Gonorrhea Rapid Test | CE-marked
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Early detection of Neisseria gonorrhoeae infection supports timely treatment, reduces disease transmission, and helps prevent pregnancy-related complications and reproductive health issues. This rapid test enables healthcare professionals to make faster clinical decisions at the point of care without relying on laboratory processing.
The Problem: Early Detection of Gonorrhea Infection
Gonorrhea is one of the four most common, and curable, sexually transmitted diseases globally. In pregnancy, it is linked with higher rates of miscarriage, amniotic sac infection, preterm birth, premature rupture of membranes, and severe eye infection passed to the baby during delivery, which can lead to blindness. Gonorrhea is safe to treat with antibiotics during pregnancy. Women presenting for antenatal care visits should be tested for the presence of gonorrhea. The CDC recommends annual testing for many at-risk populations, including sexually active women under 25, older women with risk factors such as new or multiple partners, and men who have sex with men.
The Solution: Rapid Point-of-Care Gonorrhea Testing
The Neisseria Gonorrhea (NGH) Test Kit is a rapid and convenient antigen-capture immunochromatographic assay used for the qualitative detection of Neisseria Gonorrhea antigen in urethral/genital swab specimens. It is intended for professional use as an aid in the diagnosis of gonococcus infection.
To test, a swab specimen from the urethral/genital area of the patient is collected. The swab is then placed in a micro tube where two types of specimen extraction buffer are added. The swab is then rotated against the tube and discarded. The sample left in the micro tube is then vortexed and a couple drops added into the sample well of the testing device. The test works by detecting the Neisseria Gonorrhea antigen in the urethral/genital sample as it flows through the assay by first Neisseria Gonorrhea antibodies conjugated with colloidal gold that attach to Neisseria Gonorrhea antigens and provide a “visual tag” for the antigen-antibody-colloidal gold complex and second, by a test zone with immobilized antibodies that capture the complex, the visual tags producing a visible pink-colored band that is confirmation of the presence of Neisseria Gonorrhea and a positive result for gonorrhea. If there is no pink line, Neisseria Gonorrhea is not present, indicating a negative result for gonorrhea. Results are ready in 10 minutes.
Product Features
- Rapid qualitative detection of Neisseria gonorrhoeae
- Results available in approximately 10 minutes
- Cassette-based immunochromatographic assay
- Uses urethral or genital swab specimens
- Designed for professional healthcare use
- Suitable for point-of-care testing
- CE-marked medical device
- Manufactured in North America
Clinical Applications
This rapid test is suitable for:
- Sexual health clinics
- Antenatal care (ANC) programs
- Obstetric and gynecology clinics
- Hospital outpatient departments
- Primary healthcare facilities
- STI screening programs
- Community health services
- Low-resource healthcare settings
Not for sale within the United States. MOQ is 1000 tests.
Frequently Asked Questions
What does this test detect?
The test qualitatively detects Neisseria gonorrhoeae antigens from urethral or genital swab specimens.
How quickly are results available?
Results are available in approximately 10 minutes.
Is this test intended for professional use?
Yes. The test is intended for use by trained healthcare professionals.
Can this test be used in low-resource settings?
Yes. It is designed for point-of-care testing in hospitals, clinics, and other low-resource healthcare environments.
What is the minimum order quantity?
The minimum order quantity is 1,000 tests.