KPC/IMP/NDM/VIM/OXA-48 Combo Test Kit (LFIA), EO Sterile, 20 Tests

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 KPC/IMP/NDM/VIM/OXA-48 Combo Test Kit (LFIA) for professional testing is an in vitro diagnostic medical device designed for rapid qualitative detection of KPC, IMP, NDM, VIM and OXA-48 carbapenemases in bacterial samples.

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 colloidal gold immunochromatography for the rapid qualitative detection of KPC, IMP, NDM, VIM and OXA-48 carbapenemases in bacterial samples obtained after culture. It aids in the rapid identification and infection control in detecting carbapenemase-producing Enterobacteriaceae in healthcare settings.

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 KPC/IMP/NDM/VIM/OXA-48 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: Provides clear results within 15 minutes, significantly faster than the 3 to 5 days required for antibiotic sensitivity testing.
• 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.