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The Vaginal Specimen Transport for the BD ProbeTec CT/GC Q^x Amplified DNA Assays offers a convenient way to collect and transport specimens from the patient to the laboratory. It is intended to be used for patient collection of vaginal swab specimens in a clinical setting according to the instructions provided. This transport system is for use with the BD ProbeTec CT/GC Q^x Amplified DNA Assays on the BD Viper™ System in Extracted Mode. Patient-collected vaginal swab specimens are an option for screening women when a pelvic exam is not otherwise indicated. The Vaginal Specimen Transport for the BD ProbeTec CT/GC Q^x Amplified DNA Assays is not for home use.

The Vaginal Specimen Transport for the BD ProbeTec CT/GC Q^x Amplified DNA Assays is a sterile, self-contained system. The polyester-tipped swab on a plastic purple shaft facilitates obtaining the specimen and maintaining the organisms for nucleic acid extraction and amplification on the BD Viper System in Extracted Mode.

Materials Provided: The Vaginal Specimen Transport for the BD ProbeTec CT/GC Q^x Amplified DNA Assays contains 100 units with one copy of patient collection instructions. Each unit contains one polyester-tipped swab in a transport sheath.

Storage Instructions: Store swabs at 5 – 25°C. Do not use beyond the expiration date. Swab sterility is guaranteed if primary swab container is intact.

For in vitro Diagnostic Use.

1. 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.

2. Optimal performance of the BD ProbeTec CT/GC Q^x Amplified DNA Assays requires proper specimen collection, handling and transport. Time and temperature conditions for storage must be maintained during transport.

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

4. Take care to avoid cross-contamination during the specimen handling steps. Specimens can contain high levels of organisms. If gloves come in contact with specimen, change gloves to avoid cross-contamination.

5. Specimens must be collected and processed before the expiration date of the Vaginal Specimen Transport.

6. Vaginal Specimen Transport 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.