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Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán

2012, Number 6.II

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Rev Invest Clin 2012; 64 (6.II)

Guideline for interpretation and report of the antibody to hepatitis C virus

Contreras AM, Ochoa-Jiménez RJ, Kershenobich D, Granados-García V, Conde-González CJ, Celis A, Pérez-Gómez HR, Ruelas-Hernández S, Romero-Flores P, Alcántar-Luna E, Sierra-García de Quevedo J, Ancona-Pisté Ó

Language: Spanish
References: 70
Page: 641-678
PDF size: 441.62 Kb.


ABSTRACT

Patients with hepatitis C virus (HCV) infection are detected by testing for the presence of antibodies to HCV (Anti-HCV). A positive Anti-HCV test represents a true positive result only in a variable proportion of subjects (35 to 95%). The qualitative interpretation as positive or negative Anti-HCV report is associated with a general lack of understanding regarding the interpretation of results, when more specific testing should be performed, and which tests should be considered for this purpose. Therefore, a substantial variation in supplemental testing practices exists among laboratories and physicians. This guideline was developed on the basis of the best available evidence to classify positive antibody in two (low and high) or three levels (very low, low and high) according to the signal to cutoff (S/CO) ratio: the very low level of the Anti-HCV identifies false-positive results and further diagnostic testing is not necessary. The low antibody level is frequently related with false-positive results and testing with Immunoblot is recommended; only Immunoblot-positive subjects require HCV RNA testing because of a low possibility of being viremic. The high Anti-HCV level is an accurate serological marker for predicting viremia and denotes the need of routine HCV RNA testing in order to efficiently confirm hepatitis C. Cost-effectiveness analysis, based on the Anti-HCV level, recommends the use of the two or three-levels to choose the confirmatory test of positive antibody. This approach can be implemented without increasing test costs because the S/CO ratio is automatically generated in most laboratory analyzers and would provide health care professionals with useful information for counseling and evaluating patients, to eliminate unwarranted notifications in cases of false antibody reactivity, and correctly identifying those Anti-HCV-positive patients who are infected and need antiviral treatment. The written report should include the antibody level (S/CO ratio), the type of the immunoassay applied and interpretation guideline. Anti-HCV testing is performed in multiple settings including blood banks or health department facilities; adoption of this Guideline for interpretation and report of the antibody to hepatitis C virus by laboratories and its implementation by clinicians will improve the accuracy for interpreting antibody result to determine the next step on hepatitis C diagnosis.


REFERENCES

  1. Rosen HR. Clinical practice. Chronic hepatitis C infection. N Engl J Med 2011; 364(25): 2429-38. PMID: 21696309.

  2. Alter MJ, Kuhnert WL, Finelli L. Centers for Disease Control and Prevention (CDC). Guidelines for laboratory testing and result reporting of antibody to hepatitis C virus. MMWR Recomm Rep 2003; 52(RR-3): 1-13. PMID: 12585742.

  3. Contreras AM, Ochoa-Jiménez RJ. Overestimation of HCV prevalence by assessing positive anti-HCV results only. Arch Intern Med 2009; 169(9): 903-4. PMID: 19433705.

  4. Contreras AM, Ochoa-Jiménez RJ, Celis A, Méndez C, Olivares L, Rebolledo CE, et al. High antibody level: an accurate serologic marker of viremia in asymptomatic people with hepatitis C infection. Transfusion 2010; 50(6): 1335-43. PMID: 20088833.

  5. Lai KK, Jin M, Yuan S, Larson MF, Dominitz JA, Bankson DD. Improved reflexive testing algorithm for hepatitis C infection using signal-to-cutoff ratios of a hepatitis C virus antibody assay. Clin Chem 2011; 57(7): 1050-6. PMID: 21566071.

  6. Contreras AM, Tornero Romo CM, Toribio JG, Celis A, Orozco- Hernández A, Rivera PK, et al. Very low levels of hepatitis C antibodies predict false-positive results and avoid supplemental testing. Transfusion 2008; 48(12): 2540-8. PMID: 18680546.

  7. Schünemann HJ, Oxman AD, Brozek J, Glasziou P, Jaeschke R, Vist GE, et al. GRADE Working Group. Grading quality of evidence and strength of recommendations for diagnostic tests and strategies. BMJ 2008; 336(7653): 1106-10. PMID: 18483053.

  8. Oethinger M, Mayo DR, Falcone J, Barua PK, Griffith BP. Efficiency of the Ortho VITROS assay for detection of hepatitis C virus-specific antibodies increased by elimination of supplemental testing of samples with very low sample-to-cutoff ratios. J Clin Microbiol 2005; 43(5): 2477-80. PMID: 15872288.

