A study to evaluate the performance of the UF series bacterial count and Gram stainability information on clinical urine specimens used to test for bacterial infections.

A study to evaluate the performance of the UF series bacterial count and Gram stainability information on clinical urine specimens used to test for bacterial infections. - Study on Performance Evaluation of UF Series for Urine Samples

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000053215

Enrollment

3000

Registered

2023-12-25

Start date

2023-06-08

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

urinary tract infection

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Cases in which UF-5000 assay, Gram stain, and urine culture were all ordered at the time of the usual examination.

Exclusion criteria

Exclusion criteria: Patients who have refused to participate in this study

Design outcomes

Primary

Measure	Time frame
Agreement rate, sensitivity and specificity of UF series results with results of urine culture tests and microscopic tests such as Gram stain	—

Secondary

Measure	Time frame
Evaluation of scattergrams of clinical urine specimens in comparison to ATCC strains or clinical isolates	—

Countries

Japan

Contacts

Public ContactMitsuru Yasuda

Sapporo Medical University School of Medicine Department of Infection Control & Laboratory Medicine

yasuda7jpe@sapmed.ac.jp011-611-2111

Outcome results