三种重组抗原酶免疫法检测人细小病毒B19 IgM和IgG抗体的比较评价

Jerry W Pickering , Bagher Forghani , Gordon R Shell , Linxian Wu
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引用次数: 7

摘要

背景:诊断急性和既往感染细小病毒B19是基于检测IgM和IgG抗体。目的:评价两种用于细小病毒B19 IgM和IgG抗体检测的商业重组抗原酶免疫测定试剂盒,并将商业重组抗原酶免疫测定试剂盒与国内重组抗原酶免疫测定试剂盒进行比较。研究设计:121份血清用于比较三种IgM eia。该小组包括84份提交用于细小病毒B19检测的血清和37份其他病毒病原体IgM阳性的血清。同样的血清组加上另外14份提交用于B19检测的血清用于比较三种IgG eia。商业环境影响评价是根据制造商的说明进行的。利用内部环评测试程序作为参考,确定了每种商业环评的敏感性和特异性。结果:商用B19 IgM环境影响评价与国产IgM环境影响评价的一致性分别为95.0和93.4%。与内部的B19 IgM环境影响评估相比,商业B19 IgM环境影响评估的敏感性分别为97.4和97.5%。特异性分别为93.5%和91.4%。与内部IgG EIA相比,商业IgG EIA的敏感性分别为88.0和85.2%,特异性为94.1和98.0%。结论:我们发现细小病毒B19 IgM和IgG的商业eia与标准的内部eia相当,适用于人血清B19抗体的检测。
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Comparative evaluation of three recombinant antigen-based enzyme immunoassays for detection of IgM and IgG antibodies to human parvovirus B19

Background: Diagnosis of acute and past infection with parvovirus B19 is based on detection of IgM and IgG antibodies.

Objectives: To evaluate two commercial recombinant antigen-based enzyme immunoassay (EIA) test kits for detection of IgM and IgG antibodies to parvovirus B19 and to compare the commercial EIAs to in-house EIA test procedures.

Study design: A panel of 121 sera was used to compare the three IgM EIAs. The panel included 84 sera submitted for parvovirus B19 testing and 37 sera that were IgM positive for other viral pathogens. The same serum panel plus an additional 14 sera submitted for B19 testing was used to compare the three IgG EIAs. The commercial EIAs were performed according to manufacturers' instructions. Using the in-house EIA test procedures as the reference, sensitivity and specificity for each of the commercial EIAs was determined.

Results: The commercial B19 IgM EIAs showed agreements of 95.0 and 93.4% to the in-house IgM EIA. Compared to the in-house B19 IgM EIA, the commercial B19 IgM EIAs, were 97.4 and 97.5% sensitive, respectively. Specificities were 93.5 and 91.4%, respectively. Sensitivities for the commercial IgG EIAs, compared to in-house IgG EIA, were 88.0 and 85.2%, respectively, and specificities were 94.1 and 98.0%.

Conclusion: We found that the commercial parvovirus B19 IgM and IgG EIAs are comparable to standard in-house EIAs and are suitable for testing for B19 antibodies in human sera.

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