- Condition: Factory New
- Warranty: Not Available
- Weight: 0.06 lb
- Single reagent procedure provides results in 3-8 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
- This item is non-returnable
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Learn more:
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Purchasing Restriction: Medical license or prescription required
- MFR: LifeSign Ships from Manufacturer
- MPN: 200014
- Phone: (800) 526-2125
Frequently asked questions
How quickly are the test results available?
When using the associated diagnostic kit verified by this control set, results are available rapidly. The testing procedure delivers accurate results in just 3 to 8 minutes using a streamlined, single reagent process.
Which sample types are compatible with this control set?
This control set is compatible with multiple sample types, providing flexibility for testing:
- Serum
- Plasma
- Whole Blood
The ability to use whole blood is a key benefit, as it supports convenient fingerstick sampling and allows the associated infectious mononucleosis test to maintain its CLIA waived status.
Are essential positive and negative quality controls included?
Yes, the LifeSign StatusFirst Mono Control Set is a comprehensive quality control package that includes external controls necessary for laboratory verification and compliance.
The package provides 2 x 1 mL samples, consisting of:
- External QC Positive Control Sample(s)
- External QC Negative Control Sample(s)
These controls are critical for quality assurance when performing infectious mononucleosis testing. For enhanced safety, new plastic sample transfer pipettes are also included.
Does the associated test have FDA clearance?
Yes, the diagnostic test utilized with this control set is FDA cleared by the FDA. A significant benefit is that it is cleared for use with no age restrictions.
Does this control set support CLIA waived testing?
Yes, the diagnostic test associated with these controls (for infectious mononucleosis detection) is designated as CLIA waived.
It is essential to note that the CLIA waiver status applies specifically when testing with whole blood samples.
What's included in the LifeSign StatusFirst Mono Control Set?
The LifeSign StatusFirst Mono Control Set includes essential components for reliable testing:
- External QC negative control
- External QC positive control
- New plastic sample transfer pipettes for increased safety
Are the sensitivity and specificity high?
Yes, the performance characteristics associated with the LifeSign Status Mono test are very high:
- Sensitivity: 99.9% (designed for earlier IM detection).
- Specificity: 98.8%.
These high metrics provide confidence in the qualitative detection of infectious mononucleosis IgM heterophile antibodies.
What kind of immunoassay does this support?
This control set supports an immunoassay specifically designed for the qualitative detection of infectious mononucleosis (IM) IgM heterophile antibodies.
These external controls (Positive and Negative) are critical for laboratory verification and quality assurance when performing IM screening.
Is physician licensing required for this product?
Yes, the use of the LifeSign StatusFirst Mono Control Set requires physician licensing.
This product is designated strictly for laboratory facility completion and is not intended for at-home testing.
What are the storage requirements for this control set?
This control set has specific handling requirements to ensure its effectiveness:
- It is shipped over ice.
- It must be refrigerated immediately upon receipt.