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<p>The former Health Protection Agency's Lyme Borreliosis Unit (HPA LBU) was accredited
by Clinical Pathology Accreditation who had access to, and was able to review, all
the standard operating procedures of the unit.</p><p> </p><p>The Trinity Biotech Lyme
Western Blot is a qualitative in vitro assay for the detection of Immunoglobulin (IgG
or IgM) antibodies in human samples against specific antigens/proteins of <em>Borrelia
afzelii, Borrelia garinii and Borrelia burgdorferi</em>. The Trinity Biotech Lyme
Western Blot is intended as a confirmatory assay for use in testing human samples
which have been previously found to be positive or equivocal using an Enzyme Immunoassay
and Immunofluroescent Assay or other appropriate screening method. Positive second-tier
results are supportive evidence of infection with <em>B. burgdorferi</em>. The diagnosis
of Lyme disease should be made based on history and symptoms (such as erythema migrans),
and other laboratory data, in addition to the presence of antibodies to <em>B. burgdorferi</em>.
The Trinity Biotech blot has been in use since 2007 by the former HPA’s LBU for testing
cerebrospinal fluid (CSF) and proved very reliable. This technique has also been in
use widely across Europe during this period as a diagnostic test using CSF as a sample
to support the diagnosis of neuroborreliosis.</p>
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