Description
Mono Fast Facts
Mono MSDS
Mono Package Insert
Mono Procedure Manual
Unit: 1 Box
Regulatory Status: CLIA Waived
Contents: (15) Test Cassettes, 1-Developer Solution, 15-Sample Transfer Tubes, 1-Positive Control, 1-Negative Control, Package Insert, and Procedure Card
Test Strip Storage Requirements: 36° F – 86° F (Refrigeration Not Required)
Collection Method: Blood
CLARITY Mono Test qualitatively detects infectious mononucleosis antibodies in human whole blood, serum or plasma specimens. This test is intended for use as an aid in the diagnosis of infectious mononucleosis.
Infectious mononucleosis (IM) is an acute, self-limited, lymphoproliferative disease caused by the Epstein-Barr virus (EBV). Infection with EBV usually occurs early in life with no recognizable disease. When primary infection is
delayed until young adulthood and adolescence, however, there is about a 50% chance that it will occur with the classic clinical manifestations associated with IM.
- Sensitivity > 99%
- Specificity of 98.6%
- 99% overall accuracy
- Fast and easy test results in 8 minutes or less
- No age restriction (can be used on children)
- CLIA Waived for whole blood only, can be used with plasma/serum
- 18 month dating
CLARITY Infectious Mononucleosis 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 L serum or plasma are added in the Sample Well (S) located below the result window. For ngerstick or whole blood, 25 L of blood is collected in a sample transfer pipette and spotted in the Sample Well (S). If
any IM-speci c 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 the 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-speci c 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.
