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Donald Rumsfeld and point-of-care testing (POCT): the problem of unknown unknowns—venous blood and glucose oxidase-based test strips
  1. Tim M Reynolds1,
  2. Tahir S Pillay2
  1. 1Department of Clinical Chemistry, Queens Hospital, Burton-on-Trent, UK
  2. 2Department of Chemical Pathology, University of Pretoria & NHLS, Pretoria, South Africa
  1. Correspondence to Professor Tahir S Pillay, Chemical Pathology, University of Pretoria, Faculty of Health Sciences, Pretoria 007, South Africa; tspillay{at}gmail.com

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Many laboratories manage point-of-care services either in their hospital or in their wider locality in association with primary care commissioners. As a result, they tend to be asked to contribute to assessment of the acceptability of new point-of-care systems from the point of view of accuracy and comparability to current systems. This is particularly the case for glucose testing strips, which currently make up 53.7% of the total global point-of-care testing (POCT) market.1

In testing whether systems are acceptable for clinical use, it is usual for ‘pragmatic’ testing regimes to be used. A fully correct ISO 15197:2013 evaluation2 is difficult because it requires collection of capillary blood samples from volunteers with a wide range of blood glucose concentrations, meaning that many healthy individuals and many patients with diabetes mellitus need to be recruited. It is not only difficult to find suitable volunteers but it is also difficult to simultaneously test a wide range of POCT analysers because multiple lancet punctures are necessary as one puncture site rarely stays open long enough for multiple blood drops to be collected. Moreover, there is inherent variability in capillary blood samples collected from fingerprink sites, compounding the problem even further.3 Finally, the use of live volunteers means that regulatory approval for the study would be required from a Research …

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