2009, Number 01-02
<< Back Next >>
Medicina & Laboratorio 2009; 15 (01-02)
First experience with nucleic acid amplification test (NAAT) in blood donors in Colombia
Rincón CO, Aristizábal BB, Barco AG, Jaramillo EL, Zuleta TJ, Jaramillo VS
Language: Spanish
References: 31
Page: 27-35
PDF size: 386.60 Kb.
ABSTRACT
Introduction: with the advent of molecular nucleic acid amplification test (NAAT) starting in 1998 for hepatitis B virus (HBV), and later for hepatitis C virus (HCV) and human immunodeficiency virus (HIV), there has been an increase in the relative safety of the blood compared to the serological tests, and therefore a reduction in the immune window period has been achieved. These tests are mandatory in the United States and in other countries around the world.
Objective: To describe the experience of NAAT for HIV, HCV and HBV, detect problems and implement the necessary corrective measures to improve blood quality in Colombia.
Methods: Prospective study on blood donors of Antioquia to evaluate NAAT as a screening method.
Results: A total of 4.890 donors and 14.670 tests were screened in 208 pools of plasmas. Age average of the 4.890 donors was 33 years (SD ± 10,93), 2.667 (54,5%) were men. No positive blood units were found by NAAT for HIV, HBV and HCV.
Conclusions: implement NAAT testing in our country requires high volume of samples to ensure timeliness, efficiency and effectiveness in the process. The short life and the urgency of platelets require continuous running of the tests. There is a need for trained personnel to overcome the various inconveniences that arise and to have a laboratory to conduct molecular diagnosis that meets interNAATional standards.
REFERENCES
Candido A, Chionne P, Milazzo L, Dettori S, Madonna E, Taffon S, et al. Nucleic acid testing (NAAT) for HCV RNA in Italian transfusion centres: an external quality assessment. J Clin Virol 2008; 41: 277-282.
Makroo RN, Choudhury N, JaganNAAThan L, Parihar- Malhotra M, Raina V, Chaudhary RK, et al. Multicenter evaluation of individual donor nucleic acid testing (NAAT) for simultaneous detection of human immunodeficiency virus -1 & hepatitis B & C viruses in Indian blood donors. Indian J Med Res 2008; 127: 140-147.
Piquet Y, Ivanovic Z, Laperche S, Pillonel J, Cristol G, Jeanne M, et al. Nucleic acid amplification testing detection of an HIV-1 infection in a blood donor during the preseroconversion window period. Transfus Med 2007; 17: 147-148.
Nantachit N, Thaikruea L, Thongsawat S, Leetrakool N, Fongsatikul L, Sompan P, et al. Evaluationof a multiplex human immunodeficiency virus-1, hepatitis C virus, and hepatitis B virus nucleic acid testing assay to detect viremic blood donors in northern Thailand. Transfusion 2007; 47: 1803-1808.
Goodman C, Chan S, Collins P, Haught R, Chen YJ. Ensuring blood safety and availability in the US: technological advances, costs, and challenges to payment--final report. Transfusion 2003; 43: 3S-46S.
InterNAATional Forum. Implementation of donor screening for infectious agents transmitted by blood by nucleic acid technology. Vox Sang 2002; 82: 87-111.
Pillonel J, Le Marrec N, Girault A, David D, Laperche S. [Epidemiological surveillance of blood donors and residual risk of blood-borne infections in France, 2001 to 2003]. Transfus Clin Biol 2005; 12: 239-246.
Pillonel J, Laperche S. Trends in risk of transfusion- transmitted viral infections (HIV, HCV, HBV) in France between 1992 and 2003 and impact of nucleic acid testing (NAAT). Euro Surveill 2005; 10: 5-8.
González-Díez R. NAAT y seguridad de la transfusión sanguínea. Gac Méd Méx 2004; 140: 86-89.
Gobernación de Antioquia. Dirección Seccional de Salud. Resolución No. 7238 del 28 de junio de 2005.
Soldan K, Davison K, Dow B. Estimates of the frequency of HBV, HCV, and HIV infectious doNAATions entering the blood supply in the United Kingdom, 1996 to 2003. Euro Surveill 2005; 10: 17-19.
Velati C, Fomiatti L, Baruffi L, Romano L, Zanetti A. Impact of nucleic acid amplification technology (NAAT) in Italy in the three years following implementation (2001-2003). Euro Surveill 2005; 10: 12-14.
