Cortés Liliana Jazmín, Guerra Ángela Patricia
Grupo de Parasitología, Subdirección Laboratorio Nacional de Referencia, Dirección de Redes en Salud Pública, Instituto Nacional de Salud, Bogotá, D.C., Colombia.
Biomedica. 2020 Mar 1;40(1):117-128. doi: 10.7705/biomedica.4893.
Introduction: Taking into account the difficulty of performing malaria microscopic diagnosis in rural areas, rapid diagnostic tests (RDT) are a good alternative, but it is important to verify their diagnostic performance. Objective: To evaluate the diagnostic performance of the RDTs used in five Colombian departments by comparing them with the microscopic diagnosis and using PCR as the reference standard. Materials and methods: Thick blood film and RDTs were used to diagnose symptomatic individuals; additionally, the filter paper was impregnated with blood for the molecular test. Results: We included 314 samples whose percentage of positivity for malaria was 49% by PCR, 48% by microscopy and 46% by RDT; parasitemia ranged between 180 and 23,800 p/μL of blood. The concordance of the results from the microscopy units and those of the PCR (National Laboratory of Reference) was as follows: Cohen’s kappa coefficient, 0.975 (95% CI: 0.950-0.999); sensitivity, 97% (95% CI 95-100); specificity 100% (95% CI: 100-100), and kappa index of species, 0.958 (IC95%: 0.912-1.00). The concordance between the Pf/Pv RDT (at the microscopy units) and the PCR (National Laboratory of Reference) was as follows: kappa coefficient, 0.878 (95% CI: 0.784-0.973); sensitivity, 94% (95% CI: 87-100); specificity, 95% (95% CI: 90-100), and kappa index of species, 1.0 (95% CI: 1.00-1.00). The concordance between the Pf/Pan RDT versus PCR was: Cohen’s kappa coefficient, 0.920 (95 % CI: 0.865- 0.974); sensitivity, 94% (95% CI: 90-98); specificity, 99% (95% CI 95-100), and kappa index of species, 0.750 (IC95% 0,637-0,863). Conclusion: The results of this study support the use of RDTs in Colombia; however, more training of the personnel is required to accurately differentiate Plasmodium species.
考虑到在农村地区进行疟疾显微镜诊断存在困难，快速诊断检测（RDT）是一个不错的选择，但验证其诊断性能很重要。目的：通过将哥伦比亚五个部门使用的RDT与显微镜诊断进行比较，并以PCR作为参考标准，评估其诊断性能。材料和方法：使用厚血膜和RDT对有症状个体进行诊断；此外，将滤纸浸渍血液用于分子检测。结果：我们纳入了314个样本，通过PCR检测疟疾阳性率为49%，显微镜检测为48%，RDT检测为46%；疟原虫血症范围在每微升血液180至23,800个寄生虫之间。显微镜检测单位与PCR（国家参考实验室）结果的一致性如下：科恩kappa系数为0.975（95%置信区间：0.950 - 0.999）；灵敏度为97%（95%置信区间95 - 100）；特异性为100%（95%置信区间：100 - 100），物种kappa指数为0.958（95%置信区间：0.912 - 1.00）。Pf/Pv RDT（在显微镜检测单位）与PCR（国家参考实验室）之间的一致性如下：kappa系数为0.878（95%置信区间：0.784 - 0.973）；灵敏度为94%（95%置信区间：87 - 100）；特异性为95%（95%置信区间：90 - 100），物种kappa指数为1.0（95%置信区间：1.00 - 1.0）。Pf/Pan RDT与PCR之间的一致性为：科恩kappa系数为0.920（95%置信区间：0.865 - 0.974）；灵敏度为94%（95%置信区间：90 - 98）；特异性为99%（95%置信区间95 - 100），物种kappa指数为0.750（95%置信区间0,637 - 0,863）。结论：本研究结果支持在哥伦比亚使用RDT；然而，需要对人员进行更多培训以准确区分疟原虫物种。
