用于检测抗双链DNA抗体的五种商业检测方法的评估：三种利什曼原虫间接免疫荧光检测试剂盒和两种酶免疫检测试剂盒。

Evaluation of five commercial assays for the detection of anti-dsDNA antibodies: three Crithidia luciliae indirect immunofluorescence test kits and two enzyme immunoassay kits.

作者信息

Viriyataveekul Ronnachai, Kobkitjaroen Jaruda, Jaiyen Jintana, Kongkriengdach Siriporn, Potprasart Sumalee

出版信息

J Med Assoc Thai. 2014 Feb;97(2):220-4.

Abstract

OBJECTIVE

There are various methods for anti-dsDNA detection. Crithidia luciliae indirect immunofluorescence test (CLIFT) and enzyme immunoassay (EIA) are the most commonly used at present. A number of CLIFT and EIA kits are commercially available. The objective of the present study was to evaluate the diagnostic performance of three commercial CLIFT kits, two commercial EIA kits, and their combinations for anti-dsDNA detection.

MATERIAL AND METHOD

One hundred thirty nine sera sent for anti-dsDNA testing were investigated. Three commercial CLIFT kits (kit C1, C2, and C3) and two commercial EIA kits (kit E1 and E2) were evaluated. Sensitivities and specificities were calculated. The gold standard methods were the consensus results of all five kits, together with the clinical diagnosis when the results of five kits were discrepant.

RESULTS

Of 139 sera investigated, 94 (67.6%) sera showed concordant results for all five kits and 45 (32.4%) sera showed discordant results. Thirty-five of those 45 patients (77.7%) were diagnosed as SLE. Sensitivities and specificities of the kits were as follows, Cl 82.1% and 94%, C2 46.4% and 100%, C3 78.6% and 98.8%, E1 71.4% and 94%, and E2 75% and 93.8%, respectively. Kit C3 yielded the maximum sum of sensitivity and specificity (177.4%). Sensitivities and specificities of the combinations of CLIFT and EIA kits were as follows, C1 + E1 89.3% and 90.4%, C1 + E2 98.2% and 87.9%, C2 + E1 73.2% and 94%, C2 + E2 82.1% and 92.8%, C3 + E1 85.7% and 94%, and C3 + E2 94.6% and 91.6%, respectively. The combination of kit C3 and E2 yielded the maximum sum of sensitivity and specificity (186.2%).

CONCLUSION

Kit C3 was the assay of choice for anti-dsDNA detection. EIA kits yielded lower sensitivities and specificities than two of three CLIFT kits. Therefore, they should not be used as the first assay for anti-dsDNA screening. When CLIFT and EIA assays were combined, sensitivities were increased Kit E2 helped CLIFT kits to detect more SLE cases than E1.

摘要

目的

抗双链DNA（dsDNA）检测有多种方法。目前最常用的是利什曼原虫间接免疫荧光试验（CLIFT）和酶免疫测定（EIA）。市面上有许多CLIFT和EIA试剂盒可供选择。本研究的目的是评估三种商用CLIFT试剂盒、两种商用EIA试剂盒及其组合用于抗dsDNA检测的诊断性能。

材料与方法

对139份送检抗dsDNA检测的血清进行研究。评估了三种商用CLIFT试剂盒（试剂盒C1、C2和C3）和两种商用EIA试剂盒（试剂盒E1和E2）。计算敏感性和特异性。金标准方法是所有五种试剂盒的一致结果，以及当五种试剂盒结果不一致时的临床诊断结果。

结果

在139份研究血清中，94份（67.6%）血清在所有五种试剂盒中结果一致，45份（32.4%）血清结果不一致。这45例患者中有35例（77.7%）被诊断为系统性红斑狼疮（SLE）。各试剂盒的敏感性和特异性如下：C1为82.1%和94%，C2为46.4%和100%，C3为78.6%和98.8%，E1为71.4%和94%，E2为75%和93.8%。试剂盒C3的敏感性和特异性之和最高（177.4%）。CLIFT和EIA试剂盒组合的敏感性和特异性如下：C1 + E1为89.3%和90.4%，C1 + E2为98.2%和87.9%，C2 + E1为73.2%和94%，C2 + E2为82.1%和92.8%，C3 + E1为85.7%和94%，C3 + E2为94.6%和91.6%。试剂盒C3和E2的组合敏感性和特异性之和最高（186.2%）。