Summary

Executive summary

  • Following a recommendation in a report to Health Ministers on dry chemistry pathology testing, a trial was carried out on the use in general practice and hospital wards of biochemistry analysers intended for 'office pathology' applications. This report summarises the pre trial assessment of the instruments.
  • Four types of multipurpose analysers (Arnes Seralyzer, Kodak Ektachem DT60, Abbott Vision, Boehringer Reflotron) and one haemoglobinometer  (Leo HemoCue) were evaluated by the Institute of Medical and Veterinary Science, Adelaide. All except the Vision are dry chemistry analysers.
  • Tests were carried out on the levels of imprecision, inaccuracy and linearity achievable with each instrument for a number of analytes, using protocols recommended by the Australian Association of Clinical Biochemists.
  • Most methods achieved acceptable levels of analytical imprecision and inaccuracy and showed linear responses within the ranges cited by the manufacturers.
  • The levels of inaccuracy obtained for some methods were just outside the criteria selected for acceptable performance. However, these methods were considered suitable for use by non laboratory operators, provided appropriate warning was given of necessary precautions.
  • The Working Party notes that the manufacturers concerned have subsequently taken steps to improve the analytical performance of these tests.
  • As a result of the evaluations, all instruments were recommended as suitable for use during the trial by operators in general practices and hospital wards provided that the requirements of the protocol were followed.
  • While quality control issues were not addressed in these preliminary studies, results from the evaluations indicated that all the instruments had significant potential for use in decentralised pathology services.