Multiplex B. Burgdorferi Whole Blood
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 genonmic 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 alzelii, B andersonii and B garinii.
INTERPRETATION
NEGATIVE:
Genomic: B burgdorferi DNA not detected
Plasmid: B burgdorferi DNA not detected
POSITIVE
Genomic: B burgdorferi DNA detected
Plasmid B burgdorferi DNA detected
Sample is considered positive if either genomic or plasmid is positive.
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 peraform high complexity clinical laboratory testing.
Genomic - B burgdorferi NEGATIVE
Plasmid - B burgdorferi NEGATIVE
Diagnosis should not be based on laboratory tests alone. Results should be interpreted in conjunction with clinical symptoms and patient history.
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