The cost-effectiveness of introducing nucleic acid testing to test for hepatitis B, hepatitis C, and human immunodeficiency virus among blood donors in Sweden (original) (raw)
Related papers
Transfusion, 2009
To further reduce the risk of hepatitis B virus (HBV) transmission by blood transfusion, nucleic acid testing (NAT) can be employed. The aim of this study is to estimate the incremental costeffectiveness ratio (ICER) in the Netherlands of employing a triplex NAT assay aimed at HBV nucleic acid detection in individual donations (ID-NAT) or in minipools of 6 donations (MP-6-NAT), compared to a triplex NAT assay in minipools of 24 donations (MP-24-NAT). STUDY DESIGN AND METHODS: A mathematical model was made of the whole transfusion chain from donors to recipients of blood in the Netherlands. The annual number of avoided HBV transmissions was estimated with the window-period incidence model. The natural history of a HBV infection in recipients is described by a Markov model.
Transfusion, 2008
The risk of transfusion-transmitted human immunodeficiency virus-1 (HIV-1), hepatitis C virus (HCV), and hepatitis B virus (HBV) infections is predominantly attributable to donations given during the early stage of infection when diagnostic tests may fail. In 1997, nucleic acid amplification technique (NAT)-testing was introduced at the German Red Cross (GRC) blood donor services to reduce this diagnostic window period (WP). A total of 31,524,571 blood donations collected from 1997 through 2005 were screened by minipool NAT, predominantly with pool sizes of 96 donations. These donations cover approximately 80 percent of all the blood collected in Germany during that period. Based on these data, the WP risk in the GRC blood donor population was estimated by using a state-of-the-art mathematic model. During the observation period, 23 HCV, 7 HIV-1, and 43 HBV NAT-only-positive donations were detected. On the basis of these data and estimated pre-NAT infectious WPs, the residual risk pe...
Transfusion, 2008
BACKGROUND: Nucleic acid testing (NAT) for hepatitis C virus (HCV) and human immunodeficiency virus (HIV) has been implemented in several European countries and in the United States, while hepatitis B virus (HBV) NAT is still being questioned by opinions both in favor and against such an option, depending on the HBV endemicity, health care resources, and expected benefits. STUDY DESIGN AND METHODS: This survey was aimed to assess the NAT impact in improving the safety of blood supply in Italy, 6 years after implementation. The study involved 93 Italian transfusion centers and was carried out in 2001 through 2006. A total of 10,776,288 units were tested for the presence of HCV RNA, 7,932,430 for HIV RNA, and 3,405,497 for HBV DNA, respectively. RESULTS: Twenty-seven donations or 2.5 per million tested were HCV RNA-positive/anti-HCV-negative; 14 or 1.8 per million units tested were HIV RNA-positive/ anti-HIV-negative; and 197 or 57.8 per million donations tested were HBV DNA-positive/hepatitis B surface antigen-negative. Of the latter, 8 (2.3/10 6) were collected from donors in the window phase of infection and 189 (55.5/10 6) from donors with occult HBV. Sixtyeight percent of the latter donors had hepatitis B surface antibody, 74.5 percent of whom with concentrations considered protective (Ն10 mIU/mL). CONCLUSION: NAT implementation has improved blood safety by reducing the risk of entering 2.5 HCV and 1.8 HIV infectious units per million donations into the blood supply. The yield of NAT in detecting infectious blood before transfusion was higher for HBV than for HCV or HIV. However, the benefit of HBV NAT in terms of avoided HBV-related morbidity and mortality in blood recipients needs to be further evaluated.
