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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 (table(table).). By comparison, AIDS tests have a sensitivity of 99.5%—they miss only one of every 200 AIDS cases. In simple terms, the chance of a patient with Lyme disease being diagnosed using the commercial tests approved by the Food and Drug Administration and sanctioned by the CDC is about getting heads or tails when tossing a coin, and the poor test performance assures that many patients with Lyme disease will go undiagnosed.
Until we scrap the worthless commercial tests for Lyme disease and find a better way to make the diagnosis of this protean illness, the “Lyme wars” will continue unabated.1
Competing interests: RBS serves on the advisory panel for QMedRx.