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Validation of an enzyme immunoassay for serodiagnosis of acute Q fever
Authors:D. Waag  J. Chulay  T. Marrie  M. England  J. Williams
Affiliation:(1) Pathogenesis and Immunology Branch, Bacteriology Division, United States Army Medical Research Institute of Infectious Diseases, Fort Detrick, 21702-5011 Frederick, Maryland, USA;(2) Department of Infectious Diseases and Immunology, Burroughs Wellcome Company, 3030 Cornwallis Road, 27709 Research Triangle Park, North Carolina, USA;(3) Victoria General Hospital, Halifax, B3H 2Y9 Nova Scotia, Canada;(4) Division of Vaccines and Related Products Application, Office of Vaccine Research and Review, Food and Drug Administration, 20852 Rockville, Maryland, USA
Abstract:
An enzyme immunoassay was validated for the serodiagnosis of acute Q fever. Minimum positive tests were determined for both serial dilutions and a single dilution of patient sera. To establish the specificity of the test, 152 serum samples were tested from individuals with no evidence of pastCoxiella burnetii infection. Diagnostic titers were set at ge128 for the IgM and IgG responses to phase I, at ge512 for the IgM response to phase II and at ge1,024 for the IgG response to phase IICoxiella burnetii. These titers gave a falsepositive rate of le1 %. Alternatively, testing a single dilution of sera (1:128) gave specificities ranging from 97.3 to 98.7 %. Tests with the greatest sensitivities, using serially diluted early convalescent-phase sera, were the IgM (84 %) and IgG (80 %) responses to phase IICoxiella burnetii. At a single serum dilution, 92 % of early convalescent sera had a positive IgG response to phase IICoxiella burnetii. With a high specificity and good sensitivity, the EIA can be used to diagnose acute Q fever with a single convalescent serum specimen. The duration of a positive response was greater than five years.
Keywords:
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