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팬더시스템을 이용한 Aptima HBV 및 HCV 바이러스 검사의 진단 성능 평가

Other Titles
 Performance Evaluation of Aptima HBV and HCV Quant Assays in the Panther System 
 최유정  ;  김보연  ;  김윤정  ;  이경아 
 Laboratory Medicine Online, Vol.11(3) : 177-182, 2021-07 
Journal Title
Laboratory Medicine Online
Issue Date
Aptima ; Cobas ; Comparison ; HBV ; HCV ; Linearity ; Limit of detection ; Precision
Background: Hepatitis B virus (HBV) and hepatitis C virus (HCV) infections remain a serious health problem despite advancements in their pre vention and treatment. Guidelines on their management recommend using viral DNA/RNA titers. Thus, accurate measurement and prompt report ing are crucial.
Methods: The performances of the Aptima HBV and HCV Quant assays (Hologic Inc., USA) were analyzed. The results were compared with those
of Cobas 4800 (Roche Molecular Systems, USA). Linearity, limit of detection (LoD), and precision were evaluated as recommended in each corre sponding CLSI guideline.
Results: Passing-Bablok regression analysis showed a high correlation between the two assays: regression line was y =0.0684+1.025x (95%
CI: 0.9604-1.092) for HBV and y =-0.9650+1.141x (95% CI: 1.071-1.226) for HCV. Agreement between the assays’ qualitative results based on
categorical analysis was 82.30% (185/224) (κ: 0.738, 95% CI: 0.701-0.775) for HBV and 94.52% (69/73) (κ: 0.855, 95% CI: 0.796-0.914) for
HCV. The LoD values for HBV and HCV were 4.448 IU/mL and 6.166 IU/mL, respectively. The percent coefficient of variation (%CV) for the HBV as say for both low and high positive controls was less than 2%, whereas for the HCV assay, %CV for low positive control was 3.20%.
Conclusions: Overall, the Aptima HBV and HCV Quant assays demonstrated a high correlation with Cobas 4800. These tests were both sensitive
and precise. Therefore, we conclude that the Aptima assay is a practical tool in the management of HBV- and HCV-infected patients.
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1. College of Medicine (의과대학) > Dept. of Laboratory Medicine (진단검사의학교실) > 1. Journal Papers
Yonsei Authors
Kim, Boyeon(김보연)
Kim, Yoon Jung(김윤정) ORCID logo https://orcid.org/0000-0002-4370-4265
Lee, Kyung A(이경아) ORCID logo https://orcid.org/0000-0001-5320-6705
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