- Condition: Factory New
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Country of Origin: USA
- Warranty: Not Available
- Weight: 1.09 lb
- Single reagent procedure provides results in eight minutes
- FDA cleared with no age restrictions
- CLIA waived for whole blood
- Physician's licensing required - this is NOT an at-home test and should only be completed in a lab facility
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Learn more:
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Purchasing Restriction: Medical license or prescription required
- MFR: LifeSign Ships from MFI Medical
- MPN: 68364
- Phone: (800) 526-2125
Frequently asked questions
Does this test offer rapid diagnostic results?
Yes, the LifeSign Status Mono Antibody Test is designed for rapid diagnostic feedback.
- Results are obtained quickly, in just eight minutes.
- The test uses a streamlined, single reagent procedure, supporting efficient clinical workflow.
Are quality controls included with the test?
Yes, the LifeSign Status Mono Antibody Test kit includes necessary components to ensure result validity. It comes with both external QC negative and positive controls.
Is this rapid test FDA cleared and CLIA waived?
Yes, the LifeSign Status Mono Antibody Test has strong regulatory compliance and high performance metrics:
- FDA Status: It is FDA cleared and carries no age restrictions, making it suitable for a wide range of patients.
- CLIA Waiver: The test is CLIA waived specifically when utilizing whole blood samples, offering greater convenience for point-of-care settings.
This rapid immunoassay is designed for professional use and delivers exceptional results, achieving 99.9% Sensitivity (for earlier detection) and 98.8% Specificity.
Which sample types does this rapid test use?
The LifeSign Status Mono Antibody Test is designed for flexibility, accepting minimal volumes of three distinct sample types:
- Whole Blood: Requires only 25 µl. This is often the preferred choice for point-of-care testing, as the test is CLIA waived when performed using whole blood.
- Serum: Requires only 10 µl.
- Plasma: Requires only 10 µl.
How many tests come in a box?
The LifeSign Status Mono Antibody Test is available in two package quantities:
- Box of 25
- Box of 30
Each box includes external QC negative and positive controls.
Does the LifeSign Status Mono Antibody Test offer high sensitivity and specificity?
Yes, the LifeSign Status Mono Antibody Test offers exceptional accuracy with a 99.9% sensitivity for earlier detection of infectious mononucleosis (IM) and a 98.8% specificity. This ensures highly reliable results when testing for IM IgM heterophile antibodies.
Does the Status Mono Test include quality controls?
Yes, the LifeSign Status Mono Antibody Test kits include external Quality Control (QC) components to help ensure reliable testing procedures in your professional lab setting.
Specifically, each kit contains:
- External QC negative controls
- External QC positive controls
Does the test have 99.9% sensitivity for earlier detection?
Yes, the LifeSign Status Mono Antibody Test is highly accurate for the qualitative detection of infectious mononucleosis (IM) IgM heterophile antibodies. Its performance metrics are excellent, ensuring reliable results: * Sensitivity: 99.9%, optimized for earlier infectious mononucleosis (IM) detection. * Specificity: 98.8%. This high level of performance is paired with efficiency, as the single-reagent procedure delivers results in only eight minutes.
Is physician licensing required to use this test?
Yes, physician’s licensing is required for use of the LifeSign Status Mono Antibody Test. This diagnostic tool is designed strictly for professional use by trained laboratory personnel and is not intended to be an at-home test.
Is the LifeSign Status Mono test for home use?
No, the LifeSign Status Mono Antibody Test is NOT intended for at-home use. It is an immunoassay designed for professional use and must only be completed in a laboratory facility.
Additionally, Physician’s licensing is required to administer this test.