Significance of alanine aminotransferase screening in blood donors for risk reduction of hepatitis B and C transmission by haemotherapy

Česká verzia

Authors: Katarína Kusendová ¹; Peter Gavorník ^2,3; Peter Sabaka ²; Klára Sviteková ¹
Authors place of work: Národná transfúzna služba SR Bratislava, Slovenská republika ¹; II. interná klinika LF UK a UN Bratislava, Slovenská republika ²; Prvé angiologické pracovisko (PAP) LF UK a UN Bratislava, Slovenská republika ³
Published in the journal: Vnitř Lék 2016; 62(1): 9-16
Category: Original Contributions

Summary

Background:
The goal of the retrospective observatory cross-sectional study was to evaluate the benefit of alanine aminotransferase screening of blood donors in prevention of hepatitis B and C transmission by haemotherapy in context of actual screening methods.

Methods:
Donations with elevated ALT more than the defined limit (ALT men 80 IU/l, women 64 IU/l, spectrophotometric UV test, KUADRO^TM, BPC BioSed Srt, Castelnuovo di Porto Roma, Italy) and/or reactivity any of the hepatitis screening parameters HBsAg, anti-HBc, anti-HCV (chemiluminescence method, ARCHITECT i2000^TM, Illinois, USA) were evaluated. Donors were confirmatory retested. They were classified into groups with common biological properties according to their final virological status and statistically evaluated in programs Graph Pad Prism 6.05 and Microsoft Excel 2003.

Results:
From a total of 61 214 donations elevated ALT was found in 420 (0.69 %), active HBV in 25 (0.04 %), active HCV infection in 5 (0.01 %) blood donors. Coincidental elevation of ALT and active HBV infection occured in 1 donor (0.002 %), as well as HCV (0.002 %). Levels of ALT were higher in the group with elevated ALT without active HBV or HCV infection than in groups with active HCV and HCV infection (p < 0.05). Occurence of blood donor in seronegative anti-HCV window was not observed. Elevated ALT was low specific (69.14 %) and senzitive (6.45 %) for active hepatitis. We did not prove positive correlation of ALT and S/CO (signal-to-cut-off) anti-HBc (Spearman r = -0,565, p < 0.0001), ALT and S/CO anti-HCV (Spearman r = -0.1046, p = 0.0022), in ALT and S/CO HBsAg the result was not statistically significant (Spearman r = -0.00968, p = 0.77). Positive but statistically insignificant correlation ALT and S/CO anti-HCV occured in the group of 5 blood donors with active HCV infection (Spearman r = 0.4, p = 0.51). Screening scheme for HCV infection testing anti-HCV + ALT was per one donation by € 0.18 more expensive than the scheme anti-HCV + HCV RNA due to amount of waisted donations with ALT elevation (825 TU, € 41 388.89).

Conclusion:
Elevation of ALT in blood donors was not pathognomonic for hepatitis B and C infection. Screening of HCV consisting of anti-HCV + HCV RNA (nucleic acid testing method, COBAS AmpliScreen HCV 2.0^TM, ROCHE Diagnostics, Hague Road, Indianapolis, USA) is more cost-effective than the scheme anti-HCV + ALT.

Keywords:
alanine aminotransferase – haemovigilance – hepatitis B – hepatitis C – screening

Zdroje

1. Quaranta J, Reboulot B, Cassuto J. Hepatitídy. SOFA: Bratislava 1995. ISBN 8085752419.

2. Brecher ME (ed). AABB Technical Manual. 15th ed. American Association of Blood Banks: Bethesda, Md 2005. ISBN 9781563951961.

3. WHO. Screening Donated Blood for Transfusion-Transmissible Infections-Recommendations. World Health Organization: Geneva 2010. ISBN 978–9241547888.

4. Wedemeyer H, Pawlotsky JM, McHutchison J. Acute viral hepatitis. Chronic viral and autoimmune hepatitis. In: Goldman L, Schafer AI. Goldman´s Cecil medicine. 24th ed. Elsevier Saunders: Philadelphia 2012: 966–978. ISBN 978–1437716047.

5. Národná transfúzna služba SR pracovisko Bratislava. Organizačná norma 21. Opatrenia na zabránenie prenosu infekcie krvou. Verzia číslo: 0, výtlačok číslo 5, platnosť od 2008.

6. Fábryová V, Cupaníková D, Grmanová Ľ et al. Imunohematológia a transfúzna medicína pre prax. Grada Slovakia: Bratislava 2012. ISBN ISBN 978–80–247–4391–2.

7. Biceroglu SU, Turhan A, Doskaya AD et al. Probable hepatitis C virus transmission from a seronegative blood donor via cellular blood products. Blood Transfusion 2014; 12(Suppl 1): S69-S70.

8. Busch MP, Korelitz JJ, Kleinman SH et al. Declining value of alanine aminotransferase in screening of blood donors to prevent postttransfusion hepatitis B and C virus infection. The Retrovirus Epidemiology Donor Study. Transfusion 1995; 35(11): 903–910.

9. Torezan-Filho MA, Alves VA, Neta CA et al. Clinical significance of elevated alanine aminotransferase in blood donors: a follow-up study. Liver Int 2004; 24(6): 575–581.

10. McCullough J. Transfusion Medicine. 3rd ed. Blackwell Publishing: Oxford 2011. ISBN 978–1-4443–3705–1.

11. Rossini A, Gazzola GB, Ravaggi A et al. Long-term follow-up of an infectivity in blood donors with hepatitis C antibodies and persistently normal alanine aminotransferase levels. Transfusion 1995; 35(2): 108–111.

12. Barna TK, Ozsvár Z, Szendrényi V et al. Hepatitis C virus antibody in the serum of blood donors. Orv Hetil 1996; 137(10): 507–511.

