Interisano Maria, Marucci Gianluca, Gómez-Morales Maria Angeles, Glawischnig Walter, Claes Marleen, Kärssin Age, Zakrisson Goran, Pozio Edoardo
Department of Infectious Parasitic and Immunomediated Diseases, Istituto Superiore di Sanità, viale Regina Elena 299, 00161 Rome, Italy.
Vet Parasitol. 2013 May 20;194(2-4):121-4. doi: 10.1016/j.vetpar.2013.01.035. Epub 2013 Feb 5.
An antigen detection kit (Trichin-L), based on latex agglutination and developed by the Bio-Rad company was validated at five European laboratories. The validation parameters included specificity, sensitivity, robustness and reproducibility. Specificity was evaluated by testing parasite antigens from five non-Trichinella parasites in addition to the Trichinella genus. To evaluate sensitivity, 10 pork samples spiked with 1, 3, 6 or 15 Trichinella larvae were tested in each laboratory. To evaluate the robustness of the test, the solubilized antigens were maintained at room temperature and tested at different times. Reproducibility was assessed in each laboratory using 40, 100g minced pork samples, each spiked with Trichinella spiralis. The use of larval homogenates obtained from the Trichin-L kit as a template for parasite identification at the species level by a multiplex PCR, was also evaluated. The results showed a high specificity and sensitivity where solubilized antigens maintained their stability and reactivity for up to three days. Reproducibility was high, as similar results were obtained in the five laboratories. The larval homogenates obtained using the Trichin-L kit were successfully used in multiplex PCRs to identify Trichinella species.
一款由伯乐公司研发的基于乳胶凝集法的抗原检测试剂盒（Trichin-L）在欧洲的五个实验室进行了验证。验证参数包括特异性、敏感性、稳健性和可重复性。特异性通过检测旋毛虫属之外的五种非旋毛虫寄生虫的抗原进行评估。为评估敏感性，每个实验室对添加了1、3、6或15条旋毛虫幼虫的10份猪肉样本进行了检测。为评估该检测的稳健性，将溶解的抗原置于室温下，并在不同时间进行检测。使用40份每份重100克且均添加了旋毛虫的碎猪肉样本，在每个实验室评估了可重复性。还评估了将从Trichin-L试剂盒获得的幼虫匀浆用作多重PCR在物种水平鉴定寄生虫模板的用途。结果显示，溶解的抗原在长达三天的时间内保持其稳定性和反应性，具有高特异性和敏感性。可重复性很高，因为五个实验室获得了相似的结果。使用Trichin-L试剂盒获得的幼虫匀浆成功用于多重PCR以鉴定旋毛虫物种。
