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

Engler, Kathryn H.; Efstratiou, Androulla; Norn, D V; Kozlov, Roman; Selga, I.; Glushkevich, Tatiana; Tam, Milton R.; Mel'nikov, V. G.; Мазурова, И К; Kim, V. E.; Tseneva, Galina; Titov, Leonid; George, Robert C.

doi:10.1128/jcm.40.1.80-83.2002

Cited by 52 publications

(23 citation statements)

References 12 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Classical tests commonly used to demonstrate the toxigenicity of a C. diphtheriae strain (Elek and IDR test) give a delayed answer to the diagnosis (usually more than 48 h) and are time-consuming to set up. A rapid immunochromatographic (ICS) method for detection of diphtheria toxin has recently been developed (Engler et al 2002). During epidemics, field studies within the former USSR showed 99% correlation between the Elek and ICS test (Koslov et al 2000).…”

Section: Laboratory Diagnosismentioning

confidence: 99%

Diphtheria remains a threat to health in the developing world: an overview

Mattos‐Guaraldi

Moreira

Damasco

et al. 2003

Mem. Inst. Oswaldo Cruz

View full text Add to dashboard Cite

Section: Laboratory Diagnosismentioning

confidence: 99%

Diphtheria remains a threat to health in the developing world: an overview

Mattos‐Guaraldi

Moreira

Damasco

et al. 2003

Mem. Inst. Oswaldo Cruz

View full text Add to dashboard Cite

“…Similar IC tests, such as those for diphtheria toxin (31) and Plasmodium falciparum HRP-2 antigen (11), have greater sensitivities. Our IC test may have a lower sensitivity due to its dependence upon the extraction of an OMP.…”

Section: Discussionmentioning

confidence: 99%

“…Therefore, the transmission of HIV could potentially be decreased if chancroid were eliminated (1). IC tests have been developed for other bacterial antigens (11,31) and have a number of advantages over conventional microbiological techniques, including ease of performance, stability in temperate climates, and comparatively low cost, among many others. In the case of H. ducreyi, the greatest advantage would be the rapidity of diagnosis of the etiology of the genital ulcer.…”

Section: Discussionmentioning

confidence: 99%

Development of a Rapid Immunodiagnostic Test for Haemophilus ducreyi

Patterson¹,

Olsen²,

Thomas³

et al. 2002

J Clin Microbiol

View full text Add to dashboard Cite

Haemophilus ducreyi is the etiologic agent of chancroid, a sexually transmitted disease that increases the rate of transmission of human immunodeficiency virus. Chancroid ulcerations are difficult to distinguish from those produced by syphilis and herpes. Diagnosis based solely on clinical grounds is inaccurate, and culture is insensitive. Highly sensitive PCR has largely superseded culture as the preferred method of laboratory diagnosis; however, neither culture nor PCR is feasible where chancroid is endemic. We developed a rapid (15-min) diagnostic test based on monoclonal antibodies (MAbs) to the hemoglobin receptor of H. ducreyi, HgbA. This outer membrane protein is conserved in all strains of H. ducreyi tested and is required for the establishment of experimental human infection. MAbs to HgbA were generated and tested for cross-reactivity against a panel of geographically diverse strains. Three MAbs were found to be unique and noncompetitive and bound to all strains of H. ducreyi tested. Using an immunochromatography format, we evaluated the sensitivity and specificity of the test using geographically diverse strains of H. ducreyi, other Haemophilus strains, and other bacteria known to superinfect genital ulcers. All H. ducreyi strains were positive, and all other bacteria were negative, resulting in a specificity of 100%. The minimum number of CFU of H. ducreyi detected was 2 ؋ 10 6 CFU, and the minimum amount of purified HgbA protein detected was 8.5 ng. Although this level of sensitivity may not be sufficient to detect H. ducreyi in all clinical specimens, further work to increase the sensitivity could potentially make this a valuable bedside tool in areas where chancroid is endemic.Chancroid, caused by the gram-negative bacterium Haemophilus ducreyi (for reviews, see references 2, 47, and 60), is one of the sexually transmitted genital ulcer diseases. Although outbreaks are more prevalent in developing countries, sporadic outbreaks have occurred in the United States. Up to 50% of patients visiting sexually transmitted disease clinics in subSaharan Africa may have chancroid (12,23). Additionally, it is an independent risk factor for the heterosexual transmission of human immunodeficiency virus (HIV) (34; F. A. Plummer, M. A. Wainberg, P. Plourde, P. Jessamine, L. J. DCosta, I. A. Wamola, and A. R. Ronald, Letter, J. Infect. Dis. 161:810-811, 1990); therefore, the interest in chancroid has recently intensified. In the last 10 years, several laboratories have begun to define the molecular biology of this pathogen. The study of virulence factors, the body's immune response to infection, and potential vaccines for H. ducreyi have all made significant contributions to the understanding of this bacterium (3-10, 13-16, 22, 24, 26-28, 32, 33, 36, 38, 39, 46, 50, 53, 54, 59, 61, 64). With the genome sequence completed, the process of annotation will, undoubtedly, further accelerate progress on this strictly human pathogen (www.microbial-pathogenesis.org).At present, there are several laboratory methods for the d...

show abstract

“…a dipstick assay was developed for the rapid phenotypic detection of diphtheria toxin in clinical isolates [37]. This assay does not rely on polyclonal DAT, but instead incorporates a colloidal gold-coupled mAb specific for the toxin molecule [37], while other similar assays make use of alkaline phosphatase-coupled or fluorescein isothiocyanatecoupled mAbs [38,39].…”

Section: Alternatives For Diphtheria Antitoxin For Diagnosticsmentioning

confidence: 99%

Access to diphtheria antitoxin for therapy and diagnostics

et al. 2014

View full text Add to dashboard Cite

The most effective treatment for diphtheria is swift administration of diphtheria antitoxin (DAT) with conjunct antibiotic therapy. DAT is an equine immunoglobulin preparation and listed among the World Health Organization Essential Medicines. Essential Medicines should be available in functioning health systems at all times in adequate amounts, in appropriate dosage forms, with assured quality, and at prices individuals and the community can afford. However, DAT is in scarce supply and frequently unavailable to patients because of discontinued production in several countries, low economic viability, and high regulatory requirements for the safe manufacture of blood-derived products. DAT is also a cornerstone of diphtheria diagnostics but several diagnostic reference laboratories across the European Union (EU) and elsewhere routinely face problems in sourcing DAT for toxigenicity testing. Overall, global access to DAT for both therapeutic and diagnostic applications seems inadequate. Therefore − besides efforts to improve the current supply of DAT − accelerated research and development of alternatives including monoclonal antibodies for therapy and molecular-based methods for diagnostics are required. Given the rarity of the disease, it would be useful to organise a small stockpile centrally for all EU countries and to maintain an inventory of DAT availability within and between countries.

show abstract

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

Cited by 52 publications

References 12 publications

Diphtheria remains a threat to health in the developing world: an overview

Diphtheria remains a threat to health in the developing world: an overview

Development of a Rapid Immunodiagnostic Test for Haemophilus ducreyi

Access to diphtheria antitoxin for therapy and diagnostics

Contact Info

Product

Resources

About