Follow-Up of Plasma Donors after Quarantine Storage: Results of a 5-Year Survey in Germany

Abstract

<b><i>Background and Objectives:</i></b> In 1993, a quarantine storage of 6 months was introduced for plasma for transfusion and was reduced to 4 months in 2003, owing to the improvements of screening assays used in German blood establishments. The presented survey analyses the value of quarantine storage under the current screening conditions. <b><i>Materials and Methods:</i></b> From 2015 to 2019, we collected data on the total amount of released quarantine plasma as well as on the number of quarantine plasma not released due to a reactive screening test of a follow-up donation. <b><i>Results:</i></b> Responding establishments covered 84% of plasma units released within the sampled period. In 3,583,913 (99.98%) of the total 3,584,664 test pairs, all screening assays revealed a negative result, leading to plasma release from quarantine storage<i>.</i> In 442 out of the residual 751 cases, confirmed positive results for human immunodeficiency virus (24), hepatitis C virus (22), or hepatitis B virus (396) were obtained in the follow-up donations. Of them, 372 revealed negative ID-NAT results in their retain samples confirmed by using highly sensitive individual donor nucleic acid amplification technology. In 70 cases, no testing of retain samples was performed as plasma was released for fractionation. The maximum theoretical risk for an undetected human immunodeficiency virus, hepatitis C or B virus infection was less than 0.0001%. <b><i>Conclusion:</i></b> No positive donation were found under the current screening regime and the quarantine storage during the 5-year survey period. In view of the current type and sensitivity of screening tests in German blood establishments, the results allow a reassessment of the value of quarantine storage of plasma regarding duration and release modalities. Due to the more sensitive donor screening, shorter quarantine periods as well as dispensing quarantine storage can be discussed. A reduction in the safety standard of plasma transfusions need not be feared, and the availability of plasma for transfusions could be facilitated.