Economic Evaluation of Nucleic Acid Testing for Screening of Blood Donations for Thalassemia Patients (ECONAT) in Western India.

Background: Transfusion Transmitted infections(TTI) are of significant concern for blood safety. The thalassemia patients who receive multiple transfusions are at an increased risk of TTIs and the Nucleic Acid Test (NAT ) has been advocated for safe blood. Though NAT can reduce the window period compared to serology, cost is a constraint. Methods: The thalassemia patient and NAT yield data from the centralized NAT lab in AIIMS Jodhpur was evaluated for cost-effectiveness using the Markov model. The incremental cost-effectiveness ratio (ICER) was calculated by dividing the difference between the cost for NAT and the cost of medical management of TTI-related complications by the product of the difference in utility value of a TTI health state with time and Gross National Income(GNI) per capita. Results: Out of the 48,762 samples tested by NAT, 43 samples were discriminated NAT yield all of which were reactive for Hepatitis B (NAT yield of 1:1134). There was no HCV and HIV NAT yield despite HCV being the most prevalent TTI in this population. The cost of this intervention was INR 5,85,14,400. The number of lifetime QALY saved was 1.38 years. The cost of medical management is INR 82,19,114. Therefore the ICER for intervention is INR 3,64,45,860 per QALY saved which is 274 times the GNI per capita of India. Conclusions: The provision of IDNAT-tested blood for thalassemia patients in Rajasthan state was not found to be cost-effective. Measures to bring down the cost or alternative options to increase blood safety should be explored.

NAT yield in blood donors: An observational study.

Introduction: Individual donation nucleic acid testing (ID-NAT) is considered as highly sensitive technology for viral transfusion-transmissible infections (TTIs) in blood donors. The present study was aimed to analyze the results of ID-NAT with special reference to different types of donors, their age, gender, blood group ranges in a tertiary care center in north India. Methodology: The present study was done from 24th June 2019 to 31st December 2021 in Blood Center, Department of Immunohematology and Blood Transfusion, SMS Hospital, Jaipur. A total of 18313 apparently healthy adult donors were included in present study. Result: In 2019 Combined NAT yield was 1 in 754, in 2020 it was 1 in 2368 and in 2021 it was 1 in 741. With Total NAT yield was 1 in 1017 (0.09 %) over a period of study. NAT yield in HBV is 1 in 1077, in HCV 1 in 18313 and no NAT Yield in HIV. Conclusion: NAT testing for hepatitis B provides additional safety because ELISA does not pick up occult hepatitis. The non-seroconverting or delayed seroconverting disease is missed by ELISA alone and can be picked up by NAT.

Adaptation of a Public-Private Partnership Model for the Implementation of Minipool Nucleic Acid Testing for Screening Routine Blood Donations and Assay Evaluation.

Background Nucleic acid amplification testing (NAT) for the screening of blood donations is known to improve blood safety. The decision to initiate NAT requires careful deliberation of infrastructure, skilled manpower, and financial resources. This report outlines the initiative of the Government of Odisha to implement NAT screening in government blood banks in the state of Odisha, India, through public-private partnership (PPP) and evaluates the incremental yield of minipool NAT screening over serology testing of blood donations. Methods Blood donations collected between June 2016 and September 2018 were initially screened for HBV (HBsAg), HCV (anti-HCV), and HIV (anti-HIV-1 and HIV-2) by ELISA, and syphilis and malaria. Sero-nonreactive donations were further screened in pools of six by Roche cobas TaqScreen MPX test version 2.0 (MPX2) NAT. Results On screening 3,39,472 blood donations, 1.34% seroreactive donations were detected. In all, 847 NAT-reactive donations (0.26%): 693 HBV, 58 HCV, and 96 HIV were detected. The NAT yields were 1:386 overall, 1:472 for HBV, 1:5642 for HCV, and 1:3409 for HIV. Conclusion NAT testing using the highly sensitive MPX2 assay leads to incremental detection of TTIs over serology. Implementation of NAT along with serological testing in blood centers all over India will be an important step towards providing safe blood. Our study not only highlights the benefits of minipool NAT testing but also presents a scalable PPP model that can serve as a template for application across other states.

Nucleic acid testing: Is it the only answer for safe Blood in India?

