Monitoring the Laboratory for the Presence of Amplification Product

It is recommended that this test be done at least once a month to monitor laboratory surfaces and equipment for contamination by amplification product. It is very important to test all areas that may have been exposed to processed specimens, controls, and/or amplification product. This includes routinely handled objects such as pipettes, the Abbott m2000sp and Abbott m2000rt function keys, laboratory bench surfaces, and

microcentrifuges.

1. Add 0.8 mL RNase-free water to a separate 1.7 mL RNase-free microcentrifuge tube for each laboratory surface to be monitored.

2. Saturate the cotton tip of an applicator (Puritan or equivalent) in the RNase-free water from the

microcentrifuge tube.

3. Using the saturated cotton tip of the applicator, wipe the area to be monitored using a sweeping motion. Place the applicator back into the microcentrifuge tube from step 1.

4. Swirl the cotton tip in the RNase-free water 10 times, and then press the applicator along the inside of the microcentrifuge tube so that the liquid drains back into the solution at the bottom of the tube. Discard the applicator.

5. For each additional area to be monitored repeat steps 2 through 4.

Note: A small amount of mWash 1 buffer is added to each monitor sample in order to ensure that the ionic strength of the sample is sufficient for liquid level detection during processing on the m2000sp.

6. Pipette 0.5 mL of the mWash 1 buffer to a clean tube using the pipette dedicated for Internal Control use.

7. Add 20 μL of the mWash 1 buffer from step 6 to each microcentrifuge tube from step 4.

8. Cap the microcentrifuge tubes.

9. Transfer liquid from each microcentrifuge tube to unique 5 mL Reaction Vessels.

10. Bring the volume of each 5 mL Reaction Vessel to 1.5 mL with RNase-free water.

11. Place the 5 mL Reaction Vessels into the Abbott m2000sp sample rack and complete the assay following the ASSAY PROTOCOL section of this package insert.

The Uracil-N-Glycosylase (UNG) (List No. 08L21-66) protocol should not be used to monitor the

laboratory for presence of amplification product.

12. The presence of contamination is indicated by the detection of HCV nucleic acid in the swab samples.

13. If HCV nucleic acid is detected on equipment, follow the cleaning and decontaminating guidelines given in that equipment’s operations manual. If HCV nucleic acid is detected on surfaces, clean the contaminated areas with 1.0% (v/v) sodium hypochlorite solution, followed by 70% ethanol or water.

Note: Chlorine solutions may pit equipment and metal. Use sufficient amounts or repeated applications of 70% ethanol or water until chlorine residue is no longer visible.

14. Repeat testing of the contaminated area by following Steps 1 through 13.

RESULTS

Abbott RealTime HCV Genotype II is a qualitative assay. The Abbott RealTime HCV Genotype II Controls are used to establish run validity for the HCV Genotype II assay.

The Abbott RealTime HCV Genotype II assay employs two determinations on each assay response to accurately designate HCV genotypes:

Cycle Number (CN) and CN number difference, as compared to the HCV-All-probe cycle number, for each of the genotype

specific probes (1, 1a, 1b, 2, 3, 4, and 5).