Performance of an enzyme-linked immunosorbent assay for detection of Clonorchis sinensis infestation in high- and low-risk groups.

Clonorchis sinensis is still a common parasite in South Korea. An enzyme-linked immunosorbent assay (ELISA) was developed to replace the usual intradermal test, and its performance in an area of endemicity was evaluated. From 2004 to 2006, 182 adults were included. The patient group consisted of 51 adults; 43 patients showed fluke eggs by microscopy, and 8 had their disease diagnosed clinically. The negative-control group included 131 adults: 98 at low risk and 33 at high risk of infestation. Both intradermal testing and ELISA were performed for all patients, and the sensitivity and specificity were evaluated. Statistical analysis for specificity looked at two groups: those at high risk and those at low risk. The sensitivity of the C. sinensis ELISA was 80.4%, while that of the intradermal test was 56.9% (P = 0.019). The specificities of the C. sinensis ELISA in the low-risk and high-risk groups were 93.9% and 33.3%, respectively, while those of the intradermal test were 85.7% and 30.3%, respectively (P = 0.0968, P = 0.9979). The C. sinensis ELISA may be more useful than the intradermal test; however, because of its low specificity, it may not be used independently for the diagnosis of C. sinensis infestation or a prevalence survey in a high-risk group.