Expedited Treatment of Sex Partners
http://www.100md.com
《新英格兰医药杂志》
To the Editor: The enrollment period for the study by Golden et al. of expedited treatment of sex partners of persons with gonorrhea or chlamydial infection (Feb. 17 issue)1 ended March 7, 2003, two years after the recall of one of the diagnostic tests used in the study (LCx ligase chain reaction, Abbott Diagnostics) because of "high negative control rates resulting in invalid runs and non-repeating positive" results.2 Female patients, who accounted for about 84 percent of the persons initially treated for chlamydial infection, had persistent infection in 22 of 289 cases. Can the authors comment on and provide a description of the potential effect of this technical problem? Another diagnostic test (Aptima Combo 2, Gen-Probe) is referred to in the Methods section, but no details with regard to the number of each test used or the choice of test in specific circumstances are given.
Mark J. Parta, M.D.
Science Applications International Corporations–Frederick
Frederick, MD 21702
partam@niaid.nih.gov
References
Golden MR, Whittington WLH, Handsfield HH, et al. Effect of expedited treatment of sex partners on recurrent or persistent gonorrhea or chlamydial infection. N Engl J Med 2005;352:676-685.
FDA Enforcement Report: recall no. Z-0859-1/Z-0860-1. (Accessed April 21, 2005, at http://www.fda.gov/bbs/topics/enforce/2001/enf00709.html.)
The authors reply: Dr. Parta suggests that the treatment failures for chlamydial infection that we observed among women who reported not having had sexual intercourse after treatment may have resulted from problems with the ligase-chain-reaction test. A problem with test performance is an unlikely explanation for the observed treatment failures.
First, retesting of specimens positive for chlamydial infection did not identify specimens that were not positive on repeated testing. Frozen specimens obtained from all study participants whose results were positive starting in November 2000 were retested when the problem with the ligase chain reaction was identified in February 2001. Retesting of initially positive specimens continued until our laboratory started using Aptima Combo 2, in October 2002. All 165 specimens that were positive on ligase-chain-reaction testing were positive on repeated testing. Second, the number of treatment failures among women who reported not having had sexual intercourse during the follow-up period was relatively constant throughout the study and included 3 treatment failures among 23 specimens tested with the use of Aptima Combo 2 (13 percent) and 19 among 266 specimens tested with the use of the ligase chain reaction (7 percent). Finally, we observed no treatment failures for chlamydial infection among 57 men who reported not having had sexual intercourse during follow-up.
Matthew R. Golden, M.D., M.P.H.
William L.H. Whittington, A.B.
King K. Holmes, M.D., Ph.D.
University of Washington
Seattle, WA 98104
Mark J. Parta, M.D.
Science Applications International Corporations–Frederick
Frederick, MD 21702
partam@niaid.nih.gov
References
Golden MR, Whittington WLH, Handsfield HH, et al. Effect of expedited treatment of sex partners on recurrent or persistent gonorrhea or chlamydial infection. N Engl J Med 2005;352:676-685.
FDA Enforcement Report: recall no. Z-0859-1/Z-0860-1. (Accessed April 21, 2005, at http://www.fda.gov/bbs/topics/enforce/2001/enf00709.html.)
The authors reply: Dr. Parta suggests that the treatment failures for chlamydial infection that we observed among women who reported not having had sexual intercourse after treatment may have resulted from problems with the ligase-chain-reaction test. A problem with test performance is an unlikely explanation for the observed treatment failures.
First, retesting of specimens positive for chlamydial infection did not identify specimens that were not positive on repeated testing. Frozen specimens obtained from all study participants whose results were positive starting in November 2000 were retested when the problem with the ligase chain reaction was identified in February 2001. Retesting of initially positive specimens continued until our laboratory started using Aptima Combo 2, in October 2002. All 165 specimens that were positive on ligase-chain-reaction testing were positive on repeated testing. Second, the number of treatment failures among women who reported not having had sexual intercourse during the follow-up period was relatively constant throughout the study and included 3 treatment failures among 23 specimens tested with the use of Aptima Combo 2 (13 percent) and 19 among 266 specimens tested with the use of the ligase chain reaction (7 percent). Finally, we observed no treatment failures for chlamydial infection among 57 men who reported not having had sexual intercourse during follow-up.
Matthew R. Golden, M.D., M.P.H.
William L.H. Whittington, A.B.
King K. Holmes, M.D., Ph.D.
University of Washington
Seattle, WA 98104