Diagnostic study on an immunochromato graphic rapid test for schistosomiasis: comparison between use on serum and on blood spot from fingerprick

作者:Buonfrate Dora*; Rodari Paola; Brunelli Daniele; Degani Monica; Ragusa Andrea; Tais Stefano; Todeschini Martina; Bisoffi Zeno
来源:BMJ Open, 2018, 8(3): e019228.
DOI:10.1136/bmjopen-2017-019228

摘要

Background An immunochromatographic rapid test (ICT; Schistosoma ICT IgG-IgM, LDBIO Diagnostics) demonstrated high sensitivity (96%) in the diagnosis of Sciristosonra nransoni and S. haeratobiunr. 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 arid impossibility of execution of one of the two study methods, for any reason. Severity 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% Cl 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% Cl 40 to 69) arid 93% (95% Cl 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.

  • 出版日期2018-3

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