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[评估两种快速诊断检测方法,即NOW ICT疟原虫Pf/Pv检测法和OptiMAL检测法用于疟疾诊断的效果]

[Evaluation of two rapid diagnostic tests, NOW ICT Malaria Pf/Pv and OptiMAL, for diagnosis of malaria].

作者信息

Mendoza Nohora Marcela, García Marisol, Cortés Liliana Jazmín, Vela Claudia, Erazo Rigoberto, Pérez Pilar, Ospina Olga Lucía, Burgos Javier Darío

机构信息

Grupo de Parasitología, Red Nacional de Laboratorios, Instituto Nacional de Salud, Bogotá, DC, Colombia.

出版信息

Biomedica. 2007 Dec;27(4):571-80.

Abstract

INTRODUCTION

To increase the accessibility of malaria diagnosis, the Instituto Nacional de Salud de Colombia undertook a field trial to evaluate the sensitivity and specificity of two rapid diagnostic tests.

OBJECTIVE

The sensitivity, specificity and concordance was compared for two rapid diagnostic tests for malaria, NOW ICT Malaria Pf/Pv and OptiMAL.

MATERIALS AND METHODS

A descriptive and concordance study was performed with 214 patients in the southwestern coastal city of Tumaco, Colombia, each of whom presented at least one of the symptoms of the classical malaria triad. Two strategies were applied for patient recruitment-one by passive search and a second through local health brigades.

RESULTS

NOW ICT showed a general sensitivity of 98.4% (95%CI: 90.3-99.9), and a general specificity of 98.0% (95%CI: 93.9-99.5). For Plasmodium falciparum, the sensitivity was 98.2% (95%CI: 89.4-99.9) and the specificity 98.1% (95%CI: 94.1-99.5). The sensitivity was lower (80.0%) when parasitemia ranged from 200 to 4,000 parasites/microl. The sensitivity and specificity of the NOW ICT for P. vivax malaria were 100%. The sensitivity for this test was not affected for the established ranges of parasitemia for P. vivax. The overall figures for OptiMAL were 95.2% (95%CI: 85.8-98.8) sensitivity and 99.3% (95%CI: 95.8-100.0) specificity. For P. falciparum malaria OptiMAL showed 94.7% (95%CI: 84.5-98.6) sensitivity and 99.4% (95%CI: 96.0-100.0) specificity. The sensitivity was lower (60.0%) when samples with 200-4,000 parasites/microl were tested. For P. vivax, OptiMAL presented a 66.7% (95%CI: 24.1-94.0) sensitivity, which diminished to 50% with a parasitemia between 300-2.500 parasites/microL.

CONCLUSIONS

Good results for sensitivity and specificity were obtained for malaria diagnosis using NOW ICT and OptiMAL, with NOW ICT showing higher sensitivity and specificity values than OptiMAL.

摘要

引言

为提高疟疾诊断的可及性,哥伦比亚国家卫生研究所开展了一项现场试验,以评估两种快速诊断检测的敏感性和特异性。

目的

比较两种疟疾快速诊断检测(NOW ICT疟疾Pf/Pv检测和OptiMAL检测)的敏感性、特异性和一致性。

材料与方法

在哥伦比亚西南部沿海城市图马科对214名患者进行了描述性和一致性研究,每位患者至少出现了典型疟疾三联征的一种症状。采用了两种患者招募策略——一种是被动搜索,另一种是通过当地卫生队。

结果

NOW ICT检测的总体敏感性为98.4%(95%置信区间:90.3 - 99.9),总体特异性为98.0%(95%置信区间:93.9 - 99.5)。对于恶性疟原虫,敏感性为98.2%(95%置信区间:89.4 - 99.9),特异性为98.1%(95%置信区间:94.1 - 99.5)。当疟原虫血症范围为200至4000个寄生虫/微升时,敏感性较低(80.0%)。NOW ICT检测间日疟原虫疟疾的敏感性和特异性均为100%。该检测的敏感性不受间日疟原虫既定疟原虫血症范围的影响。OptiMAL检测的总体数据为敏感性95.2%(95%置信区间:85.8 - 98.8),特异性99.3%(95%置信区间:95.8 - 100.0)。对于恶性疟原虫疟疾,OptiMAL检测的敏感性为94.7%(95%置信区间:84.5 - 98.6),特异性为99.4%(95%置信区间:96.0 - 100.0)。当检测含有200 - 4000个寄生虫/微升的样本时,敏感性较低(60.0%)。对于间日疟原虫,OptiMAL检测的敏感性为66.7%(95%置信区间:24.1 - 94.0),当疟原虫血症在300 - 2500个寄生虫/微升之间时,敏感性降至50%。

结论

使用NOW ICT检测和OptiMAL检测进行疟疾诊断,在敏感性和特异性方面均取得了良好结果,NOW ICT检测显示出比OptiMAL检测更高的敏感性和特异性值。

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