Revvity’s new automated free testosterone assay receives FDA clearance
Revvity Inc has announced FDA 510(k) clearance for EUROIMMUN’s automated chemilumin-escence immunoassay (ChLIA) for direct quantitative measurement of free testosterone. The assay, which runs on the company’s iSYS and i10 platforms, represents the first FDA-cleared automated direct measurement method for free testosterone in human serum or plasma.
Technical specifications
The ChLIA-based system employs monoclonal antibodies to ensure consistent specificity across batches whilst delivering rapid results. The first result is available within 48 minutes, with the platform capable of processing approximately 60 tests per hour. This high-throughput capability is particularly valuable for clinical laboratories managing large sample volumes.
Laboratory implementation and clinical applications
The assay has been designed to integrate seamlessly into existing laboratory workflows, requiring minimal technical training whilst maintaining precision and reliability. Its primary clinical applications include the investigation of hypogonadism, impotence, polycystic ovarian syndrome (PCOS), and various androgenital disorders. Jonathan Friend, general manager at Revvity’s EUROIMMUN US, commented: “Laboratory customers have been asking for a user-friendly FDA-cleared test, on a random-access platform, for direct measurement of free testosterone.”
Advancing diagnostic capabilities
The development marks a significant step forward in testosterone testing methodology. Traditional approaches to free testosterone measurement have often relied on calculated indices or more complex analytical techniques.
This direct measurement system offers potential advantages in terms of workflow efficiency and result standardisation.
The system operates on the company’s random-access iSYS or i10 instruments, offering flexibility for different laboratory settings. Full technical support and training programmes are available to facilitate implementation.
For more information, visit: www.euroimmun.us
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