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أعرض في EDS

Performance evaluation of the MAGLUMI Hepatitis B virus surface antigen chemiluminescence immunoassay.

التفاصيل البيبلوغرافية
العنوان: Performance evaluation of the MAGLUMI Hepatitis B virus surface antigen chemiluminescence immunoassay.
المؤلفون: Shen L; Department of Clinical Laboratory, Affiliated Jinhua Hospital, Zhejiang University School of Medicine, Jinhua, China., Zhang Y; Research & Development Department, Shenzhen New Industries Biomedical Engineering Co. Ltd., Shenzhen, China., Shi M; Research & Development Department, Shenzhen New Industries Biomedical Engineering Co. Ltd., Shenzhen, China., Shao L; Department of Clinical Laboratory, Affiliated Jinhua Hospital, Zhejiang University School of Medicine, Jinhua, China., Feng S; Department of Clinical Laboratory, Affiliated Jinhua Hospital, Zhejiang University School of Medicine, Jinhua, China., Li W; Research & Development Department, Shenzhen New Industries Biomedical Engineering Co. Ltd., Shenzhen, China., Fang Z; Research & Development Department, Shenzhen New Industries Biomedical Engineering Co. Ltd., Shenzhen, China., Yin J; Research & Development Department, Shenzhen New Industries Biomedical Engineering Co. Ltd., Shenzhen, China., Li T; Research & Development Department, Shenzhen New Industries Biomedical Engineering Co. Ltd., Shenzhen, China.
المصدر: Journal of medical virology [J Med Virol] 2024 Jul; Vol. 96 (7), pp. e29817.
نوع المنشور: Journal Article; Evaluation Study
اللغة: English
بيانات الدورية: Publisher: Wiley-Liss Country of Publication: United States NLM ID: 7705876 Publication Model: Print Cited Medium: Internet ISSN: 1096-9071 (Electronic) Linking ISSN: 01466615 NLM ISO Abbreviation: J Med Virol Subsets: MEDLINE
أسماء مطبوعة: Publication: New York Ny : Wiley-Liss
Original Publication: New York, Liss.
مواضيع طبية MeSH: Hepatitis B Surface Antigens*/blood , Hepatitis B Surface Antigens*/immunology , Sensitivity and Specificity* , Hepatitis B*/diagnosis , Hepatitis B*/blood , Luminescent Measurements*/methods , Hepatitis B virus*/immunology , Hepatitis B virus*/genetics , Hepatitis B virus*/isolation & purification, Humans ; Immunoassay/methods ; Immunoassay/standards ; Genotype ; Adult ; Female ; Male ; Middle Aged ; Young Adult ; Reproducibility of Results ; Aged ; Adolescent
مستخلص: A highly sensitive and reliable Hepatitis B virus surface antigen (HBsAg) measurement is essential to universal screening, timely diagnosis, and management of Hepatitis B virus (HBV) infection. This study aimed to evaluate the performance of MAGLUMI HBsAg chemiluminescence immunoassay (CLIA). MAGLUMI HBsAg (CLIA) was compared against ARCHITECT HBsAg. 411 HBsAg positive samples, including different stages of infection, genotypes, subtypes, mutants, and 30 seroconversion panels were tested to evaluate diagnostic sensitivity. Diagnostic specificity was evaluated by testing 205 hospitalized samples and 5101 blood donor samples. Precision, limit of blank (LoB), limit of detection (LoD), and linearity were also verified. The diagnostic sensitivity of the MAGLUMI HBsAg (CLIA) was 100% with better seroconversion sensitivity than ARCHITECT HBsAg. The MAGLUMI HBsAg (CLIA) has optimal detection efficacy for HBV subgenotypes samples. The analytical sensitivity is 0.039 IU/mL. The initial diagnostic specificity is 99.63% on blood donors and 96.59% on hospitalized samples. The verification data demonstrated high repeatability, a LoB of 0.02 IU/mL, LoD of 0.05 IU/mL and an excellent linearity of 0.050-250 IU/mL (R 2  = 0.9946). The MAGLUMI HBsAg (CLIA) is proved a highly sensitive and reliable assay with optimal subgenotype detection efficacy.
(© 2024 Wiley Periodicals LLC.)
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معلومات مُعتمدة: JY2021-1-04 Jinhua Central Hospital; 2021-4-009 Jinhua Science and Technology Bureau
فهرسة مساهمة: Keywords: Hepatitis B virus surface antigen; Hepatitis B virus surface antigen sensitivity; Hepatitis B virus surface antigen subgenotypes; MAGLUMI; immunoassay; performance evaluation
المشرفين على المادة: 0 (Hepatitis B Surface Antigens)
تواريخ الأحداث: Date Created: 20240722 Date Completed: 20240722 Latest Revision: 20240722
رمز التحديث: 20240722
DOI: 10.1002/jmv.29817
PMID: 39034740
قاعدة البيانات: MEDLINE
الوصف
تدمد:1096-9071
DOI:10.1002/jmv.29817