The Know Rapid STD Screening Kit (Urine Test Cassette) includes individual test cassettes for:1. Chlamydia Trachomatis (CHT)2. Neisseria Gonorrhoeae (NGH)3. Trichomonas Vaginalis (TV)4. Mycoplasma Genitalium (MG).Each test strip in the cassette is suitable for urine specimen tests. During testing, if a specific antigen presented in the urine specimen reacts with each test cassette in the Treagent area, the conjugate antigens complex will be bound with the test cassette’s antibody coated on the membrane in case of a positive result. This would show in a darkred colored line in the T line region of a positive result. In case of negative result, no conjugate would bind at the test cassette’s antibody in the T line region and no line would form in the T line region of the test membrane. The C line serves as an internal qualitative control of the test system to indicate that an adequate volume of specimen has been applied and the flow occurred. Absence of C line indicates an invalid test result.
A collection of devices intended to be used by a layperson in the home to collect a clinical specimen for subsequent in vitro diagnostic investigation of sexually transmitted infections (STI) [e.g., Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, syphilis and human immunodeficiency virus (HIV)]. It consists of one or multiple transport containers, with or without an additive/medium [e.g., preservative solution, microbiological medium (e.g., Amies, Stuart, anaerobic, viral transport/inactivation medium)], and sampling/collection tool(s) [e.g., vaginal, rectal or oropharyngeal swab, brush, spatula, lancet, pipette]. This is a single-use device.
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