Transfusion · 2026
Impact of delayed blood donation sample processing and testing on SARS-CoV-2 serological assay results in an evolving pandemic response.
СтатьяМногоцентровое исследованиеНазвание и аннотация: Перевод в очереди
Обработка статьи · этапы, ошибки и управление
Загрузка состояния…
Ошибки и ограничения
История · было → стало
Состояние обновляется каждые 5 секунд, пока блок открыт. Процент показывается только там, где известен объём работы. Пауза останавливает продолжение этапа; текущий запрос к источнику может завершиться.
Lanteri Marion C, Green Valerie, Sulaeman Hasan, Stone Mars, Haynes James, Di Germanio Clara, Smith Sakina, Villaflor Patricia G, Groves Jamel, Williamson Phillip C, Stramer Susan L, Coughlin Melissa M, Jones Jefferson M, Grebe Eduard, Busch Michael P, Saa Paula
Аннотация
BACKGROUND: The two largest US blood collection organizations led a multiphased, multicenter nationwide SARS-CoV-2 blood donor-based serosurveillance program. The potential impact of delayed sample processing and prolonged refrigerated or frozen storage on anti-SARS-CoV-2 antibody detection was investigated.
METHODS: Anti-spike (S) IgG and anti-nucleocapsid (N) total immunoglobulin levels were compared for 20 paired plasma/serum samples tested fresh and frozen after separation from cellular components on Day 5 or after ≤40 days of 4°C storage; 10 paired plasma/serum samples separated on Day 5 and tested immediately or after ≤67 days of 4°C storage; and 85 plasma and 950 serum samples tested fresh on Day 1 and after ≤209 days of -20°C storage post-separation. Proportional Bland-Altman analyses were used to estimate average bias and 95% limits of agreement (LOA).
RESULTS: Antibody reactivity was stable over time regardless of serum or plasma processing delays or prolonged refrigerated or frozen storage. Bland-Altman analyses suggest only minor deviations for anti-S antibodies for samples separated within 5 days and tested frozen compared to fresh (bias: 4.23%, 95% LOA: -10.02; 18.47), after ≤40 days of storage at 4°C pre-separation (9.51%, [-73.20; 92.22]) and after ≤67 days at 4°C post-separation (-14.04%, [-28.12; 0.04]). Similar observations were obtained for anti-N antibodies including samples retested after ≤209 days of storage at -20°C (-20.3%, [-81; 40.5]).
CONCLUSION: Despite challenges encountered in sample access and processing during a rapidly evolving pandemic, sample processing variability and testing delays minimally impacted serologic results and thus provide evidence for the validity of results in studies requiring variable sample handling conditions.
METHODS: Anti-spike (S) IgG and anti-nucleocapsid (N) total immunoglobulin levels were compared for 20 paired plasma/serum samples tested fresh and frozen after separation from cellular components on Day 5 or after ≤40 days of 4°C storage; 10 paired plasma/serum samples separated on Day 5 and tested immediately or after ≤67 days of 4°C storage; and 85 plasma and 950 serum samples tested fresh on Day 1 and after ≤209 days of -20°C storage post-separation. Proportional Bland-Altman analyses were used to estimate average bias and 95% limits of agreement (LOA).
RESULTS: Antibody reactivity was stable over time regardless of serum or plasma processing delays or prolonged refrigerated or frozen storage. Bland-Altman analyses suggest only minor deviations for anti-S antibodies for samples separated within 5 days and tested frozen compared to fresh (bias: 4.23%, 95% LOA: -10.02; 18.47), after ≤40 days of storage at 4°C pre-separation (9.51%, [-73.20; 92.22]) and after ≤67 days at 4°C post-separation (-14.04%, [-28.12; 0.04]). Similar observations were obtained for anti-N antibodies including samples retested after ≤209 days of storage at -20°C (-20.3%, [-81; 40.5]).
CONCLUSION: Despite challenges encountered in sample access and processing during a rapidly evolving pandemic, sample processing variability and testing delays minimally impacted serologic results and thus provide evidence for the validity of results in studies requiring variable sample handling conditions.