The BioStar OIA GC test is a rapid assay for the diagnosis of gonorrhea. We've solved the challenge of developing a specific rapid assay for Neisseria gonorrhoeae by using the proprietary ribosomal protein, L7/L12, to bring about a first in GC diagnostics.

Easy to Use

• No instrumentation.
• All components included in kit.
• Minimal hands-on time.
• Test may be performed in discrete or batch format.
• Built-in controls and permanent test results provide assurance that test is performed properly.

Further Benefits of the BioStar OIA GC test

• Test and Treat in a single office visit
• Reduce unecessary treatment

The BioStar OIA GC test offers rapid point-of-care benefit in settings where results for the sexually transmitted disease, N. gonorrhoeae, are needed immediately. Based on 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 specimens for males. This test incorporates scientific advances that have overcome previous obstacles to developing a rapid immunoassay for this disease. The BioStar OIA GC 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.

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, we've 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 offers 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.

About Gonorrhea

Gonorrhea is a very common infectious disease and is the second most frequently reported communicable disease. According to the Centers for Disease Control (CDC), Neisseria gonorrhoeae is second only to chlamydia as the most common sexually transmitted disease, resulting in 650,000 new gonorrhea infections annually. - CDC

Regarding Chlamydia trachomatis point-of-care testing, the CDC states:

“…rapid or STAT tests can offer advantages in physicians’ offices, small clinics and hospitals, detention centers, and other settings where results are needed immediately (e.g., when decisions need to be made regarding additional testing or treatment while the patient is still present). - CDC, 2002 Lab Guidelines