拭子自我检测与感染经济监测试验（SYSTEMATIC）：第 2 部分。比较直肠、咽和泌尿生殖道样本单独分析与混合样本分析用于淋病和衣原体诊断的诊断准确性和成本效益研究。
Swab-Yourself Trial With Economic Monitoring and Testing for Infections Collectively (SYSTEMATIC): Part 2. A Diagnostic Accuracy and Cost-effectiveness Study Comparing Rectal, Pharyngeal, and Urogenital Samples Analyzed Individually, Versus as a Pooled Specimen, for the Diagnosis of Gonorrhea and Chlamydia.
机构信息
Leeds Sexual Health, Leeds Teaching Hospitals National Health Services Trust, Leeds, United Kingdom.
Department of Infectious Disease Epidemiology, Imperial College London, London, United Kingdom.
出版信息
Clin Infect Dis. 2021 Nov 2;73(9):e3183-e3193. doi: 10.1093/cid/ciaa1546.
BACKGROUND
Sexual history does not accurately identify those with extragenital Neisseria gonorrhoeae (NG) and Chlamydia trachomatis (CT), so universal extragenital sampling is recommended. Nucleic acid amplification tests (NAATs) are expensive. If urogenital, plus rectal and pharyngeal, samples are analyzed, the diagnostic cost is trebled. Pooling samples into 1 NAAT container would cost the same as urogenital samples alone. We compared clinician triple samples analyzed individually with self-taken pooled samples for diagnostic accuracy, and cost, in men who have sex with men (MSM) and females.
METHODS
This was a prospective, convenience sample in United Kingdom sexual health clinic. Randomized order of clinician and self-samples from pharynx, rectum, plus first-catch urine (FCU) in MSM and vulvovaginal swabs (VVS) in females, for NG and CT detection.
RESULTS
Of 1793 participants (1284 females, 509 MSM), 116 had NG detected (75 urogenital, 83 rectum, 72 pharynx); 276 had CT detected (217 urogenital, 249 rectum, 63 pharynx). There was no difference in sensitivities between clinician triple samples and self-pooled specimens for NG (99.1% and 98.3%), but clinician samples analyzed individually identified 3% more chlamydia infections than pooled (99.3% and 96.0%; P = .027). However, pooled specimens identified more infections than VVS/FCU alone. Pooled specimens missed 2 NG and 11 CT infections, whereas VVS/FCU missed 41 NG and 58 CT infections. Self-taken pooled specimens were the most cost-effective.
CONCLUSIONS
FCU/VVS testing alone missed many infections. Self-taken pooled samples were as sensitive as clinician triple samples for identifying NG, but clinician samples analyzed individually identified 3% more CT infections than pooled. The extragenital sampling was achievable at no additional diagnostic cost to the FCU/VVS.
CLINICAL TRIALS REGISTRATION
NCT02371109.
背景
性史不能准确识别外生殖器淋病奈瑟菌（NG）和沙眼衣原体（CT）感染者，因此推荐进行广泛的外生殖器采样。核酸扩增检测（NAAT）费用昂贵。如果对泌尿生殖道、直肠和咽部样本进行分析，诊断费用将增加两倍。将样本合并到 1 个 NAAT 容器中，费用与仅对泌尿生殖道样本进行分析相同。我们比较了临床医生对男性性接触者（MSM）和女性进行的单独分析的三联样本和自我采集的混合样本的诊断准确性和成本。
方法
这是英国性健康诊所的一项前瞻性、方便样本研究。对 MSM 的咽、直肠和首次尿样（FCU）以及女性的外阴阴道拭子（VVS）进行临床医生和自我样本的随机顺序分析，用于检测 NG 和 CT。
结果
在 1793 名参与者中（1284 名女性，509 名 MSM），有 116 人检测到 NG（75 例泌尿生殖道，83 例直肠，72 例咽部）；有 276 人检测到 CT（217 例泌尿生殖道，249 例直肠，63 例咽部）。对于 NG，临床医生的三联样本和自我采集的混合样本的敏感性没有差异（99.1%和 98.3%），但单独分析的临床医生样本比混合样本多发现 3%的衣原体感染（99.3%和 96.0%；P=0.027）。然而，混合样本比 VVS/FCU 单独检测出更多的感染。混合样本漏检了 2 例 NG 和 11 例 CT 感染，而 VVS/FCU 漏检了 41 例 NG 和 58 例 CT 感染。自我采集的混合样本最具成本效益。
结论
仅进行 FCU/VVS 检测会漏检许多感染。自我采集的混合样本与临床医生的三联样本一样能准确识别 NG，但单独分析的临床医生样本比混合样本多发现 3%的 CT 感染。外生殖器采样可在不增加 FCU/VVS 检测费用的情况下实现。
临床试验注册
NCT02371109。
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