Johnson Barbara W, Goodman Christin H, Holloway Kimberly, de Salazar P Martinez, Valadere Anne M, Drebot Michael A
Diagnostic and Reference Laboratory, Arboviral Diseases Branch, Division of Vector-Borne Diseases, Centers for Disease Control and Prevention, Fort Collins, Colorado.
Viral Zoonosis, National Microbiology Laboratory, Public Health Agency of Canada, Winnipeg, Canada.
Am J Trop Med Hyg. 2016 Jul 6;95(1):182-192. doi: 10.4269/ajtmh.16-0013. Epub 2016 Mar 14.
Commercial chikungunya virus (CHIKV)-specific IgM detection kits were evaluated at the Centers for Disease Control and Prevention (CDC), the Public Health Agency of Canada National Microbiology Laboratory, and the Caribbean Public Health Agency (CARPHA). The Euroimmun Anti-CHIKV IgM ELISA kit had ≥ 95% concordance with all three reference laboratory results. The limit of detection for low CHIK IgM+ samples, as measured by serial dilution of seven sera up to 1:12,800 ranged from 1:800 to 1:3,200. The Euroimmun IIFT kit evaluated at CDC and CARPHA performed well, but required more retesting of equivocal results. The InBios CHIKjj Detect MAC-ELISA had 100% and 98% concordance with CDC and CARPHA results, respectively, and had equal sensitivity to the CDC MAC-ELISA to 1:12,800 dilution in serially diluted samples. The Abcam Anti-CHIKV IgM ELISA had high performance at CARPHA, but at CDC, performance was inconsistent between lots. After replacement of the biotinylated IgM antibody controls with serum containing CHIKV-specific IgM and additional quality assurance/control measures, the Abcam kit was rereleased and reevaluated at CDC. The reformatted Abcam kit had 97% concordance with CDC results and limit of detection of 1:800 to 1:3,200. Two rapid tests and three other CHIKV MAC-ELISAs evaluated at CDC had low sensitivity, as the CDC CHIKV IgM in-house positive controls were below the level of detection. In conclusion, laboratories have options for CHIKV serological diagnosis using validated commercial kits.
美国疾病控制与预防中心（CDC）、加拿大公共卫生署国家微生物实验室以及加勒比公共卫生署（CARPHA）对市售的基孔肯雅病毒（CHIKV）特异性IgM检测试剂盒进行了评估。欧蒙抗CHIKV IgM ELISA试剂盒与所有三个参考实验室的结果一致性≥95%。通过对7份血清进行系列稀释至1:12,800来测定低CHIK IgM+样本的检测限，范围为1:800至1:3,200。在CDC和CARPHA评估的欧蒙免疫印迹法（IIFT）试剂盒表现良好，但对可疑结果需要更多的复测。InBios CHIKjj Detect MAC-ELISA与CDC和CARPHA结果的一致性分别为100%和98%，并且在系列稀释样本中对1:12,800稀释度的检测灵敏度与CDC MAC-ELISA相当。Abcam抗CHIKV IgM ELISA试剂盒在CARPHA表现出色，但在CDC，不同批次之间的性能不一致。在用含有CHIKV特异性IgM的血清替换生物素化IgM抗体对照并采取额外的质量保证/控制措施后，Abcam试剂盒在CDC重新发布并重新评估。重新调整格式的Abcam试剂盒与CDC结果的一致性为97%，检测限为1:800至1:3,200。在CDC评估的两种快速检测方法和其他三种CHIKV MAC-ELISA检测灵敏度较低，因为CDC CHIKV IgM内部阳性对照低于检测水平。总之，实验室可以选择使用经过验证的市售试剂盒进行CHIKV血清学诊断。
