Chlamydia/Gonococcus − Client-provided Aliquot

ThinPrep® preservative vial processing: ThinPrep® instructions for removal of material are specifically listed in the ThinPrep® 2000 and ThinPrep® 3000 System Operator's manual Addenda. These instructions include the following statement. “Good laboratory practices should be followed to avoid introducing contaminants into either the PreservCyt® sample vial (ThinPrep® vial) or the aliquot. It is recommended to use powder-free gloves and an individually wrapped, disposable pipetting device with an aerosol barrier tip that is sized appropriately for the volume being withdrawn and dispensed. You should not use serological pipettes. In order to minimize the potential for cross contamination, aliquot removal should be performed in an appropriate location outside an area where amplification is performed.”

LabCorp uses the following procedure and believes it is consistent with the previous instructions as well as with the amplified assay that will be performed on the specimen to be sent. Note: For testing, aliquots must be transferred to Aptima® specimen transport tubes or Aptima® Unisex specimen transport tubes (both referred to as “Aptima® tube” in the following procedure) from ThinPrep® vials within seven days of specimen collection when ThinPrep® vials are stored at 15°C to 30°C.

Aliquot Removal Procedure

1. Put on clean gloves.

2. Wipe down work surfaces and pipettors with 1:1 bleach:water solution.

3. Allow bleach to contact work surfaces and pipettors for at least one minute and then follow with a water rinse.

4. Cover the bench with clean, plastic-backed absorbent laboratory bench covers.

5. Retrieve ThinPrep® vials that are to have aliquots removed.

6. In the specimen transfer area, place a test tube rack containing a sufficient number of Aptima® tubes to the number of ThinPrep® Pap specimens being tested for Ct/Ng.

7. Label each Aptima® tube with the appropriate specimen label.

8. Put on clean gloves before proceeding to specimen transfer.

9. Loosen the cap on the Aptima® tube. Be sure not to touch the pierceable foil cap of the Aptima® tube.

10. Vortex the ThinPrep® vial for 8 to 12 seconds at high speed. Caution: The desired aliquot must be removed immediately after vortexing the vial to ensure homogeneity of the sample.

11. Uncap the vial and place it on the work surface with the threads facing up.

12. Using a pipetting device with an aerosol barrier tip, immediately withdraw a 1 mL aliquot from the ThinPrep® vial.

13. Uncap the Aptima® tube and retain the cap in your hand.

14. Carefully dispense the aliquot into the appropriately labeled Aptima® tube.

15. Recap the Aptima® tube tightly. Gently invert the tube two to three times to ensure complete mixing of the specimen.

16. Dispose of the pipette tip into a biohazard bag containing absorbent material soaked with bleach.

17. Recap the ThinPrep® Liquid Pap specimen for Pap smear processing.

18. Store the aliquot in Aptima® tube at 15°C to 30°C for transport to LabCorp.

19. Put on clean gloves and repeat steps 8 to 18 with subsequent specimens. To reduce the chance of contaminating other specimens, work with one ThinPrep® Liquid Pap specimen at a time.

20. Remember that prior to processing for Pap smear in the ThinPrep® instrumentation, a volume of PreservCyt® equal to that removed for testing must be added back to the vial.

Maintain specimen at room temperature or refrigerate (2°C to 30°C). Aliquots must be transferred to the Aptima® tube within seven days of collection.

Gen-Probe Pace® transport system; bacterial swab specimen; transport with multiple swabs; specimen received in grossly leaking transport container; specimen submitted in fixative or additives; specimen received in expired transport media or incorrect transport device; inappropriate specimen transport conditions; specimen received after prolonged delay in transport (usually more than 72 hours); swab in transport device; unlabeled specimen or name discrepancy between specimen and request label; prequot specimens with more than 1 mL of PreservCyt® added