify statistically significant directional changes in shared-target classifications. Newly introduced targets require comprehensive validation, and prospective evaluation of the final V5 configuration is needed before conclusions regarding clinical or stewardship benefit can be made.

Indexed as

antimicrobial resistanceassay bridgingcomplicated urinary tract infectiondiagnostic agreementmolecular diagnosticsmultiplex PCRrecurrent urinary tract infectionspecies-level reportinguropathogens

Identifiers

PMID42793286
PMCPMC13605023

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