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

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). MAGLUM...

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Vydané v:Journal of medical virology Ročník 96; číslo 7; s. e29817 - n/a
Hlavní autori: Shen, Lihong, Zhang, Yun, Shi, Min, Shao, Lijia, Feng, Shengchun, Li, Weiting, Fang, Zhonggang, Yin, Jun, Li, Tinghua
Médium: Journal Article
Jazyk:English
Vydavateľské údaje: United States Wiley Subscription Services, Inc 01.07.2024
Predmet:
Adolescent
Adult
Aged
Antigens
Blood
Blood donors
Chemiluminescence
Diagnostic systems
Effectiveness
Female
Genotype
Genotypes
Hepatitis
Hepatitis B
Hepatitis B - blood
Hepatitis B - diagnosis
Hepatitis B surface antigen
Hepatitis B Surface Antigens - blood
Hepatitis B Surface Antigens - immunology
Hepatitis B virus - genetics
Hepatitis B virus - immunology
Hepatitis B virus - isolation & purification
Hepatitis B virus surface antigen
Hepatitis B virus surface antigen sensitivity
Hepatitis B virus surface antigen subgenotypes
Humans
Immunoassay
Immunoassay - methods
Immunoassay - standards
Linearity
Luminescent Measurements - methods
MAGLUMI
Male
Middle Aged
Performance evaluation
Reproducibility of Results
Sensitivity analysis
Sensitivity and Specificity
Seroconversion
Viruses
Young Adult
performance evaluation
Hepatitis B virus surface antigen
Hepatitis B virus surface antigen sensitivity
Hepatitis B virus surface antigen subgenotypes
MAGLUMI
immunoassay
ISSN:0146-6615, 1096-9071, 1096-9071
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Popis
Shrnutí: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 (R2 = 0.9946). The MAGLUMI HBsAg (CLIA) is proved a highly sensitive and reliable assay with optimal subgenotype detection efficacy.
Bibliografia:Lihong Shen, Yun Zhang, and Min Shi contributed equally to this work and share first authorship.
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ISSN:0146-6615
1096-9071
1096-9071
DOI:10.1002/jmv.29817