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Rapid Whole Blood Testing for Infectious Mononucleosis Antibodies

LIA-moderate (using serum, plasma or whole blood specimens) and waived labs (using whole blood specimens only).

The test uses color immunochromatographic dipstick technology in which bovine erythrocyte extract interacts with the serum, plasma or whole blood sample. If the IM heterophile antibody is present in the sample a visible blue test line will appear to indicate a positive result; a red line indicates a negative test outcome.

The product provides two visible indicators to assure that the test is functioning properly and that the proper amount of sample has been used. According to the company, the test requires one minute of hands-on time and provides a test result in as little as one minute. The kit can be stored at room temperature prior to use.

Jant Pharmacal Corporation, Encino, Calif. manufactures the Accutest Infectious Mononucleosis Whole Blood Test. Sensitivity is rated at 98.6 percent and specificity at 98.8 percent, with an overall accuracy of 98.8 percent. Results are available in five minutes.

This test also uses color to indicate the presence of IM antibodies. Unlike the bovine erythrocyte material used in the Thermo Electron test, however, the Accutest sample interacts with heterophile antigen extracts derived from goat and mouse cell lines. The presence of IM heterophile antibodies forms a visible line while the absence of a visible color band indicates a negative result. Regardless of test outcome, the control band includes a procedural indicator to assure the proper performance of the test and the device.

Other waived test product manufacturers include:

  • Princeton BioMeditech Corporation, Princeton, N.J., which makes the BioSign Mono WBRapid Infectious Mononucleosis Heterophile Antibody (IgM) Test for Whole Blood.
  • Genzyme Diagnostics, Cambrige, Mass., which produces the OSOM Mono Test, with a sensitivity of 100 percent and specificity of 96 percent, readable in five minutes. <
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