The Infectious Diseases Biobank (IDB) has a dedicated laboratory and use of a Category III laboratory within the Department of Infectious Diseases at Kings College London. The laboratory is well equipped to perform molecular biology studies on the samples and has a robot for the extraction of RNA and DNA.
The IDB is regulated by the Governance Committee and by internal (KCL) representatives of the Human Tissue Authority (HTA). In practice this means that the IDB is audited approximately four times per year and has had one external audit by the HTA.
All staff involved in recruiting and consenting volunteers have attended courses on ‘Good Clinical Practice’ and ‘in-house’ phlebotomy and HTA consent training. IDB staff (JC) also contribute to King’s College Research Ethics Committee and sub-committees.
The IDB utilizes standardized operating procedures based on EEC standards (ISO guideline 34, # 17025: 2005) and works within the UNE-EN-ISO 9001:2000 guidelines to facilitate future inter-biobank networking capabilities. Samples are continuously tracked from the time of collection by the courier from tissue collection centres through to freezing with a target of processing >75% of samples within 4 hours of bleeding. All material from patients with infectious diseases is processed in a negative pressure Category III laboratory and then stored in locked freezers. None of the released samples from the core collection have undergone a freeze-thaw cycle. Purified DNA samples are tested for the concentration of DNA and by PCR amplification of a house keeper gene β-globin, to ensure that samples are of sufficient quality prior to release.
Assessing the quality of archived samples
Samples are routinely assessed for viability: viral RNA has been recovered from the all plasmas of HIV infected patients tested. Similarly, an independent analysis of RNA quality has demonstrated that 104 samples were of very high quality and suitable for transcriptome analyses.