Abstract:
Lyme disease requires a clinical diagnosis – A clinical diagnosis means that your doctor will base his diagnosis on the signs of the disease that you show and the symptoms that you report. He should also take into account how likely it is that you have been exposed to the ticks that carry Lyme disease.
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Abstract:
Lyme disease is usually diagnosed and treated based on clinical manifestations. However, laboratory testing is useful for patients with confusing presentations and for validation of disease in clinical studies. Although cultivation of Borrelia burgdorferi is definitive, prior investigations have shown that no single test is optimal for Lyme disease diagnosis. We applied high-volume blood culture, skin biopsy culture, PCR, and serodiagnosis to a cohort of patients with suspected Lyme disease acquired in Maryland and southern Pennsylvania. The study was performed to confirm the relative utility of culture and to identify laboratory testing algorithms that will supplement clinical diagnosis.
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Abstract:
The risk of obtaining false-negative results in serological assays in serum and CSF specimens with only one strain of Borrelia burgdorferi sensu lato as antigen was investigated in 79 patients with neuroborreliosis with specimens obtained at initial presentation. From this study it is concluded that there is a small, but real, risk of false-negative serological findings at the time of initial clinical presentation in patients with typical symptoms of neuroborreliosis. In these patients a negative serological result with one strain should prompt the repetition of the test with other strains of B. burgdorferi sensu lato.
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Abstract:
The two tier testing system endorsed by the Centers for Disease Control and Prevention (CDC) has a high specificity (99%) and yields few false positives. But the tests have a uniformly miserable sensitivity (56%)-they miss 88 of every 200 patients with Lyme disease.
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Abstract:
The Food and Drug Administration (FDA) is concerned about the potential for misdiagnosis of Lyme disease based on the results of commonly marketed tests for detecting antibodies to Borrelia burgdorferi, the organism that causes Lyme disease. It is important that clinicians understand that a positive test result does not necessarily indicate current infection with B. burgdorferi, and a patient with active Lyme disease may have a negative test result. The tests should be used only to support a clinical diagnosis of Lyme disease and should never be the primary basis for making diagnostic or treatment decisions. Diagnosis should be based on a patient history, which includes symptoms and exposure to the tick vector and physical findings. The most definitive diagnostic procedure is biopsy and isolation of B. burgdorferi in culture.
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Until better commercial testing is developed, Lyme disease should remain a clinical diagnosis, and commercial testing should only support, but NEVER RULE OUT, the diagnosis of Lyme disease.
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Topic Overview: How should a clinician employ serologic tests in a Lyme disease evaluation? Before ordering an ELISA or Western blot the clinician should develop a clinical impression of the patient, taking into account the exposure history, symptoms and exam findings. If Lyme disease is judged to be a diagnostic possibility then testing is reasonable. Neither ELISA nor Western blot testing is sensitive enough to rule out Lyme disease. Because positive ELISA results require confirmation with a Western blot, one can make the case for eliminating the test altogether. Positive Western blots can confirm the clinical diagnosis of Lyme but, in and of themselves, they do not necessarily indicate that a patient is actively infected. In summary, serologic testing does not offer a reliable laboratory shortcut to the diagnosis of Lyme disease – Lyme disease remains a clinical diagnosis.
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Abstract:
Causes of Seronegativity in Lyme disease list.
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Abstract:
Listing of abstracts supporting seronegativity in Lyme disease.
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Abstract:
Improved Sensitivity of Lyme disease Western Blots Prepared with a Mixture of Borrelia Burgdorferi Strains 297 and B31 – by Shah JS, Du Cruz I, Narciso W, Lo W and Harris NS
Testing for Borrelia burgdorferi (BB), the spirochetal agent of Lyme disease, is problematic due to poor sensitivity of commercially available serological tests. The authors evaluated an in-house Western Blot (WB) prepared with a mixture of two strains of Borrelia, the spirochete that causes Lyme disease, B31 and 297.
Based on the results of the work described in the full article, the authors conclude that the use of the two-strain IgG and IgM WB and in-house interpretation criteria significantly increased the combined sensitivity of the test without significant loss of specificity.
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