Yoshikawa A, Gotanda Y, Itabashi M, Minegishi K, Kanemitsu K, Nishioka K. HBV NAAT positive [corrected] blood donors in the early and late stages of HBV infection: analyses of the window period and kinetics of HBV DNA. Vox Sang 2005; 88: 77-86.
Laperche S. Blood safety and nucleic acid testing in Europe. Euro Surveill 2005; 10: 3-4.
Niederhauser C, Schneider P, Fopp M, Ruefer A, Levy G. Incidence of viral markers and evaluation of the estimated risk in the Swiss blood donor population from 1996 to 2003. Euro Surveill 2005; 10: 14-16.
Offergeld R, Faensen D, Ritter S, Hamouda O. Human immunodeficiency virus, hepatitis C and hepatitis B infections among blood donors in Germany 2000-2002: risk of virus transmission and the impact of nucleic acid amplification testing. Euro Surveill 2005; 10: 8-11.
Owusu-Ofori S, Temple J, Sarkodie F, Anokwa M, Candotti D, Allain JP. PredoNAATion screening of blood donors with rapid tests: implementation and efficacy of a novel approach to blood safety in resource-poor settings. Transfusion 2005; 45: 133-140.
Stramer SL, Glynn SA, Kleinman SH, Strong DM, Caglioti S, Wright DJ, et al. Detection of HIV-1 and HCV infections among antibody-negative blood donors by nucleic acid-amplification testing. N Engl J Med 2004; 351: 760-768.
Lelie PN, van Drimmelen HA, Cuypers HT, Best SJ, Stramer SL, Hyland C, et al. Sensitivity of HCV RNA and HIV RNA blood screening assays. Transfusion 2002; 42: 527-536.
Hadgu A, Dendukuri N, Hilden J. Evaluation of nucleic acid amplification tests in the absence of a perfect gold-standard test: a review of the statistical and epidemiologic issues. Epidemiology 2005; 16: 604-612.
Brojer E, Gronowska A, Medynska J, Grabarczyk P, Mikulska M, Letowska M, et al. The hepatitis C virus genotype and subtype frequency in hepatitis C virus RNA-positive, hepatitis C virus antibody-negative blood donors identified in the nucleic acid test screening program in Poland. Transfusion 2004; 44: 1706-1710.
Busch MP. Should HBV DNA NAAT replace HBsAg and/or anti-HBc screening of blood donors? Transfus Clin Biol 2004; 11: 26-32.
Kuhns MC, Kleinman SH, McNamara AL, Rawal B, Glynn S, Busch MP. Lack of correlation between HBsAg and HBV DNA levels in blood donors who test positive for HBsAg and anti-HBc: implications for future HBV screening policy. Transfusion 2004; 44: 1332-1339.
Lopez RA, Romero-Estrella S, Infante-Ramirez L, Mendez-Aquino JS, Berron-Ruiz P, Morales-Alfaro NA, et al. Hepatitis C seroprevalence in accepted versus deferred blood-donor candidates evaluated by medical history and self-exclusion form. Transfusion 2004; 44: 1344-1349.
Schmunis GA, Cruz JR. Safety of the blood supply in Latin America. Clin Microbiol Rev 2005; 18: 12-29.
Seed CR, Kiely P, Keller AJ. Residual risk of transfusion transmitted human immunodeficiency virus, hepatitis B virus, hepatitis C virus and human T lymphotrophic virus. Intern Med J 2005; 35: 592-598.
Jose M, Gajardo R, Jorquera JI. Stability of HCV, HIV-1 and HBV nucleic acids in plasma samples under long-term storage. Biologicals 2005; 33: 9-16.
Marshall DA, Kleinman SH, Wong JB, AuBuchon JP, Grima DT, Kulin NA, et al. Cost-effectiveness of nucleic acid test screening of volunteer blood doNAATions for hepatitis B, hepatitis C and human immunodeficiency virus in the United States. Vox Sang 2004; 86: 28-40.
Dodd RY. Current safety of the blood supply in the United States. Int J Hematol 2004; 80: 301-305.
Gonzalez M, Regine V, Piccinini V, Vulcano F, Giampaolo A, Hassan HJ. Residual risk of transfusion- transmitted human immunodeficiency virus, hepatitis C virus, and hepatitis B virus infections in Italy. Transfusion 2005; 45: 1670-1675.
Alvarez do Barrio M, Gonzalez Diez R, Hernandez Sanchez JM, Oyonarte Gomez S. Residual risk of transfusion-transmitted viral infections in Spain, 1997-2002, and impact of nucleic acid testing. Euro Surveill 2005; 10: 20-22.