LifeSign Status Mono Tests (30 Count)
For The Qualitative Detection Of Infectious Mononucleosis Heterophile Antibodies In Whole Blood, Serum Or Plasma
- CLIA WAIVED for whole blood
- FDA cleared with no age restrictions
- Single reagent procedure provides results in 3-8 minutes
- Fingerstick whole blood convenience
- Superior 99.9% sensitivity for earlier IM detection, specificity of 98.8%
- Multiple kit sizes available, ideal for any practice
- External QC negative and positive controls included (item # 68364 & 84M30)
- New plastic sample transfer pipettes
Status Mono one-step antibody test for IM uses direct solid-phase immunoassay technology for the qualitative detection of IM heterophile antibodies in human serum, plasma or whole blood. In the test procedure, 10 μl serum or plasma are added in the Sample Well (S) located below the result window. For finger-tip or whole blood, 25 μl of blood are collected in a sample transfer pipette and spotted in the Sample Well (S). If any IM-specific heterophile antibody is present in the sample, it will be captured
by the antigen band (bovine erythrocyte extracts) impregnated in the test membrane. The developer solution is then added in Sample Well (S). As the specimen, followed by the developer, moves by capillary action to the antigenband, the solution mobilizes the dye conjugated to anti-human IgM antibodies. Visualization of the antigen band at the Test position (T) in the result window will occur only when the IM-specific heterophile antibody binds to the extracted antigen obtained from bovine erythrocytes. As the
antibody-dye conjugate continues to move along the test membrane, it will bind to another band located at the Control position (C) to generate a colored band regardless of the presence of IM heterophile antibodies in the sample. Therefore, the presence of two colored bands, one at the Test position (T) and the other at the Control position (C), indicates a positive result, while the absence of a colored band at the Test position (T) indicates a negative result.
