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CLSI starts work to standardize IVD connectivity

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Aug. 13, 2015—The Clinical and Laboratory Standards Institute has started working on a standard addressing next-generation in vitro diagnostic instrument interface (AUTO16). The document development committee consists of individuals from the IVD industry, laboratory information system vendors, and clinical laboratorians.

The new AUTO16 standard, based on Health Level Seven, aims to improve IVD instrument connectivity by defining an interface that is more consistent across instruments and leverages modern health care connectivity protocols and network technologies. The standard will provide plug-and-play connectivity between instruments, middleware, and LIS systems, and additional capabilities not supported by the current CLSI standard, “Specification for Transferring Information Between Clinical Instruments and Computer Systems (LIS02).”

The CLSI standards “Specification for Low-Level Protocol to Transfer Messages Between Clinical Laboratory Instruments and Computer Systems (LIS01)” and LIS02, which were developed more than 20 years ago, describe specifications based on RS-232 serial communication for interfacing with an IVD instrument. Although later updated to support transmission control protocol/Internet protocol communication, the protocols described by the standards essentially remained the same. In addition, the variability allowed by the LIS02 standard has resulted in unique instrument vendor implementations, requiring LIS and middleware vendors to develop interfaces tailored to each specific instrument.

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