Harding-Esch Emma M, Nori Achyuta V, Hegazi Aseel, Pond Marcus J, Okolo Olanike, Nardone Anthony, Lowndes Catherine M, Hay Phillip, Sadiq S Tariq
Applied Diagnostic Research and Evaluation Unit, St George's University of London, Institute for Infection & Immunity, London, UK.
HIV/STI Department, National Infection Service, Public Health England, London, UK.
Sex Transm Infect. 2017 Sep;93(6):424-429. doi: 10.1136/sextrans-2016-052988. Epub 2017 Feb 3.
To assess clinical service value of STI point-of-care test (POCT) use in a 'sample first' clinical pathway (patients providing samples on arrival at clinic, before clinician consultation). Specific outcomes were: patient acceptability; whether a rapid nucleic acid amplification test (NAAT) for (CT/NG) could be used as a POCT in practice; feasibility of non-NAAT POCT implementation for (TV) and bacterial vaginosis (BV); impact on patient diagnosis and treatment.
Service evaluation in a south London sexual health clinic. Symptomatic female and male patients and sexual contacts of CT/NG-positive individuals provided samples for diagnostic testing on clinic arrival, prior to clinical consultation. Tests included routine culture and microscopy; CT/NG (GeneXpert) NAAT; non-NAAT POCTs for TV and BV.
All 70 (35 males, 35 females) patients approached participated. The 'sample first' pathway was acceptable, with >90% reporting they were happy to give samples on arrival and receive results in the same visit. Non-NAAT POCT results were available for all patients prior to leaving clinic; rapid CT/NG results were available for only 21.4% (15/70; 5 males, 10 females) of patients prior to leaving clinic. Known negative CT/NG results led to two females avoiding presumptive treatment, and one male receiving treatment directed at possible infection causing non-gonococcal urethritis. Non-NAAT POCTs detected more positives than routine microscopy (TV 3 vs 2; BV 24 vs 7), resulting in more patients receiving treatment.
A 'sample first' clinical pathway to enable multiple POCT use was acceptable to patients and feasible in a busy sexual health clinic, but rapid CT/NG processing time was too long to enable POCT use. There is need for further development to improve test processing times to enable POC use of rapid NAATs.
评估即时检验(POCT)在“先采样”临床路径(患者在到达诊所时,在临床医生会诊之前提供样本)中用于性传播感染(STI)检测的临床服务价值。具体结果包括:患者接受度;沙眼衣原体(CT)/淋病奈瑟菌(NG)的快速核酸扩增检测(NAAT)在实际应用中能否用作POCT;针对滴虫(TV)和细菌性阴道病(BV)实施非NAAT POCT的可行性;对患者诊断和治疗的影响。
在伦敦南部一家性健康诊所进行服务评估。有症状的女性和男性患者以及CT/NG阳性个体的性接触者在到达诊所后、临床会诊之前提供样本进行诊断检测。检测包括常规培养和显微镜检查;CT/NG(GeneXpert)NAAT;针对TV和BV的非NAAT POCT。
所有70名(35名男性,35名女性)前来就诊的患者均参与其中。“先采样”路径是可接受的,超过90%的患者表示他们愿意在到达时提供样本并在同一次就诊中获得结果。所有患者在离开诊所前均可获得非NAAT POCT结果;只有21.4%(15/70;5名男性,10名女性)的患者在离开诊所前可获得快速CT/NG结果。已知的CT/NG阴性结果使两名女性避免了推定治疗,一名男性接受了针对可能导致非淋菌性尿道炎的感染的治疗。非NAAT POCT检测出的阳性病例比常规显微镜检查更多(TV:3例对2例;BV:24例对7例),从而使更多患者接受了治疗。
“先采样”临床路径可使多种POCT得以应用,患者能够接受,且在繁忙的性健康诊所中可行,但快速CT/NG检测的处理时间过长,无法实现POCT的应用。需要进一步改进以缩短检测处理时间,从而实现快速NAAT的即时检测应用。