Evaluation of the Atellica TnIH cardiac troponin I assay and assessment of biological equivalence.

OBJECTIVES: We evaluated the analytical performance characteristics and the biological equivalence of the Atellica TnIH assay. METHODS: Precision, detection capability, linearity, and sex specific 99th percentiles were determined de novo. Classification of patients relative to the 99th percentiles was used to assess biological equivalence. RESULTS: Analytical precision and detection capability of the Atellica TnIH assay is excellent with a limit of blank <1 ng/L and 62.5% of women and 93% of men had results above the limit of detection. The 99th percentiles (90% CI) in women were 49 ng/L (31-67) and 70 ng/L (48-121) in men. An asymmetrical distribution involving 5% of results was notable. Agreement was moderate (Kappa 0.58, 95% CI 0.53-0.63) with 20% of patients discordantly classified with Atellica TnIH below and Access hsTnI above the 99th percentiles. Serial results in 195 patients demonstrated good agreement (Kappa 0.84, 95% CI 0.77-0.90). Differences greater than the assay specific reference change values (z≥±1.96) occurred in 65% (95% CI 53-76%) of 99th percentile discordant patients compared to 2.7% (p<0.001) and 76% (p=0.17) of the concordant low and high cTnI groups respectively. CONCLUSIONS: The 99th percentile discordant and the concordantly elevated groups are more alike with respect to their z≥±1.96 rates. This favours an overestimated Atellica TnIH 99th percentile as more likely, and we hypothesize that antibody interference resulting in asymmetric scatter of nearly 5% samples may be the underlying mechanism. Analytical accuracy and interferences in cardiac troponin assays should be investigated and resolved with high priority.

Policy change to improve pathology turnaround time and reduce costs--possible to do both?

BACKGROUND: Overcrowding and prolonged length of stay in emergency departments (ED) are increasing problems in hospitals. Rapid availability of all laboratory results has an impact on clinical decision-making, admissions or discharge decisions and resource utilisation. Increasing number of our urinary drugs of abuse (DOA) screens had a turnaround time (TAT) of up to 33 days after the discharge of the patient. MATERIALS AND METHODS: Following an audit and a consultation period with clinicians using the service, a policy change was implemented to reduce the use of gas chromatography mass spectroscopy (GCMS): all requests would have a standard immunoassay (IA) test panel undertaken unless specifically they requested GCMS (including medico-legal) analysis. RESULTS: Almost all of the clinicians interviewed had no understanding of the DOA screening or the difference in the information generated between a confirmatory GCMS urine toxicology screen and IA DOA panel. It appeared none of the patients surveyed in the audit would have had a different clinical decision made if a GCMS had not been undertaken. Post change audit showed only 4.3% of drug requests for IA also received a confirmatory GCMS testing. The estimated saving post change implementation was $127,000 (AU $) in test costs alone over a two year period. The TAT of GCMS results was reduced to 3-4 days. CONCLUSION: A laboratory-led behavioural change in test requesting is possible and sustainable provided the reason is clinically sound and accompanied by consultation and availability of advice by phone when requested on test requesting or interpretation.