Cancer Diagnosis Program | Biorepositories and Biospecimen Research Branch

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Stability of lyophilised specimens for the molecular detection of viral DNA/RNA.

Author(s): Vaughan H, Chalker VJ, Mee Z, Rossouw A, James V

Publication: J Clin Virol, 2006, Vol. 35, Page 135-40

PubMed ID: 16024290 PubMed Review Paper? No

Purpose of Paper

Conclusion of Paper

Studies

1. Study Purpose

   The purpose of this study was to determine whether hepatitis B viral load is affected by storage of infected lyophilized serum at room temperature, 4 degrees C, or -30 degrees C.

   Summary of Findings:

   No decrease in viral load was detected using either a manual PCR assay or an automated one after 11 months of storage at room temperature, 4 degrees C, or -30 degrees C.

   Biospecimens

   • Bodily Fluid - Serum

   Preservative Types

   • Other Preservative

   Diagnoses:

   • Hepatitis

   Platform:

   Analyte	Technology Platform
   DNA	PCR

   Pre-analytical Factors:

   Classification	Pre-analytical Factor	Value(s)
   Preaquisition	Diagnosis/ patient condition	Hepatitis B
   Storage	Storage duration	10 d 1 month 2 months 3 months 4 months 5 months 6 months 11 months
   Storage	Storage temperature	4 degrees C -30 degrees C Room temperature
   PCR Specific	Technology platform	Roche Amplicor Monitor assay (manual) Amplicor COBAS Monitor assay (automated)

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2. Study Purpose

   The purpose of this study was to determine whether hepatitis C viral load is affected by storage of infected lyophilized plasma at room temperature or -30 degrees C.

   Summary of Findings:

   Storage of lyophilized specimens at room temperature decreased the hepatitis C viral load by 0.74 log10 copies/mL in one specimen after 7 months and by 0.24 log10 copies/mL in the second specimen after 6 months. Storage of lyophilized plasma specimens for up to 26 months at -30 degrees C had no effect on hepatitis C viral load.

   Biospecimens

   • Bodily Fluid - Plasma

   Preservative Types

   • Other Preservative

   Diagnoses:

   • Hepatitis

   Platform:

   Analyte	Technology Platform
   RNA	RT-PCR

   Pre-analytical Factors:

   Classification	Pre-analytical Factor	Value(s)
   Preaquisition	Diagnosis/ patient condition	Hepatitis C
   Storage	Storage duration	10 d 2 months 6 months 7 months 15 months 26 months
   Storage	Storage temperature	Room temperature -30 degrees C

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3. Study Purpose

   The purpose of this study was to determine whether HIV viral load is affected by storage of lyophilized infected plasma at -30 degrees C.

   Summary of Findings:

   After lyophilized plasma specimens were stored for 36 months at -30 degrees C there was no significant decrease detected in HIV viral load by the Bayer branch DNA method. However, when the Roche COBAS Amplicor Monitor PCR-based assay was used, decreases in viral load up to 0.51 log10 copies/mL were detected, but the authors suggest this was due to inter-assay variability rather than a significant loss in viral load.

   Biospecimens

   • Bodily Fluid - Plasma

   Preservative Types

   • Other Preservative

   Diagnoses:

   • AIDS/HIV-related

   Platform:

   Analyte	Technology Platform
   RNA	RT-PCR
   RNA	Branch DNA assay

   Pre-analytical Factors:

   Classification	Pre-analytical Factor	Value(s)
   Preaquisition	Prognostic factor	Viral load 10,000 copies/mL Viral load 1000 copies/mL Viral load 40,000 copies/mL Viral load 4000 copies/mL
   Storage	Storage duration	10 d 36 months
   Storage	Storage temperature	-30 degrees C

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