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.
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.
Study Type
OBSERVATIONAL
Enrollment
40,000
Southern California Permanente Medical Group (SCPMG) Regional Reference Laboratories
North Hollywood, California, United States
Mayo Clinic
Rochester, Minnesota, United States
Cleveland Clinic
Cleveland, Ohio, United States
Riverside Methodist Hospital
Columbus, Ohio, United States
Agreement
Agreement of the POCARED quantification and identification compared with standard methods.
Time frame: 6 months
Sensitivity
Sensitivity of the POCARED quantification and identification compared with standard methods.
Time frame: 6 months
Specificity
Specificity of the POCARED quantification and identification compared with standard methods.
Time frame: 6 months
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Chaim Sheba Medical Center
Tel Aviv, Israel