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Journal of Clinical Microbiology, January 2002, p. 80-83, Vol. 40, No. 1
0095-1137/02/$04.00+0     DOI: 10.1128/JCM.40.1.80-83.2002
Copyright © 2002, American Society for Microbiology. All Rights Reserved.

Immunochromatographic Strip Test for Rapid Detection of Diphtheria Toxin: Description and Multicenter Evaluation in Areas of Low and High Prevalence of Diphtheria

K. H. Engler,1* A. Efstratiou,1 D. Norn,2 R. S. Kozlov,3 I. Selga,4 T. G. Glushkevich,5 M. Tam,2 V. G. Melnikov,6 I. K. Mazurova,6 V. E. Kim,7 G. Y. Tseneva,8 L. P. Titov,9 and R. C. George1

Central Public Health Laboratory, Public Health Laboratory Service, London, United Kingdom,1 Program for Appropriate Technology in Health, Seattle, Washington,2 Institute of Antimicrobial Chemotherapy, Smolensk,3 National Environmental Health Centre, Ministry of Welfare, Riga, Latvia,4 Ukrainian Centre of National Sanitary and Epidemiological Surveillance, Kiev, Ukraine,5 G. N. Gabrichevsky Institute of Epidmiology and Microbiology, Moscow,6 Sanitary and Epidemiological Surveillance Station, Almaty, Kazakhstan,7 Pasteur Institute, St. Petersburg, Russia,8 Belarussian Research Institute for Epidemiology and Microbiology, Minsk, Belarus9

Received 20 June 2001/ Returned for modification 24 August 2001/ Accepted 15 October 2001

An immunochromatographic strip (ICS) test was developed for the detection of diphtheria toxin by using an equine polyclonal antibody as the capture antibody and colloidal gold-labeled monoclonal antibodies specific for fragment A of the diphtheria toxin molecule as the detection antibody. The ICS test has been fully optimized for the detection of toxin from bacterial cultures; the limit of detection was approximately 0.5 ng of diphtheria toxin per ml within 10 min. In a comparative study with 915 pure clinical isolates of Corynebacterium spp., the results of the ICS test were in complete agreement with those of the conventional Elek test. The ICS test was also evaluated for its ability to detect toxigenicity from clinical specimens (throat swabs) in two field studies conducted within areas of the former USSR where diphtheria is epidemic. Eight hundred fifty throat swabs were examined by conventional culture and by use of directly inoculated broth cultures for the ICS test. The results showed 99% concordance (848 of 850 specimens), and the sensitivity and specificity of the ICS test were 98% (95% confidence interval, 91 to 99%) and 99% (95% confidence interval, 99 to 100%), respectively.


* Corresponding author. Mailing address: Respiratory and Systemic Infection Laboratory, Central Public Health Laboratory, 61, Colindale Ave., London NW9 5HT, United Kingdom. Phone: 44 20 8200 4400. Fax: 44 20 8205 6528. E-mail: kengler{at}phls.nhs.uk.


Journal of Clinical Microbiology, January 2002, p. 80-83, Vol. 40, No. 1
0095-1137/02/$04.00+0     DOI: 10.1128/JCM.40.1.80-83.2002
Copyright © 2002, American Society for Microbiology. All Rights Reserved.




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