title: Diagnostic Performance of an Immunoassay for Simultaneous Detection of Hcv Core Antigen and Antibodies among Haemodialysis Patients.
abstract: Nosocomial transmission of HCV is a concern in haemodialysis (HD) units worldwide. Diagnosis of HCV infection among dialysis patients is currently based on the detection of anti HCV antibodies by ELISA, and is confirmed by HCV RNA. The average window period between HCV infection and seroconversion with new generations of HCV antibody tests remains approximately 70 days with more prolonged period among dialysis patients. In this study we assessed the diagnostic performance of an immunoassay designed for simultaneous detection of anti HCV antibodies and core antigen in one step in comparison to qualitative RT-PCR and anti HCV antibodies detection test among Egyptian haemodialysis patients. The studied patients were 39 chronic renal failure patients on maintenance haemodialysis. The results obtained in the present study revealed HCV infection of 56.4%. Combined Ag/Ab test detected 3 out of the 4 anti-HCV negative viraemic patients who were in the window period. The sensitivity, specificity and accuracy of the test were higher than that of anti HCV antibodies detection test (95.45%, 94.1% and 94.87% versus 81.8%, 88.23% and 84.6%) and they were raised to 100% on combining its positivity with liver enzymes elevation results. Therefore, this simple combined Ag/Ab test can be applied for early detection of HCV infection during window period among HD patients as an alternative to HCV RNA detection.
authors.affiliation: Department of Clinical Pathology, Mansoura University , Egypt.
authors.forename: Wafaa M
authors.initials: WM
authors.lastname: El-Emshaty
authors.forename: Douaa
authors.initials: D
authors.lastname: Raafat
authors.forename: Doaa M
authors.initials: DM
authors.lastname: Elghannam
authors.forename: Niveen
authors.initials: N
authors.lastname: Saudy
authors.forename: Ehab E
authors.initials: EE
authors.lastname: Eltoraby
authors.forename: Abd Elhameed A
authors.initials: AE
authors.lastname: Metwalli
keywords: Egypt; HCV; HCV core antigen; haemodialysis; immunoassay
references.citation: Vox Sang. 1995;68(1):15-8
references.pmid: 7536987
references.citation: World J Gastroenterol. 2008 Apr 14;14(14):2288-9
references.pmid: 18407613
references.citation: Transfusion. 2003 Aug;43(8):1173-4
references.pmid: 12869127
references.citation: Ren Fail. 2006;28(8):729-35
references.pmid: 17162434
references.citation: Semin Dial. 2004 Jul-Aug;17(4):310-9
references.pmid: 15250925
references.citation: Transfusion. 2002 Aug;42(8):1037-45
references.pmid: 12385416
references.citation: J Med Virol. 2008 May;80(5):808-15
references.pmid: 18360894
references.citation: N Engl J Med. 1996 Nov 21;335(21):1609-10
references.pmid: 8927113
references.citation: Minerva Gastroenterol Dietol. 2005 Mar;51(1):31-46
references.pmid: 15756144
references.citation: J Egypt Public Health Assoc. 2007;82(5-6):379-404
references.pmid: 18706295
references.citation: Transfusion. 2005 Dec;45(12):1965-72
references.pmid: 16371051
references.citation: MMWR Recomm Rep. 2001 Apr 27;50(RR-5):1-43
references.pmid: 11349873
references.citation: J Hepatol. 1999;31 Suppl 1:71-9
references.pmid: 10622564
references.citation: J Clin Microbiol. 1999 Jun;37(6):1802-8
references.pmid: 10325327
references.citation: Pathol Biol (Paris). 2007 Mar;55(2):121-6
references.pmid: 16631320
references.citation: J Clin Microbiol. 2005 Aug;43(8):3877-83
references.pmid: 16081925
references.citation: World J Gastroenterol. 2009 Feb 14;15(6):641-6
references.pmid: 19222088
references.citation: Braz J Microbiol. 2008 Oct;39(4):644-7
references.pmid: 24031281
references.citation: Mem Inst Oswaldo Cruz. 2005 May;100(3):303-7
references.pmid: 16113873
references.citation: J Med Virol. 2008 Apr;80(4):603-6
references.pmid: 18297713
references.citation: Vox Sang. 2004 Apr;86(3):198
references.pmid: 15078255
references.citation: Transfusion. 2003 Aug;43(8):1067-74
references.pmid: 12869112
references.citation: Mol Diagn. 2000 Mar;5(1):11-22
references.pmid: 10837085
references.citation: Transfusion. 2003 Oct;43(10):1433-41
references.pmid: 14507276
references.citation: Chin Med J (Engl). 2007 Feb 20;120(4):294-9
references.pmid: 17374280
references.citation: Nephrol Dial Transplant. 1998 Dec;13(12):3037-40
references.pmid: 9870462
references.citation: Enferm Infecc Microbiol Clin. 2007 Mar;25(3):172-6
references.pmid: 17335695
references.citation: Aliment Pharmacol Ther. 2005 Apr 1;21(7):861-9
references.pmid: 15801921
references.citation: Hepatology. 2002 Jul;36(1):3-10
references.pmid: 12085342
references.citation: Clin Biochem. 2008 May;41(7-8):447-52
references.pmid: 18267117