The test allows for direct measurement of testosterone-related markers on a single platform to simplify clinical workflows.
Revvity Inc, through its subsidiary Immunodiagnostic Systems, received clearance from the Food and Drug Administration (FDA) for its Total Testosterone automated chemiluminescence immunoassay (ChLIA).
The assay complements the company’s existing FDA-cleared tests for free testosterone and sex hormone-binding globulin (SHBG). According to Revvity, the combined portfolio provides a comprehensive solution for testing testosterone-related disorders on a single platform.
Streamlining Clinical Workflows
The portfolio enables direct ChLIA measurements of total testosterone, SHBG, and free testosterone, providing diagnostic testing capabilities for suspected hypogonadism in men. These assays are processed on IDS random-access automation platforms.
The expanded portfolio allows for single-platform testing and the replacement of equilibrium dialysis-liquid chromatography/mass spectrometry (ED-LC/MS) methods. According to the company, ED-LC/MS methods require complex technologies and calculations that present operational and reproducibility challenges.
“Adding the total testosterone assay to our automated ChLIA platform transforms the offering to a wholly integrated solution that supports diagnostic testing for androgen-related conditions in both men and women,” says Arvind Kothandaraman, vice president and general manager, Euroimmun North America, in a release.
Expanding Endocrinology Capabilities
The clearance is part of the company’s efforts to expand its portfolio to aid in the diagnosis of endocrine disorders, according to the release.
In addition to the testosterone testing suite, other FDA-cleared assays in the company’s reproductive endocrine portfolio include 17-OH progesterone, androstenedione, and prolactin.
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