A Multisite Trial Comparing Two Cytomegalovirus (CMV) pp65 Antigenemia Test Kits, Biotest CMV Brite and Bartels/Argene CMV Antigenemia
A Multisite Trial Comparing Two Cytomegalovirus (CMV) pp65 Antigenemia Test Kits, Biotest CMV Brite and Bartels/Argene CMV Antigenemia
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DOI：
10.1128/jcm.38.4.1430-1433.2000
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发表时间：
2000-04
影响因子：
9.4
通讯作者：
K. St. George;M. J. Boyd;S. Lipson;D. Ferguson;G. F. Cartmell;L. Falk;C. Rinaldo;M. Landry
中科院分区：
文献类型：
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作者：
K. St. George;M. J. Boyd;S. Lipson;D. Ferguson;G. F. Cartmell;L. Falk;C. Rinaldo;M. Landry
摘要：513份主要来自器官移植受者、人类免疫缺陷病毒阳性患者和骨髓移植受者的血液标本，通过培养和pp65抗原血症在四个检测点检测巨细胞病毒（CMV）。采用Biotest CMV Brite和Bartels/Argene CMV Antigenemia试剂盒检测外周血白细胞。CMV阳性109例，抗原血症阳性106例（97%），培养阳性34例（31%）。根据制造商的说明，Biotest试剂盒每载15万个细胞，Bartels试剂盒每载20万个细胞。共有93例（88%）标本经Biotest试剂盒检测为阳性，86例（81%）标本经Bartels试剂盒检测为阳性。在仅通过一种试剂盒检测出阳性的标本中，阳性细胞计数较低（中位数为1；范围为1至7）。当所有四个站点的数据合并和分析时，两种试剂盒的性能之间没有统计学差异；发现Biotest和Bartels试剂盒在检测CMV pp65抗原血症的敏感性、特异性以及阳性和阴性预测值方面是相同的。
ABSTRACT A total of 513 blood specimens, predominantly from organ transplant recipients, human immunodeficiency virus-positive patients, and bone marrow transplant recipients, were tested for cytomegalovirus (CMV) by culture and pp65 antigenemia across four test sites. Peripheral blood leukocytes were examined by using both the Biotest CMV Brite and the Bartels/Argene CMV Antigenemia kits. A total of 109 specimens were positive for CMV, 106 (97%) were positive by antigenemia, and 34 (31%) were positive by culture. According to the manufacturers' instructions, 150,000 cells were applied per slide for the Biotest kit and 200,000 cells per slide for the Bartels kit. A total of 93 specimens (88%) were positive by the Biotest kit, and 86 (81%) were positive by the Bartels kit. In specimens found to be positive by only one kit, the positive cell counts were low (median, 1; range, 1 to 7). When the data from all four sites were combined and analyzed, there was no statistical difference between the performance of the two kits; the Biotest and Bartels kits were found to be equivalent in sensitivity, specificity, and positive and negative predictive values for the detection of CMV pp65 antigenemia.