Current Lyme Disease Testing Problems

Elizabeth Maloney, MD, explains current Lyme disease testing issues, including the ELISA and Western Blot, sensitivity and specificity of the testing, and the problems associated with the two-tier testing recommended by the CDC. It begins with the general characteristics of diagnostic testing

The Summary states: “Serologic testing for Lyme is inaccurate. While the inadequate sensitivity of ELISA and Western blot tests is the primary problem, imprecision and the lack of clinical validity contribute to the poor performance of two-tier testing in clinical settings. Although the high specificity of the CDC two-tier strategy works well for epidemiologic purposes, the testing sequence reduces the overall sensitivity, thereby limiting its clinical effectiveness. While positive results on two-tier testing in an untreated patient who has symptoms of Lyme disease would confirm the clinical diagnosis (and it would be a mistake to label such results as “false positives”), negative results do not rule out Lyme disease.”

See full article by Elizabeth Maloney, MD here:  Applying Basic Concepts in Laboratory Testing to Serologic Testing for Lyme Disease

See International Lyme & Associated Diseases (ILADS) Controversy & Challenges Page – Issues with Diagnosis & Diagnostics

Lyme disease testing problems by Elizabeth Maloney, MD
ELISA Test: The original whole cell sonicate test