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. 2024 Nov 7;14(1):27128.
doi: 10.1038/s41598-024-77329-2.

Limited stability of Hepatitis B virus RNA in plasma and serum

Valerie Ohlendorf  1 , Birgit Bremer  1 , Lisa Sandmann  1 , Carola Mix  1 , Tammo Tergast  1 , Markus Cornberg  1   2   3   4   5 , Heiner Wedemeyer  1   2   5 , Katja Deterding  1 , Benjamin Maasoumy  6   7
Affiliations

Limited stability of Hepatitis B virus RNA in plasma and serum

Valerie Ohlendorf et al. Sci Rep. .

Abstract

Pregenomic hepatitis B virus RNA (HBV pgRNA) is a potential biomarker in the management of HBV infected patients. However, prior to the use in routine clinical practice potential confounders of test results need to be identified. This study investigates the stability of HBV pgRNA under various storage conditions. HBV-RNA level of 26 HBV patients were determined using the Roche cobas® 6800/8800 investigational HBV-RNA assay. Plasma and serum were stored for 6,48,169 h at 4,25 and 42 °C, respectively. Additionally, 10 serum and plasma samples underwent 4 or 11 cycles of freezing (-80 °C) and thawing (25 °C). A significant decline in mean pgRNA concentration compared to baseline was observed after storage for 48 h at 25 °C as well as after 6 h of storage at 42 °C. Accordingly, sub-analyses of predefined pgRNA baseline concentrations (≤ 10 cp/mL, > 10-100 cp/ml, > 100 cp/mL) revealed significant changes in pgRNA level after storage at 25 and 42 °C. No effect of freezing and thawing on pgRNA level was observed. A qualitative detection of HBV pgRNA is feasible in samples with > 100 cp/mL up to 48 h under storage temperatures of 4-42 °C. For most stable quantitative HBV pgRNA values storage at 4 °C should be preferred.

Keywords: Hepatitis B virus; Pregenomic HBV RNA; Relapse; Stability; Treatment cessation.

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Conflict of interest statement

The authors declare no competing interests.

Figures

Fig. 1
Fig. 1
Workflow of blood collection and sample processing of baseline, whole blood and supernatant samples, analyzed in the study.
Fig. 2
Fig. 2
Mean HBV RNA (copies/mL) levels in supernatant and whole blood of serum and plasma samples after storage for 6, 48 and 169 h at 4, 25 and 42 °C.
Fig. 3
Fig. 3
Median HBV RNA (copies/mL) in serum and plasma samples after 11 cycles of freezing and thawing.
See this image and copyright information in PMC

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