Article type
Year
Abstract
Background:
Nucleic Acid Amplification (NAT) tests detect and amplify viral nucleic acids of the Human Immunodeficiency Virus (HIV 1), Hepatitis B (HBV), and Hepatitis C viruses (HCV), present even in small amounts in infected blood donors, in the potentially infective time period between infection and appearance of an antibody response by an infected individual, that current serological tests cannot detect. Their high costs and doubts about their incremental cost-effectiveness have led to uncertainties about their inclusion as an additional screening method of blood donors in low- and middle-income countries.
Objectives:
To:
- describe the process employed to inform the recommendations of the Health Technology Assessment (HTA) Group for NAT testing at a tertiary care hospital in India;
- briefly describe the outcomes of donor screening after implementation of the recommendations.
Methods:
The HTA group sought data regarding the: prevalence of Transmission Transmissible Infections (TTIs) in blood donors, globally and locally; accuracy of NAT versus other screening tests; incremental yield of NAT over other tests; cost of NAT testing; and the perspectives of the administration and users of blood products. The group factored these in with the ethical, moral, and legal obligations of the institution to frame recommendations; and used a consultative, and evidence-informed process.
Results:
The available data indicated that, unlike in developed countries, the NAT yield in countries such as India with a higher prevalence of TTIs in the donor population is likely to be higher. The HTA group estimated that that NAT would prevent about 50 infections annually with HBV and HCV and maybe HIV, if added to existing tests. The HTA group recommended implementing NAT screening of blood donors at Christian Medical College because of legal, moral and ethical implications, and suggested methods to minimize the financial impact of this decision.
Conclusions:
Implementing resource-intensive technologies requires information not only about incremental cost-efficacy but also multiple other perspectives. Many more infections than estimated were averted.
Nucleic Acid Amplification (NAT) tests detect and amplify viral nucleic acids of the Human Immunodeficiency Virus (HIV 1), Hepatitis B (HBV), and Hepatitis C viruses (HCV), present even in small amounts in infected blood donors, in the potentially infective time period between infection and appearance of an antibody response by an infected individual, that current serological tests cannot detect. Their high costs and doubts about their incremental cost-effectiveness have led to uncertainties about their inclusion as an additional screening method of blood donors in low- and middle-income countries.
Objectives:
To:
- describe the process employed to inform the recommendations of the Health Technology Assessment (HTA) Group for NAT testing at a tertiary care hospital in India;
- briefly describe the outcomes of donor screening after implementation of the recommendations.
Methods:
The HTA group sought data regarding the: prevalence of Transmission Transmissible Infections (TTIs) in blood donors, globally and locally; accuracy of NAT versus other screening tests; incremental yield of NAT over other tests; cost of NAT testing; and the perspectives of the administration and users of blood products. The group factored these in with the ethical, moral, and legal obligations of the institution to frame recommendations; and used a consultative, and evidence-informed process.
Results:
The available data indicated that, unlike in developed countries, the NAT yield in countries such as India with a higher prevalence of TTIs in the donor population is likely to be higher. The HTA group estimated that that NAT would prevent about 50 infections annually with HBV and HCV and maybe HIV, if added to existing tests. The HTA group recommended implementing NAT screening of blood donors at Christian Medical College because of legal, moral and ethical implications, and suggested methods to minimize the financial impact of this decision.
Conclusions:
Implementing resource-intensive technologies requires information not only about incremental cost-efficacy but also multiple other perspectives. Many more infections than estimated were averted.