POCARED Diagnostics, LTD, Field Study Protocol

Pocared Diagnostics

Status: Unknown

Conditions: Urinary Tract Infections

Study type: Observational

Funder types: Industry

Identifiers

NCT01487148

POCARED001

Details and patient eligibility

About

This study is designed to compare the performance of the P-1000 System, POCARED's Rapid Diagnostic System which uses optical fluorescence analysis, to standard methods of uropathogen quantification and identification.

Full description

This study will be conducted at 5 sites, 4 in the United States and 1 site in Israel. 40,000 clinical specimens will be included and assessed by the laboratories using standard reference methods and the P-1000.

Enrollment: 40,000 estimated patients

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Samples arriving in the laboratory for urine culture

Exclusion criteria

• Samples <=2mL
• Specimens stored at room temperature for more than 2 hours (unless a preservative is used)
• Specimens refrigerated for more than 24 hours
• Specimens requesting low count urine culture (<100,000 CFU/mL [colony forming units per milliliter])
• Bloody specimens