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用于埃塞俄比亚恶性疟诊断的Parasight-F试纸条抗原检测

Parasight-F dipstick antigen test in the diagnosis of falciparum malaria in Ethiopia.

作者信息

Mengesha T, Gebreselassie H, Mohammed H, Assefa T, Woldemichael T

机构信息

Ethiopian Health and Nutrition Research Institute, Addis Ababa, Ethiopia.

出版信息

East Afr Med J. 1999 Nov;76(11):626-9.

Abstract

OBJECTIVE

To determine the shelf life, rapidity and diagnostic performance of ParaSight-F.

DESIGN

Prospective randomised study.

SETTINGS

Malaria diagnostic and treatment posts and health centres in central-southern part of the Ethiopian Rift Valley.

SUBJECTS

Three hundred and eighty two subjects randomly selected.

MAIN OUTCOME MEASURES

Double blind evaluation of the sensitivity, specificity and predictive values of PFT versus CBF.

RESULTS

The point prevalence was found to be 29.7% with species dominance of P. falciparum to P. vivax in the ratio of 4:1. The ParaSight-F test showed, considering P. falciparum only, a sensitivity of 92.5% and specificity of 93%. A remarkably high positive predictive value (PPV) of 82% as well as a negative predictive value (NPV) of 99% was obtained. Considering all species of Plasmodium, sensitivity was 78.6% and specificity 93%, with PPV and NPV of 82% and 91% respectively. Moreover, PFT was found to be rapid with a batch of ten-strips--a rack completed in 30 to 50 minutes, which was five to six times faster than CBF reading. In shelf-life studies, after one year of storage at room temperature, results were found similar to the original readings, indicating the stability and long durability of the test strips.

CONCLUSION

In their durability and high diagnostic performances, both the microscopic slide readings and PFT were found comparable and interchangeable, and advantage in endemic areas where laboratory facilities are not available. The rapidity of PFT may be of greater value during malaria epidemics. But during non-epidemic seasons, the inability of PFT not to detect all forms of malaria remains a draw back.

摘要

目的

确定ParaSight - F的保质期、检测速度及诊断性能。

设计

前瞻性随机研究。

地点

埃塞俄比亚裂谷中南地区的疟疾诊断与治疗点及健康中心。

研究对象

随机选取382名研究对象。

主要观察指标

对PFT(ParaSight - F检测)与CBF(厚血膜镜检)的敏感性、特异性及预测值进行双盲评估。

结果

发现点患病率为29.7%,恶性疟原虫与间日疟原虫的种类优势比为4:1。仅考虑恶性疟原虫时,ParaSight - F检测显示敏感性为92.5%,特异性为93%。获得了显著高的阳性预测值(PPV)82%以及阴性预测值(NPV)99%。考虑所有疟原虫种类时,敏感性为78.6%,特异性为93%,PPV和NPV分别为82%和91%。此外,发现PFT检测速度快,一批十条试纸条——一个架子在30至50分钟内完成检测,比CBF读数快五到六倍。在保质期研究中,在室温下储存一年后,结果与原始读数相似,表明试纸条稳定性好、耐用性强。

结论

在耐用性和高诊断性能方面,显微镜玻片读数和PFT检测相当且可相互替代,在没有实验室设施的流行地区具有优势。PFT检测速度快在疟疾流行期间可能更有价值。但在非流行季节,PFT检测无法检测到所有形式疟疾这一情况仍是一个缺点。

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