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The Male Urethral Specimen Collection Kit for the BD ProbeTec CT/GC Q^x Amplified DNA Assays is used to collect and transport male patient urethral specimens to the laboratory for testing with the BD ProbeTec CT/GC Q^x Amplified DNA Assays on the BD Viper™ System in Extracted Mode.

The Male Urethral Specimen Collection Kit for the BD ProbeTec CT/GC Q^x Amplified DNA Assays consists of a sterile swab and a tube of Q^x Swab Diluent for specimen transport. The rayon-tipped collection swab consists of a stainless steel wire in a blue-colored plastic shaft that is scored for breaking. After the specimen is collected, the cap of the diluent tube is removed, the swab is placed into the Q^x Swab Diluent tube and the shaft is broken at the score mark. The tube is recapped and transported to the testing facility.

Materials Provided: Each Male Urethral Specimen Collection Kit for the BD ProbeTec CT/GC Q^x Amplified DNA Assays contains one sterile rayon-tipped collection swab and one tube of Q^x Swab Diluent. The Swab Diluent contains approximately 2 mL of potassium phosphate/potassium hydroxide buffer with DMSO and preservative.

Materials Required But Not Provided: Gloves

For in vitro Diagnostic Use.

1. Do not pre-wet the swab with the Q^x Swab 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 CT/GC Q^x Amplified DNA Assays requires proper specimen collection, handling and transport.

4. Use only collection and transport systems labeled for use with the BD ProbeTec CT/GC Q^x Amplified DNA Assays.

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

6. The Q^x Swab 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 Q^x Swab Diluent tubes according to the Material Safety Data Sheet.

9. Take care to avoid cross-contamination during the specimen handling steps. Specimens can contain high levels of organisms. Ensure that specimen containers do not contact one another, and discard used materials without passing over open containers. If gloves come in contact with specimen, change gloves to avoid cross-contamination.

10. Specimens must be collected and tested before the expiration date of the Q^x Swab Diluent tube.

11. Male Urethral Specimen Collection Kit for the BD ProbeTec Chlamydia trachomatis/Neisseria gonorrhoeae (CT/GC) Q^x Amplified DNA Assays is for single use only; reuse may cause a risk of infection and/or inaccurate results.