Performance Evaluation of Thyroid Function Tests on a Novel Chemiluminescent Microparticle Immunoassay System

Area of Science:

• Clinical chemistry
• Laboratory automation
• Immunoassay technology

Background:

• The Alinity i system is a new automated immunoassay analyzer with a high throughput.
• Thyroid function tests (TFTs) are crucial for diagnosing thyroid disorders.

Purpose of the Study:

• To evaluate the performance of TFTs on the Alinity i system.
• To assess the system's suitability for routine laboratory use.

Main Methods:

• Evaluated precision, linearity, comparison, functional sensitivity, and carryover for TSH, total T3, free T4, and total T4.
• Used manufacturer-provided reagents and followed Clinical Laboratory Standards Institute guidelines.
• Compared Alinity i performance against the Architect i2000 immunoassay analyzer.

Main Results:

• Within-laboratory coefficients of variation ranged from 1.6-3.6% for all hormones.
• Excellent linearity (R2 ≥ 0.99) and strong correlation (r ≥ 0.978) with Architect i2000 were observed.
• Functional sensitivity was below the analytical measurement range, and carryover was <1.0%.

Conclusions:

• The Alinity i system exhibits acceptable performance for TFTs.
• The system demonstrates good precision, linearity, and comparability.
• Alinity i is a potentially valuable tool for thyroid function testing in clinical laboratories.