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Vendor: LifeSign

Status LifeSign Mono 25 Tests per Box

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Product Type: Medical Tests
Vendor: LifeSign

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CLIA WAIVED Test- CLIA Required 

For The Qualitative Detection of Infectious Mononucleosis Heterophile Antibodies in Whole Blood, Serum or Plasma


  • FDA cleared with no age restrictions
  • CLIA waived for whole blood
  • Single reagent procedure provides results in 3 to 8 minutes
  • Fingerstick whole blood convenience
  • 99.9% sensitivity for earlier IM detection
  • Available in multiple kit sizes; ideal for any practice size
  • New plastic sample transfer pipettes for increased safety
  • CPT: 86308

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 antigen band, 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.

Safety data sheet: