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马拉维疟疾快速诊断试验(Paracheck pf.®)弱阳性条带与显微镜检查在疟疾诊断中的相关性

The correlation between malaria RDT (Paracheck pf.®) faint test bands and microscopy in the diagnosis of malaria in Malawi.

作者信息

Makuuchi Ryoko, Jere Sandy, Hasejima Nobuchika, Chigeda Thoms, Gausi January

机构信息

Nippon International Cooperation for Community Development, 101 Nishi-rokkaku-cho, Nakagyo-ku, Kyoto, 604-8217, Japan.

Ministry of health, Community Health Science Unit, PO Box 30377, Lilongwe, Malawi.

出版信息

BMC Infect Dis. 2017 May 2;17(1):317. doi: 10.1186/s12879-017-2413-x.

Abstract

BACKGROUND

Faint test bands of Paracheck Pf.® are interpreted as malaria positive according to world health organization (WHO) guideline. However if there are conspicuous number of faint test bands, a performance of Paracheck Pf.® could be influenced depending on whether interpreting faint test bands as malaria positive or negative. Finding out the frequency and accurate interpretation of faint test bands are important to prevent the overdiagnosis and drug resistance.

METHODS

A cross-sectional, descriptive study was conducted to find out the frequency of faint test bands and evaluate the performance of Paracheck Pf.® by sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and accuracy of diagnosis of Paracheck Pf.® using microscopy as the gold standard. 388 suspected patients with malaria in Malawi were recruited in this study. Malaria rapid diagnostic tests (RDTs) and microscopy were used and patients' information which includes age, sex, body temperature and signs or symptoms of malaria were recorded.

RESULTS

Among all patients involved in the study, 29.1% (113/388) were found malaria positive by RDT. Overall 5.4% (21/388) of all Paracheck Pf.® tests resulted in a "faint test band" and 85.7% (18/21) corresponded with malaria negative by microscopy. Faint test bands which corresponded with malaria positive by microscopy were lower parasite density and there are no patients who showed definitive symptom of malaria, such as fever. When Paracheck Pf.® "faint test bands" were classified as positive, accuracy of diagnosis was 76.5% (95% CI 72%-80.7%) as compared to 80.4% (95% CI 76.1%-84.2%) when Paracheck Pf.® "faint test bands" were classified as negative.

CONCLUSIONS

This study shows that frequency of faint test bands is 5.4% in all malaria RDTs. The accuracy of diagnosis was improved when faint test bands were interpreted as malaria negative. However information and data obtained in this study may not be enough and more intensive research including a frequency and property of faint test bands is needed for significant interpretation of faint test bands.

摘要

背景

根据世界卫生组织(WHO)指南,Paracheck Pf.®检测条出现的淡色条带被判定为疟疾阳性。然而,如果淡色条带数量显著,将淡色条带判定为疟疾阳性或阴性可能会影响Paracheck Pf.®的检测性能。明确淡色条带的出现频率及准确判定对于预防过度诊断和耐药性至关重要。

方法

开展了一项横断面描述性研究,以确定淡色条带的出现频率,并以显微镜检查作为金标准,通过灵敏度、特异度、阳性预测值(PPV)、阴性预测值(NPV)以及Paracheck Pf.®诊断准确性来评估Paracheck Pf.®的性能。本研究招募了马拉维388名疑似疟疾患者。使用疟疾快速诊断检测(RDT)和显微镜检查,并记录患者的信息,包括年龄、性别、体温以及疟疾的体征或症状。

结果

在所有参与研究的患者中,29.1%(113/388)通过RDT检测为疟疾阳性。总体而言,所有Paracheck Pf.®检测中有5.4%(21/388)出现了“淡色条带”,其中85.7%(18/21)经显微镜检查为疟疾阴性。与显微镜检查疟疾阳性对应的淡色条带寄生虫密度较低,且没有出现如发热等明确疟疾症状的患者。当将Paracheck Pf.®“淡色条带”判定为阳性时,诊断准确性为76.5%(95%CI 72%-80.7%);而当将Paracheck Pf.®“淡色条带”判定为阴性时,诊断准确性为80.4%(95%CI 76.1%-84.2%)。

结论

本研究表明,在所有疟疾RDT检测中,淡色条带的出现频率为5.4%。将淡色条带判定为疟疾阴性时,诊断准确性有所提高。然而,本研究获得的信息和数据可能不足,需要开展更深入的研究,包括淡色条带的出现频率和特性,以便对淡色条带进行有意义的解读。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c325/5414284/ae82d404f054/12879_2017_2413_Fig1_HTML.jpg

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