stat simple Pylori

Available in the United States - 510(k) Cleared

A single-use, self-contained system for the collection, processing and analysis of whole blood specimen for the detection of antibodies to Helicobacter pylori (H.pylori).

Sample collection, processing, and analysis in one device.

Individually packaged for use as needed.

Fingerstick sample.

Uses only 3ml of whole blood.

On-site results in minutes.

Room temperature storage.

Operating Procedure

PERFORMANCE CHARACTERISTICS
Preliminary data gathered at U.S. sites by independent investigators indicate excellent sensitivity and specificity. A comparison of the StatðSimple test to biopsy (culture and/or histology) after resolution of discrepant specimens by EIA analysis showed:

	+	-
+	49	0
-	1	70

n = 120
Sensitivity = 98%
Specificity = 100%
Overall agreement = 99%

FOR PROFESSIONAL USE ONLY.