The production of EQA (PT) samples is based on the acquisition of disease-marker positive material which has been well-characterised for the particular marker and also for unwanted pathogens. Most materials are obtained at significant expense and then further manipulated to ensure all recipients of the EQA samples receive a homogeneous representation of the batch and one that is stable for the period of the distribution.
The primary goal of EQA is to assist laboratories in an assessment of their performance which is based on benchmarking against other laboratories and methodologies. Therefore the primary need for spare samples is to help laboratories identify the problems causing any failed EQA. There are also secondary benefits to this assessment such as identification of kit or batch problems, methodology issues and increased scientific debate. However, the most important aspect of EQA remains with the learning and educational benefits that arise from the exercise.
With the introduction of ISO 15189:2012, the requests for spare EQA samples for use in verification of new test platforms have increased markedly to the point where the primary function of the spares (to investigate EQA failures) is at risk for availability and is causing unnecessary pressure on staffing requirements. Examination of several published papers and articles has shown that whilst EQA samples can be used for verification, they are not the only source and in some authors’ opinions, not the best source. Tibbetts1; Burd2; Khatami3
Therefore, it is now the policy of UK NEQAS for Microbiology to not provide free extra samples for the purpose of verification and/or validation of new test kits and methodologies. All requests for panels for verification will be reviewed.
1 Tibbetts, R. J. Clinical Microbiology Newsletter 37:19,2015
2 Burd, E. M. Clinical Microbiology Reviews, July 2010, p. 550–576 Vol. 23, No. 3 doi:10.1128/CMR.00074-09
3 Khatami Z., Hill, R; Sturgeon C., Kearney E., Breadon P., & Kallner A. Measurement verification in the clinical laboratory: A guide to assessing analytical performance during the acceptance testing of methods (quantitative examination procedures) and/or analysers. Association for Clinical Biochemistry