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The BD ProbeTec™ ET Chlamydia trachomatis/Neisseria gonorrhoeae (CT/GC) Amplified DNA Assay Collection Kit for Male Urethral Specimens is used to collect and transport male patient urethral specimens to the laboratory for testing with the BD ProbeTec ET Chlamydia trachomatis and Neisseria gonorrhoeae Amplified DNA Assays.

The BD ProbeTec ET Chlamydia trachomatis/Neisseria gonorrhoeae (CT/GC) Amplified DNA Assay Collection Kit for Male Urethral Specimens consists of a sterile swab and a CT/GC Diluent tube for specimen transport. The rayon-tipped collection swab consists of a flexible aluminum wire in a plastic shaft. After the specimen is collected, the swab is placed into the CT/GC Diluent tube and the shaft is broken at the score mark. The tube is recapped and transported to the testing facility.

Materials Provided: The BD ProbeTec ET Chlamydia trachomatis/Neisseria gonorrhoeae (CT/GC) Amplified DNA Assay Collection Kit contains 100 units. Each unit contains one sterile rayon-tipped collection swab and one CT/GC Diluent tube. The CT/GC Diluent tube contains 2 mL of diluent composed of potassium phosphate, DMSO, glycerol, Polysorbate 20 and 0.03% Proclin™ (preservative).

Materials Required But Not Provided: Gloves.

Storage Instructions: Store Collection Kit at 15 – 30°C. Do not use beyond the expiration date. Swab sterility guaranteed if primary swab container is intact.

Precautions: For in vitro Diagnostic Use.

Warnings:

1. Do not pre-wet swab with CT/GC Diluent prior to collecting specimen.

2. Pathogenic microorganisms, including hepatitis viruses and Human Immunodeficiency Virus, may be present in clinical specimens. “Standard Precautions”^1-4 and institutional guidelines should be followed in handling all items contaminated with blood and other body fluids.

3. Optimal performance of the BD ProbeTec ET Amplified DNA Assays requires proper specimen collection, handling and transport.

4. Use only collection and transport systems labeled for use with the BD ProbeTec ET Chlamydia trachomatis and Neisseria gonorrhoeae Amplified DNA Assays.

5. Proper labeling should accompany each specimen to the laboratory.

6. The CT/GC Diluent tube contains dimethyl sulfoxide (DMSO). DMSO is harmful by inhalation, in contact with skin and if swallowed. Keep container in a well-ventilated place. Avoid contact with eyes. In case of contact with eyes, rinse immediately with plenty of water and seek medical advice. After contact with skin, wash immediately with plenty of water. Wear suitable protective clothing and gloves.

7. When breaking the shaft of the swab, take care to avoid splashing of contents.

8. Dispose of unused CT/GC Diluent tubes according to the Material Safety Data Sheet.

9. BD ProbeTec ET Chlamydia trachomatis/Neisseria gonorrhoeae (CT/GC) Amplified DNA Assay Collection Kit for Male Urethral Specimens is for single use only; reuse may cause a risk of infection and/or inaccurate results.