Commercially Available Rapid Hepatitis B Tests

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1 Type of Test: Lateral Flow Commercially Available Rapid Tests Manufacturer Name of Test Web Site Abbott Acon Laboratories, Inc. Akers Laboratories Alfa Scientific Designs Inc. AmeriTek, Inc. Beijing Blue Cross Biotech. Determine HbsAg HBcAb)Test Devices or Strips HealthTEST HbsAg Assay HbsAg Cassette or Dip-Strip Tests HbsAg Test Cassette or Strip One-Step HBcAb) Strip om om om/new/newenglish/blue2.html,,,, whole blood, Plasma, serum Biokit, S.A. biorapid HbsAg BRIA Cortez, Inc. Cyprus Genix Technology HBsAb Strip & HBsAb Card HBsAb, HBcAb, HBeAg) RapiDip InstaTest HBsAg Test RapidTech HbsAg Test Strip ess/

2 Manufacturer Name of Test Web Site International Immuno- International Newtech Development Mega, Inc. Nubenco Orchid Biomedical Systems Orgenics Orgenics Princeton BioMeditech Corporation Standard Inc. Trinity Biotech Vision Biotech (Pty) Ltd. HbsAg, HbsAb, HbeAb, HBeAg HBsAb, HBeAg, (HBcAB) Test MegaKwik (HBsAb or HBsAg) Card Test Surface Antigen EasiStep/EasiStr ip Virucheck RapidSignal HBsAg RapidSignal Panel tics.com chid/index.htm BioSign HbsAg Hepatitis Anti- HBsAg, or HBeAg) Test Uni-Gold HBsAg Vision Hepatitis B test whole blood

3 Manufacturer Name of Test Web Site World, Inc. Smart Strip HBsAg Test, Smart Strip Anti-HBc, Smart Check Panel (5) Test Card, Smart Check HBsAg Test Vencor International Inc. DxStrip HBsAg

4 Type of Test: Flow-through Manufacturer Name of Test Web Site Cyprus Anti-HBsAg RAPID TEST ess/ International Newtech Development Membrane-EIA HBsAb, HBeAg, (HBcAB) Test MedMira Laboratories MiraWell Rapid HBV Test (anti-hbc) Type of Test: Agglutination Manufacturer Name of Test Web Site Axiom Diagnostic HBsAg Latex rapid test Cyprus latex test ess/ Fujirebio Inc. SERODIA - HBs sh/product/pc02.html SPAN AUSTRAGEN LATEX World, Inc. Pulse Hepatitis B Surface Antigen Latex Slide Test Type of Test: Immunoblot Manufacturer Orgenics Name of Test ImmunoCo mb II HBs Ag 90 Web Site Reference List

5 1. Re-evaluation of HBsAg detection kits approved for marketing in Japan. Jpn J Infect Dis. October, 2001;54(5): Attallah AM, Ismail H, Tabll AA, Shiha GE, El Dosoky I. A novel antigen detection immunoassay for field diagnosis of hepatitis C virus infection. J Immunoassay Immunochem. 2003;24(4): Clement F, Dewint P, Leroux-Roels G. Evaluation of a new rapid test for the combined detection of hepatitis B virus surface antigen and hepatitis B virus e antigen. J Clin Microbiol. December, 2002;40(12): Kaur H, Dhanao J, Oberoi A. Evaluation of rapid kits for detection of HIV, HBsAg and HCV infections. Indian J Med Sci. October, 2000;54(10): Lau DT, Ma H, Lemon SM, Doo E, Ghany MG, Miskovsky E et al. A rapid immunochromatographic assay for hepatitis B virus screening. J Viral Hepat. July, 2003;10(4): Mvere D, Constantine NT, Katsawde E, Tobaiwa O, Dambire S, Corcoran P. Rapid and simple hepatitis assays: encouraging results from a blood donor population in Zimbabwe. Bull World Health Organ. 1996;74(1): Raj AA, Subramaniam T, Raghuraman S, Abraham P. Evaluation of an indigenously manufactured rapid immunochromatographic test for detection of HBsAg. Indian J Pathol Microbiol. October, 2001;44(4): Richards AL, Perrault JG, Caringal LT, Manaloto CR, Sie A, Graham R et al. A noninvasive assessment of hepatitis B virus carrier status using saliva samples. Southeast Asian J Trop Med Public Health. March, 1996;27(1): Sato K, Ichiyama S, Iinuma Y, Nada T, Shimokata K, Nakashima N. Evaluation of immunochromatographic assay systems for rapid detection of hepatitis B surface antigen and antibody, Dainascreen HBsAg and Dainascreen Ausab. J Clin Microbiol. June, 1996;34(6): Shin HS, Kim CK, Shin KS, Chung HK, Heo TR. Pretreatment of for use in immunochromatographic assays for hepatitis B virus surface antigen. Clin Diagn Lab Immunol. January, 2001;8(1): Sumathy S, Thyagarajan SP, Latif R, Madanagopalan N, Raguram K, Rajasambandam P et al. A dipstick immunobinding enzyme-linked immunosorbent assay for serodiagnosis of hepatitis B and delta virus infections. J Virol Methods. July, 1992;38(1):

6 12. Torlesse H, Wurie IM, Hodges M. The use of immunochromatography test cards in the diagnosis of hepatitis B surface antigen among pregnant women in West Africa. Br J Biomed Sci. December, 1997;54(4): Verstraeten T, Keya A. Evaluation of two rapid hepatitis B surface antigen detection tests for screening in a blood bank. East Afr Med J. November, 1997;74(11): WHO. Assays: Operational Characteristics Report