11. Load the three Amplification Reagent Packs (A, B, and C) and three master mix vials on the m2000sp

worktable after sample preparation is completed. Load the three Amplification Reagent Packs (A, B, and C) into the reagent positions (1, 2, and 3), respectively.

The three RealTime HCV Genotype II Amplification Reagent Packs support up to 24 reactions.

Ensure the Amplification reagents are thoroughly thawed before use.

Label each vial cap within each amplification reagent pack (i.e. A, B, C) prior to opening the

amplification reagents.

Prior to opening the amplification reagents, ensure that the contents are at the bottom of the vials by tapping the vials in an upright position on the bench.

Remove the amplification vial caps.

12. Select the appropriate deep well plate from the Run Master Mix Addition screen that matches the

corresponding sample preparation extraction. Initiate the Abbott m2000sp Master Mix Addition protocol. Follow the instructions as described in the Abbott m2000sp Operations Manual, Operating Instructions section.

NOTE: The m2000rt protocol (step 17) must be started within 90 minutes of the initiation of the Master Mix Addition protocol (step 12).

If the Abbott m2000sp master mix addition protocol is not initiated, re-cap the Amplification Reagent vials and return the Amplification Reagent Packs to -25 to -15°C storage. Once thawed, the Abbott

RealTime HCV Genotype II Amplification Reagent Packs can be frozen and thawed a maximum of three additional times. If the Abbott m2000sp master mix addition protocol is aborted, then discard the

amplification reagents.

Amplification Area

13. Switch on and initialize the Abbott m2000rt in the amplification area.

The Abbott m2000rt requires 15 minutes to warm up.

NOTE: Change laboratory coats and gloves before returning to the sample preparation area.

14. Place the Abbott 96-Well Optical Reaction Plate into the Abbott Splash-Free Support Base after the Abbott m2000sp instrument has completed addition of samples and master mix.

15. Seal the Abbott 96-Well Optical Reaction Plate according to the Abbott m2000sp Operations Manual,

Operating Instructions section. Export the completed PCR plate results via a network connection directly to a mapped m2000rt (or indirectly via a CD).

Abbott m2000rt Procedures

For a detailed description of how to perform an Abbott m2000rt protocol, refer to the Operating Instructions section in the Abbott m2000rt Operations Manual.

16. Place the Abbott 96-Well Optical Reaction Plate in the Abbott m2000rt instrument. Import the m2000sp test order via a network connection directly to a mapped m2000rt (or indirectly via a CD) per the Import Order instructions in the Abbott m2000rt Operations Manual, Operating Instructions section.

17. Initiate the Abbott RealTime HCV Genotype II protocol as described in the Abbott m2000rt Operations Manual. The Abbott m2000rt completes the run in approximately 2 hours and forty-five minutes.

If the Abbott m2000rt instrument run is not initiated within 90 minutes from initiation of Master Mix

Addition (Step 12), or is interrupted or aborted, seal the Abbott 96-Well Optical Reaction Plate in a sealable plastic bag and dispose according to the Abbott m2000rt Operations Manual along with the gloves used to handle the plate.

18. After the Abbott m2000rt instrument has completed the amplification and detection protocol, remove the 96-Well Optical Reaction Plate and dispose according to the instructions in the Handling Precautions section of this package insert.