  9. Bossi V, Galli C. Quantitative signal of anti-HCV by an automated assay predicts viremia in a population at high prevalence of hepatitis C virus infection. J Clin Virol 2004; 30(1): 45-9. PMID: 15072753.

  10. Kim S, Kim JH, Yoon S, Park YH, Kim HS. Clinical performance evaluation of four automated chemiluminescence immunoassays for hepatitis C virus antibody detection. J Clin Microbiol 2008; 46(12): 3919-23. PMID: 18945839

  11. Seo YS, Jung ES, Kim JH, Jung YK, Kim JH, An H, et al. Significance of Anti-HCV signal-to-cutoff ratio in predicting hepatitis C viremia. Korean J Intern Med 2009; 24(4): 302-8. PMID 19949727.

  12. Dufour DR, Talastas M, Fernandez MD, Harris B, Strader DB, Seeff LB. Low-positive anti-hepatitis C virus enzyme immunoassay results: an important predictor of low likelihood of hepatitis C infection. Clin Chem 2003; 49(3): 479-86. PMID: 12600961.

  13. Dufour DR, Talastas M, Fernandez MD, Harris B. Chemiluminescence assay improves specificity of hepatitis C antibody detection. Clin Chem 2003; 49(6): 940-4. PMID: 12765991.

  14. Kiely P, Walker K, Parker S, Cheng A. Analysis of sample-tocutoff ratios on chemiluminescent immunoassays used for blood donor screening highlights the need for serologic confirmatory testing. Transfusion 2010; 50(6): 1344-51. PMID: 20113456.

  15. Oxford Centre for Evidence-based Medicine [sitio de internet]. Oxford, UK [actualizado 2010 Enero 03; consultado 2010 Mayo 22]. University of Oxford; [1 pantalla]. Avaliable: http://www.cebm.net/index.aspx?o=1025

  16. AGREE Collaboration. Development and validation of an international appraisal instrument for assessing the quality of clinical practice guidelines: the AGREE project. Qual Saf Health Care 2003; 12(1): 18-23. PMID: 12571340.

  17. Ly KN, Xing J, Klevens RM, Jiles RB, Ward JW, Holmberg SD. The increasing burden of mortality from viral hepatitis in the United States between 1999 and 2007. Ann Intern Med 2012; 156(4): 271-8. PMID: 22351712.

  18. Valdespino JL, Conde-González CJ, Olaiz-Fernández G, Palma O, Kershenobich D, Sepúlveda J. Seroprevalencia de la hepatitis C en adultos de México: ¿un problema de salud pública emergente? Salud Publica Mex 2007; 49(Supl. 3): 395- 403. Disponible en: http://www.scielo.org.mx/pdf/spm/v49s3/ 10.pdf.

  19. Prati D. Transmission of hepatitis C virus by blood transfusions and other medical procedures: a global review. J Hepatol 2006; 45(4): 607-16. PMID: 16901579.

  20. Contreras AM, Reta CB, Torres O, Celis A, Domínguez J. Safe blood in the absence of viral infections due to HBV, HCV and HIV in serological window period in donors. Salud Publica Mex 2011; 53(Supl. 1): 13-18. PMID: 21877067.

  21. Contreras AM, Sotelo M, Celis A, Villalobos DB, Ancona-Piste O, Ochoa-Jiménez RJ, et al. Nosocomial transmission of hepatitis C associated with anesthesia procedures: a case-control study. Salud Publica Mex 2011; 53(Supl. 1): 19-25. PMID: 21877068.

  22. Martínez-Bauer E, Forns X, Armelles M, Planas R, Solà R, Vergara M, et al. Spanish Acute HCV Study Group. Hospital admission is a relevant source of hepatitis C virus acquisition in Spain. J Hepatol 2008; 48(1): 20-7. PMID: 17998149.

  23. Thompson ND, Perz JF, Moorman AC, Holmberg SD. Nonhospital health care-associated hepatitis B and C virus transmission: United States, 1998-2008. Ann Intern Med 2009; 150(1): 33-9. PMID: 19124818.

  24. Gutelius B, Perz JF, Parker MM, Hallack R, Stricof R, Clement EJ, et al. Multiple clusters of hepatitis virus infections associated with anesthesia for outpatient endoscopy procedures. Gastroenterology 2010; 139(1): 163-70. PMID: 20353790.

