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[在哥伦比亚疟疾流行地区使用ICT疟疾免疫层析Binax NOW ICT P.f/P.v检测法进行疟疾快速诊断的评估]

[Evaluation of ICT malaria immunochromatographic Binax NOW ICT P.f/P.v test for rapid diagnosis of malaria in a Colombian endemic area].

作者信息

Pabón Adriana, Alvarez Gonzalo, Yánez Jorge, Céspedes Carlos, Rodríguez Yensa, Restrepo Angela, Blair Silvia

机构信息

Grupo de Malaria, Sede de Investigación Universitaria, Universidad de Antioquia, Calle 62 No. 52-59, Medellín, Colombia.

出版信息

Biomedica. 2007 Jun;27(2):225-35. Epub 2007 Aug 21.

Abstract

INTRODUCTION

One of the strategies to reduce malarial morbidity and mortality is to make an early diagnosis, using simple rapid tests which are highly sensitive and specific. Furthermore, the tests must be easy to perform and understand by local people in such a way that a suitable and prompt antimalarial treatment is guaranteed.

OBJECTIVE

The sensitivity and specificity was determined for the immuno-chromographic malaria dipstick (ICT Pf/Pv) test for the rapid diagnosis of malaria in Turbo, Antioquia.

MATERIALS AND METHODS

The sample consisted of 171 patients distributed into two groups: the first group was 118 patients with acute febrile syndrome compatible with malaria to which ICT Pf/Pv and thick smears were applied simultaneously; a second group was 53 patients with positive diagnosis by thick smear, with follow-up on the 4th and 7th days after beginning treatment.

RESULTS

Sensitivity and specificity of the ICT Pf/Pv test for Plasmodium falciparum infections were 54.2% (95%CI: 52.0-53.4%) and 93.6% (95%CI: 93.1-94.2%), respectively. In addition, for Plasmodium vivax the sensitivity and specificity were 80% (95%CI: 77.9-82.1%) and 100% (95%CI: 99.5-100%); there was a 21.4% loss of sensitivity for P. falciparum 21.4% and a 33% loss for P. vivax malaria with parasitaemias under 500 parasites/ul. For the confirmatory test, ICT Pf/Pv showed a global sensitivity of 71.6% with 20.7% false positive and 5.6% false negative results. During follow-up, ICT showed 36% and 34% false positive results for day 4 and 7, respectively.

CONCLUSIONS

The ICT Pf/Pv test has a poor sensitivity for P. falciparum malaria and its capacity to detect parasitemias under 500 parasites/ul is minimal. As a confirmatory test, the ICT Pf/Pv has a good sensitivity for P. falciparum. Its use for patient follow-up is not recommended.

摘要

引言

降低疟疾发病率和死亡率的策略之一是使用高度敏感和特异的简单快速检测方法进行早期诊断。此外,检测方法必须易于操作且当地民众易于理解,以便确保能及时进行适当的抗疟治疗。

目的

确定免疫层析疟疾快速检测试纸(ICT Pf/Pv)在安蒂奥基亚省图尔博市用于疟疾快速诊断的敏感性和特异性。

材料与方法

样本包括171名患者,分为两组:第一组为118例患有与疟疾相符的急性发热综合征的患者,同时对其进行ICT Pf/Pv检测和厚血膜涂片检测;第二组为53例厚血膜涂片诊断为阳性的患者,在开始治疗后的第4天和第7天进行随访。

结果

ICT Pf/Pv检测对恶性疟原虫感染的敏感性和特异性分别为54.2%(95%置信区间:52.0 - 53.4%)和93.6%(95%置信区间:93.1 - 94.2%)。此外,对间日疟原虫的敏感性和特异性分别为80%(95%置信区间:77.9 - 82.1%)和100%(95%置信区间:99.5 - 100%);对于每微升寄生虫数低于500个的恶性疟原虫,敏感性损失21.4%,间日疟原虫敏感性损失33%。作为确诊检测,ICT Pf/Pv的总体敏感性为71.6%,假阳性率为20.7%,假阴性率为5.6%。在随访期间,ICT在第4天和第7天的假阳性率分别为36%和34%。

结论

ICT Pf/Pv检测对恶性疟原虫疟疾的敏感性较差,其检测每微升低于500个寄生虫血症的能力极小。作为确诊检测,ICT Pf/Pv对恶性疟原虫具有良好的敏感性。不建议将其用于患者随访。

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