Description
The LifeSign Status Mono Antibody Test includes external QC negative and positive controls.
Note: Physician's licensing required. This is NOT an at-home test and should only be completed in a lab facility.
An immunoassay designed for the qualitative detection of infectious mononucleosis IgM heterophile antibodies in whole blood, serum, or plasma, the LifeSign Status Mono is both FDA cleared with no age restrictions and CLIA waived for whole blood. The new plastic sample transfer pipettes have increased safety.
Extra StatusFirst Mono Controls (#200014) are available for sale separately.
Features
LifeSign Status Mono Antibody Test Features
- FDA cleared with no age restrictions.
- CLIA waived for whole blood.
- Single reagent procedure provides results in eight minutes.
- Fingerstick for whole blood convenience.
- Requires only 25 µl of whole blood or 10 µl serum/plasma.
Specifications
LifeSign Status Mono Antibody Test Specifications
- Sensitivity: 99.9% for earlier IM detection.
- Specificity: 98.8%.
Package Quantities
LifeSign Status Mono Antibody Test Package Quantities
- #68364: Box of 25.
- #84M30: Box of 30.
Literature
LifeSign Status Mono Antibody Test Literature
LifeSign Status Mono Package Insert
LifeSign Status Mono Test Procedure