PubMed · 9681062
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D G Bullock. 1998. Scoring systems in EQA.. https://doi.org/10.1177/000456329803500414
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The lack of standardization of cardiac troponin I (cTnI) assay systems has meant an inability to compare absolute values between methods, and non-traceability of cTnI measurement in clinical laboratories. The present study tested whether a common calibrator for cTnI would harmonize values between different methods. Twenty fresh-frozen plasma samples and a common calibrator were analyzed in duplicate using the Dade Behring Stratus II, Chiron ACS:180, Abbott AxSYM, and Beckman Coulter Access immunoassay systems. Uncorrected cTnI values varied up to 60-fold between systems, and when correlated to the Stratus, linear regression slopes were 0.97 (ACS:180), 4.86 (AxSYM), and 0.03 (Access), verifying the differences in calibration. After correction for calibration differences by reference to the common calibrator, among-assay CV ranged from 2.7% to 55%, and was >25% for eight samples. However, the exclusion of Access results reduced the CV to 32% with only four outliers. The results show that comparable cTnI values between methods are possible by the use of a common calibrator. The lack of method harmonization for some samples may be due to non-equal antibody immunoreactivity of different plasma cTnI forms. The complete standardization of cTnI measurement requires both a secondary reference material and standardization of manufacturers' cTnI antibodies.
The i-STAT point-of-care testing analyser, which utilizes single-use multisensor cartridges, was evaluated. Two cartridges were assessed: the 6+ and the G3+, which provide results for urea, glucose, sodium, potassium, chloride, haematocrit, pH, PCO2, PO2 and various calculated parameters. The results for all analytes agreed well with the analysers in routine use in the laboratory. The reproducibility was comparable even when analysis was carried out by a nurse with only 5 min training. The system was found to be reliable, easy to use and required no maintenance (only a 2-min daily check of the electronics). These features, together with portability and the storage capacity for results, make the i-STAT suitable for point-of-care use, particularly in critical care units.
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