Molecular diagnostics are essential for detecting intestinal parasites, but evaluating clinical samples from low endemic areas, including Korea, is challenging. We tested the performance of the BD MAX Enteric Parasite Panel in simulated samples for clinical use. Simulated samples were prepared with residual stool samples to confirm the diagnostic performance of the kits. Standard materials for Cryptosporidium parvum, Giardia lamblia, and Entamoeba histolytica were obtained for assessment. Limit of detection was determined by diluting standard materials into multiple concentrations and testing each in duplicate. Repeatability was assessed by retesting all samples twice. Accuracy was evaluated by comparing BD MAX System results with intended results. The limit of detection values obtained using standard materials were 781 cysts/ml, 6,250 oocysts/ml, and 125 DNA copies/ml for G. lamblia, C. parvum, and E. histolytica, respectively. Simulated G. lamblia-positive stool samples with concentrations above 6,250 cysts/ml consistently yielded positive results (100% concordance). However, C. parvum-positive stool samples at 6,250 oocysts/ml showed 50% concordance initially and 75% after retesting. At 62,500 oocysts/ml, the concordance rates were 89% initially and 100% after retesting. Overall agreement was 95.2%, but that for C. parvum was relatively low (82.4%). The diagnostic performances were 87.8% of sensitivity and 100% of specificity. Despite the limited clinical samples, BD MAX Enteric Parasite Panel showed good performance for clinical use, and spiked samples proved useful for evaluating protozoan PCR in low-incidence regions.
The positive rate of Clonorchis sinensis is the highest among intestinal parasites in the Republic of Korea (Korea). More than 1.2 million people were at risk of C. sinensis infection in Korea in 2012. An intensive control program is being implemented for residents of the 5 major river basins to reduce helminthic infections, including C. sinensis infection. This study evaluated the continuous intensive control program for parasitic diseases including clonorchiasis in areas near the 5 major river basins in Korea over the past 10 years (2011-2020). A total of 335,020 fecal samples (one sample per resident) prepared by the modified sedimentation technic were microscopically examined. Those who expelled helminth eggs were treated with anthelmintics through local health centers and re-examined 3 months later. The overall positive rate of helminths egg was 7.1%. The annual positive rates were dramatically decreased from 14.4% (2011) to 5.9% (2020). The egg positive rate was highest in C. sinensis (5.3%), followed by heterophyid flukes (1.5%) and Trichuris trichiura (0.2%). The prevalence of C. sinensis was significantly higher in males (7.6%) than in females (3.7%), and the highest in the 50–59 years (7.0%) age group. Our results are beneficial to establish prevention and control policies against helminthiases including clonorchiasis in endemic areas in this country.
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