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Rapid Whole Blood Testing for Infectious Mononucleosis Antibodies

The Epstein Barr virus (EBV), which causes infectious mononucleosis (IM), is one of the most common human viruses. EBV occurs worldwide, and most people become infected with EBV sometime during their lives. In the United States, as many as 95 percent of adults between 35 and 40 years of age have been infected. In most developed countries, including the U.S., infection with EBV most often occurs during adolescence or young adulthood, causing infectious mononucleosis in 35 percent to 50 percent of infected individuals.

While treatment of IM normally entails mere bed rest and adequate intake of fluids and the disease is typically self-limiting, it can be devastating in immunocompromised patients and occasionally precipitates serious complications that can include: coronary and neurologic infections, compromised respiration secondary to acute lymphadenopathy, anemia and ruptured spleen. Therefore, accurate diagnosis and prompt treatment of complications is important. Differential diagnosis of IM is also useful in ruling out other mononucleosis-like illnesses induced by cytomegalovirus, adenovirus, or Toxoplasma gondii.

The characteristic triad of fever, pharyngitis, and lymphadenopathy lasting for one to four weeks, together with the age of the patient (most typically adolescent) suggest the clinical diagnosis of (IM). Laboratory tests are usually advisable for confirmation. Serologic findings include a normal to moderately elevated white blood cell count, an increased total number of lymphocytes and greater than 10 percent atypical lymphocytes. In keeping with the rapid proliferation of point-of-care diagnostic kits and devices, several products have now been CLIA-waived by the Centers for Disease Control and Prevention (CDC).

At present, 13 biomedical manufacturers produce 17 distinct test kit products that have gained CLIA waivers.

Thermo Electron Corporation, Waltham, Mass., manufactures the BioStar Acceava Mono Test for both C 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. < li>Applied Biotech, Inc., San Diego, Calif., manufactures the SureStep Mono Test, for qualitative detection of heterophile antibodies specific to IM in human serum, plasma or whole blood specimens. The test procedure can be completed in five minutes.

A bout of IM is likely to remain a tiresome rite of passage for many American adolescents. The availability of rapid, inexpensive and definitive diagnostic tests will at least quickly remove uncertainty and hasten appropriate care for infected individuals.

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