13. Gonḉales Júnior FL, Stucchi RS, Papaiordanou PM et al. Elevated alanine aminotransferase (ALT) in blood donors: an assessment of the main associated conditions and its relationship to the development of hepatitis C. Rev Inst Med Trop Sao Paulo 1998; 40(4): 219–224.

14. Ščepkinová E, Sviteková K. Príčiny. nešpecifickej (falošnej) reaktivity screeningového vyšetrenia protilátok proti core-antigénu vírusu hepatitídy B (anti-HBc). Interná medicína 2011; 11(Suppl): 26.

15. Ren FR, Wang JX, Huang Y et al. Hepatitis B virus nucleic acid testing in Chinese blood donors with normal and elevated alanine aminotransferase. Transfusion 2011; 51(12): 2588–2595.

16. Bamaga MS, Bokhari FF, Aboud AM et al. Nucleic acid amplification technology screening for hepatitis C virus and human immunodeficiency virus for blood donations. Saudi Med J 2006; 27(6): 781–787.

17. Roche Molecular Systems. Cobas AmpliScreen HCV Test, verzia 2.0. Roche: Indianapolis 2007. Dostupné z WWW: <http://molecular.roche.com/assays/Pages/COBASAmpliScreenHCVTestv20.aspx>.

18. FDA. Vaccines, Blood and Biologics. Dostupné z WWW: <http://www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/LicensedProductsBLAs/BloodDonorScreening/InfectiousDisease/ucm126581.htm>. Citované 18.2.2015.

19. Papatheodoridis GV, Goulis J, Christodoulou D et al. High prevalence of elevated liver enzymes in blood donors: association with male gender and central adiposity. Eur J Gastroenterol Hepatol 2007; 19(4): 281–287.

20. Pourshams A, Malekzadeh R, Monavvari A et al. Prevalence and etiology of persistently elevated alanine aminotransferase levels in healthy Iranian blood donors. J Gastroenterol Hepatol 2005; 20(2): 229–233.

21. Alter MJ. Epidemiology of Hepatitis C. Hepatology 1997; 26: (3 Suppl 1): S62-S65.

22. Sláčiková M. Aktuálna problematika vírusovej hepatitídy typu A a typu B. Via pract 2006; 3(7–8): 351–355.

23. Romano L, Velati C, Cambié G et al. Hepatitis B virus infection among first-time blood donors in Italy: prevalence and correlates between serological pattern and occult infection. Blood Transfusion 2013; 11(2): 281–288.

24. Hennig H, Puchta I, Luhm J et al. Frequency and load of hepatitis B virus DNA in first-time blood donors with antibodies to hepatitis B core antigen. Blood 2002; 100(7): 2637–2641.

25. Hugecová D, Schréter I, Adamkovičová E et al. Hepatitis C Virus Infection and Blood Donors in Eastern Slovakia. Xl. International Congress of Liver Diseases. Basel. Falk Symposium No 115 1999: 94 (abstract).

26. Kalibatas V, Kalibatiene L. The results of nucleic acid testing in remunerated and non-remunerated blood donors in Lithuania. Blood Transfusion 2014; 12(Suppl 1): S58-S62.

27. Kristian P, Mikas J, Schréter I. Epidemiológia hepatitídy C. Trendy v hepatológii 2010; 2(1): 12–17.

28. Gazdíková K, Gazdík F, Kajaba I et al. Vývoj séroprevalencie hepatitídy C v rizikovej skupine drogovo závislých jedincov v rokoch 2004–2008 na Slovensku. Vnitř Lék 2012; 58(3): 179–182.

29. Seo YS, Jung ES, Kim JH et al. Significance of Anti-HCV Signal-to-Cutoff Ratio in Predicting Hepatitis C Viremia. Korean J Intern Med 2009; 24(4): 302–308.

30. Rodella A, Galli C, Terlenghi L et al. Quantitative analysis of HBsAg, IgM anti-HBc and anti-HBc avidity in acute and chronic hepatitis B. J Clin Virol 2006; 37(3): 206–212.

31. Galli C, Orlandini E, Penzo L et al. What is the role of serology for the study of chronic hepatitis B virus infection in the age of molecular biology? J Med Virol 2008; 80(6): 974–979.

32. Behzad-Behbahani A, Mafi-Nejad A, Tabei SZ et al. Anti-HBc & HBV-DNA detection in blood donors negative for hepatitis B virus surface antigen in reducing risk of transfusion associated HBV infection. Indian J Med Res 2006; 123(1): 37–42.

33. Nabuco LC, Villela-Nogueira CA, Perez RM et al. HBV-DNA levels in HBsAg-positive blood donors and its relationship with liver histology. J Clin Gastroenterol 2007; 41(2): 194–198.

34. Muñoz-Gómez R, García-Monzón C, García-Buey L et al. Hepatitis C virus infection in Spanish volunteer blood donors: HCV RNA analysis and liver disease. Eur J Gastroenterol Hepatol 1996; 8(3): 273–277.

35. Ali N, Moiz B, Moatter T et al. Correlation of hepatitis C RNA and serum alanine aminotransferase in hepatitis B and C seronegative healthy blood donors. Indian J Pathol Microbiol 2010; 53(3): 480–485.

36. Balk M, Saydam G, Cengiz D et al. The Utility of anti-HCV S/CO Ratio, HCV-RNA and ALT Test in Predicting Viremia in anti-HCV Positive Patients. Turk J Biochem 2007; 32(2): 51–54.

37. Ščepkinová E, Gašparovič JJ. Eliminácia rizika prenosu vírusu hepatitídy B transfúziou vo fáze možnej okultnej HBV infekcie. Transfuze a hematologie dnes 2014; 20(2): 67–74.