Feng Tang, Jian-Xia Tang, Feng Lu, Sui Xu, Ya-Ping Gu, De-Sheng Tong, Guo-Ding Zhu, Hai-Yong Hua, Hua-Yun Zhou, Jun Cao
Jiangsu Institute of Parasitic Diseases, Key Laboratory of Parasitic Disease Control and Prevention, Ministry of Health, Jiangsu Provincial Key Laboratory on Parasite and Vector Control Technology, Wuxi 214064, China.
Zhongguo Xue Xi Chong Bing Fang Zhi Za Zhi. 2016 Mar 21;28(2):146-150. doi: 10.16250/j.32.1374.2016022.
To evaluate the Wondfo Rapid Diagnostic Kit (Pf-LDH/Pan -pLDH) for detecting and analyze the influence of parasitaemia, concentration and polymorphism of pLDH on the performances.
A total of 100 blood samples from patients confirmed by PCR were detected with the Wondfo Rapid Diagnostic Kit according to the manufacturers'instructions. The parasitaemia was determined by the microscopic examination. The concentration of pLDH was measured by ELISA tests. The LDH gene of was amplified by PCR and sequenced. The influence of these three factors on the positive rate was analyzed.
The overall positive rate of Wondfo Rapid Diagnostic Kit was 70.0% (70/100). The positive rate was 27.3% for the samples with parasitaemia ≤ 500 parasites/μl and reached 75.0%-75.4% when parasitaemia > 500 parasites/μl. The positive rate was 6.7% for samples with a low pLDH concentration ( values ≤ 0.100) and reached 95.1%-100% at a high pLDH concentration ( values > 0.100). The results of sequence analysis indicated that all the samples could be divided into 2 types, and . The gene homology of LDH between 2 types was 97%. There were 24 single nucleotide polymorphism (s) (SNPs) between 2 types, while only 3 SNPs were non-synonymous mutations. The homology of LDH amino acid sequences between 2 types was 99%; only 3 amino acids were different. The positive rates for and were 73.1% (38/52) and 66.7% (32/48) respectively; there was no statistically significant difference ( > 0.05).
The Wondfo Rapid Diagnostic Kit (Pf-LDH/Pan-pLDH) performs better than most of the similar products for the detection of , and the positive rates are closely related to the parasitaemia and concentration of pLDH, while no related to the polymorphism of pLDH gene.
评估万孚快速诊断试剂盒（Pf-LDH/Pan-pLDH）检测疟原虫的性能，并分析疟原虫血症、pLDH浓度及多态性对检测性能的影响。
按照试剂盒说明书，使用万孚快速诊断试剂盒对100例经PCR确诊患者的血样进行检测。通过显微镜检查确定疟原虫血症。采用ELISA法检测pLDH浓度。通过PCR扩增LDH基因并测序。分析这三个因素对阳性率的影响。
万孚快速诊断试剂盒的总体阳性率为70.0%（70/100）。疟原虫血症≤500个/μl的样本阳性率为27.3%，疟原虫血症>500个/μl时阳性率达75.0% - 75.4%。pLDH浓度低（值≤0.100）的样本阳性率为6.7%，高浓度（值>0.100）时阳性率达95.1% - 100%。序列分析结果表明，所有样本可分为2种类型，即A和B。两种类型LDH的基因同源性为97%。两种类型之间有24个单核苷酸多态性（SNP），其中只有3个SNP是非同义突变。两种类型LDH氨基酸序列的同源性为99%；只有3个氨基酸不同。A和B型的阳性率分别为73.1%（38/52）和66.7%（32/48）；差异无统计学意义（P>0.05）。
万孚快速诊断试剂盒（Pf-LDH/Pan-pLDH）在检测疟原虫方面比大多数同类产品性能更好，阳性率与疟原虫血症和pLDH浓度密切相关，而与pLDH基因多态性无关。
