Annals of Laboratory Medicine

Korean Society for Laboratory Medicine (대한진단검사의학회)
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Evaluation of Anti-dsDNA Antibody Tests: Crithidia luciliae Immunofluorescence Test, Immunoblot, Enzyme-linked Immunosorbent Assay, Chemiluminescence Immunoassay

  • Yang, Jin-Young (Department of Laboratory Medicine, The Catholic University of Korea School of Medicine) ;
  • Oh, Eun-Jee (Department of Laboratory Medicine, The Catholic University of Korea School of Medicine) ;
  • Kim, Yong-Goo (Department of Laboratory Medicine, The Catholic University of Korea School of Medicine) ;
  • Park, Yeon-Joon (Department of Laboratory Medicine, The Catholic University of Korea School of Medicine)
  • Received : 2010.05.31
  • Accepted : 2010.10.09
  • Published : 2010.12.01
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Abstract

Background : Anti-double stranded DNA antibody (anti-dsDNA) test is useful for the diagnosis and monitoring of systemic lupus erythematosus (SLE). Although several methods are available, none of them is completely satisfactory and differences among them have been reported. We evaluated the diagnostic performance of 6 commercial kits for anti-dsDNA detection. Methods : A total of 142 sera (SLE [N=74], other systemic rheumatic diseases [N=50], other diseases [N=18]) were tested by 6 different assay kits using different antigenic sources of DNA: Crithidia luciliae immunofluorescence test (CLIFT), salmon testes (immunoblot, IB), human (ELISA I), salmon testes with nucleosome linker (ELISA II), plasmid (ELISA III), and synthetic oligonucleotides (chemiluminescence immunoassay, CLIA). Results : With manufacturers' cut-off values, 6 test kits showed sensitivities of 55.4-91.9%. ELISA I had a greater sensitivity than the other five assays (P<0.001). The specificities of ELISA II, ELISA III, CLIA, and CLIFT were higher than those of ELISA I and IB (P<0.05). In ROC curve analysis, 3 ELISA kits and CLIA showed AUC values of 0.845-0.893, and revealed no significant differences among them (P>0.05). With cut-off values set at 95% of specificity, ELISA II had a higher sensitivity than ELISA III (63.5% vs. 41.9%, P<0.05). IB had poor concordance rates with other assays (42.0-65.0%). Pearson correlation coefficients among 4 quantitative assays were 0.667-0.798. Conclusions : Six different assays showed various performances depending on the methods and cut-off values used. Except IB, the other five assays can be used for the detection of anti-dsDNA.

배경 : 항 double stranded DNA (dsDNA)항체는 전신홍반루푸스(systemic lupus erythematosus, SLE)의 진단과 질환의 활성을 추적하는 데 유용한 진단도구이다. 여러 방법들이 사용되고 있지만 그 어느 방법도 완전히 만족할 만한 것은 아니며 각 방법들 사이에 차이가 보고되어 왔다. 본 연구에서는 항 ds-DNA항체 검출을 위해 6가지 검사 키트의 진단적 수행능과 임상적 유용성을 평가하였다. 방법 : 142개의 혈청 검체(SLE 환자 74개, SLE 이외의 다른 전신성류마티스 환자 50개, 그 외 다른 질환을 가진 환자 18개)를 모아 6가지 검사 키트로 항 dsDNA항체를 측정하였다. 각 검사에서 사용된 dsDNA 항원은 Crithidia luciliae immunofluorescence test (CLIFT), salmon testes (immunoblot, IB), human DNA (ELISA I), salmon testes with nucleosome linker (ELISA II), plasmid DNA (ELISA III), synthetic oligonucleotides (chemiluminescence immunoassay, CLIA)였다. 결과 : 6가지 검사 키트의 제조사 양성기준에 따른 민감도는 55.4-91.9%로서 ELISA I의 민감도가 나머지 5가지 검사 키트에 비해 유의하게 높았다(P<0.001). 특이도는 ELISA II, ELISA III, CLIA, CLIFT가 ELISA I과 IB에 비해 유의하게 높았다.(P<0.05). ROC 곡선 분석에서 3가지 ELISA 키트와 CLIA의 AUC 값은 0.845-0.893이었고, 각 검사들의 AUC 값 차이에 통계적 유의성은 없었다(P>0.05). 특이도를 95%로 정했을 때는 ELISA II의 민감도(63.5%)가 ELISA III (41.9%)에 비해 유의하게 높았다(P<0.05). IB는 다른 검사들과의 일치율이 42.0-65.0%로 낮았다. 4가지 정량검사들 간의 상관성 분석 결과, Pearson 상관계수는 0.667-0.798이었다. 결론 : 6가지 항 dsDNA항체 검사 키트는 검출 방법과 사용된 경계치에 따라 다양한 검사수행능을 나타냈으며, IB를 제외한 나머지 검사들은 항 dsDNA항체의 검출을 위해 유용하게 사용할 수 있을 것이다.

Keywords

References

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