Test ID: FMENS
Meningoencephalitis Comprehensive Panel (Serum)

MENINGOENCEPHALITIS COMPREHENSIVE PANEL (SERUM)

LYMPHOCYTIC CHORIOMENINGITIS (LCM), IFA

MEASLES (RUBEOLA) AB PANEL, IFA

MUMPS ANTIBODY PANEL, IFA

EASTERN EQUINE ENCEPHALITIS VIRUS ANTIBODY PANEL, IFA

CALIFORNIA ENCEPHALITIS VIRUS ANTIBODY PANEL, IFA

ST. LOUIS ENCEPHALITIS VIRUS SEROLOGY, IFA

WESTERN EQUINE ENCEPHALITIS AB PANEL, IFA

IFA REFERENCE RANGES:

IgG (All viruses except measles) <1:16

IgG (Measles Virus) <1:8

IgM (LCM, Measles, Mumps) <1:20

IgM (Encephalitis Viruses) <1:16

CYTOMEGALOVIRUS (CMV) AB PANEL, ELISA REFERENCE RANGE:

IgG <0.80

IgM <0.90

INTERPRETIVE CRITERIA:

IgG:

<0.80 Antibody not detected

0.80 - 0.99 Equivocal

> or =1.00 Antibody detected

IgM:

<0.90 Antibody not detected

0.90 - 1.09 Equivocal

> or =1.10 Antibody detected

Antibody to lymphocytic choriomeningitis virus is often detectable within a few days of clinical symptoms. The presence of mumps IgG antibody in the absence of mumps IgM antibody indicates prior exposure and immunity to mumps virus. Measles IgM antibody is typically detectable for only 30 days after rash onset. Detection of CMV IgG antibody indicates prior exposure. CMV IgM antibody may persist for up to 2 years following primary infection. Human infections caused by arboviruses are seasonal, from mid-summer to late summer. Typical geographic distributions are: Eastern equine encephalitis virus from New England to Texas, California encephalitis virus in the north central states, St. Louis encephalitis virus throughout the southern, southwestern, and west central states, and Western encephalitis virus throughout the western states. For all viruses mentioned, the presence of IgM antibody or a four fold increase in IgG titer between acute and convalescent sera indicates recent or current infection.

Note: Positive results for arbovirus antibody are CDC reportable. Please contact your local public health agency.

The LCM, measles, and mumps antibody tests 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 tests.

ADENOVIRUS AB, CF

INFLUENZA A AB, CF

INFLUENZA B AB, CF

VARICELLA-ZOSTER VIRUS AB, CF

COXSACKIE A ANTIBODIES, SERUM (Types A2, A4, A7, A9, A10, A16)

COXSACKIE B(1-6) ANTIBODIES, SERUM (Types B1, B2, B3, B4, B5, B6)

ECHOVIRUS ANTIBODY PANEL, SERUM (Types 4, 7, 9, 11, 30)

CF REFERENCE RANGES:  <1:8

CF INTERPRETIVIE CRITERIA:

<1:8 Antibody Not Detected

1:8 - 1:16 (Coxsackie A, B, Echovirus) Equivocal

1:8 - 1:32 (Adenovirus, Influenza A, B) Equivocal

1:8 - 1:128 (Varicella Zoster) Equivocal

> or =1:32  (Coxsackie A,B, Echovirus) Antibody Detected

> or =1:64  (Adenovirus, Influenza A,B) Antibody Detected

> or =1:256  (Varicella Zoster) Antibody Detected

Single titers in the appropriate "antibody detected" range are suggestive of recent infection. Due to the short-lived nature of complement fixing antibodies, equivocal titers may also be indicative of recent infection. A four fold or greater change in titer between acute and convalescent sera is considered confirmatory evidence of infection. Among the enteroviruses (Coxsackie A, B, and Echovirus), there is considerable crossreactivity; however, the highest titer is usually associated with the infecting serotype.

The complement fixation tests were developed and their performance characteristics have been determined by Focus Diagnostics. Performance characteristics refer to the analytical performance of these tests.

HSV 1/2 IgM AND TYPE-SPECIFIC IgG (HerpeSelect), ELISA

REFERENCE RANGE:  <0.90

  IgG INDEX                   ANTIBODY STATUS

        <0.90                    Antibody not detected

0.90 - 1.10                     Equivocal

        >1.10                    Antibody detected

  IgM INDEX                   ANTIBODY STATUS

         <0.90                   Antibody not detected

0.90 - 1.09                     Equivocal

> or =1.10                     Antibody detected

The HerpeSelect test system utilizes recombinant type-specific HSV-1 and HSV-2 antigens to detect only type-specific IgG antibodies. Results from these serologic assays must be correlated with clinical history and other data to evaluate the patient’s HSV status. As with all serologic tests, false positives may occur. Repeat testing or utilization of a different assay may be indicated in some settings (e.g., patients with a low likelihood of HSV infection).

The HSV IgM ELISA detects type-common as well as type-specific IgM antibodies; thus, the type-specificity of any HSV IgM antibodies detected cannot be reliably determined. All samples giving an equivocal or positive IgM ELISA result are confirmed by an IFA procedure. As with the HSV IgM ELISA, however, IgM reactivity in the IFA is not type-specific.

Test Performed by: Focus Diagnostics, Inc.

                                      5785 Corporate Ave.

                                      Cypress, CA 90630-4750