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

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.

SUBMITTER: Buonfrate D

PROVIDER: S-EPMC5855210 | biostudies-literature | 2018 Mar

REPOSITORIES: biostudies-literature

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

Buonfrate Dora D Rodari Paola P Brunelli Daniele D Degani Monica M Ragusa Andrea A Tais Stefano S Todeschini Martina M Bisoffi Zeno Z

BMJ open 20180303 3

<h4>Background</h4>An immunochromatographic rapid test (ICT; Schistosoma ICT IgG-IgM, LDBIO Diagnostics) demonstrated high sensitivity (96%) in the diagnosis of <i>Schistosoma mansoni</i> and <i>S. haematobium</i>. 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.< ...[more]

PMID: 29502091

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Project description:BackgroundThe development of rK39-based immunochromatographic rapid diagnostic tests represents an important advance for serodiagnosis of visceral leishmaniasis, being cheap and easy to use at the point of care (POC). Although the use of rK39 have considerably improved the sensitivity and specificity of serological tests compared with total antigens, great variability in sensitivity and specificity was reported. This study aimed at the evaluation of "Kalazar Detect™ Rapid Test, Whole Blood" (Kalazar Detect RDT) for Visceral Leishmaniasis (VL) diagnosis using oral fluid, whole blood and serum specimens collected at different endemic areas of VL of Brazil.MethodologyTo evaluate Kalazar Detect RDT, oral fluid, whole blood and serum specimens from 128 VL patients, 85 healthy individuals, 22 patients with possible cross-reactivity diseases and 20 VL/aids coinfected patients were collected and assayed at the POC.Principal findings and conclusionsThe performance of Kalazar Detect RDT in whole blood and serum was similar; however, using oral fluid, the sensitivity was low. Particularly in samples from the city of Natal, Rio Grande do Norte state in Northeastern Brazil, we observed low sensitivity, 80.0% (95% CI: 62.7-90.5), using whole blood and serum, and poor sensitivity, 43.3% (95% CI: 27.4-60.8) with oral fluid. Those values were much lower than in the other regions, where sensitivity ranged from 92.7-96.3% in whole blood and serum, and 80.0-88.9% in oral fluid. Besides, in VL/aids coinfected patients, lower sensitivity was achieved compared with VL patients. In samples from Natal, the sensitivity was 0.0% (95% CI: 0.0-49.0) and 25.0% (95% CI: 4.6-69.9), using oral fluid and serum/whole blood, respectively; in samples from the other regions, the sensitivity ranged from 40.0-63.6% and 80.0-81.8%, respectively. As for specificity, high values were observed across the fluids, 100.0% (95% CI: 96.5-100.0) in whole blood, 96.3% (95% CI: 90.8-98.5) in serum, and 95.3% (95% CI: 89.5-98.0) in oral fluid; across localities, specificity ranged from 85.7-100.0%. Serum samples sent by the collaborating centers to Instituto de Medicina Tropical (n = 250) were tested by Kalazar Detect RDT, Direct Agglutination Test, Indirect immunofluorescence assay, Enzyme-linked immunosorbent assay, and IT-Leish® RDT. The regional difference in the performance of rK39-based RDT and lower sensitivity in Leishmania/HIV coinfected patients raise concern on the routine use of these products for the diagnosis of VL.

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Dataset Information

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

Publications

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

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