Commercially Available Rapid Hepatitis B Tests

Commercially Available Rapid Hepatitis B Tests

Type of Test: Lateral Flow

Manufacturer Name of Test Web Site Useable

Specimen Abbott Diagnostics Determine HbsAg http://www.abbottdiagnostics.c om Serum, plasma, whole blood Acon Laboratories, Inc. One Step (HBsAg, HBeAb, or HBcAb)Test Devices or Strips

http://www.aconlabs.com Serum, plasma, whole blood Akers Laboratories HealthTEST HbsAg Assay http://www.akerslaboratories.c om Serum, plasma, whole blood Alfa Scientific Designs Inc. HbsAg Cassette or Dip-Strip Tests

http://www.alfascientific.com/ Serum, whole blood

AmeriTek, Inc. One Step HbsAg Test Cassette or Strip

http://www.ameritek.org Serum, plasma, whole blood Beijing Blue Cross Biotech. One-Step (HBsAg, HBeAb, or HBcAb) Strip http://www.bluecrossbiotech.c om/new/newenglish/blue2.html Plasma, serum

Biokit, S.A. biorapid HbsAg http://www.biokit.com Serum, plasma BRIA HBsAb Strip &

HBsAb Card http://www.pacific-biotech.com/enlish/hbv_en.php Serum, plasma Cortez Diagnostics, Inc. One Step (HBsAg, HBsAb, HBcAb, HBeAb, or HBeAg) RapiDip InstaTest http://rapidtest.com Serum Cyprus Diagnostics One Step HBsAg Test http://www.diagnostics.be/cypr ess/ Serum, plasma Genix Technology RapidTech

HbsAg Test Strip

Manufacturer Name of Test Web Site Useable Specimen International Immuno-Diagnostics HbsAg, HbsAb, HbeAb, HBeAg http://www.intlimmunodiagnos tics.com Serum International Newtech Development One Step Hepatitis B (HBsAg, HBsAb, HBeAg, HBeAb, or (HBcAB) Test http://www.ind.ca Serum Mega Diagnostics, Inc. MegaKwik (HBsAb or HBsAg) Card Test

http://mega-dx.com Serum, plasma, whole blood Nubenco Diagnostics Hepatitis B Surface Antigen EasiStep/EasiStr ip

http://www.nubenco.com Serum, plasma

Orchid Biomedical Systems Virucheck http://www.tulipgroup.com/Or chid/index.htm Serum, plasma Orgenics RapidSignal™ HBsAg

http://www.orgenics.com/ Serum, plasma, whole blood Orgenics RapidSignal

Hepatitis B Panel

http://www.orgenics.com/ Serum, plasma

Princeton BioMeditech Corporation

BioSign HbsAg http://www.pbmc.com Serum, plasma, whole blood Standard Diagnostics Inc. Hepatitis (HBsAg, Anti-HBsAg, or HBeAg) Test

http://www.standardia.com Serum, plasma

Trinity Biotech Uni-Gold HBsAg

http://www.trinitybiotech.com Serum, plasma, whole blood Vision Biotech

(Pty) Ltd.

Vision Hepatitis B test

http://www.visionbiotech.com Serum, whole blood

Manufacturer Name of Test Web Site Useable Specimen World Diagnostics, Inc. Smart Strip HBsAg Test, Smart Strip Anti-HBc, Smart Check Hepatitis B Panel (5) Test Card, Smart Check HBsAg Test http://www.globalemed.com Serum Vencor International Inc.

DxStrip HBsAg http://www.vencorinternational .com/

Type of Test: Flow-through

Manufacturer Name of Test Web Site Useable

Specimen Cyprus Diagnostics Anti-HBsAg RAPID TEST http://www.diagnostics.be/cypr ess/ Serum International Newtech Development Membrane-EIA (HBsAg, HBsAb, HBeAg, HBeAb, or (HBcAB) Test

http://www.ind.ca Serum, plasma

MedMira Laboratories

MiraWell™ Rapid HBV Test (anti-HBc)

http://www.medmira.com/ Serum, plasma whole blood

Type of Test: Agglutination

Manufacturer Name of Test Web Site Useable

Specimen Axiom Diagnostic HBsAg Latex

rapid test

http://www.axiom-mms.com Serum, plasma, Cyprus Diagnostics Hepatitis B latex test http://www.diagnostics.be/cypr ess/ Serum Fujirebio Diagnostics Inc. SERODIA®-HBs http://www.fujirebio.co.jp/engli sh/product/pc02.html Serum, plasma SPAN Diagnostics AUSTRAGEN

LATEX

http://www.span.co.in/ Serum, plasma World Diagnostics, Inc. Pulse Hepatitis B Surface Antigen Latex Slide Test

http://www.globalemed.com Serum, plasma

Type of Test: Immunoblot

Test

Web Site Useable

Specimen Orgenics ImmunoCo

mb II HBs Ag 90

http://www.orgenics.com/ Serum, plasma

1. Re-evaluation of HBsAg detection kits approved for marketing in Japan. Jpn J Infect Dis. October, 2001;54(5):201–207.

2. 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):395–407.

3. 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):4603–4606.

http://www.pubmedcentral.nih.gov/articlerender.fcgi?tool=pubmed&pubmedid=12454159. 4. 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):432–434.

5. 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):331–334.

http://www.pubmedcentral.nih.gov/articlerender.fcgi?tool=pubmed&pubmedid=12454159. 6. 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):19–24.

7. 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):413–414.

8. Richards AL, Perrault JG, Caringal LT, Manaloto CR, Sie A, Graham R et al. A non-invasive assessment of hepatitis B virus carrier status using saliva samples. Southeast Asian

J Trop Med Public Health. March, 1996;27(1):80–84.

9. 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):1420–1422.

http://www.pubmedcentral.nih.gov/articlerender.fcgi?tool=pubmed&pubmedid=8735091.

10. Shin HS, Kim CK, Shin KS, Chung HK, Heo TR. Pretreatment of whole blood for use in immunochromatographic assays for hepatitis B virus surface antigen. Clin Diagn Lab

Immunol. January, 2001;8(1):9–13.

http://www.pubmedcentral.nih.gov/articlerender.fcgi?tool=pubmed&pubmedid=11139189.

11. 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):145–152.

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):256–259.

13. 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):717–718.

14. WHO. Hepatitis B Assays: Operational Characteristics