POCARED Diagnostics, LTD, Field Study Protocol



Status:Completed
Conditions:Other Indications, Urology, Urinary Tract Infections
Therapuetic Areas:Nephrology / Urology, Other
Healthy:No
Age Range:Any
Updated:4/2/2016
Start Date:December 2011
End Date:June 2012
Contact:Jonathan Gurfinkel
Email:jonathan.gurfinkel@pocared.com
Phone:972-8-6999779

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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.

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
We found this trial at
4
sites
Rochester, Minnesota 55905
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Rochester, MN
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9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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Cleveland, OH
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3535 Olentangy River Rd
Columbus, Ohio 43214
(614) 566-5000
Riverside Methodist Hospital Serving central Ohio since 1892, Riverside Methodist Hospital is consistently ranked one...
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Columbus, OH
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North Hollywood, CA
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