Newborns Analyzed for Irregularities Associated With Metabolic Diseases

The instrument is fully automated, performing every stage of an assay from retrieval of the sample plate from the stacker to measurement and reporting of results.

Called a genetic screening processor (GSP) system, it simplifies analysis of newborn blood samples by being able to run more than one test at once on very small samples. The GSP can analyze blood spot samples for irregularities associated with metabolic diseases that when detected early, can often be easily treated. The GSP utilizes specific workstation software for handling the newborn screening data.

In newborn screening programs, infants are tested for a range of genetic, metabolic, or hematologic disorders. When identified within the first few days of life, these disorders are often easily managed, but if left untreated, they could lead to serious illness or even death. The testing process begins with the collection of a few drops of blood from a heel prick.

PerkinElmer's (Waltham, MA, USA) GSP system provides multianalyte analysis capability and a two-fold capacity over prior systems, the system delivers increased efficiency and flexibility over other methods, while reducing the risk of errors associated with manual processing of samples.

The GSP analyzer eliminates the need to analyze all samples in batches, and processes them as they arrive in the laboratory. This improves response time for delivering results and eases the challenge of sample workflow management. Its multi-analyte capability enables analysis of several analytes simultaneously, preserving the small sample volume for a wider range of analysis. The GSP neonatal thyroid-stimulating hormone (TSH) assay is the first assay to receive U.S. Food and Drug Administration (FDA; Silver Spring, MD, USA) clearance for the GSP instrument. Several additional newborn screening assays are in development.

Designed to be flexible the GSP can be seamlessly integrated into a range of lab operations, enabling both multianalyte screening and having the ability to run traditional immunoassays or enzymatic-assays. Other design features include the refrigeration of onboard reagents, the integration of direct access to water and waste lines to streamline processes, and dedicated software.

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PerkinElmer
U.S. Food and Drug Administration