Abstract
BackgroundClonorchiasis ranks among the most important food-borne parasitic diseases in China. However, due to low compliance to traditional fecal examination techniques in the general population and medical personnel, immunodiagnosis is expected. This study evaluated, in parallel, the performance of four immunodiagnostic kits detecting clonorchiasis in China.ResultsA bank with 475 sera was established in this study. Except for the low performance of the kit detecting IgM, the other three kits detecting IgG showed sensitivities ranging from 81.51% (194/238) to 99.16% (236/238). Higher sensitivity was presented in heavy infection intensity [89.47% (68/76) to 100% (76/76)]. Among the four kits, the overall specificity varied from 73.42% (174/237) to 87.34% (207/237). It was observed that the specificity was lower in the sera of the participants living in clonorchiasis-endemic areas but without any parasite infection [67.5% (81/120) to 90% (108/120)], as compared to those from the non-endemic area [94% (47/50) to 98% (49/50)]. The cross-reaction rate varied from 14.93% (10/67) to 31.34% (21/67). Youden’s index was -0.022, 0.689, 0.726, and 0.802 for kits T1, T2, T3 and T4, respectively. Repeatability was high in all four kits.ConclusionsThree immunodiagnosis kits targeting IgG antibody had high performance on detecting chronic Clonorchis sinensis infection, but that detecting IgM antibody had not. The kits detecting IgG antibody also showed high sensitivity in heavy infection intensity. Research on immunological diagnosis of clonorchiasis is expected to be strengthened to improve the sensitivity in light infection and specificity.
Highlights
Clonorchiasis ranks among the most important food-borne parasitic diseases in China
In spite of molecular techniques including polymerase chain reaction (PCR) and loop-mediated isothermal amplification (LAMP) being successfully applied in the diagnosis of C. sinensis infection [16–19], sample contamination and high costs hinder their application in large-scale surveys in the field
In the light infection groups, T1 still presented a markedly low sensitivity, while T3 was outstanding high (97.53%), and significant differences were detected in all pairwise comparisons between all kits in the light infection group (McNemar’s test: T1 vs T2: P < 0.0001; T1 vs T3: P < 0.0001; T1 vs T4: P < 0.0001; T2 vs T3: P < 0.0001; T2 vs T4: P < 0.0001; T3 vs T4: P = 0.021) (Table 3)
Summary
Clonorchiasis ranks among the most important food-borne parasitic diseases in China. Clonorchiasis is caused by an infection with Clonorchis sinensis (Opisthorchiidae), through the consumption of raw or undercooked freshwater fish, and ranks among the most important food-borne parasitic diseases in public health [1–3]. Adult worms inhabit intrahepatic bile ducts, which can lead to Accurate and rapid diagnosis of C. sinensis infection is crucial for early case management and treatment; traditional fecal examination for C. sinensis eggs is the “gold standard” for diagnosis. Among those fecal examination methods, the Kato-Katz method is most widely applied, as it is simple, inexpensive, and quantitative [11–13]. In spite of molecular techniques including polymerase chain reaction (PCR) and loop-mediated isothermal amplification (LAMP) being successfully applied in the diagnosis of C. sinensis infection [16–19], sample contamination and high costs hinder their application in large-scale surveys in the field
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