BACKGROUND: With the implementation of NAT in countries around the world, there is a growing pressure on the transfusion services in India to adopt NAT testing. India has about 2545 licensed Blood Centres. The Transfusion Services in India are fragmented, poorly regulated and the quality standards are poorly implemented. Blood Centres are still dependent on replacement/family donors and in most places laboratory testing for Transfusion transmitted infections is not quality assured, laboratory equipment are not calibrated and maintained, and validation of results is not carried out. Against the current scenario introducing NAT for screening of blood donors in India would pose a challenge. AIM: To study the prudence of universal NAT testing in India. MATERIALS AND METHODS: A retrospective study of 5 years from 2008-2012 was undertaken to study the true reactivity of donors using WHO strategy II and III and therefore the true seroprevalence of TTI infections in the donor populations. RESULTS: The true reactivity of the donors was much less as compared to the initially reactive donors due to the use of a well designed testing algorithm. In addition having a total voluntary blood collection along with good pre-donation counseling program also reduces the transmission of infections. CONCLUSIONS: What India essentially needs to do is religiously implement the strategies outlined in the WHO Aide-memoire. The blood should be collected only from voluntary non remunerative and repeat donors, there should be stringent donor selection with pre-donation counseling instituted. Strict implementation of quality management system, development of well defined testing startegies and strong haemovigilance system could take us a step in the right direction.

Confirmation and follow up of initial "NAT yields": Prospective study from a tertiary healthcare center in India.

BACKGROUND: In India variable rate of "NAT yield" has been demonstrated in several published reports. This study was performed with the objective to know the rate of "true NAT yield" in blood donors by confirmation with supplementary tests and follow up of initial "NAT yield" donors. MATERIALS AND METHODS: A total of 48,441 blood donors were tested for HIV, HBV and HCV with enhanced chemiluminescence and ID-NAT. To know the true NAT yield status confirmation of NAT yield donors was done as with an array of serological tests, repeat ID-NAT and alternate NAT. RESULTS: The cumulative initial "NAT yield" rate was 1:4404 (11/48,441). Seven of 11 initial "NAT yields" were for hepatitis B whereas two each were in HIV and HCV. Among the 11 "NAT-yield" donors, eight donors were followed-up for confirmation. Out of these eight donors only 4 were found to be true HBV NAT yields. Out of four true NAT yields two were window period donations while the other two were occult hepatitis B infection with anti-HBcore total positive. CONCLUSION: Our findings suggest that all "initial NAT yields" may not be "true NAT yields". We would also like to suggest that to demonstrate the true "NAT yield" status supplementary tests and donor follow up are important to differentiate true NAT yields.

Two years' experience of implementing molecular screening of hepatitis B virus, hepatitis C virus and human immunodeficiency virus 1, 2 in Riyadh blood donors.

Molecular screening technologies have improved blood safety by reducing the number of window-period transmissions relative to serological screening. In the two years following the introduction of molecular testing in King Khalid University Hospital, Saudi Arabia, 25,920 donor samples were screened in parallel by both serological and molecular techniques for hepatitis B virus (HBV), hepatitis C virus (HCV) and human immunodeficiency virus (HIV). No HCV or HIV NAT yields were detected. However, molecular screening enabled the interdiction of two confirmed HBV NAT yields. This is only the second report of confirmed HBV NAT yield in the Kingdom of Saudi Arabia, and amongst the few reports in the wider Middle East and North Africa region.

Evaluation of the Procleix Ultrio Plus ID NAT assay for detection of HIV 1, HBV and HCV in blood donors.

INTRODUCTION: The Procleix Ultrio Plusassay is a new-generation qualitative in vitro nucleic acid amplification test used to screen for human immunodeficiency virus type 1 (HIV-1) RNA, hepatitis C virus (HCV) RNA and hepatitis B virus (HBV) DNA in blood donors. This study was performed to compare the Procleix Ultrio assay with the new-generation Procleix Ultrio Plus Nucleic Acid Test (NAT) assays. MATERIALS AND METHODS: Ten thousand three hundred and two donor samples were run in parallel for ID NAT using the Procleix Ultrio and the Procleix Ultrio Plus assay. Simultaneously, enzyme-linked immunosorbent assay testing was performed on an EVOLIS Walk away System for HIV, HCV, HBsAg and anti-HBc. Reactive samples were confirmed using polymerase chain reaction. RESULTS: In the 10,302 samples tested during the study period, we identified 15 NAT yields, and all these revealed HBV DNA in the discriminatory assays. Eight of these were exclusive yields from the Ultrio Plus assay and the remaining seven cases were determined as HBV NAT yield, both by the Procleix Ultrio as well as the Ultrio Plus assays, i.e. "Combined" yields. No HCV or HIV 1 yields were detected during the study period by either of two assays. CONCLUSION: With an overall yield rate of 1 in 687 and an exclusive yield rate of 1 in 1287, the Procleix Ultrio Plus assay proved to be highly sensitive in detecting occult HBV infections.