Introduction
Candiduria, the presence of Candida species in the urine, is a common clinical finding, particularly in hospitalized patients. Accurate diagnosis is crucial for appropriate management. This article outlines the study design employed to investigate Candiduria Diagnosis, utilizing urinalysis and urine culture techniques. The study incorporates both a pilot phase and a cross-sectional approach to comprehensively evaluate diagnostic methods.
Study Design and Patient Population
This research was conducted in two phases: an initial pilot study followed by a cross-sectional study. The pilot study focused exclusively on patients with candiduria (n=79). Expanding upon this, the cross-sectional study included both candiduric patients (n=54) and a control group of non-candiduric, uninfected individuals (n=68). Patients were recruited from both outpatient and inpatient settings at Montefiore Medical Center.
Inclusion and Exclusion Criteria
For both study phases, the key inclusion criteria were the clinician’s request for and performance of both microscopic urinalysis (UA) and standard urine culture. In the clinical laboratory setting, if microscopic urinalysis documented the presence of yeast, the urine sample was categorized into the “candiduria” group. Conversely, in the cross-sectional study, if no microorganisms were detected via microscopy, the sample was assigned to the “control group”. To ensure specificity, samples exhibiting bacterial co-infection, defined by a bacterial colony forming unit (CFU) count exceeding 104/ml, were excluded from the study.
Sample Collection and Processing
Urine samples were collected and maintained at 4°C prior to being transported to both the microbiology and research laboratories. The time interval between urine collection and plating in either laboratory was consistently short, typically occurring on the same day, ensuring comparable sample handling conditions. Standard urine culture was performed by inoculating 1 μl of urine onto both blood agar and Mac Conkey agar plates, following established laboratory protocols. It’s important to note that Candida growth is primarily expected on blood agar plates.
Data Collection
To provide clinical context, patient data were gathered through retrospective chart reviews. This included demographic information such as age, underlying diagnoses, and details of the hospital course, including symptoms like fever, dysuria, and altered mental status. Furthermore, data on the presence of indwelling urinary drainage devices, administered therapies, and hospital outcomes were also collected. To ensure a focused clinical data comparison specifically for candiduric patients diagnosed by standard versus fungal urine culture, outpatients were excluded due to potentially incomplete medical records regarding relevant clinical details.
Ethical Considerations
The study protocol underwent rigorous review and received approval from the Albert Einstein College of Medicine Institutional Review Board (IRB). The IRB granted a waiver of consent under 45 CFR 46.116(d), acknowledging the retrospective nature of the data collection and minimal risk to patient privacy.
Conclusion
This study design, incorporating a pilot study followed by a cross-sectional analysis, provides a robust framework for investigating candiduria diagnosis through urinalysis and urine culture. By carefully defining inclusion and exclusion criteria, standardizing sample processing, and collecting comprehensive clinical data, this research aims to enhance our understanding and approach to candiduria diagnosis in diverse patient populations.
