Manufacturer's recall of rapid assay kits based on false positive Cryptosporidium antigen tests--Wisconsin, 2001-2002.
The Wisconsin Division of Public Health and the Wisconsin State Laboratory of Hygiene (WSLH) reported that a recent cluster of cryptosporidiosis cases in a three-county area in southeastern Wisconsin was the result of false-positive tests. During December 1, 2001-February 1, 2002, approximately 30 cases of cryptosporidiosis were diagnosed at a laboratory in southeastern Wisconsin using the Becton, Dickinson, and Company (Franklin Lakes, New Jersey) ColorPAC Cryptosporidium/Giardia rapid assay (lot number 219370, expiration date 2002-06-05). Seventeen stool specimens, which were collected from 11 patients and tested positive by the rapid assay, were re-evaluated at WSLH. Six of these stool specimens were in EcoFix (Meridian Bioscience Inc., Cincinnati, Ohio), eight were in Cary-Blair transport media, and three were formalin fixed. All 17 specimens tested negative for Cryptosporidium at WSLH using the hot safranin stain and MeriFluor (Meridian Bioscience Inc., Cincinnati, Ohio) Cryptosporidium/Giardia direct fluorescent antibody kit with concentrated specimens.
D000818:Animals; D000953:Antigens, Protozoan; D003457:Cryptosporidiosis / Q000175:diagnosis* / Q000453:epidemiology; D003458:Cryptosporidium / Q000276:immunology / Q000302:isolation & purification*; D004868:Equipment Failure; D005189:False Positive Reactions; D005243:Feces / Q000469:parasitology; D006801:Humans; D007118:Immunoassay; D014922:Wisconsin / Q000453:epidemiology
D000953:Antigens, Protozoan