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Abstract
Background An immunochromatographic rapid test (ICT; Schistosoma ICT IgG-IgM, LDBIO Diagnostics) demonstrated high sensitivity (96%) in the diagnosis of Schistosoma mansoni and S. haematobium. To date, the test has been validated for use on serum only, but in the absence of lab equipment, blood drop from fingerprick could be a useful option. This method is acquiring more interest because of the high flow of migrants rapidly moving across Italy and other European countries.
Objective The aim of this prospective study was to evaluate the use of ICT on whole blood obtained from fingerprick.
Setting Centre for Tropical Diseases (CTD), Sacro Cuore Don Calabria Hospital, Negrar, Verona, Italy.
Participants The inclusion criteria were African migrants aged ≥18 years with epidemiological risk of infection. The exclusion criteria were refusal to participate in the study and impossibility of execution of one of the two study methods, for any reason. Seventy of the 72 eligible patients completed the study, 79% of whom were male.
Interventions The ICT was performed twice for each included patient: one on blood drop (by the research nurses, in the ward) and one on serum (by staff of CTD lab). The primary outcome was the concordance between the two methods, assessed by Cohen’s kappa.
Results Cohen’s kappa was 0.45 (95% CI 27.0 to 63.6), indicating moderate agreement between the ICT on serum and the ICT on blood drop. Assuming the results on serum as reference standard for diagnosis, the sensitivity and specificity of ICT on blood drop were 55% (95% CI 40 to 69) and 93% (95% CI 79 to 98), respectively.
Conclusions The agreement between the two diagnostic methods is too low to support the alternative one. Implementation of the kit for using blood drop instead of the serum and/or further studies aimed to identify easy-to-use tests for schistosomiasis feasible outside referral centres for tropical diseases are needed.
- schistosomiasis
- schistosoma
- rapid diagnostic test
- immunochromatographic test
- blood spot
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Footnotes
Contributors ZB and DoB conceived and designed the study. PR, DaB, MD, AR, ST and MT contributed to the acquisition of data. DoB, PR, ZB and AR analysed and interpreted the data. DoB drafted the manuscript, and ZB and PR revised it critically. All authors approved the final version of the manuscript.
Funding The ICT kits were donated by Effegiemme diagnostici srl.
Disclaimer The manufacturer did not have any role in the design of the study, in the collection, analysis and interpretation of data, and in writing the manuscript.
Competing interests None declared.
Patient consent Detail has been removed from this case description/these case descriptions to ensure anonymity. The editors and reviewers have seen the detailed information available and are satisfied that the information backs up the case the authors are making.
Ethics approval The protocol (online supplementary file 1) received ethical clearance from the competent ethics committee (Comitato Etico per la Sperimentazione Clinica delle Province di Verona e Rovigo) on 14 March 2017 (study protocol number 13043).
Provenance and peer review Not commissioned; externally peer reviewed.
Data sharing statement The study data set is available on request to the corresponding author.