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Condition:
Factory New
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Warranty:
Not Available
- Weight: 0.04 lb
- Requires only 25 μl of whole blood or 10 μl serum/plasma
- CLIA waived for whole blood
- Results are ready in as little as 10 minutes
- Physician’s licensing required. This is NOT an at-home test and should only be completed in a lab facility
- This item is non-returnable
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Learn more:
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Purchasing Restriction: Medical license or prescription required
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MFR:
LifeSign
Ships from Manufacturer
- MPN: 200013
- Phone: (800) 526-2125
+ Free Shipping
Frequently asked questions
What is the purpose of this H. Pylori control?
The LifeSign Status H. Pylori Control is a specialized rapid immunoassay control solution used for quality assurance in professional settings.Its primary function is to:
- Verify the accuracy and confirm the reliability of the LifeSign Status H. Pylori test (#37030).
- Perform the qualitative detection of anti-Helicobacter pylori antibodies in human whole blood, serum, or plasma specimens as a control measure.
Crucial Requirement: This control is strictly intended for use in a laboratory facility and requires a physician
s licensing. It is not an at-home test.
How quickly can I get results using the LifeSign Status H. Pylori Control?
The LifeSign Status H. Pylori Control provides results in as little as 10 minutes, allowing for a quick assessment.
What types of samples can be used with this control?
This control can be used with human whole blood, serum, or plasma samples.
What are the minimal sample volume requirements?
This control is designed for high convenience and requires minimal volumes, depending on the specimen type used:
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Whole Blood: 25
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Serum or Plasma: 10
This low volume requirement supports the rapid, single-reagent procedure, enabling results in as little as 10 minutes. Using whole blood also allows for convenient fingerstick collection.
Is the LifeSign Status H. Pylori Control CLIA waived?
Yes, the LifeSign Status H. Pylori Control is CLIA waived for whole blood, facilitating its use in point-of-care settings.
Does the H. Pylori Control require specific storage conditions?
Yes, the LifeSign Status H. Pylori Control requires specific temperature-controlled handling to maintain its quality and accuracy. The manufacturer ensures proper transport by shipping the product over ice. Immediate refrigeration upon receipt is mandatory.
Is a physician's license required to use this product?
Yes, a physician’s license is required to use the LifeSign Status H. Pylori Control. It is not an at-home test and must be performed in a lab facility.
Does the control offer high diagnostic sensitivity?
Yes, the LifeSign Status H. Pylori test system, which this control verifies, demonstrates high accuracy for reliable laboratory use. It features:
- 95.9% sensitivity for detecting anti-Helicobacter Pylori antibodies.
- 91.6% overall agreement when compared directly to biopsy histology, confirming its strong correlation with established diagnostic standards.
How many control units are included?
The LifeSign Status H. Pylori Control kit includes two separate control solution vials, packaged as 2 x 1 mL. This provides sufficient material for two separate quality control verification runs of the H. Pylori test system.
Is this control test strictly for professional use only?
Yes, the LifeSign Status H. Pylori Control is designed strictly for professional, laboratory use and is NOT an at-home test.
This control is essential for ensuring the quality and accuracy of the LifeSign Status H. Pylori test, which detects anti-Helicobacter pylori antibodies.
Key requirements for its use include:
- Required Setting: Testing must be conducted in a laboratory facility.
- CLIA Status: The corresponding test is CLIA waived when whole blood samples are used, allowing for convenient fingerstick collection.
- Speed: Results are generated rapidly, in as little as 10 minutes.