Transfusion, 2003
BACKGROUND: Residual risk of posttransfusion hepatitis B (PT-HB) may be reduced through implementation of HBV NAT or the new, enhanced-sensitivity HBsAg assays in routine donor testing. However, there are some doubts about the cost-effectiveness of these new safety measures, because hepatitis B acquired in adulthood is not regarded as a severe disease in western countries. STUDY DESIGN AND METHODS: A computer model was designed to estimate the health outcomes and associated costs of patients with PT-HB. Results from this model and estimations of the residual risk of HBV transmission, the risk reduction yielded by the new assays, and their cost were used to calculate the cost-effectiveness of including the new HBsAg assays or singlesample HBV NAT in the routine screening of blood donors. RESULTS: The model predicts that 0.97 percent of patients with PT-HB die of liver disease (54% of them due to fulminant hepatitis). The mean loss of life expectancy was 0.178 years per patient, and the present value of the lifetime costs of treating PT-HB was 4160 euros per patient. Single-donor HBV NAT or the new HBsAg assays would increase the life expectancy of blood recipients by 16 (95% CI, 8-40) or 14 (95% CI, 7-28) years, respectively, per every 10 million donations tested. The projected cost per life-year gained was 0.79 (95% CI, 0.15-1.85) million euros for the enhanced-sensitivity HBsAg assays and 5.8 (95% CI, 1.9-13.1) million euros for single-donation HBV NAT, both compared with current HBsAg assays. If single-donation HBV NAT is compared with the new HBsAg assays, its costeffectiveness ratio increases to 53 (95% CI, 16-127) million euros. CONCLUSION: PT-HB has few health or economic repercussions. Single-donation HBV NAT would provide a small health benefit at a very high cost. Instead, in some circumstances, the cost-effectiveness of enhanced-sensitivity HBsAg assays would be within acceptable ranges for new public health interventions. ABBREVIATIONS: HCC = hepatocellular cancer; LY(s) = life expectancy year(s); PT-HB = posttransfusion hepatitis B; QALY(s) = quality-adjusted, discounted year(s).
Cureus
Background Ensuring blood safety is the primary goal of transfusion medicine. Despite extensive serological tests and strict safety measures, the risk of transfusion-transmitted infections (TTIs) still exists. As applied to blood screening, Nucleic Acid Amplification Test (NAT) offers much higher sensitivity for detecting viral infections. It is, however, currently available to a handful of centers due to the high cost. This study aims to establish the Effectiveness of NAT by assessing the NAT yield and residual risk of transmission of Hepatitis B virus (HBV), hepatitis C virus (HCV) and HIV with and without NAT testing. Material and method This prospective cross-sectional study recruited blood donors from January 2020 to November 2022. All donors underwent routine serologic screening. Only serologically negative donors were tested for HBV, HCV, and HIV by NAT. The NAT yield and residual risk (RR) per million donors were computed for viral infections in seronegative blood donors and calculated using the incidence/window period model. Result A total of 59708 donors were included during the study period. The overall prevalence of TTI's were: For HCV 1.7% (n = 1018), HBV 1.5% (n = 918), HIV 0.07% (n = 47), Syphilis 1.2% (n = 758) and malaria 0.3% (n = 218). Out of 57759 seronegative donors, thirty-four NAT-reactive samples were identified, with 3 cases of HCV, 31 cases of HBV, and Nil HIV cases. NAT yield of HBV was 1 in 1863 with an RR of 8.6 per million, followed by HCV with a NAT yield of 1 in 19253 and RR of 0.8 per million donations. NAT testing reduced RR for HBV by 48.9% and HCV by 94.5%. Conclusion Our study showed that NAT detected 34 out of 57759 cases initially missed by serological tests. The study suggests that the parallel use of serology and NAT screening of donated blood would be beneficial.
Eurosurveillance
Blood and plasma donations in Germany are collected by several institutions, namely the German Red Cross, community and hospital-based blood services, private blood centres, commercial plasma donation sites and transfusion services of the army. All blood donation centres are required to report quarterly data on infection markers to the Robert Koch Institute, thus providing current and accurate epidemiological data. The prevalence and incidence of relevant viral infections are low in the blood donor population in Germany, with a decreasing trend for hepatitis C infections in new and repeat donors since 1997. The implementation of mandatory nucleic acid amplification technique (NAT) testing for hepatitis C virus (HCV) in 1999 has markedly improved transfusion safety. HIV-NAT became mandatory in 2004 but was done voluntarily by the majority of the blood donation services before then. The potential benefit of hepatitis B virus (HBV) minipool NAT is not as clear because chronic HBV carri...
2005
Blood and plasma donations in Germany are collected by several institutions, namely the German Red Cross, community and hospital-based blood services, private blood centres, commercial plasma donation sites and transfusion services of the army. All blood donation centres are required to report quarterly data on infection markers to the Robert Koch Institute, thus providing current and accurate epidemiological data. The prevalence and incidence of relevant viral infections are low in the blood donor population in Germany, with a decreasing trend for hepatitis C infections in new and repeat donors since 1997. The implementation of mandatory nucleic acid amplification technique (NAT) testing for hepatitis C virus (HCV) in 1999 has markedly improved transfusion safety. HIV-NAT became mandatory in 2004 but was done voluntarily by the majority of the blood donation services before then. The potential benefit of hepatitis B virus (HBV) minipool NAT is not as clear because chronic HBV carriers with very low virus levels might donate unidentified. The residual risk of an infectious window period donation inadvertently entering the blood supply can be estimated using a mathematic model which multiplies the incidence rate by the number of days during which an infection may be present but not detectable, i.e. the length of the window period.
