{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,19]],"date-time":"2026-09-19T14:04:08Z","timestamp":1789826648049,"version":"4.0.1"},"reference-count":16,"publisher":"Wiley","license":[{"start":{"date-parts":[[2026,9,19]],"date-time":"2026-09-19T00:00:00Z","timestamp":1789776000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2026,9,19]],"date-time":"2026-09-19T00:00:00Z","timestamp":1789776000000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Transfusion"],"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>Data on the long\u2010term stability and reproducibility of nucleic acid amplification testing (NAT) results in frozen stored positive samples (\u2264\u221220\u00b0C) remain limited. This study evaluated the long\u2010term performance of frozen virus\u2010positive samples in quantitative PCR assays and aimed to provide evidence for their analytical reliability in retrospective NAT and quality assurance. Because blood transfusions, despite their high safety, still carry a residual risk of transmission of blood\u2010borne viruses, these data may also be relevant for look\u2010back investigations in hemovigilance.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Materials and Methods<\/jats:title>\n                    <jats:p>Diluted and aliquoted internal run controls from positive patient samples were retrospectively analyzed using routine quantitative PCR assays. Long\u2010term stability was assessed over 37 months for HIV, 25 and 29 months for HBV\u2010A and HBV\u2010B, and 49 and 38 months for HCV\u2010A and HCV\u2010B. Descriptive statistics and linear regression were used to assess variability and temporal trends. Compliance with the German Medical Association's guidelines for quality assurance in medical laboratory testing (Rili\u2010BAEK) was evaluated using an acceptance range of \u00b10.5 log10.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>All internal run controls demonstrated stable long\u2010term performance during frozen storage and routine use. Across the datasets, 99.2%\u2013100% of measurements remained within the acceptance range. Results outside mean\u2009\u00b1\u20093 SD were rare, and no statistically significant temporal trend was observed for any internal run control.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>Frozen HBV\u2010, HCV\u2010, and HIV\u2010positive samples showed robust long\u2010term stability and reproducibility in routine quantitative PCR assays for up to 4\u2009years. These findings support the suitability of long\u2010term stored specimens for retrospective NAT.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/trf.70398","type":"journal-article","created":{"date-parts":[[2026,9,19]],"date-time":"2026-09-19T13:06:39Z","timestamp":1789823199000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Long\u2010term stability and reproducibility of frozen plasma control samples for hepatitis B virus, hepatitis C virus, and human immunodeficiency virus by quantitative\n                    <scp>PCR<\/scp>\n                    : Implications for retrospective testing in hemovigilance"],"prefix":"10.1111","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-8086-0454","authenticated-orcid":false,"given":"Benjamin","family":"Marx","sequence":"first","affiliation":[{"name":"Institute for Medical Virology University Hospital Frankfurt, Goethe University Frankfurt  Frankfurt am Main Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4612-4290","authenticated-orcid":false,"given":"Annemarie","family":"Berger","sequence":"additional","affiliation":[{"name":"Institute for Medical Virology University Hospital Frankfurt, Goethe University Frankfurt  Frankfurt am Main Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Niko","family":"Kohmer","sequence":"additional","affiliation":[{"name":"Institute for Medical Virology University Hospital Frankfurt, Goethe University Frankfurt  Frankfurt am Main Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marhild","family":"Kortenbusch","sequence":"additional","affiliation":[{"name":"Institute for Medical Virology University Hospital Frankfurt, Goethe University Frankfurt  Frankfurt am Main Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5100-9385","authenticated-orcid":false,"given":"Sebastian","family":"Hoehl","sequence":"additional","affiliation":[{"name":"Institute for Medical Virology University Hospital Frankfurt, Goethe University Frankfurt  Frankfurt am Main Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sandra","family":"Ciesek","sequence":"additional","affiliation":[{"name":"Institute for Medical Virology University Hospital Frankfurt, Goethe University Frankfurt  Frankfurt am Main Germany"},{"name":"Fraunhofer Institute for Translational Medicine and Pharmacology (ITMP)  Frankfurt am Main Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9394-2176","authenticated-orcid":false,"given":"Holger F.","family":"Rabenau","sequence":"additional","affiliation":[{"name":"Institute for Medical Virology University Hospital Frankfurt, Goethe University Frankfurt  Frankfurt am Main Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2026,9,19]]},"reference":[{"key":"e_1_2_11_2_1","unstructured":"World Health Organization.WHO action framework to advance universal access to safe effective and quality\u2010assured blood products 2020\u20132023.2021. Available from:https:\/\/www.who.int\/publications\/i\/item\/9789240035744"},{"key":"e_1_2_11_3_1","doi-asserted-by":"publisher","DOI":"10.1182\/blood-2008-07-077370"},{"key":"e_1_2_11_4_1","doi-asserted-by":"publisher","DOI":"10.1001\/jama.289.8.959"},{"key":"e_1_2_11_5_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1537-2995.2010.02851.x"},{"key":"e_1_2_11_6_1","doi-asserted-by":"publisher","DOI":"10.1056\/nejm199606273342601"},{"key":"e_1_2_11_7_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa040085"},{"key":"e_1_2_11_8_1","unstructured":"FunkMB MeyerB M\u00fcllerS.H\u00e4movigilanz\u2010Bericht des Paul\u2010Ehrlich\u2010Instituts 2022: Auswertung der Meldungen von schwerwiegenden Reaktionen und Zwischenf\u00e4llen nach \u00a7 63i AMG.2025. 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