论文部分内容阅读
目的比较两种疟疾快速诊断试剂盒(RDTs)检测疟疾患者血样的效果。方法在云南采集流行区疟疾患者血样200份,上海地区采集健康者血样60份,以显微镜镜检为金标准,比较胶体金免疫层析法(GICA)和瑞士产OptiMAL试剂盒检测疟原虫的敏感性和特异性。并用这两种RDTs试剂盒分别检测10份原虫密度梯度样品,比较其疟原虫最低检出限并分析检测效果。结果本次共检测血样260份,镜检确诊为恶性疟原虫阳性100份,间日疟原虫阳性100份,阴性60份。GICA检测疟疾患者血样的敏感性和特异性分别为87.5%(175/200)和93.3%(56/60),恶性疟和间日疟患者血样的敏感性和特异性分别为83.0%(83/100)、89.0%(89/100)和96.9%(155/160)、98.8%(158/160)。OptiMAL的敏感性和特异性分别为95.5%(191/200)和100.0%(60/60),恶性疟、间日疟的敏感性和特异性分别为90.0%(90/100)、96.0%(96/100)和99.4%(159/160)、97.5%(156/160)。两种试剂盒检出疟原虫的差异具有统计学意义(χ2=8.23,P<0.05)。两种试剂盒检测恶性疟(χ2=2.10)和间日疟(χ2=3.53)的差异无统计学意义(P>0.05)。GICA检测恶性疟原虫和间日疟原虫3个级别原虫密度血样的检出结果差异均无统计学意义(P>0.05);OptiMAL检测间日疟原虫不同密度的差异无统计学差异(P>0.05),检测恶性疟原虫不同密度的差异有统计学意义(P<0.05),高密度原虫检出率较高。两种试剂盒检测疟原虫的最低检出限约为100~200个/μl血。结论 OptiMAL试剂盒检测疟原虫的敏感性、特异性和检出率均高于GICA试剂盒,GICA检测疟原虫的最低检测限较低,且重复性较好。
Objective To compare the efficacy of two malaria rapid diagnostic kits (RDTs) in the detection of blood samples from malaria patients. Methods Two hundred and seventy blood samples of malaria patients were collected from epidemic areas in Yunnan. Sixty blood samples were collected from healthy subjects in Shanghai. Microscopic examination was used as the gold standard. The GICA and Swiss OptiMAL kits were used to test the sensitivity of the malaria parasite Sexual and specific. The two RDTs kits were used to detect 10 samples of protozoa density gradient respectively. The minimum detection limit of plasmodium was compared and the detection effect was analyzed. Results A total of 260 blood samples were tested, 100 were positive for Plasmodium falciparum by microscopic examination, 100 were positive for Plasmodium vivax and 60 were negative. The sensitivity and specificity of GICA for blood samples from malaria patients were 87.5% (175/200) and 93.3% (56/60), respectively. The sensitivity and specificity of blood samples from patients with P. falciparum and P. vivax were 83.0% (83 / 100), 89.0% (89/100) and 96.9% (155/160), 98.8% (158/160). The sensitivity and specificity of OptiMAL were 95.5% (191/200) and 100.0% (60/60), respectively. The sensitivity and specificity of P. falciparum and P. vivax were 90.0% (90/100) and 96.0% 96/100) and 99.4% (159/160), 97.5% (156/160). The differences between the two kits in detection of Plasmodium were statistically significant (χ2 = 8.23, P <0.05). There was no significant difference between the two kits in the detection of P. falciparum (χ2 = 2.10) and P. vivax (χ2 = 3.53) (P> 0.05). There were no significant differences in the detection results of GICA between the blood samples of three levels of Plasmodium falciparum and Plasmodium vivax (P> 0.05). There was no significant difference in the density of Plasmodium vivax between the two groups (P> 0.05 ). There was a significant difference in the detection of different density of P. falciparum (P <0.05), and the detection rate of high density protozoa was high. The minimum detectable limit of detection of malaria parasites by both kits is about 100 to 200 / μl of blood. Conclusion The sensitivity, specificity and detection rate of OptiMAL kit for detecting Plasmodium were higher than those of GICA kit. The detection limit of GICA for Plasmodium was lower and the reproducibility was better.