- Condition: Factory New
- Warranty: Not Available
- Weight: 0.25 lb
- CLIA waived for whole blood
- Requires only 25 μl of whole blood or 10 μl serum/plasma
- Convenient finger stick makes sample collection easier
- Results are available in as little as 10 minutes
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Learn more:
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Purchasing Restriction: Medical license or prescription required
- MFR: LifeSign Ships from Manufacturer
- MPN: 37030
- Phone: (800) 526-2125
Frequently asked questions
Do these H. Pylori tests provide rapid results?
Yes, the LifeSign Status H. Pylori test provides rapid results in as little as 10 minutes.
Is the LifeSign Status H. Pylori test CLIA waived?
Yes, the LifeSign Status H. Pylori test is CLIA waived for whole blood samples. This simplifies testing procedures and allows for convenient fingerstick sample collection.
How many tests are included in one kit of the LifeSign Status H. Pylori?
Each kit of the LifeSign Status H. Pylori contains 30 tests.
What is the accuracy of the Status H. Pylori test?
The LifeSign Status H. Pylori test is a rapid immunoassay known for its strong diagnostic performance in the qualitative detection of anti-Helicobacter pylori antibodies. Its accuracy is measured against biopsy histology standards:
- Sensitivity: 95.9%
- Overall Agreement: 91.6%
This high level of agreement and sensitivity ensures reliable results.
Does this H. Pylori test provide rapid, convenient results?
Yes, the LifeSign Status H. Pylori test is engineered for both rapid results and operational convenience within professional settings.
It streamlines the diagnostic process with several key features:
- Rapid Results: Results are available in as little as 10 minutes.
- Easy Sample Collection: It supports a convenient fingerstick method for whole blood collection.
- Minimal Sample Volume: Only requires 25 extmu l of whole blood or 10 extmu l of serum/plasma.
- Simple Procedure: Features an easy-to-use, single reagent procedure.
- CLIA Waived Status: The test is CLIA waived when whole blood is used, simplifying accessibility for many clinical environments.
Important Note: This is a waived/moderate complexity immunoassay intended for use only in a qualified laboratory facility; it is not intended for at-home testing.
What volume of sample is required for the LifeSign Status H. Pylori test?
The LifeSign Status H. Pylori test requires 25 μl of whole blood or 10 μl of serum/plasma.
Is a physician's license required to use the LifeSign Status H. Pylori test?
Yes, the LifeSign Status H. Pylori test requires a physician’s license for use.
Is this LifeSign Status H. Pylori test suitable for at-home use?
No, this LifeSign Status H. Pylori test is not suitable for at-home or personal use. It is a professional medical diagnostic product intended solely for use in authorized clinical settings.
Testing must be completed in a lab facility or appropriate medical office under appropriate physician’s licensing.
What type of samples can be used with the LifeSign Status H. Pylori test?
The LifeSign Status H. Pylori test can be used with human whole blood, serum, or plasma samples.
Is this H. Pylori test easy to perform?
Yes, the LifeSign Status H. Pylori test is engineered for operational simplicity and rapid diagnostics in a professional clinical environment.
Features that make the testing procedure easy include:
- Simple Procedure: It uses an easy-to-follow single reagent procedure, which streamlines the testing process.
- Rapid Turnaround: Results are highly efficient, providing qualitative results in as little as 10 minutes.
- Convenient Collection: It supports a convenient fingerstick method for whole blood collection.
- Minimal Sample Volume: Only a small sample is required: 25 µl of whole blood or 10 µl of serum/plasma.
Important Note: This test is classified as a CLIA waived/moderate test and must be performed in a qualified laboratory facility by licensed personnel; it is not intended for at-home use.