False-positive laboratory tests for Cryptosporidium involving an enzyme-linked immunosorbent assay--United States, November 1997-March 1998.

From November 1997 through March 1998, the number of positive tests for Cryptosporidium increased in several locations in the United States. Several laboratories (e.g., the New York state laboratory and the Medical Science Laboratories in Wisconsin) retested original stool specimens and could not confirm the original positive test result. Following reports to the manufacturer by the Massachusetts, New York, and Wisconsin state health departments about possibly inaccurate test results, Alexon-Trend (Ramsey, Minnesota) notified its laboratory customers in a March 25, 1998, letter that three lots of its enzyme-linked immunosorbent assay (ELISA) 24 well (catalog number 540-24) ProSpecT Cryptosporidium Microplate Assay (lot numbers 970717,975011, and 980401) and seven lots of its ELISA 96 well (catalog number 540-96) ProSpect Cryptosporidium Microplate Assay (lot numbers 970696, 970775, 970883, 975006, 980402, 980808, and 980809) were subject to a "non-specific reaction between some stool specimens and the microplate assay" (i.e., a false-positive test result) (K. Hood, Alexon-Trend, personal communication, March 25, 1998). Alexon-Trend directed laboratories to discontinue using kits with implicated lot numbers. This report summarizes an analysis of reports of false-positive tests and describes identification of apparent clusters in three states.