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Vstrip

Vstrip
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Vstrip

Product catalog summary
Overview: The document provides details on the Immuno-Fecal Occult Blood Rapid Test, a US FDA-approved commercial kit designed for detecting fecal occult blood. It includes performance metrics, usage instructions, and technical support information.
Clinical Performance: The test's clinical performance was evaluated in Taiwan in 2023 using stool specimens. The evaluation was conducted by professionals using both the FDA-approved commercial kit and a CE-marked ELISA kit as comparators.
Performance Metrics:
  • FDA-approved Kit:
    • Positive Percent Agreement (PPA): 96.7% (29/30), 95% CI: 82.8% - 99.9%
    • Negative Percent Agreement (NPA): 95.7% (134/140), 95% CI: 90.9% - 98.4%
    • Overall Percent Agreement (OPA): 95.9% (163/170), 95% CI: 91.7% - 98.3%
  • CE-marked ELISA Kit:
    • PPA: 100.0% (28/28), 95% CI: 87.7% - 100.0%
    • NPA: 97.9% (139/142), 95% CI: 94.0% - 99.6%
    • OPA: 98.2% (167/170), 95% CI: 94.9% - 99.6%
Test Specifications:
  • Designed for fecal sample testing with a cut-off value of 50 hHb/mL in the extraction buffer.
  • Includes dual-color result lines for quick and easy operation.
Inclusivity: The test detects Hemoglobin A, Hemoglobin A2, and Hemoglobin S.
Instructions for Use: The kit includes a quick reference guide for specimen collection and instructions for use.
Technical Support: Contact information for technical support is provided, including a phone number and email address.
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Catalog excerpts

Vstrip-1

Immuno-Fecal Occult Blood Rapid Test19) Quick Result& Easy Operation .easy Dual-Color Result Lines CUT-OFF VALUE Hemoglobin A Hemoglobin A2 Hemoglobin S 50 ng hHb/mL Extraction Buffer Instruction for Use Extraction Collection QjxkBefeaxeGukSe Patient Label Test Cassette Buffer Paper fcxSperimenColectkxi CLINICAL PERFORMANCE The clinical performance was established with stool specimen in Taiwan in 2023. The evaluation was conducted by professionals or trained operators using FDA-approved commercial kit / CE marking ELISA kit as comparator.

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Vstrip-2

ASSAY PROCEDURE INTERPRETATION OF RESULTS 2 IG15002C02 2 Test Cassette TECHNICAL SUPPORTTEL : + 886-5-216-0700 Email: [email protected] Ctrl

 Open the catalog to page 2

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*Prices are pre-tax. They exclude delivery charges and customs duties and do not include additional charges for installation or activation options. Prices are indicative only and may vary by country, with changes to the cost of raw materials and exchange rates.