title: Stool diagnosis of giardiasis using a commercially available enzyme immunoassay to detect Giardia-specific antigen 65 (GSA 65).
abstract: A commercially available enzyme immunoassay for the diagnosis of giardiasis was evaluated in a clinical trial. The ProSpecT/Giardia diagnostic test (Alexon, Inc., Mountain View, Calif.) was compared with the standard ova and parasite (O&P) microscopic examination. Additionally, several widely used stool fixatives and a commonly used transport medium were assessed for compatibility with the immunoassay. A total of 325 stool specimens were collected and used to evaluate assay performance. Of those, 93 specimens were collected from symptomatic Giardia O&P-positive patients and 232 specimens were randomly collected from patients as part of a routine health screening procedure. All 93 Giardia O&P-positive stool specimens were strongly positive by visual and spectrophotometric examination using the immunoassay. Of the 232 randomly collected specimens, 16 were positive by O&P examination and immunoassay, 6 were negative by O&P examination but positive by immunoassay, and 1 was positive by O&P examination and negative by immunoassay. There was substantial supportive evidence that indicated that the six immunoassay-positive, O&P-negative specimens were true-positives. When these six specimens were accepted as true-positives, the immunoassay detected almost 30% more cases of Giardia infection than did O&P examination. Its sensitivity and specificity were 96 and 100%, respectively, while the sensitivity and specificity of O&P examination were 74 and 100%, respectively. The immunoassay also performed well on specimens treated with 10% neutral Formalin, sodium acetate-Formalin fixative, and Cary-Blair transport medium. However, the test was not compatible with polyvinyl alcohol-treated specimens. Overall, the ProSpecT/Giardia test was a sensitive, specific immunoassay which was easy to run and interpret. It offers a simple solution to traditional difficulties encountered in diagnosing Giardia infection.
authors.affiliation: Department of Medicine (Infectious Disease), Stanford University, California 94305.
authors.forename: J D
authors.initials: JD
authors.lastname: Rosoff
authors.forename: C A
authors.initials: CA
authors.lastname: Sanders
authors.forename: S S
authors.initials: SS
authors.lastname: Sonnad
authors.forename: P R
authors.initials: PR
authors.lastname: De Lay
authors.forename: W K
authors.initials: WK
authors.lastname: Hadley
authors.forename: F F
authors.initials: FF
authors.lastname: Vincenzi
authors.forename: D M
authors.initials: DM
authors.lastname: Yajko
authors.forename: P D
authors.initials: PD
authors.lastname: O'Hanley
mesh_terms: D000818:Animals; D000953:Antigens, Protozoan / Q000032:analysis*; D003429:Cross Reactions; D003470:Culture Media; D005243:Feces / Q000469:parasitology*; D005872:Giardia / Q000276:immunology*; D005873:Giardiasis / Q000175:diagnosis*; D006801:Humans; D006863:Hydrogen-Ion Concentration; D007124:Immunoenzyme Techniques; D010270:Parasite Egg Count; D011237:Predictive Value of Tests; D013048:Specimen Handling
chemical_list: D000953:Antigens, Protozoan; D003470:Culture Media