engleski

Verification of Abbott Stat High Sensitive Troponin-I assay

Background: Our aim was to verify the Architect STAT high sensitive troponin-I assay (hsTnI) prior to its introduction into our daily routine. The protocol included the verification of: (i) the 99th percentile of the reference population for both men and women declared by the manufacturer (34.2 and 15.6 ng/L, respectively) ; (ii) the declared imprecision at the 99th percentiles (3.5% at 34.2 ng/L ; 5.3% at 15.6 ng/L) ; and (iii) the carry-over. Materials and Methods: The 99th percentiles were verified according to the CLSI C28-A3c guideline on 40 male and 40 female healthy participants, without coronary heart disease. Method imprecision (repeatability and within-laboratory precision) was verified according to CLSI EP15- A2 protocol, by analyzing two serum pools with concentration near the 99th percentiles, for five consecutive days in triplicate. Carry-over was tested according to IUPAC protocol by analyzing one sample with hsTnI >50000.0 ng/L in duplicate followed by a triplicate measurement of a negative sample (hsTnI <4.7 ng/L). All measurements were performed on Abbott Architect i2000 analyzer. Results: Median age was 55 years (range: 39-82) for women and 57 years (range: 31-83) for men. Values of hsTnI have exceeded the 99th percentile for 3/40 women (hsTnI values: 26.4, 41.9 and 44.2 ng/L) and for 2/40 men (hsTnI values: 41.8 and 71.0 ng/L). The hsTnI concentrations were above limit of quantitation (4.7 ng/L) for only 7/40 women and 6/40 men. The repeatability and within-laboratory precision at 18.4 ng/L were 6.10% and 6.69% and at 25.5 ng/L 5.83% and 9.53%, respectively. The carry-over of hsTnI was 0%. Conclusion: Declared hsTnI 99th percentiles both for men and women can be used on our population. No carry-over was observed for the hsTnI assay and method imprecision is higher than declared by the manufacturer, but still below the recommended 10%.

high sensitive troponin I, method verification, precision, carry-over

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