Dayian G, Morse D L, Schryver G D, Stevens R W, Birkhead G S, White D J, Hechemy K E
Wadsworth Center for Laboratories and Research, New York State Department of Health, Albany 12201-0509.
Arch Pathol Lab Med. 1994 May;118(5):501-5.
Nine proficiency test events for Lyme disease (Borrelia burgdorferi) antibody were carried out from October 1988 to January 1992 by the New York State Department of Health, Albany, Overall sensitivity for the 846 participants averaged 95.4%, with varying sensitivities of 98.7% for users (71 laboratories) of immunofluorescence assays, 97.4% for users (144 laboratories) of solid-phase fluorescence immunoassays, and 94.6% for users (631 laboratories) of enzyme immunoassays. Thirty percent of the enzyme immunoassay laboratories tested at greater than or equal to 98.4% sensitivity by the DiaMedix test kit (DiaMedix Corp, Miami, Fla) and MarDx test kit (MarDx Diagnostics Inc, Scotch Plains, NJ), while 7% tested at less than or equal to 83% by the Access test kit (Access Medical Systems Inc, Branford, Conn) and the Cambridge BioScience test kit (Cambridge BioScience, Worcester, Mass). Overall specificity was 98.8%, with specificities greater than 99% for both solid-phase fluorescence immunoassay and enzyme immunoassay users and 92.9% for immunofluorescence assay users. Cross-reactivity with Treponema pallidum antibody was high for the Hillcrest (Hillcrest Biologicals, Cypress, Calif) (30%) and Wampole (Wampole Laboratories, Cranbury, NJ) (25%) immunofluorescence assay test kit users and for the MarDx (30%) and 3M (3M Diagnostics Systems Inc, Santa Clara, Calif) (24%) enzyme immunoassay test kit users. Laboratories that tested by the Wampole immunofluorescence assay test kit had also high cross-reactivity (25%) against heterophile antibody.
1988年10月至1992年1月期间，纽约州卫生部在奥尔巴尼开展了9次莱姆病（伯氏疏螺旋体）抗体熟练度测试活动。846名参与者的总体敏感性平均为95.4%，其中免疫荧光检测法使用者（71个实验室）的敏感性为98.7%，固相荧光免疫检测法使用者（144个实验室）的敏感性为97.4%，酶免疫检测法使用者（631个实验室）的敏感性为94.6%。30%的酶免疫检测实验室使用DiaMedix检测试剂盒（DiaMedix公司，佛罗里达州迈阿密）和MarDx检测试剂盒（MarDx诊断公司，新泽西州斯科茨平原）时，检测敏感性大于或等于98.4%，而7%的实验室使用Access检测试剂盒（Access医疗系统公司，康涅狄格州布兰福德）和剑桥生物科学检测试剂盒（剑桥生物科学公司，马萨诸塞州伍斯特）时，检测敏感性小于或等于83%。总体特异性为98.8%，固相荧光免疫检测法和酶免疫检测法使用者的特异性均大于99%，免疫荧光检测法使用者的特异性为92.9%。Hillcrest（Hillcrest生物制品公司，加利福尼亚州赛普里斯）（30%）和Wampole（Wampole实验室，新泽西州克兰伯里）（25%）免疫荧光检测试剂盒使用者以及MarDx（30%）和3M（3M诊断系统公司，加利福尼亚州圣克拉拉）（24%）酶免疫检测试剂盒使用者与梅毒螺旋体抗体的交叉反应性较高。使用Wampole免疫荧光检测试剂盒进行检测的实验室对嗜异性抗体也有较高的交叉反应性（25%）。
