Summary:
Objective: Presented is the pilot study using Randox Evidence Investigator biochip array technology in measurement
of thyroid hormones in serum compared to electrochemiluminiscent immunoassay by Modular E-170 (Roche).
Method: In the determination of TSH we compared data measured by system Evidence Investigator (Thyroid total panel
and Thyroid free panel, Randox), with results gained on equipment Modular E-170 (Elecsys TSH, Roche). Investigator
Biochip Array Technology is used to perform simultaneous quantitative detection of multiple analytes from a single
patient. A combination of competitive and sandwich chemiluminiscent immunoassays is employed.
Results and Conclusion: The Bland & Altman plots comparing two measurements techniques shows statistically
significant differences in results. We determined bias (95% confidence interval): -1.3 to 2.7 mU/l for TSH (Thyroid total
panel); -1.7 to 3.0 mU/l for TSH (Thyroid free panel); -53.9 to 54.0 nmol/l (total T4), -1.11 to 0.66 nmol/l (total T3), -4.7 to
3.0 pmol/l (free T4) and -1,4 - 4,2 pmol/l (free T3). The main reason for result differences appears to be in insufficient
harmonisation of biochip and routine method calibrations.
Key words:
immunoassay, biochip, decision limit, traceability
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