Brook Gary
Sex Transm Infect. 2015 Dec;91(8):539-44. doi: 10.1136/sextrans-2014-051997. Epub 2015 May 2.
To identify point-of-care (POC) and rapid nucleic acid amplification techniques (NAATs) for the diagnosis of chlamydia and gonorrhoea and assess their utility.
Literature search for available POC and rapid NAATs. The performance from the best-performing assays were applied hypothetically to patients in the clinic in which 100 consecutive patients with chlamydia and 100 with gonorrhoea were diagnosed in 1737 and 4575 patients respectively, with 44/100 and 54/100 treated at first attendance, respectively.
11 POC and 1 rapid NAAT were identified. Published performances for the best POC for chlamydia (CRT) were: sensitivity 41%-87%, specificity 89%-99.6%. Our data suggest that if this assay was used instead of our current NAAT, for every 100 patients diagnosed currently, 23-46 extra patients would be treated at first attendance; 10-35 would go undiagnosed with 7-191 false-positives. Best chlamydia rapid NAAT (GeneXpert): sensitivity 97.5%-98.7%, specificity 99.4%-99.9%. Anticipated performance for every 100 patients diagnosed currently: 0 extra patients treated at first attendance, 1-3 undiagnosed, 0-2 false-positives. Best POC for gonorrhoea (GC Check): sensitivity 54%-70%, specificity 97%-98%. Anticipated performance for every 100 patients diagnosed currently: 14-18 extra patients treated at first attendance, 28-32 undiagnosed, 92-137 false-positives. Best rapid NAAT for gonorrhoea (GeneXpert): sensitivity 96%-100%, specificity 99.9%-100%. Anticipated performance for every 100 patients diagnosed currently: 0 extra patients treated at first attendance, 0-4 undiagnosed, 0-5 false-positives. Rapid NAAT would reduce time to treatment by 4 days for initially untreated patients.
POC assays would need to be used in conjunction with a NAAT, increasing early treatment rates expense and false-positive results. The rapid NAAT could be used alone, with a reduction in average time-to-treat and a small reduction in sensitivity and specificity.
确定用于诊断衣原体和淋病的即时检验（POC）及快速核酸扩增技术（NAATs），并评估其效用。
检索有关可用POC和快速NAATs的文献。将表现最佳的检测方法的性能假设性地应用于临床患者，其中在1737例和4575例患者中分别诊断出100例衣原体感染患者和100例淋病患者，首次就诊时分别有44/100和54/100的患者接受了治疗。
确定了11种POC和1种快速NAAT。已发表的衣原体最佳POC（CRT）的性能为：敏感性41%-87%，特异性89%-99.6%。我们的数据表明，如果使用该检测方法替代我们目前的NAAT，对于目前诊断的每100例患者，首次就诊时将多治疗23-46例患者；10-35例患者将漏诊，7-191例假阳性。最佳衣原体快速NAAT（GeneXpert）：敏感性97.5%-98.7%，特异性99.4%-99.9%。目前诊断的每100例患者的预期性能：首次就诊时无额外患者接受治疗，1-3例漏诊，0-2例假阳性。淋病最佳POC（GC Check）：敏感性54%-70%，特异性97%-98%。目前诊断的每100例患者的预期性能：首次就诊时多治疗14-18例患者，28-32例漏诊，92-137例假阳性。淋病最佳快速NAAT（GeneXpert）：敏感性96%-100%，特异性99.9%-100%。目前诊断的每100例患者的预期性能：首次就诊时无额外患者接受治疗，0-4例漏诊，0-5例假阳性。快速NAAT可将初始未治疗患者的治疗时间缩短4天。
POC检测需要与NAAT联合使用，这会增加早期治疗率、费用和假阳性结果。快速NAAT可单独使用，平均治疗时间缩短，敏感性和特异性略有降低。
