聚合酶链反应方法与传统诊断技术在临床或流行病学疑似皮肤利什曼病（CL）患者中的 CL 检测准确性比较：系统评价和荟萃分析。

Test accuracy of polymerase chain reaction methods against conventional diagnostic techniques for Cutaneous Leishmaniasis (CL) in patients with clinical or epidemiological suspicion of CL: Systematic review and meta-analysis.

机构信息

PECET- Medical Research Institute, School of Medicine, University of Antioquia-UdeA, Calle, Medellín-Colombia.

Epidemiology and Biostatistic, Universidad CES Calle, Medellín-Colombia.

出版信息

PLoS Negl Trop Dis. 2020 Jan 21;14(1):e0007981. doi: 10.1371/journal.pntd.0007981. eCollection 2020 Jan.

BACKGROUND

Molecular diagnostic tests, notably polymerase chain reaction (PCR), are highly sensitive test for Leishmania detection, which is especially relevant in chronic cutaneous lesion with lower parasite load. An accurate diagnosis is essential because of the high toxicity of the medications for the disease. Nevertheless, diagnosis of cutaneous leishmaniasis (CL) is hampered by the absence of a reference standard. Assuming that the PCR-based molecular tools are the most accurate diagnostic method, the objective of this systematic review was to assess the diagnostic accuracy of PCR-based molecular tools in a meta-analysis of the published literature.

METHODOLOGY/PRINCIPAL FINDINGS: A search of the published literature found 142 papers of which only 13 studies met the selection criteria, including conventional PCR, real-time PCR, Loop-mediated isothermal amplification (LAMP), recombinase polymerase amplification (RPA), polymorphism-specific PCR (PS-PCR). The sensitivities of the individual studies ranged from 61% to 100%, and specificities ranged from 11% to 100%. The pooled sensitivities of PCR in smears were 0.95 (95% CI, 0.90 to 0.98), and the specificity was 0.91(95% CI, 0.70 to 0.98). In general population, estimates were lower in aspirates, skin biopsies and swab samples with 0.90 (95% CI, 0.80 to 0.95) and 0.87 (95% CI, 0.76 to 0.94) for sensitivity and specificity, respectively. The specificity was lower in consecutive studies, at 0.88 (95% CI, 0.59 to 0.98) and its CI were wider.

CONCLUSIONS/SIGNIFICANCE: No statistically significant differences between the accuracy in smears, aspirate, skin biopsies or swabs samples were observed. Therefore, a simple smear sample run by PCR, instead more invasive samples, may be enough to obtain a positive diagnosis of CL. The results for PCR in all samples type confirm previous reports that consider PCR as the most accurate method for the diagnosis of CL.

背景

分子诊断测试，尤其是聚合酶链反应（PCR），是一种高度敏感的利什曼原虫检测方法，在寄生虫负荷较低的慢性皮肤病变中尤其相关。由于疾病药物的高毒性，准确的诊断至关重要。然而，由于缺乏参考标准，皮肤利什曼病（CL）的诊断受到阻碍。假设基于 PCR 的分子工具是最准确的诊断方法，本系统评价的目的是通过对已发表文献的荟萃分析来评估基于 PCR 的分子工具的诊断准确性。

方法/主要发现：对已发表文献的搜索发现了 142 篇论文，其中只有 13 项研究符合选择标准，包括常规 PCR、实时 PCR、环介导等温扩增（LAMP）、重组酶聚合酶扩增（RPA）、多态性特异性 PCR（PS-PCR）。个别研究的敏感性范围为 61%至 100%，特异性范围为 11%至 100%。涂片的聚合酶敏感性为 0.95（95%CI，0.90 至 0.98），特异性为 0.91（95%CI，0.70 至 0.98）。在一般人群中，抽吸物、皮肤活检和拭子样本的估计值较低，敏感性分别为 0.90（95%CI，0.80 至 0.95）和 0.87（95%CI，0.76 至 0.94），特异性分别为 0.87（95%CI，0.76 至 0.94）。连续研究的特异性较低，为 0.88（95%CI，0.59 至 0.98），其 CI 较宽。

结论/意义：在涂片、抽吸物、皮肤活检或拭子样本的准确性方面没有观察到统计学上的显著差异。因此，运行 PCR 的简单涂片样本可能足以获得 CL 的阳性诊断，而无需更具侵入性的样本。所有样本类型的 PCR 结果证实了先前的报告，认为 PCR 是 CL 诊断最准确的方法。