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 |
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.
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.
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
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Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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Riverside Methodist Hospital Serving central Ohio since 1892, Riverside Methodist Hospital is consistently ranked one...
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North Hollywood, California 91367
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