Candida Albicans/Trichomonas Vaginalis/Gardnerella Vaginalis Antigen Combo Test

It is intended for in vitro diagnostic use only and is designed exclusively for professional testing. Carefully read and follow the instructions for use before performing the test.

This Candida Albicans/Trichomonas Vaginalis/Gardnerella Vaginalis Antigen Combo Test Kit (LFIA) for professional testing is an in vitro diagnostic medical device designed for the rapid qualitative detection of Candida albicans, Trichomonas vaginalis, and Gardnerella vaginalis.

As a rapid antigen test, it is intended for single use only and must be used within one hour of opening the inner foil packaging. Users must carefully read and follow the instructions for use before testing to ensure accurate results. This test complies with applicable regulatory requirements for in vitro diagnostic devices.

Intended Use

This rapid antigen test is a latex microsphere immunochromatography for the qualitative detection of Candida albicans, Trichomonas vaginalis, and Gardnerella vaginalis in female vaginal swab samples in vitro. It is used to aid in the diagnosis of Candidiasis, Trichomoniasis, and Bacterial Vaginosis at the point of care by health professionals.

The kit is to be used with the Candida Albicans/Trichomonas Vaginalis/ Gardnerella Vaginalis Antigen Combo Test Kit (LFIA) External Quality Control Swab Kit to validate the correct performance of the test procedure.

Warnings, Precautions & Limitations

The test kit is for in vitro diagnostic use only and must not be reused. All components should be brought to room temperature before testing.

The buffer solution must not be ingested or used in the eyes, and the kit should not be used if the packaging is damaged, contaminated or expired.

Storage & Handling

This self-test should be stored in a dry, well-ventilated environment between 2°C and 30°C and protected from direct sunlight. Freezing is not permitted.

It has a shelf life of 24 months and must be used within one hour of opening the foil pouch to maintain test performance.

Disposal & Environmental Considerations

After use, dispose of all test components - including the cassette, swab, and buffer - as medical waste in accordance with local disposal guidelines.

Compliance

This single-use Candida Albicans/Trichomonas Vaginalis/Gardnerella Vaginalis Antigen Test Kit provides results within 15 minutes and is sufficient for one test. The device is ethylene oxide sterilised and classified as an IVD Class 3 medical device. It is ARTG listed and CE certified, ensuring compliance with recognised medical device standards.

Product Features

• Rapid Detection: Delivers clear test results within 15 minutes, supporting timely decision-making.
• Single-Use Safety Design: Reduces cross-contamination risks and supports hygienic testing practices.
• User-Friendly Kit Format: Includes all required components for convenient at-home or point-of-care testing.
• Regulatory Approved Device: ARTG listed and CE certified to meet medical diagnostic standards.