Test Type: Kit Based - Serum

Overview:

The Relapsing Fever (RF) Borrelia group real-time PCR Assay is designed for qualitative detection of RF Borrelia group DNA in clinical samples. The RF group includes B. miyamotoi, B. hermsii, B. coriaceae, B. lonestari and B. anserine, etc. The assay detects RF Borrelia group genomic DNA and B. miyamotoi specific DNA. For diagnostic purposes, PCR results should be used in conjunction with other data available to the physician.

Principle: The multiplex PCR-based diagnostic test is performed directly on the clinical specimen in a three-step assay. The steps are as follows:

Selection hybridization step: Specifically removes the “common PCR inhibitors” from the clinical sample while simultaneously selecting and purifying the DNA fragment of interest. This procedure also concentrates the fragment of interest, thereby improving sensitivity.

PCR amplification: The purified pathogen DNA fragment of interest is PCR-amplified with pathogen-specific primers. This sequence “hybridizes” or binds specifically to pathogen DNA of interest under predetermined PCR conditions. Therefore, only pathogen-specific DNA is amplified.

Detection of amplified products: The PCR-amplified products are transferred and bound to a nitrocellulose membrane. The membrane-bound, PCR-amplified products are hybridized with pathogen-specific probes. Only samples that have pathogen-specific DNA hybridize to the probes and give a blue-purple color dot on the membrane.

The combination of these three steps imparts very high specificity and sensitivity to the test.

Stage of Disease: Any Stage of Disease

Test Methodology: PCR

Collection Details:

Collection Instructions:

Specimen: 1 SST/ minimum volume 2mL serum