FDA grants 510(k) clearance to chemiluminescence-based immunoassay

FDA grants 510(k) clearance to chemiluminescence-based immunoassay | Image Credit: © syahrir - © syahrir - stock.adobe.com.

The FDA has granted 510(k) clearance to EUROIMMUN’s automated chemiluminescence-based immunoassay (ChLIA) test for free testosterone, according to Revvity.¹

Using random-access iSYS or i10 instruments, the ChLIA assay provides a quick turnaround with superior accuracy and reliability. Technicians may provide high throughput testing with little training and expertise using the assay. Currently, it is the only ChLIA assay to receive FDA approval for direct quantitative measurement of free testosterone.¹

The assay measures testosterone in human serum or plasma, using monoclonal antibodies for high specificity and consistent performance between test batches. With a single test, patients may receive direct measurements of free testosterone levels.¹

By connecting to the lab track system, the IDS-i10 allows for multiple samples to be loaded continuously.² This lets each patient sample be processed as a single determination, reducing the effort and time necessary to complete this process.

Flexibility is also provided to laboratories with different requirements and sample volumes through the preferred processing of emergency (STAT) samples. The iSYS and i10 instruments allow for batch, continuous, and STAT loading. Additionally, stored master curves lead to minimum calibration effort.²

Autoimmune, allergy, and infection parameters are all available on a single instrument, alongside antigen detection. Up to 120 samples per hour may be tested, with barcode recognition making the operation convenient and reliable.²

The instrument also has ready-for-use reagent cartridges and calibrators that provide long stability and cooling.³ Quality control data is automatically transmitted in an error-free and quick loading process with an RFID chip. With high signal intensity, the ChLIA has broad dynamic analytical range.

During antibody detection, ChLIA incubates antigen-coated magnetic particles with diluted samples. Those with antibodies directed against the antigen then bind to the antigen-coated magnetic particles. Afterward, an acridinium-labelled antibody is added to bind to certain antibodies, and a chemiluminescence reaction is induced by a trigger solution.³

During antigen detection, incubation of antibody-coated magnetic particles occurs with the sample and an antigen-specific biotinylated antibody. The magnetic particle-coupled antibody and biotinylated antibody bind the antigen, after which acridinium-labelled ExtrAvidin is added to bind to the biotinylated antibody. Finally, a chemiluminescence reaction is induced by a trigger solution.³

Conditions such as impotence, hypogonadism, polycystic ovarian syndrome, and additional androgenital syndromes may receive enhanced diagnostic options through the assay.¹ Approximately 60 tests may be performed per hour, and patients will receive their first result within only 48 minutes.

References

1. Revvity announces FDA clearance for first automated free testosterone test. Revvity, Inc. January 10, 2025. Accessed January 10, 2025. https://www.businesswire.com/news/home/20250109821344/en/Revvity-Announces-FDA-Clearance-for-First-Automated-Free-Testosterone-Test
2. IDS-i10 and IDS-iSYS. EUROIMMUN. Accessed January 10, 2025. https://www.euroimmun.us/products/automation/chlia/ids-i10-and-ids-isys-2/
3. ChLIA random access and high speed. EUROIMMUN. Accessed January 10, 2025. https://www.euroimmun.us/techniques/chlia/