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The BD ProbeTec™ Q^x Collection Kit for Endocervical or Lesion Specimens is used to collect and transport patient endocervical 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 Collection Kit also may be used to collect and transport external anogenital lesion specimens to the laboratory for testing with the BD ProbeTec HSV1&2 Q^x Amplified DNA Assays on the BD Viper System in Extracted Mode.

The BD ProbeTec Q^x Collection Kit for Endocervical or Lesion Specimens consists of a sterile cleaning swab with a white shaft, a sterile collection swab with a pink shaft that is scored for breaking and a tube of Q^x Swab Diluent for specimen transport. The polyester fiber-tipped cleaning swab with the white shaft (not to be used for lesion collection for the HSV1&2 Q^x Amplified DNA Assays) is provided to clean the cervical os of blood and mucus prior to endocervical specimen collection.^† The polyurethane foam-tipped swab with the pink-colored shaft is used to collect the specimen for testing. 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 BD ProbeTec Q^x Collection Kit for Endocervical or Lesion Specimens contains:

- one sterile polyester fiber-tipped cleaning swab with a white shaft*

- one sterile polyurethane foam-tipped collection swab with a pink shaft*

- one tube of Q^x Swab Diluent

The Swab Diluent contains approximately 2 mL of potassium phosphate/potassium hydroxide buffer with DMSO and preservative.

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 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 Q^x Amplified DNA Assays.

5. The polyester fiber-tipped swab with the white shaft is for cleaning the cervical os and should not be used for collecting the patient specimen.

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

7. The Q^x Swab Diluent 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.

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

9. Dispose of unused Q^x Swab Diluent tubes according to the Material Safety Data Sheet.

10. 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.

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

12. BD ProbeTec Q^x Collection Kit for Endocervical or Lesion Specimens is for single use only; reuse may cause a risk of infection and/or inaccurate results.