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Preanalytical stability of HIV‐1 and HCV RNA: impact of storage and plasma separation from cells on blood donation testing by NAT
Author(s) -
Schulze T. J.,
Weiß C.,
Luhm J.,
Brockmann C.,
Görg S.,
Hennig H.
Publication year - 2011
Publication title -
transfusion medicine
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.471
H-Index - 59
eISSN - 1365-3148
pISSN - 0958-7578
DOI - 10.1111/j.1365-3148.2010.01051.x
Subject(s) - nat , rna , hepatitis c virus , nucleic acid , virology , nucleic acid test , whole blood , viral load , human immunodeficiency virus (hiv) , hepatitis c , medicine , virus , blood donor , immunology , chemistry , biochemistry , covid-19 , disease , computer network , computer science , infectious disease (medical specialty) , gene
Background: The aim of this study was to evaluate the optimal preanalytical conditions prior to nucleic acid amplification technology (NAT) for human immunodeficiency virus‐1 (HIV‐1) or Hepatitis C virus (HCV) RNA in pools of 96 plasma specimens with regard to storage temperature, time and plasma separation in a blood donation environment. Study design and methods: Changes in viral nucleic acid concentration of HIV‐1 and HCV were observed for 5 days according to the Paul‐Ehrlich‐Institute's (PEI) guidelines that demand 95%‐detection limit of at least 10 000 IU mL −1 for HIV‐1 RNA and 5000 IU mL −1 for HCV RNA within a single donor blood specimen. Ninety‐five per cent detection limits of HIV‐1 RNA over 3 days after storage at either 5 or 21 °C were evaluated by using standardised HIV‐1 RNA‐positive plasma. Results: HCV RNA in whole blood samples proved to be more stable than HIV‐1 RNA. Whole blood storage at 21 °C was shown to decrease the detectability of HIV‐1 RNA even after only 18 h. Plasma samples once used for NAT at time 18 h did not alter viral stability up to 48 h after donation. Ninety‐five per cent detection limits of HIV‐1 RNA were securely below 10 000 IU mL −1 for 24 h after whole blood storage at 5 °C. Conclusions: These results may lead to a discussion around the most suitable preanalytical conditions in blood donation environments. Contrary to the current PEI guidelines that allow storage of whole blood specimens up to 18 h at 21 °C, these results suggest that immediate storage in a 5 °C container after blood donation is more suitable and would permit storage of whole blood up to 24 h prior to the separation of plasma from cells.