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

Abstract

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.

Keywords

• nucleic acid amplification technology
• minipool
• transfusion-transmitted infection
• blood donation
• public–private partnership model
• nat yield