  25. Almroth G, Ekermo B, Akerlind, B, Mansson AS, Widell A. Monitoring hepatitis C infection in a major Swedish nephrology unit and molecular resolution of a new case of nosocomial transmission. J Med Virol 2010; 82(2): 249-56. PMID: 20029812.

  26. Laporte F, Tap G, Jaafar A, Saune-Sandres K, Kamar N, Rostaing L, et al. Mathematical modeling of hepatitis C virus transmission in hemodialysis. Am J Infect Control 2009; 37(5): 403-7. PMID: 18945513.

  27. Centers for Disease Control and Prevention (CDC). Acute hepatitis C virus infections attributed to unsafe injection practices at an endoscopy clinic—Nevada, 2007. MMWR Morb Mortal Wkly Rep 2008; 57(19): 513-7. PMID: 18480743.

  28. Spada E, Sagliocca L, Sourdis J, Garbuglia AR, Poggi V, De Fusco C, et al. Use of the minimum spanning tree model for molecular epidemiological investigation of a nosocomial outbreak of hepatitis C virus infection. J Clin Microbiol 2004; 42(9): 4230-6. PMID: 15365016.

  29. Macedo de Oliveira A, White KL, Leschinsky DP, Beecham BD, Vogt TM, Moolennar RL, et al. An outbreak of hepatitis C virus infections among outpatients at a hematology/oncology clinic. Ann Intern Med 2005; 142(11): 898-902. PMID: 15941696.

  30. Patel PR, Larson AK, Castel AD, Ganova-Raeva LM, Myers RA, Roup BJ, et al. Hepatitis C virus infections from a contaminated radiopharmaceutical used in myocardial perfusion studies. JAMA 2006; 296(16): 2005-11. PMID: 17062864.

  31. Comstock RD, Mallonee S, Fox JL, Moolenaar RL, Vogt TM, Perz JF, et al. A large nosocomial outbreak of hepatitis C and hepatitis B among patients receiving pain remediation treatments. Infect Control Hosp Epidemiol 2004; 25(7): 576-83. PMID: 15301030.

  32. Centers for Disease Control and Prevention (CDC). Transmission of hepatitis B and C viruses in outpatient settings—New York, Oklahoma, and Nebraska, 2000-2002. MMWR Morb Mortal Wkly Rep 2003; 52(38): 901-6. PMID: 14508437.

  33. González-Candelas F, Guiral S, Carbó R, Valero A, Vanaclocha H, González F, et al. Patient-to-patient transmission of hepatitis C virus (HCV) during colonoscopy diagnosis. Virol J 2010; 7: 217. PMID: 20825635.

  34. Germain JM, Carbonne A, Thiers V, Gros H, Chastan S, Bouvet E, et al. Patient-to-patient transmission of hepatitis C virus through the use of multidose vials during general anesthesia. Infect Control Hosp Epidemiol 2005; 26(9): 789-92. PMID: 16209386.

  35. Massari M, Petrosillo N, Ippolito G, Solforosi L, Bonazzi L, Clementi M, et al. Transmission of hepatitis C virus in a gynecological surgery setting. J Clin Microbiol 2001; 39(8): 2860- 3. PMID: 11474004.

  36. Bennett SN, McNeil MM, Bland LA, Arduino MJ, Villarino ME, Perrotta DM, et al. Postoperative infections traced to contamination of an intravenous anesthetic, propofol. N Engl J Med 1995; 333(3): 147-54. PMID: 7791816.

  37. Mele A, Spada E, Sagliocca L, Ragni P, Tosti ME, Gallo G, et al. Risk of parenterally transmitted hepatitis following exposure to surgery or other invasive procedures: results from the hepatitis surveillance system in Italy. J Hepatol 2001; 35(2): 284-9. PMID: 11580153.

  38. Siegel JD, Rhinehart E, Jackson M, Chiarello L. Health Care Infection Control Practices Advisory Committee. 2007 guideline for isolation precautions: preventing transmission of infectious agents in health care settings. Am J Infect Control 2007; 35 (10 Supl. 2): 65-164. PMID: 18068815.

  39. Miller MA, Pisani E. The cost of unsafe injections. Bull World Health Organ 1999; 77(10): 808-11. PMID: 10593028.

  40. Ciesek S, Friesland M, Steinmann J, Becker B, Wedemeyer H, Manns MP, et al. How stable is the hepatitis C virus (HCV)? Environmental stability of HCV and its susceptibility to chemical biocides. J Infect Dis 2010; 201(12): 1859-66. PMID: 20441517.

  41. Contreras AM, Tinoco E, Celis A, Novelo B, Romero MVP, Carrada E, et al. donHCVir Mexican Study Group. Hepatitis C antibody intraassay correlation: is retest in duplicate necessary? Transfusion 2007; 47(9): 1686-90. PMID: 17725735.

