Item Brochure

Acceava
®
H. pylori
30 Test Kit
Order No. 92403
CLIA Waived: Whole Blood
Non-waived: Serum, Plasma
H. pylori Control Kit
1 positive, 1 negative
Order No. 200013
1. Acceava H. pylori Package Insert
Alere North America, Inc.
30 South Keller Road, Suite 100
Orlando, FL 32810
© 2011 Alere. All rights reserved. The Alere Logo, Alere and Acceava are trademarks of the Alere group of companies.
All other trademarks referenced are trademarks of their respective owners. PN: 12000280-01 9/11
Acceava
®
H. pylori Test Procedure
2 Bands = Positive
1 Band = Negative
Add Whole Blood, Serum
or Plasma Sample
fill Whole Blood
to Red Line (25 µL)
fill Serum or Plasma to
Green Line (10 µL)
Add 2 drops Developer
Solution
Read at
10 minutes
Enterics & GIH. pylori
Acceava
®
H. pylori Features & Benefits
• Testsfortotalantibodies(IgG/IgA/IgM)toH.pylori - Enables detection of
those patients who do not develop the lgG antibody
• Single-reagentprocedure - Reduce operator error
• Resultsavailablein10minutes - Treatment protocol confirmed before patient
leaves office
• CLIAWaived(wholeblood) - Easy regulatory compliance
• Roomtemperaturestorage- Save valuable refrigerator space
• Reimbursable- Keep diagnostic revenues in-house
Acceava
®
H. pylori
Performance
Compared to biopsy
100%
80%
60%
40%
20%
Performance
Sensitivity
95.9%
Specicity
89.1%
Overall Accuracy
91.6%
Package Insert Data - Compared to Biopsy
1
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