2008, Number 3
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Bioquimia 2008; 33 (3)
Evaluation of the ImmunoLISA™ HBsAg 1 Step Orgenics LTD diagnostic kit for detection of hepatitis B surface antigen
Basualdo-Sigales MC, Alcántara-Pérez PA, Soler-Claudín C
Language: Spanish
References: 14
Page: 122-127
PDF size: 93.16 Kb.
ABSTRACT
The aim of this study was to evaluate the sensitivity and specificity of the third generation ELISA for qualitative determination of hepatitis B surface antigen (HbsAg) in human plasma or serum: ImmunoLISATM HBsAg 1 Step by Orgenics LTD. We use a panel of 200 pre-evaluated plasmas with UMELISA HBs Ag PLUS by Centro de Inmunoensayo de la Habana Cuba. Assay protocols were followed according the manufacturer. All twice positive samples were assayed for confirmatory test. The assay showed 100% specificity, 96.3% sensitivity, 100% positive predictive value and 99.43% negative predictive value. Our results support the use of this assay as a screening test for hepatitis B and as is suggested for all screening test a confirmatory assay must be performed a assure accurate results.
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