In Vitro Diagnostic Industry in China - Immunoassay III

1.3 The Period of Automated Immunoassay

Various automated immunoassay analyzers were applied in clinical lab using different principles, which offered great convenience to our daily work in the laboratory, with more stability and accuracy than manual operation.

The automated procedure of clinical immunoassay was to control each step in the whole immunoassay procedure such as sampling, adding reagents, mixing, incubation, solid-phase separation, signal detection, data processing, result interpretation, and instrument cleansing. This procedure was done by the specific methodology and corresponding analyzer. The automated analyzers currently in the market were analyzers of immunoscattering turbidimetry, chemiluminescence immunoassay, fluorescence immunoassay, and automated analyzers for ELISA.

The selection and application of the automation system should be considered with specific situation and requirement of the clinical laboratory itself, including the performance of the system, the facilities and environmental conditions for the instruments, the laboratory testing throughput, information system of lab, and balance of cost and benefit.

1.4 The Period of Intelligent Immunoassay

Immunoassay has been developed from manual version to semi-automatic then to fully automatic. It now has been intelligentized by internet throughout from lab to clinics, from lab to individual, and from lab to family. Root level medical organization could be equipped by digital lab system for data sharing and individual data review, which was part of the Medical Cloud and future of intelligentization.

Considering the demand of precision medicine, in addition to clinical diagnosis, challenges emerged for more accurate, more scientific, and more rapid testing for screening of more diseases, surveillance, and prognosis. With the continuous stepping ahead of immunoassay technology, laboratory and clinical testing instruments have gradually been changed from semi-automated to fully automated, of which the working flow has also been evolved from the automatic operation of a single unit to the current total laboratory automation (TLA) or fully automated workflow. The intelligentization should be integrated in every single step of identification, transmission, processing, detection, storage, re-testing, and reporting with whole process to shorten the TAT.

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