CDC and the Food and Drug Administration (FDA) have become aware of
commercial laboratories that conduct testing for Lyme disease by using assays
whose accuracy and clinical usefulness have not been adequately established.
These tests include urine antigen tests, immunofluorescent staining for cell
wall–deficient forms of Borrelia burgdorferi,
and lymphocyte transformation tests. In addition, some laboratories perform
polymerase chain reaction tests for B. burgdorferi DNA
on inappropriate specimens such as blood and urine or interpret Western blots
using criteria that have not been validated and published in peer-reviewed
scientific literature. These inadequately validated tests and criteria also
are being used to evaluate patients in Canada and Europe, according to reports
from the National Microbiology Laboratory, Public Health Agency of Canada;
the British Columbia Centres for Disease Control, Canada; the German National
Reference Center for Borreliae; and the Health Protection Agency Lyme Borreliosis
Unit of the United Kingdom.