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[不同抗囊尾蚴抗体检测试剂盒用于囊尾蚴病血清学诊断的效率评估]

[Evaluation of efficiency of different anti-cysticercus antibody test kits for serodiagnosis of cysticercosis].

作者信息

Zhang Y L, Jiang T T, Ji P H, He Z Q, Chen X, Hong Y, Zhao D Y, Deng Y, Chen W Q, Zhang H W

机构信息

Henan Center for Disease Control and Prevention, Zhengzhou, Henan 450016, China.

Henan Medical Key Laboratory for Pathogen and Vector of Parasites, Zhengzhou, Henan 450016, China.

出版信息

Zhongguo Xue Xi Chong Bing Fang Zhi Za Zhi. 2022 Feb 23;34(1):36-40. doi: 10.16250/j.32.1374.2021216.

Abstract

OBJECTIVE

To evaluate the diagnostic efficiency of four anti-cysticercus IgG, IgG4 or IgM antibody test kits (enzyme-linked immunosorbent assay, ELISA) by different manufacturers, so as to provide insights into the epidemiological investigation and clinical detection of cysticercosis.

METHODS

Forty serum samples from cerebral cysticercosis patients, 100 serum samples from healthy volunteers, 30 serum samples from paragonimiasis skrjabini patients, 17 serum samples from cystic echinococcosis and 19 serum samples from subcutaneous or cerebral sparganosis patients were collected and detected using anti-cysticercus IgG, IgG4 or IgM antibody test kits (brand A) and the anti-cysticercus IgG antibody test kit (brand B). The sensitivity, specificity and false negative rate of the four kits for detection of cysticercosis were estimated.

RESULTS

The anti-cysticercus IgG, IgG4 or IgM antibody test kits (brand A) showed 95.00% (38/40), 87.50% (35/40), 7.50% (3/40) sensitivities and 98.00% (98/100), 100.00% (100/100) and 100.00% (100/100) for detection of cysticercosis, while the anti-cysticercus IgG antibody test kit (brand B) presented a 75.00% (30/40) sensitivity and 100.00% (100/100) specificity for detection of cysticercosis. The sensitivity for detection of cysticercosis was significantly higher by the anti-cysticercus IgG antibody test kit (brand A) than by the anti-cysticercus IgG antibody test kit (brand B) ( = 6.28, < 0.05); however, no significant difference was seen in the specificity by two kits ( = 2.01, > 0.05). The four ELISA kits showed overall false positive rates of 37.88% (25/66), 22.73% (15/66), 62.12% (41/66) and 15.15% (10/66) for detection of paragonimiasis, echinococcosis and sparganosis ( = 37.61, < 0.05), and the anti-cysticercus IgG antibody test kit (brand A) presented the highest overall false positive rate for detection of paragonimiasis, echinococcosis and sparganosis ( = 7.56, ' < 0.008), while a higher overall false positive rate was seen for detection of paragonimiasis, echinococcosis and sparganosis by the anti-cysticercus IgG antibody test kit (brand A) than by the anti-cysticercus IgG antibody test kit (brand B) ( = 8.75, ' < 0.008). The four ELISA kits showed false positive rates of 40.00% (12/30), 16.67% (5/30), 76.67% (23/30) and 13.33% (4/30) for detection of paragonimiasis (2 = 32.88, < 0.05) and 21.05% (4/19), 26.32% (5/19), 73.68% (14/19) and 15.79% (3/19) for detection of sparganosis ( = 19.97, < 0.05), and the highest false positive rates were found by the anti-cysticercus IgM antibody test kit (brand A) for detection of paragonimiasis and sparganosis (all ' < 0.008). However, the four ELISA kits showed comparable false positive rates of 52.94% (9/17), 29.41% (5/17), 23.53% (4/17) and 17.65% (3/17) for detection of echinococcosis ( = 8.24, > 0.05). In addition, the anti-cysticercus IgM anti-body test kit (brand A) showed false positive rates of 76.67% (23/30), 23.53% (4/17) and 73.68% (14/19) for detection of paragonimiasis, echinococcosis and sparganosis ( = 14.537, < 0.05), with the lowest false positive rate seen for detection of echinococcosis ( = 14.537, ' < 0.014), while no significant differences were seen in the false positive rate for detection of paragonimiasis, echinococcosis and sparganosis by other three ELISA kits (all > 0.05).