  42. Contreras-Navarro AM, Tornero-Romo CM, Orozco-Hernández A, Hernández-Lugo MI, Romero-Flores P, Celis de la Rosa A. Redescubriendo el anticuerpo a hepatitis C. Nuevas estrategias de escrutinio y diagnóstico. Gac Med Mex 2007; 143 (Supl. 2): 3-12. Disponible en: http://www.medigraphic.com/ pdfs/gaceta/gm-2007/gms072b.pdf.

  43. Obuchowski NA, Lieber ML, Wians FH Jr. ROC curves in Clinical Chemistry: uses, misuses, and possible solutions. Clin Chem 2004; 50(7): 1118-25. PMID: 15142978.

  44. Tynell E, Norda R, Ekermo B, Sanner M, Andersson S, Björkman A. False-reactive microbiologic screening test results in Swedish blood donors-how big is the problem? A survey among blood centers and deferred donors. Transfusion 2007; 47(1): 80-9. PMID: 17207234.

  45. Tobler LH, Lee SR, Stramer SL, Peterson J, Kochesky R, Watanabe K, et al. Performance of second-and third-generation RIBAs for confirmation of third-generation HCV EIA-reactive blood donations. Retrovirus Epidemiology Donor Study. Transfusion 2000; 40(8): 917-23. PMID: 10960517.

  46. Lee SR, Kardos KW, Schiff E, Berne CA, Mounzer K, Banks AT, et al. Evaluation of a new, rapid test for detecting HCV infection, suitable for use with blood or oral fluid. J Virol Methods 2011; 172(1-2): 27-31. PMID: 21182871.

  47. Peeling RW, Holmes KK, Mabey D, Ronald A. Rapid test for sexually transmitled infection (STIs): they way for ward. Sex Transm Infect 2006; 82 (Suppl. 5): VI-6. PMID: 17151023.

  48. Food and Drug Administration [sitio de internet]. Silver Spring, MD, USA [actualizado 29 de Julio 2010; consultado 11 de Agosto del 2010]. Rapid Test for Antibodies to Hepatitis C Virus Approved by the US Food and Drug Administration. Disponible en: http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ DeviceApprovalsandClearances/ Recently-ApprovedDevices/ucm220489.htm.

  49. Park Y, Lee JH, Kim BS, Kim do Y, Han KH, Kim HS. New automated hepatitis C virus (HCV) core antigen assay as an alternative to real-time PCR for HCV RNA quantification. J Clin Microbiol 2010; 48(6): 2253-6. PMID: 20351215.

  50. Kesli R, Polat H, Terzi Y, Kurtoglu MG, Uyar Y. Comparison of a newly developed automated and quantitative hepatitis C virus (HCV) core antigen test with the HCV RNA assay for clinical usefulness in confirming anti-HCV results. J Clin Microbiol 2011; 49(12): 4089-93. PMID: 21940466.

  51. Maertens G, Dekeyser F, Van Geel A, Sablon E, Bosman F, Zrein M, et al. Confirmation of HCV antibodies by the Line Immunoassay INNO-LIA HCV Ab III. Methods Mol Med 1999; 19: 11-25. PMID: 21374346.

  52. Busch MP, Kleinman SH, Jackson B, Stramer SL, Hewlett I, Preston S. Committee report. Nucleic acid amplification testing of blood donors for transfusion-transmitted infectious diseases: report of the Interorganizational Task Force on Nucleic Acid Amplification Testing of Blood Donors. Transfusion 2000; 40(2): 143-59. PMID: 10685998.

  53. Proyecto de Norma Oficial Mexicana PROY-NOM-253-SSA1- 2009, Para la disposición de sangre humana y sus componentes con fines terapéuticos. Diario Oficial de la Federación, 23 de septiembre del 2011. Disponible en: http://dof.gob.mx/ nota_detalle.php?codigo=5210821&fecha=23/09/2011.

  54. Respuesta a los comentarios recibidos respecto del Proyecto de Modificación de la Norma Oficial Mexicana NOM-003-SSA2- 1993, Para la disposición de sangre humana y sus componentes con fines terapéuticos, para quedar como Proyecto de Norma Oficial Mexicana PROY-NOM-253-SSA1-2009, Para la disposición de sangre humana y sus componentes con fines terapéuticos. Diario Oficial de la Federación, 01 de octubre del 2012. Disponible en: http://dof.gob.mx/nota_detalle.php? codigo=5270762&fecha=01/10/2012.