Economic evaluation of HCV testing approaches in low and middle income countries
BMC Infectious Diseases, 2017
Background: Hepatitis C virus (HCV) infection represents a major public health burden with diverse epidemics worldwide, but at present, only a minority of infected persons have been tested and are aware of their diagnosis. The advent of highly effective direct acting antiviral (DAA) therapy, which is becoming available at increasingly lower costs in low and middle income countries (LMICs), represents a major opportunity to expand access to testing and treatment. However, there is uncertainty as to the optimal testing approaches and who to prioritize for testing. We undertook a narrative review of the cost-effectiveness literature on different testing approaches for chronic hepatitis C infection to inform decision-making and formulation of recommendations in the 2017 World Health Organization (WHO) viral hepatitis testing guidelines. Methods: We undertook a focused search and narrative review of the literature for cost effectiveness studies of testing approaches in three main groups:-1) focused testing of specific high-risk groups (defined as those who are part of a population with higher seroprevalence or who have a history of exposure or high-risk behaviours); 2) "birth cohort" testing among easily identified age groups (i.e. specific birth cohorts) known to have a high prevalence of HCV infection; and 3) routine testing in the general population. Articles included were those published in PubMed, written in English and published after 2000. Results: We identified 26 eligible studies. Twenty-four of them were from Europe (n = 14) or the United States (n = 10). There was only one study from a LMIC (Egypt) and this evaluated general population testing. Thirteen studies evaluated focused testing among specific groups at high risk for HCV infection, including nine in persons who inject drugs (PWID); five among people in prison, and one among HIV-infected men who have sex with men (MSM). Eight studies evaluated birth cohort testing, and five evaluated testing in the general population. Most studies were based on a one-time testing intervention, but in one study testing was undertaken every 5 years and in another among HIV-infected MSM there was more frequent testing. Comparators were generally either: 1) no testing, 2) the status quo, or 3) multiple different strategies. Overall, we found broad agreement that focused testing of high risk groups such as persons who inject drugs and men who have sex with men was cost-effective, as was birth cohort testing. Key drivers of cost-effectiveness were the prevalence of HCV infection in these groups, efficacy and cost of treatment, stage of disease and linkage to care. The evidence for routine population testing was mixed, and the cost-effectiveness depends largely on the prevalence of HCV.
Vox Sanguinis, 2005
Background and Objectives To reduce the risk of transfusion-transmissible viruses entering the blood supply, the nucleic acid amplification testing (NAT) was implemented to screen Scottish and Northern Irish blood donations in minipools. After 5 years of NAT for hepatitis C virus (HCV) and 2 years for human immunodeficiency virus-1 (HIV-1), the yield of serologically negative, nucleic acid positive ‘window donations’ and cost-benefit of NAT is under review.Materials and Methods When the Scottish National Blood Transfusion Service (SNBTS) implemented NAT in 1999, a fully automated ‘black box’ system was not available. Therefore, an ‘in-house’ assimilated NAT assay was developed, validated and implemented. The system is flexible and allows testing for additional viral markers to be introduced with relative ease.Results The HCV and HIV NAT assays have 95% detection levels of 7·25 IU/ml and 39·8 IU/ml, respectively, as determined by probit analysis. One HCV (1 in 1·9 million) and one HIV (1 in 0·77 million) window donation have been detected in 5 and 2 years, respectively, of NAT.Conclusion The SNBTS NAT assays are robust and have performed consistently over the last 5 years. The design of the in-house system allowed HIV NAT to be added in 2003 at a relatively small additional cost per sample, although for both assays, the royalty fee far exceeds the cost of the test itself. Clearly NAT has a benefit in improving the safety of the blood supply although the risks of transfusion-transmitted viral infections, as reported in the Serious Hazards of Transfusion (SHOT) report, are extremely low. Also, in UK the yield of HCV antibody negative, NAT positive donations is far lower than predicted although the early detection of an HIV window period donation and the increase of HIV in the blood donor and general populations may provide a stronger case for HIV NAT.Summary sentence The yield of HCV and HIV NAT in UK is significantly less than that anticipated from statistical models.