Coleman P, Varitek V, Mushahwar I K, Marchlewicz B, Safford J, Hansen J, Kurpiewski G, Grier T
Infectious Disease and Immunology Research, Abbott Laboratories, Illinois 60064.
J Clin Microbiol. 1989 Dec;27(12):2811-4. doi: 10.1128/jcm.27.12.2811-2814.1989.
TestPack Chlamydia (Abbott Laboratories) is a rapid enzyme immunoassay for the direct antigen detection of Chlamydia trachomatis in endocervical specimens. The assay is self-contained, requires no specialized equipment, and yields results in less than 30 min. The clinical performance of TestPack Chlamydia versus chlamydial cell culture was evaluated with a total of 1,694 paired endocervical specimens. Discordant samples were further investigated by immunofluorescent staining and by Chlamydiazyme immunoassay, with confirmatory procedures. The sensitivity of TestPack Chlamydia with less-than-48-h-old specimens was 76.5%, while culture sensitivity was 86.7%. TestPack Chlamydia specificity was determined to be 99.5%. These results indicate that TestPack Chlamydia is an accurate test for chlamydial infection, with a positive predictive value of 96.2%. This assay is suitable for low-volume chlamydial testing in physician offices, clinics, and smaller laboratories.
衣原体检测试剂盒（雅培实验室）是一种快速酶免疫测定法，用于直接检测宫颈标本中的沙眼衣原体抗原。该检测试剂盒自成一体，无需专门设备，30分钟内即可得出结果。采用总共1694对宫颈标本对衣原体检测试剂盒与衣原体细胞培养的临床性能进行了评估。对不一致的样本通过免疫荧光染色和衣原体酶免疫测定法进行进一步研究，并采用了确证程序。对于保存时间少于48小时的标本，衣原体检测试剂盒的灵敏度为76.5%，而培养灵敏度为86.7%。衣原体检测试剂盒的特异性确定为99.5%。这些结果表明，衣原体检测试剂盒是一种用于衣原体感染的准确检测方法，阳性预测值为96.2%。该检测方法适用于医生办公室、诊所和较小实验室的少量衣原体检测。
