2024-03-28T16:41:06Zhttp://repisalud.isciii.es/oai/requestoai:repisalud.isciii.es:20.500.12105/120292023-06-08T11:30:58Zcom_20.500.12105_15322com_20.500.12105_2051com_20.500.12105_2060com_20.500.12105_2052col_20.500.12105_16978col_20.500.12105_2061
00925njm 22002777a 4500
dc
Avellón, Ana
author
Ala, Aftab
author
Diaz, Antonio
author
Domingo, Daniel
author
Gonzalez, Rosario
author
Hidalgo, Lorena
author
Kooner, Paul
author
Loganathan, Sabarinathan
author
Martin, Dolores
author
McPherson, Stuart
author
Muñoz-Chimeno, Milagros
author
Ryder, Stephen
author
Slapak, Gabrielle
author
Ryan, Pablo
author
Valbuena, Marta
author
Kennedy, Patrick T
author
2020-04-09
Hepatitis B virus (HBV) infection is estimated to affect 292 million people worldwide, 90% of them are unaware of their HBV status. The Determine HBsAg 2 (Alere Medical Co, Ltd Chiba Japan [Now Abbott]) is a rapid test that meets European Union (EU) regulatory requirements for Hepatitis B surface antigen 2 (HBsAg) analytical sensitivity, detecting the 0.1 IU/mL World Health Organization (WHO) International HBsAg Standard. This prospective, multicentre study was conducted to establish its clinical performance. 351 evaluable subjects were enrolled, 145 HBsAg-positive. The fingerstick whole blood sensitivity and specificity were 97.2% and 98.5% (15' reading, reference assay cut-off 0.05 IU/mL), sensitivity increasing to 97.9% with the prespecified cut-off 0.13 IU/mL (EU regulations). The venous whole blood, serum and plasma sensitivity was 97.2%, 97.9%, and 98.6%, respectively (15' reading); reaching 99%, 99.5% and 100% specificity. A testing algorithm following up an initial positive fingerstick test result with plasma/serum test demonstrates 100% specificity. The Determine HBsAg 2 test gives 15-minute results with high sensitivity and specificity, making it an ideal tool for point-of-care testing, with the potential to enable large-scale population-wide screening to reach the WHO HBV diagnostic targets. The evaluated test improves the existing methods as most of the reviewed rapid tests do not meet the EU regulatory requirements of sensitivity.
J Med Virol. 2020;92:3403-3411.
http://hdl.handle.net/20.500.12105/12029
32270883
10.1002/jmv.25862
1096-9071
Journal of medical virology
HBsAg
Hepatitis B surface antigen
Lateral flow
Point of care
Rapid test
Clinical performance of Determine HBsAg 2 rapid test for Hepatitis B detection