CONCLUSIONS

The four anti-cysticercus IgG, IgG4 or IgM antibody test kits exhibit various efficiencies for serodiagnosis of cysticercosis. The anti-cysticercus IgG antibody test kit (brand A) has a high sensitivity for serodiagnosis of cysticercosis; however, it still needs to solve the problems of cross-reaction with other parasitic diseases and stability.

摘要

目的

评估不同厂家生产的4种抗囊尾蚴IgG、IgG4或IgM抗体检测试剂盒(酶联免疫吸附测定,ELISA)的诊断效率,为囊尾蚴病的流行病学调查和临床检测提供参考。

方法

收集40份脑囊尾蚴病患者血清样本、100份健康志愿者血清样本、30份斯氏肺吸虫病患者血清样本、17份细粒棘球蚴病患者血清样本和19份皮下或脑裂头蚴病患者血清样本,使用抗囊尾蚴IgG、IgG4或IgM抗体检测试剂盒(A品牌)和抗囊尾蚴IgG抗体检测试剂盒(B品牌)进行检测。估算4种试剂盒检测囊尾蚴病的敏感性、特异性和假阴性率。

结果

抗囊尾蚴IgG、IgG4或IgM抗体检测试剂盒(A品牌)检测囊尾蚴病的敏感性分别为95.00%(38/40)、87.50%(35/40)、7.50%(3/40),特异性分别为98.00%(98/100)、100.00%(100/100)、100.00%(100/100);而抗囊尾蚴IgG抗体检测试剂盒(B品牌)检测囊尾蚴病的敏感性为75.00%(30/40),特异性为100.00%(100/100)。抗囊尾蚴IgG抗体检测试剂盒(A品牌)检测囊尾蚴病的敏感性显著高于抗囊尾蚴IgG抗体检测试剂盒(B品牌)( = 6.28, < 0.05);然而,两种试剂盒的特异性差异无统计学意义( = 2.01, > 0.05)。4种ELISA试剂盒检测肺吸虫病、棘球蚴病和裂头蚴病的总体假阳性率分别为37.88%(25/66)、22.73%(15/66)、62.12%(41/66)和15.15%(10/66)( = 37.61, < 0.05),抗囊尾蚴IgG抗体检测试剂盒(A品牌)检测肺吸虫病、棘球蚴病和裂头蚴病的总体假阳性率最高( = 7.56,' < 0.008),且抗囊尾蚴IgG抗体检测试剂盒(A品牌)检测肺吸虫病、棘球蚴病和裂头蚴病的总体假阳性率高于抗囊尾蚴IgG抗体检测试剂盒(B品牌)( = 8.75,' < 0.008)。4种ELISA试剂盒检测肺吸虫病的假阳性率分别为40.00%(12/30)、16.67%(5/30)、76.67%(23/30)和13.33%(4/30)(2 = 32.88, < 0.05),检测裂头蚴病的假阳性率分别为21.05%(4/19)、26.32%(5/19)、73.68%(14/19)和15.79%(3/19)( = 19.97, < 0.05),抗囊尾蚴IgM抗体检测试剂盒(A品牌)检测肺吸虫病和裂头蚴病的假阳性率最高(均' < 0.008)。然而,4种ELISA试剂盒检测棘球蚴病的假阳性率相当,分别为52.94%(9/17)、29.41%(5/17)、23.53%(4/17)和17.65%(3/17)( = 8.24, > 0.05)。此外,抗囊尾蚴IgM抗体检测试剂盒(A品牌)检测肺吸虫病、棘球蚴病和裂头蚴病的假阳性率分别为76.67%(23/30)、23.53%(4/17)和73.68%(14/19)( = 14.537, < 0.05),检测棘球蚴病的假阳性率最低( = 14.537,' < 0.014),而其他3种ELISA试剂盒检测肺吸虫病、棘球蚴病和裂头蚴病的假阳性率差异无统计学意义(均 > 0.05)。

结论

4种抗囊尾蚴IgG、IgG4或IgM抗体检测试剂盒对囊尾蚴病的血清学诊断效率各异。抗囊尾蚴IgG抗体检测试剂盒(A品牌)对囊尾蚴病血清学诊断具有较高的敏感性;然而,仍需解决与其他寄生虫病的交叉反应及稳定性问题。

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