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Automated fluorometer/photometer system for homogeneous immunoassays.

T M Li, S P Robertson, T H Crouch

    Clinical Chemistry
    |September 1, 1983
    PubMed
    Summary
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    The OPTIMATE system offers automated, high-throughput analysis of therapeutic drugs and other blood analytes using fluorescent immunoassays. This automated analyzer demonstrates excellent precision and accuracy, correlating well with reference methods for drug monitoring.

    Area of Science:

    • Clinical chemistry
    • Analytical chemistry
    • Biomedical instrumentation

    Background:

    • Automated clinical analyzers are crucial for efficient and accurate laboratory diagnostics.
    • Homogeneous immunoassays offer advantages in speed and simplicity for drug and analyte quantification.
    • The OPTIMATE system represents an advancement in automated analytical instrumentation.

    Purpose of the Study:

    • To evaluate the performance of the OPTIMATE automated system for therapeutic drug monitoring using substrate-labeled fluorescent immunoassays.
    • To assess the system's capabilities for analyzing a range of routine blood analytes, including drugs, enzymes, metabolites, proteins, and hormones.

    Main Methods:

    • The study utilized the OPTIMATE automated bench-top clinical analyzer.
    • Performance was evaluated using homogeneous fluorescent immunoassays for specific drugs (gentamicin, tobramycin, amikacin, theophylline, phenytoin, phenobarbital, primidone, carbamazepine, quinidine).

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  • Key performance metrics assessed included sample throughput, precision (CVs), and correlation with reference methods.

    • Main Results:

    • The OPTIMATE system achieved a sample throughput of 92 samples per hour.
    • Precision studies showed typical coefficients of variation (CVs) of less than or equal to 6% for mid-range controls.
    • Results from clinical samples correlated well (r ≥ 0.97) with a reference method, demonstrating high accuracy.

    Conclusions:

    • The OPTIMATE system is a reliable and efficient automated analyzer for therapeutic drug monitoring and routine blood analyte determination.
    • Its unique features, including a combination thermocuvette and photon-counting fluorometer, contribute to its high performance.
    • The system demonstrates excellent precision and accuracy, making it suitable for clinical laboratory use.