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FLEXSURE HP
 

FlexSure HP is a visually read, qualitative immunochromatographic method for rapid detection of antibodies to H. pylori, a bacterium that grows in the stomach and is associated with peptic ulcer disease and some gastric cancers. FlexSure HP, available for use with either whole blood or serum 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 FlexSure HP) or order appropriate follow-up tests for patients with negative FlexSure HP tests.

PRODUCT FEATURES
  • Simple, one capillary fingerstick procedure for whole blood
  • Immediate diagnosis allows treatment to begin the same day
  • CLIA waived whole blood test
  • Test results within 4 minutes (both serum and whole blood)
  • No reconstitution, dilutions or wasted reagents
  • Ideal for flexible schedule and unpredictable testing volumes

Frequently Asked Questions (FAQs)

Q: How should this product be stored?

A: At 2-8C. Alternatively, the kit may be stored at room temperature for up to 30 days.

Q: How long is the sample stable?

A: Serum samples may be stored at 2-8C for up to 48 hours before testing. If longer storage time is required, serum samples may be frozen at ­20C or colder. Fingerstick whole blood samples must be tested immediately after collection.

Q: Can I use plasma?

A: No, the test is not validated for use with plasma.

Q: Can I use a whole blood sample obtained via a venipuncture for the FlexSure HP Whole Blood test?

A: No, there is no clinical data to support any sample other than a fingerstick collected into the FlexSure Capillary Tube.

Q: Can I interchange components from different kit lot numbers?

A: No.

Q: What is the CPT code?

A: The CPT code for serum is 86677. The CPT code for whole blood is

86318QW.

Q: What is the reimbursement?

A: The 2002 National Cap for 86677 is $20.05, and $17.89 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.

Q: Can I read this test past 4 minutes?

A: No.

Q: What is the Quality Control for this test?

A: See the Product Instructions. External controls are available, Product Number 81001.

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

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Flexsure® is a registered trademark of Beckman Coulter