Gun-Munro J, Mahony J, Lyn P, Luinstra K, Smaill F, Richardson H
McMaster University Medical Centre, Hamilton, Ontario, Canada.
Sex Transm Dis. 1996 Mar-Apr;23(2):115-9. doi: 10.1097/00007435-199603000-00005.
The VIDAS Enzyme Linked Fluorescent Assay is a fully automated assay for the detection of Chlamydia trachomatis in clinical specimens. Because there is an increasing demand for automated assays for large volume laboratories and there is little performance data available, the authors evaluated the performance of the VIDAS enzyme linked fluorescent assay by comparing it with Chlamydiazyme and polymerase chain reaction.
Endocervical swabs from 330 women attending a hospital based obstetrics/gynecology clinic and 100 first void urine specimens from males attending a sexually transmitted disease clinic were tested by enzyme linked fluorescent assay, Chlamydiazyme, and polymerase chain reaction.
Fourteen of 330 endocervical specimens and 14 of 100 first void urine specimens were positive by Chlamydiazyme. Enzyme linked fluorescent assay detected 12 of 14 endocervical and 11 of 14 first void urine specimens. Compared with Chlamydiazyme, enzyme linked fluorescent assay had a sensitivity of 85.7% (12 of 14) for endocervical swabs and 76.9% (11 of 14) for first void urine specimens. Polymerase chain reaction detected an additional five endocervical and two first void urine specimens that had negative results by both enzyme linked fluorescent assay and Chlamydiazyme. All 7 were confirmed positive by polymerase chain reaction using a second primer set. Using an expanded gold standard of blocked Chlamydiazyme and confirmed polymerase chain reaction, enzyme linked fluorescent assay had a sensitivity of 63.2% (12 of 19) for endocervical swabs and 68.8% (11 of 16) for first void urine specimens compared with 73.7% (14 of 19) and 87.5% (14 of 16) for Chlamydiazyme. Polymerase chain reaction had a sensitivity of 100% (19 of 19) and 93.8% (15 of 16) for endocervical swabs and first void urine specimens, respectively. The specificity of enzyme linked fluorescent assay and Chlamydiazyme was 100%.
The VIDAS enzyme linked fluorescent assay for the detection of Chlamydia trachomatis in genitourinary specimens is highly specific but is not sufficiently sensitive for use as a routine diagnostic test.
VIDAS酶联荧光分析法是一种用于检测临床标本中沙眼衣原体的全自动检测方法。由于大型实验室对自动化检测方法的需求日益增加，且可用的性能数据较少，作者通过将VIDAS酶联荧光分析法与衣原体酶免疫测定法和聚合酶链反应进行比较，评估了其性能。
对来自一家医院妇产科门诊的330名女性的宫颈拭子和来自一家性传播疾病门诊的100名男性的首次晨尿标本进行酶联荧光分析法、衣原体酶免疫测定法和聚合酶链反应检测。
衣原体酶免疫测定法检测出330份宫颈标本中的14份和100份首次晨尿标本中的14份呈阳性。酶联荧光分析法检测出14份宫颈标本中的12份和14份首次晨尿标本中的11份。与衣原体酶免疫测定法相比，酶联荧光分析法对宫颈拭子的敏感性为85.7%（14份中的12份），对首次晨尿标本的敏感性为76.9%（14份中的11份）。聚合酶链反应检测出另外5份宫颈标本和2份首次晨尿标本，这两份标本经酶联荧光分析法和衣原体酶免疫测定法检测均为阴性。使用第二组引物进行聚合酶链反应，所有7份标本均被确认为阳性。采用扩展的金标准，即阻断衣原体酶免疫测定法和经确认的聚合酶链反应，酶联荧光分析法对宫颈拭子的敏感性为63.2%（19份中的12份），对首次晨尿标本的敏感性为68.8%（16份中的11份），而衣原体酶免疫测定法分别为73.7%（19份中的14份）和87.5%（16份中的14份）。聚合酶链反应对宫颈拭子和首次晨尿标本的敏感性分别为100%（19份中的19份）和93.8%（16份中的15份）。酶联荧光分析法和衣原体酶免疫测定法的特异性均为100%。
用于检测泌尿生殖标本中沙眼衣原体的VIDAS酶联荧光分析法具有高度特异性，但作为常规诊断试验其敏感性不足。
