Thermo Electron Corporation has introduced a rapid test for the sexually transmitted disease gonorrhea. Based on the company's patented Optical ImmunoAssay (OIA) technology, the GC OIA product is the only specific, rapid test for the detection of Neisseria gonorrhoeae (GC) from an endocervical swab for females and from urine for males. This test, which was developed by Thermo Electron's Point of Care and Rapid Diagnostics business unit (formerly known as Thermo BioStar), incorporates scientific advances that have overcome previous obstacles to developing a rapid immunoassay for this disease. The GC OIA test detects the proprietary L7/L12 ribosomal protein marker, a revolutionary new marker found within the cell and unique in the rapid diagnostics test market. The test also uses a unique, patented accessory, the UFD (Urine Filtration Device), to concentrate and extract the antigen from male urine prior to placement on the OIA platform.
"We are pleased to offer this important STD assay to all healthcare providers, along with our current rapid Chlamydia OIA test," said Lewis Rosenblum, president of Thermo Electron's clinical diagnostics division. "The ability to accurately detect gonorrhea will be of great value to our customers, and this test is specific, quick, and easy to use. The launch of the GC OIA product allows clinicians to implement a test-and-treat strategy for better patient management."
According to the Centers for Disease Control (CDC), Neisseria gonorrhoeae is the second most common sexually transmitted disease, resulting in 650,000 new infections annually.
The development of rapid diagnostic tests for Neisseria gonorrhoeae has been extremely challenging due to the difficulty in identifying single protein targets that are found only in GC, in all strains of GC, and not in other Neisseria species. By focusing on the detection of the proprietary ribosomal protein L7/L12, Thermo Electron has been able to bring about a first in GC diagnostics - a rapid test that is truly specific for GC.
Unlike the previous non-rapid products, the GC OIA test detects L7/L12, a ribosomal protein that is found within the cell. Detection of this protein offered some key advantages in the development of this highly sensitive and specific test. First, a ribosomal protein has a high number of copies within the cell, resulting in a significant increase in the available amount of L7/L12 when compared to the GC-specific proteins that others have targeted on the surface of the cell. This natural amplification was exploited in the development of a very sensitive test. Secondly, the epitope (the part of an antigen that binds to an antibody) detected within the L7/L12 protein is only present in GC and, therefore, the Optical ImmunoAssay test is very specific and does not show cross reactivity to other Neisseria species. Lastly, the targeting of a single protein such as L7/L12 allows for the use of a single detection antibody, whereas previous non-rapid GC products have required multiple antibodies directed to multiple protein targets on the cell surface.