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目的对比金标准的厚薄血膜显微镜检查法(以下简称“镜检法”),对国产疟原虫核酸实时荧光PCR检测试剂(以下简称“RT-PCR检测试剂”)进行研究。方法首先提取全血样本的DNA,加入RT-PCR检测试剂进行荧光定量PCR检测,比较其相关指标。结果 2种方法经配对比较,RT-PCR检测试剂检测45份全血临床标本的总符合率达93.33%,经测序对3例不符样本进行复检,3例镜检法检测为阴性,经RT-PCR检测试剂检测为阳性的样本经测序结果显示均含有疟原虫核酸序列。结论 RT-PCR检测试剂与镜检方法在各项指标差异无统计学意义,甚至在样本处理的时效性和阳性率等方面更具有明显的优势,该实时荧光PCR试剂有良好的检测质量,特别适用于口岸、进出境等单位疟原虫DNA的检测。
Objective To compare the real-time fluorescence real-time PCR detection reagent of Plasmodium falciparum (referred to as “RT-PCR detection reagent”) with gold standard thickness thin film microscopy (hereinafter referred to as “microscopy method”). Methods Firstly, DNA from whole blood samples was extracted, and RT-PCR detection reagent was added to detect the DNA by fluorescence quantitative PCR, and the relative indexes were compared. Results The results of the two methods were compared. The total coincidence rate of the 45 clinical samples tested by RT-PCR was 93.33%. Three cases of non-conformity were re-examined by sequencing. The negative results of microscopic examination were detected by RT-PCR. The PCR-positive samples were sequenced and both contained the parasite’s nucleic acid sequence. Conclusion There is no significant difference between RT-PCR test and microscopic examination in each index, even more obvious in the timeliness and positive rate of sample processing. The real-time fluorescent PCR reagent has good quality of detection, especially Apply to the port, entry and exit and other units of Plasmodium DNA testing.