Gonorrhea Rapid Screening Test Kit

The screening kits we supply have been chosen for their quality and reliability in STD/STI screening. We supply kits that have a high rate of agreement compared to laboratory testing using ELISA or PCR methods. ELISA or PCR testing methods are carried out in a testing laboratory and are seen as reliable and accurate methods by which to compare another testing products performance. A very high agreement rate for a rapid STD/STI screening kit indicates a similar result to a gold standard laboratory test. A low agreement rate indicates a poor performance compared to a laboratory test and should not be considered a suitable product. Agreement rates vary slightly across the various STDs due to various factors but in general products have an agreement rate of between 95%-100%. The ISO and GMP manufacturing standards also ensure consistency of production quality. Some test such as Chlamydia test for the detection of an antigen, in this case a bacteria. Other test kits such as Hep B test for antibodies produced by the human immune system in response to infection. Each STD screening method relies on its own detection window period in order to function. It is important to understand the detection window period of each test you are taking to ensure that it complies with the test kit requirements. Disclaimer: Rapid test kits are designed as a primary screening solution and all results should be consulted with your health professional. It is important to read and follow the instructions carefully.

ISO 13485 is an internationally recognized quality standard which states the requirements of the Quality Management System (QMS) for the design and manufacture of Medical Devices. Certification to ISO 13485 requires its quality system to pass a third-party Medical Device Single Audit Program, or “MDSAP” audit. ISO 13485 is recognized by WHO.

You can read more about ISO 13485 here https://en.wikipedia.org/wiki/ISO_13485