IFA, B BURGDORFERI G/M/A - REVISED 1/11/11

The Lyme Immunofluorescence Assay (IFA) detects antibodies (IgG, IgM, IgA) against B Burgdorferi. Seroconversion usually occurs 2-3 weeks after infection and may remain elevated in case of persistent disease. Cross-reactions with other Borrelia and other spirochetes occur. A positive or equivocal result is preliminary and should be confirmed with IgG and IgM Western blot.

This test was developed and its performance determined by IGeneX, Inc. It has not been approved by the FDA, The FDA has determined that such approval is not necessary. The test is used for clinical purposes and should not be regarded as invetigational or for research. IGeneX, Inc. is licensed by CMS and NYS to perform high complexity clinical testing.

Diagnosis should not be based on laboratory tests alone. Results should be interpreted in conjunction with clinical symptoms and patient history.

IGeneX interpretation is based on internal validation studies. By IGeneX criteria, IgM WB is considered positive if two or more of the double stared bands below are present. The IgM WB is considered negative if less than 2 starred bands are present. A positive result suggests exposure to B. Burgdorferi. By CDC/NYS criteria, IgM WB is reported positive if 2 of the following bands are present: 23-25, 39, 41kDa. The IgM WB is negative if less than 2 bands are present.

LIMITATION: Positive result for 31 and/or 34Da may be present after Lyme vaccination in uninfected persons. Positive result for 83/93 kDa and 41kDa may be present in persons infected with HSV, EBV, HCV and/or syphilis (RPR+) and may give false (+) results.

****PRESENCE OF ONLY ONE DOUBLE STARRED BAND OR INDETERMINATE DOUBLE STARRED BANDS IN A NEGATIVE REPORT MAY INDICATE CLINICAL SIGNIFICANCE.****

THEREFORE, WE RECOMMEND TESTING WITH ANOTHER METHOD AND/OR RETEST IN 4-6 WEEKS.

BAND INTENSITY: Negative (-): No band detected. Indeterminate (IND): Band present with intensity < calibration standard. Positive (1+ to 4+): Band present at an intensity >= to calibration standard.

IGENEX IGM RESULT: POSITIVE

CDC/NYS RESULT:       NEGATIVE

Diagnosis should not be based on laboratory tests alone. Results should be interpreted in conjunction with clinical symptoms and patient history.

IGeneX interpretation is based on internal validation studies. By IGeneX criteria, IgG WB is reported positive if two or more of double starred bands below are present. IgG WB is negative if less than 2 starred bands are present. A positive result suggests exposure to B Burgdorferi.

By CDC/NYS criteria, IgG WB is reported positive if 5 of the following bands are present: 18, 23-25, 28, 30, 39, 41, 48, 58, 66, 83-93kDa. The IgG WB is negative if less than 5 bands are present.

LIMITATION: Positive result for 31 and/or 34kDa may be present after Lyme vaccination in uninfected persons.

*****PRESENCE OF ONLY ONE DOUBLE STARRED BAND OR INDETERMINATE DOUBLE STARRED BANDS IN A NEGATIVE REPORT MAY INDICATE CLINICAL SIGNIFICANCE. THEREFORE, WE RECOMMEND TESTING WITH ANOTHER METHOD AND/OR RETEST IN 4-6 WEEKS.*****

Diagnosis should not be based on laboratory tests alone. Results should be interpreted in conjunction with clinical symptoms and patient history.

The multiplex PCR test is a 3 step amplified nucleic acid assay that detects Borrelia Burgdorferi specific DNA sequences from Osp A plasmid and flagellin genomic genes, in a clinical sample. The gene fragments are first selected with specific probes. DNA is amplified in two independent PCR assays using different primers. Lastly, the amplified products are detected by hybridization to specific probes in a dot-blot assay.

Test is not specific to B Burgdorferi and also detects DNA to other Borrelia: B afzelii, B andersonii and B garinii.

This test was developed and its performance characteristics determined by IGeneX, Inc. It has not been cleared or approved by the FDA. The FDA has determined that such approval is not necessary. The test is used for clinical purposes and should not be regarded as investigational or for research. IGeneX, Inc. is licensed by CMS and NYS to perform high complexity clinical laboratory testing.

Diagnosis should not be used on laboratory tests alone. Results should be interpreted in conjunction with clinical symptoms and patient history.

The Multiplex PCR test is a 3 step amplified nucleic acid assay that detects Borrelia Burgdorferi specific DNA sequences from Osp A plasmid and flagellin genomic genes, in a clinical sample. The gene fragments are first selected with specific probes. DNA is amplified in two independent PCR assays using different primers. Lastly, the amplified products are detected by hybridization to specific probes in a dot-blot assay.

Test is not specific to B Burgdorferi and also detects DNA to other Borrelia: B afzelii, B andersonii and B garinii.

This test was developed and its performance characteristics determined by IGeneX, Inc. It has not been cleared or approved by the FDA. The FDA has determined that such approval is not necessary. The test is used for clinical purposes and should not be regarded as investigational or for research. IGeneX, Inc. is licensed by CMS and NYS to perform high complexity clinical laboratory testing.

Diagnosis should not be based on laboratory tests alone. Results should be interpreted in conjunction with clinical symptoms and patient history.