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Condition:
- Weight: 0.8 lb
- Quickvue H. Pylori GII, CLIA Waived, 10 tests/kit (Continental US Only - including Alaska & Hawaii)
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Learn more:
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MFR:
Quidel Corporation
Ships from MFI Medical
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MPN: 0W010
- Phone: (858) 552-1100
Frequently asked questions
Does this highly reliable test provide rapid results?
Yes, the QuickVue One-Step H. Pylori Gii Kit is optimized for rapid patient management by minimizing both processing time and hands-on requirements.
Key time specifications are:
- Test Results: Detection results for H. pylori are delivered in just 5 minutes.
- Hands-On Time: The simple, one-step procedure requires less than one minute of active handling time, significantly streamlining the workflow.
Is this QuickVue test a rapid, one-step procedure?
Yes, the Quidel QuickVue One-Step H. Pylori Gii Kit is engineered for both speed and simplicity, making it ideal for rapid screening.
- Speed: Provides detection results in only 5 minutes.
- Simplicity: The entire procedure is a one-step process requiring less than one minute of hands-on time.
This immunoassay is designed for easy use and also boasts a 92% overall agreement compared against EIA testing methods.
What is the test's overall agreement rate?
The Quidel Quickvue One-Step H. Pylori Gii Kit demonstrates strong performance metrics regarding accuracy.
- Overall Agreement: The test achieves a 92% overall agreement when its results are compared against established Enzyme Immunoassay (EIA) methods.
- Quality Assurance: To ensure reliable results and system performance, the kit is supplied complete with both positive and negative controls.
What sample types does this rapid test accept?
The Quidel Quickvue One-Step H. Pylori Gii Kit is validated for use with three specific sample types:
- Whole blood
- Serum
- Plasma
Notably, the procedure utilizing whole blood is CLIA waived, which broadens its accessibility for rapid screening in many point-of-care settings.
Does the kit include positive and negative controls?
Yes, the Quidel Quickvue One-Step H. Pylori Gii Kit is supplied complete with quality control reagents to ensure the accuracy and reliability of your testing.
The kit includes:
- Positive control
- Negative control
These controls are provided for routine verification of the assay performance.
Is the whole blood testing procedure CLIA waived?
Yes, the whole blood testing procedure for the Quidel Quickvue One-Step H. Pylori Gii Kit is CLIA waived.
This is a significant advantage, as it allows for simplified regulatory compliance and makes the test highly suitable for use in various decentralized, rapid point-of-care (POC) clinical settings. The test can also be performed using serum or plasma samples.
Is the kit stored at room temperature?
Yes, the components of the Quidel Quickvue One-Step H. Pylori Gii Kit are designed for convenient room temperature storage. This simplifies inventory management and ensures the test is readily available for use without needing refrigeration.
Which bacterium does this rapid test detect?
This rapid diagnostic tool is specifically designed for the qualitative detection of the bacterium Helicobacter pylori (H. pylori).
It operates as a quick immunoassay, yielding results in approximately 5 minutes. It is validated for use with whole blood, serum, or plasma samples, and the whole blood procedure is CLIA waived.
Does this rapid test feature minimal hands-on time?
Yes, the Quidel QuickVue One-Step H. Pylori Gii Kit is designed for maximum efficiency and ease of use in point-of-care settings. Its key features contribute to rapid screening:
- Minimal Hands-On Time: The assay utilizes a simple, one-step procedure that requires less than one minute of hands-on time.
- Rapid Results: This efficiency ensures quick patient management, delivering detection results for H. pylori in just 5 minutes.
- CLIA Waived: The procedure is CLIA waived when using whole blood samples, simplifying regulatory requirements for applicable settings.
Does the kit include positive and negative controls?
Yes, the Quidel Quickvue One-Step H. Pylori Gii Kit is a complete diagnostic system and includes both controls for quality assurance. The inclusion of these components ensures test validity and helps verify the accurate performance of the system.
The kit includes:
- Positive control
- Negative control