Pratistha Tamrakar1, Cyrus Bett1, Ruth Damaris Molano2, Amna Ayub1, David M Asher1, Luisa Gregori1. 1. Division of Emerging and Transfusion-Infected Diseases, US Food and Drug Administration, Center for Biologics Evaluation and Research, Office of Blood Research and Review, Silver Spring, Maryland, USA. 2. Division of Veterinary Services, US Food and Drug Administration, Center for Biologics Evaluation and Research, Office of Management, Silver Spring, Maryland, USA.
Abstract
BACKGROUND: Blood donations must be tested for evidence of syphilis, a transfusion-transmitted infection. Screening blood for syphilis-related antibodies greatly reduced the risk of transfusion-transmitted syphilis (TTS). It is commonly believed that Treponema pallidum (Tp), the bacterium causing syphilis, does not survive in blood during cold storage-suggested as one reason why no cases of TTS have been recognized in the United States for many years. Some have suggested that routine syphilis screening of blood donations is no longer needed. To address the effect of storage, we investigated the survival of Tp experimentally spiked into blood and platelets stored under conventional conditions. STUDY DESIGN AND METHODS: We spiked fresh human blood products with high concentrations of Tp and inoculated samples at intervals into rabbits, a sensitive assay detecting infectious Tp. We tested whole blood (WB) stored refrigerated (1-6°C) for 9 days and platelets stored at room temperature for 7 days or refrigerated for 14 days. We assayed sera of the rabbits collected at intervals for seroconversion using two different tests and assessed orchitis. Rabbits were considered infected if one or both serological test results became positive. RESULTS: Viable Tp survived 7 days in WB and 6 days in platelets stored at both ambient and cold temperatures. DISCUSSION: Tp at concentrations much higher than those possibly present in an infected blood unit survived in cold blood products longer than previously reported and, thus, storage conditions cannot be relied upon to eliminate T. pallidum from blood or platelets. TTS remains a topic of concern for public health. Published 2021. This article is a U.S. Government work and is in the public domain in the USA.
BACKGROUND: Blood donations must be tested for evidence of syphilis, a transfusion-transmitted infection. Screening blood for syphilis-related antibodies greatly reduced the risk of transfusion-transmitted syphilis (TTS). It is commonly believed that Treponema pallidum (Tp), the bacterium causing syphilis, does not survive in blood during cold storage-suggested as one reason why no cases of TTS have been recognized in the United States for many years. Some have suggested that routine syphilis screening of blood donations is no longer needed. To address the effect of storage, we investigated the survival of Tp experimentally spiked into blood and platelets stored under conventional conditions. STUDY DESIGN AND METHODS: We spiked fresh human blood products with high concentrations of Tp and inoculated samples at intervals into rabbits, a sensitive assay detecting infectious Tp. We tested whole blood (WB) stored refrigerated (1-6°C) for 9 days and platelets stored at room temperature for 7 days or refrigerated for 14 days. We assayed sera of the rabbits collected at intervals for seroconversion using two different tests and assessed orchitis. Rabbits were considered infected if one or both serological test results became positive. RESULTS: Viable Tp survived 7 days in WB and 6 days in platelets stored at both ambient and cold temperatures. DISCUSSION: Tp at concentrations much higher than those possibly present in an infected blood unit survived in cold blood products longer than previously reported and, thus, storage conditions cannot be relied upon to eliminate T. pallidum from blood or platelets. TTS remains a topic of concern for public health. Published 2021. This article is a U.S. Government work and is in the public domain in the USA.
Entities:
Keywords:
donors; infectious disease testing; transfusion-transmitted disease - other
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