The National Blood Service (England) approach to evaluation of kits for detecting infectious agents.

Blood services test their donations for a range of infectious agents before release for transfusion. To ensure that the assays used have appropriate sensitivity, subtype detection range, and specificity, and meet operational requirements (timeliness, automation, and process control), some form of selection is needed. The approach of the English National Blood Service (NBS) to the evaluation of commercial kits to assess their suitability is presented. As a centrally coordinated national service the NBS has the "critical mass" and can generate the economies of scale, to support a national kit evaluation group (KEG). Because England is within the European Union, KEG has no "licensing" function for manufacturers' kits which must be "Communautés Européennes marked" before they can be sold within the Union. The European Union's in vitro diagnostics directive sets out common technical specifications which manufacturers must meet. There are also UK ethical constraints on the use of patient/donor blood or tissue samples which must be complied with. In this context, KEG assesses the specificity of assays in collaboration with the blood center donation testing departments. The sensitivity of assays is determined in collaboration with the Health Protection Agency and the NBS National Transfusion Microbiology Reference Laboratory using performance panels, seroconversion panels, and a large range of divergent strains to assess detection range.

Accelerating root system phenotyping of seedlings through a computer-assisted processing pipeline.

BACKGROUND: There are numerous systems and techniques to measure the growth of plant roots. However, phenotyping large numbers of plant roots for breeding and genetic analyses remains challenging. One major difficulty is to achieve high throughput and resolution at a reasonable cost per plant sample. Here we describe a cost-effective root phenotyping pipeline, on which we perform time and accuracy benchmarking to identify bottlenecks in such pipelines and strategies for their acceleration. RESULTS: Our root phenotyping pipeline was assembled with custom software and low cost material and equipment. Results show that sample preparation and handling of samples during screening are the most time consuming task in root phenotyping. Algorithms can be used to speed up the extraction of root traits from image data, but when applied to large numbers of images, there is a trade-off between time of processing the data and errors contained in the database. CONCLUSIONS: Scaling-up root phenotyping to large numbers of genotypes will require not only automation of sample preparation and sample handling, but also efficient algorithms for error detection for more reliable replacement of manual interventions.

British Thoracic Society Guideline for the management of non-tuberculous mycobacterial pulmonary disease (NTM-PD).

The full guideline for the management of non-tuberculous mycobacterial pulmonary disease is published in Thorax. The following is a summary of the recommendations and good practice points. The sections referred to in the summary refer to the full guideline.

The value to blood establishments of supplier quality audit and of adopting a European Blood Alliance collaborative approach.

BACKGROUND: The assessment of suppliers of critical goods and services to European blood establishments is a regulatory requirement proving difficult to resource. This study was to establish whether European Blood Alliance member blood services could collaborate to reduce the cost of auditing suppliers without diminishing standards. MATERIALS AND METHOD: Five blood services took part, each contributing a maximum of one qualified auditor per audit (rather than the usual two). Four audits were completed involving eight auditors in total to a European Blood Alliance agreed policy and process using an audit scope agreed with suppliers. RESULTS: Audits produced a total of 22 observations, the majority relating to good manufacturing practice and highlighted deficiencies in processes, procedures and quality records including complaints' handling, product recall, equipment calibration, management of change, facilities' maintenance and monitoring and business continuity. Auditors reported that audits had been useful to their service and all audits prompted a positive response from suppliers with satisfactory corrective action plans where applicable. Audit costs totalled € 3,438 (average € 860 per audit) which is no more than equivalent traditional audits. The four audit reports have been shared amongst the five participating blood establishments and benefitted 13 recipient departments in total. Previously, 13 separate audits would have been required by the five blood services. DISCUSSION: Collaborative supplier audit has proven an effective and efficient initiative that can reduce the resource requirements of both suppliers and individual blood service's auditing costs. Collaborative supplier audit has since been established within routine European Blood Alliance management practice.