Summary

  • This report presents preliminary assessments of the performance of three products intended for pathology testing outside the laboratory setting.
  • The products considered are: URISCREEN - a test for detection of urinary tract infection (UTI); MICRAL-TEST - a test for detection and semi-quantitative measurement of urinary microalbumin; and the HemoCue Blood-Glucose Test - a analyser for quantitative measurement of blood glucose levels.
  • Particular consideration has been given to the analytical performance of the products and their potential for contribution to patient management. Cost factors are briefly discussed.
  • The assessments reflect the data available to the Institute from the literature and from distributors of the products. More definitive descriptions of performance and potential impact would require additional information.
  • URISCREEN is a low unit cost test which is easy to perform and appears to be a useful method for testing urine specimens for the presence of bacteria. Some questions remain regarding the significance of infection not detected by the test because of low concentrations of bacteria.
  • URISCREEN is considered to have the potential to contribute to patient management in general practice and hospital settings. Users of the test should be aware of its level of performance, particularly the relatively high proportion of false positive results. Both URISCREEN and other products for detection of UTI offer equivalent or better performance than microscopy on urine specimens.
  • MICRAL-TEST is inexpensive and could offer an effective method of testing specimens within the laboratory. Data from trials indi ate that the test has good sensitivity and specificity. There is some uncertainty concerning the number of false positives about the decision point (20 mg/L). The colour generated in the test varies with the depth and time of immersion and the time of reaction. Such variation could decrease the reliability of this product in the hands of operators who do not have laboratory experience.
  • The HemoCue Blood-Glucose Test is based on a satisfactory chemistry and on the basis of limited available data appears to be capable of giving appropriate performance in the non-laboratory environment. It is considered that, as is the case with other glucose analysers, pathology accreditation provisions should apply to use of this product.
  • While analytical data were available for each product, there was very little information on their performance under routine conditions outside the laboratory. It would be desirable for all products intended for use in the non-laboratory setting to be subject to properly designed investigations under Australian conditions.
  • These products are useful approaches to the development of methods for decentralised testing. The potential for their use outside the laboratory to contribute to effective patient management and to achieve cost savings will depend on a number of factors related to training, reimbursement, patterns of practice and availability of alternative types of testing.
  • The extent to which pathology accreditation provisions should apply to kits used outside the laboratory is a matter that might usefully be considered by the National Pathology Accreditation Advisory Council.