Test ID: FMPP    
Myocarditis/Pericarditis Panel

MYOCARDITIS-PERICARDITIS PANEL

 COXSACKIE B(1-6) ANTIBODIES, SERUM

    REFERENCE RANGE: <1:8

    INTERPRETIVE CRITERIA:  

                 <1:8  Antibody Not Detected

                 > or = 1:8  Antibody Detected

Single titers of > or = 1:32 are indicative of recent infection. Titers of 1:8 or 1:16 may be indicative of either past or recent infection, since CF antibody levels persist for only a few months. A four-fold or greater increase in titer between acute and convalescent specimens confirms the diagnosis. There is considerable crossreactivity among enteroviruses; however, the highest titer is usually associated with the infecting serotype.

This test was developed and its performance characteristics have been determined by Focus Diagnostics. Performance characteristics refer to the analytical performance of the test.

 ECHOVIRUS ANTIBODIES, SERUM

     REFERENCE RANGE: <1:8

     INTERPRETIVE CRITERIA:  

                       <1:8  Antibody Not Detected

                       > or = 1:8  Antibody Detected

Single titers > or = 1:32 are indicative of recent infection. Titers of 1:8 and 1:16 may be indicative of either past or recent infection, since CF antibody levels persist for only a few months. A four-fold or greater increase in titer between acute and convalescent specimens confirms the diagnosis. There is considerable crossreactivity among enteroviruses; however, the highest titer is usually associated with the infecting serotype.

      This test was developed and its performance characteristics have been determined by Focus Diagnostics. Performance characteristics refer to the analytical performance of the test.

 INFLUENZA TYPES A AND B ANTIBODIES, SERUM

     REFERENCE RANGE: <1:8

     INTERPRETIVE CRITERIA:

       <1:8 Antibody Not Detected

       > or = 1:8 Antibody Detected

Single titers of > or = 1:64 are indicative of recent infection. Titers of 1:8 to 1:32 may be indicative of either past or recent infection, since CF antibody levels persist for only a few months. A four-fold or greater increase in titer between acute and convalescent specimens confirms the diagnosis.

This test was developed and its performance characteristics have been determined by Focus Diagnostics. Performance characteristics refer to the analytical performance of the test.

CHLAMYDOPHILA PNEUMONIAE ANTIBODIES (IgG,

IgA, IgM)

     REFERENCE RANGE: IgG <1:64

                                        IgA <1:16

                                        IgM <1:10

The immunofluorescent detection of specific antibodies to Chlamydophila pneumoniae may be complicated by cross-reactive antibodies, non-specific antibody stimulation, or past exposure to similar organisms such as C. psittaci and Chlamydia trachomatis. IgM titers of 1:10 or greater usually indicate recent infection, and any IgG titer may indicate past exposure. IgA is typically present at low titers during primary infection, but may be elevated in recurrent exposures or in chronic infection.

These assays were developed and their performance characteristics have been determined by Focus Diagnostics. They have not been cleared or approved by the U.S. Food and Drug Administration. The FDA has determined that such clearance or approval is not necessary. Performance characteristics refer to the analytical performance of the test.

     Test Performed by:  Focus Diagnostics, Inc.

                                    5785 Corporate Avenue

                                    Cypress, CA   90630-4750