{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,29]],"date-time":"2026-05-29T19:01:08Z","timestamp":1780081268304,"version":"3.54.0"},"reference-count":8,"publisher":"Wiley","issue":"12","license":[{"start":{"date-parts":[[2025,10,29]],"date-time":"2025-10-29T00:00:00Z","timestamp":1761696000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"},{"start":{"date-parts":[[2025,10,29]],"date-time":"2025-10-29T00:00:00Z","timestamp":1761696000000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"funder":[{"DOI":"10.13039\/100030123","name":"American Red Cross","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100030123","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Transfusion"],"published-print":{"date-parts":[[2025,12]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background and Objectives<\/jats:title>\n                    <jats:p>\n                      Red blood cells (\n                      <jats:styled-content style=\"fixed-case\">RBCs<\/jats:styled-content>\n                      ) and platelets are evaluated for in vivo quality using recovery and survival measurements in healthy volunteers. Radiolabeling is the standard method for tracking blood cells post\u2010transfusion. The supply of chromium\u201051 (\n                      <jats:styled-content style=\"fixed-case\">\n                        <jats:sup>51<\/jats:sup>\n                        Cr)\n                      <\/jats:styled-content>\n                      manufactured under Good Manufacturing Practices (\n                      <jats:styled-content style=\"fixed-case\">GMP<\/jats:styled-content>\n                      ) has been challenging, and in 2024, the only remaining supplier ceased production. Now, only research\u2010grade\n                      <jats:styled-content style=\"fixed-case\">\n                        <jats:sup>51<\/jats:sup>\n                        Cr\n                      <\/jats:styled-content>\n                      is available, requiring risk control measures. Simultaneously, the Pyrophosphate (\n                      <jats:styled-content style=\"fixed-case\">PYP<\/jats:styled-content>\n                      ) kits used to condition\n                      <jats:styled-content style=\"fixed-case\">RBCs<\/jats:styled-content>\n                      for technetium\u201099m (\n                      <jats:styled-content style=\"fixed-case\">\n                        <jats:sup>99<\/jats:sup>\n                        mTc)\n                      <\/jats:styled-content>\n                      labeling are also no longer available. This report summarizes validations performed leading to reinfusions of blood cells labeled with a new kit for\n                      <jats:styled-content style=\"fixed-case\">\n                        <jats:sup>99<\/jats:sup>\n                        mTc RBC\n                      <\/jats:styled-content>\n                      labeling and research\u2010grade\n                      <jats:styled-content style=\"fixed-case\">\n                        <jats:sup>51<\/jats:sup>\n                        Cr\n                      <\/jats:styled-content>\n                      .\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Materials and Methods<\/jats:title>\n                    <jats:p>\n                      Three validations were conducted to confirm: (1) labeling efficiency of an alternative kit for\n                      <jats:sup>99<\/jats:sup>\n                      mTc labeling RBCs, (2) safety and labeling efficiency using research\u2010grade\n                      <jats:sup>51<\/jats:sup>\n                      Cr, and (3) the ability of the Pyrosate\u00ae\u2010Rapid Endotoxin Detection (PRED) kit to detect pyrogens in research\u2010grade material and in end\u2010products for in vivo use.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      Labeling efficiency of RBCs with\n                      <jats:sup>99<\/jats:sup>\n                      mTc using the Ultratag\u2122 RBC kit was &gt;98% and demonstrated consistency in labeling across different sample preparation conditions. Filtration of the radioisotope stock and endotoxin testing of the infusate served as effective risk mitigation steps, supporting safe use of research\u2010grade\n                      <jats:sup>51<\/jats:sup>\n                      Cr, with labeling efficiency &gt;98%.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>\n                      We validated the use of research\u2010grade\n                      <jats:sup>51<\/jats:sup>\n                      Cr, an updated kit for\n                      <jats:sup>99<\/jats:sup>\n                      mTc labeling, and endotoxin testing for in vivo reinfusion of research\u2010grade\n                      <jats:sup>51<\/jats:sup>\n                      Cr labeled blood cells, and have infused &gt;30 research participants with these changes under US FDA\u2013approved protocols.\n                    <\/jats:p>\n   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