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  ICON® HP

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ICON HP is a visually read, qualitative immunochromatographic method for rapid detection of antibodies to H. pylori in adult patients with symptoms of gastrointestinal disorders. H. pylori is a bacterium that grows in the stomach and is associated with peptic ulcer disease and some gastric cancers. ICON HP, available for use with whole blood, serum or plasma samples, provides the physician with the opportunity to perform "on-the-spot" testing while the patient is still in the office and available to begin treatment.

The presence or absence of antibodies to H. pylori in combination with the patient's clinical symptoms allow the physician to either treat patients for H. pylori infections (positive ICON HP) or order appropriate follow-up tests for patients with negative ICON HP tests.



Product Features
  • Rapid detection of H. pylori allows diagnosis and treatment to begin the same day
  • CLIA waived test using whole blood samples
  • CLIA moderately complex test using serum samples
  • Test results in 10 minutes not after 15 minutes
  • No reconstitution, dilutions or wasted reagents
  • Ideal for flexible schedule and unpredictable testing volumes

More Info

Frequently Asked Questions (FAQs)

Q: How should this product be stored?
A: In sealed pouch at 2-30° C until expiration date on the sealed pouch..

Q: How long is the sample stable?
A: Serum samples may be stored at 2-8° C for up to 48 hours before testing. If longer storage time is required, serum samples may be frozen at -20° C or colder. Do not repeatedly freeze and thaw the sample.

Q: Can I use plasma?
A: Yes, the test is validated for use with plasma.

Q: Can I interchange components from different kit lot numbers?
A: No.

Q: What is the CPT code?
A: The CPT code for serum/plasma is 86677*. The CPT code for whole blood is 86318QW*.

Q: What is the reimbursement?
A: The National Cap* for 86677 is $20.28, and $18.09 for 86318QW.

Q: What types of configurations are available?
A: See the Product Instructions.

Q: How do you interpret a positive test?
A: Two lines (Test and Control) visible in the viewing window. Test is read after 10 minutes, do not read after 15 minutes.

Q: What is the Quality Control for this test?
A: See the Product Instructions. External controls are available- H. pylori positive and negative - LifeSign Status 200013. Contact Technical Marketing for a written statement verifying that these controls have been validated for use with the ICON Hp test. LifeSign # 1(800) 526-2125

* Exemplar CPT codes and reimbursements provided. Refer to regional CMS fee schedule for relevant/current CPT codes and reimbursement rates.

For technical assistance, contact Technical Marketing at 800-877-6242 or 650-845-3526 or e-mail askpcd@beckman.com.

Note: Not all products are available in all countries.

 

 
 
 
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