  55. Pereira A, Sanz C. A model of the health and economic impact of posttransfusion hepatitis C: application to cost-effectiveness analysis of further expansion of HCV screening protocols. Transfusion 2000; 40(10): 1182-91. PMID: 11061853.

  56. Husereau D, Bassett K, Koretz R. Inteferon-based therapies for chronic hepatitis C virus infection: an assessment of clinical outcomes. Canadian Agency for Drugs and Technologies in Health 2004. Consultado el 15 de septiembre del 2012. Disponible en: http://www.ccohta.ca/publications/pdf/171_ hepc_tr_e.pdf.

  57. Drummond MF, Sculpher MJ, Torrance GW, O’brien BJ, Stoddart GL. Methods for the Economic Evaluation of Health Care Programmes. 3rd. Ed. Great Britain: Oxford University Press; 2005, p. 379. ISBN 019-852-944-9.

  58. Singer ME, Younossi ZM. Cost effectiveness of screening for hepatitis C virus in asymptomatic, average-risk adults. Am J Med 2001; 111(8): 614-21. PMID: 11755504.

  59. Tramarin A, Gennaro N, Compostella FA, Gallo C, Wendelaar Bonga LJ, Postma MJ. HCV screening to enable early treatment of hepatitis C: a mathematical model to analyse costs and outcomes in two populations. Curr Pharm Des 2008; 14(17): 1655-60. PMID: 18673188.

  60. Helsper CW, Borkent-Raven BA, de Wit NJ, van Essen GA, Bonten MJ, Hoepelman AI, et al. Cost-effectiveness of targeted screening for hepatitis C in The Netherlands. Epidemiol Infect 2012; 140(1): 58-69. PMID: 21324216.

  61. Rein DB, Smith BD, Wittenborn JS, Lesesne SB, Wagner LD, Roblin DW, et al. The cost-effectiveness of birth-cohort screening for hepatitis C antibody in U.S. primary care settings. Ann Intern Med 2012; 156(4): 263-70. PMID: 22056542.

  62. Cammà C, Petta S, Enea M, Bruno R, Bronte F, Capursi V, et al. Cost-effectiveness of boceprevir or telaprevir for untreated patients with genotype 1 chronic hepatitis C. Hepatology 2012; 56(3): 850-60. PMID: 22454336.

  63. Chapko MK, Sloan KL, Davison JW, Dufour DR, Bankson DD, Rigsby M, et al. Cost effectiveness of testing strategies for chronic hepatitis C. Am J Gastroenterol 2005; 100(3): 607-15. PMID: 15743359.

  64. Barreto AMEC, Takei K, Sabino EC, Bellesa MAO, Salles NA, Barreto CC, et al. Cost-effective analysis of different algorithms for the diagnosis of hepatitis C virus infection. Braz J Med Biol Res 2008; 41(2): 126-34. PMID: 18235967.

  65. Sroczynski G, Esteban E, Conrads-Frank A, Schwarzer R, Mühlberger N, Wright D, et al. Long-term effectiveness and cost-effectiveness of screening for hepatitis C virus infection. Eur J Public Health 2009; 19(3): 245-53. PMID: 19196737.

  66. Nakamura J, Terajima K, Aoyagi Y Akazawa K. Cost-effectiveness of the national screening program for hepatitis C virus in the general population and the high-risk groups. Tohoku J Exp Med 2008; 215(1): 33-42. PMID: 18509233.

  67. Marín y López RA, Romero-Estrella S, Infante-Ramírez L, Méndez-Aquino JS, Berrón-Ruiz P, Morales-Alfaro NA, et al. Hepatitis C seroprevalence in accepted versus deferred blooddonor candidates evaluated by medical history and self-exclusion form. Transfusion 2004; 44(9): 1344-9. PMID: 15318859.

  68. Fundación Mexicana para la Salud Hepática. Hepatitis C as a public health problem in México. Salud Publica Mex 2011; 53 (Supl. 1): S61-7. PMID: 21877075.

  69. Contreras AM, Cervantes-Ocampo M. El IMSS tiene ciencia: Modelo de aplicación del conocimiento científico generado en las investigaciones locales, regionales y nacionales para la mejora de los programas de salud. Guadalajara, Jalisco, México: Ediciones de la Noche; 2010, p. 75. ISBN: 978-9700-764-923-1.

  70. Contreras AM, Ochoa-Jiménez RJ. Guía de Redacción de Artículos Originales en Ciencias de la Salud. Guadalajara, Jalisco, México: Ediciones de la Noche; 2012, p. 522. ISBN 978-607-9147-15-0.




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