to testing. Aliquot each specimen into clean tubes or vials if necessary. Refer to the Abbott m2000sp Operations Manual for tube sizes. Avoid touching the inside of the cap when opening tubes.

2. Thaw assay controls and IC at 15 to 30°C or at 2 to 8°C; see QUALITY CONTROL PROCEDURES

section of this package insert.

Once thawed, assay controls and IC can be stored at 2 to 8°C for up to 24 hours before use.

Vortex each control three times for 2 to 3 seconds before use. Ensure that bubbles or foam are not created. If found, remove them with a new sterile pipette tip for each tube. Ensure that the contents of each vial are at the bottom after vortexing by tapping the vials on the bench to bring liquid to the bottom of the vial.

3. Thaw amplification reagents at 15 to 30°C or at 2 to 8°C and store at 2 to 8°C until required for the

amplification master mix procedure. This step can be initiated before completion of the sample preparation procedure.

Note: Do not vortex the Amplification Reagent Pack.

Once thawed, store at 2 to 8°C for up to 24 hours if amplification reagents are not being processed

immediately.

NOTE: Use one bottle of mLysis Buffer and two vials of Internal Control to support processing up to 24 samples. Each sample is tested with each of the three RealTime HCV Genotype II Amplification Reagent Packs. Use one each of RealTime HCV Genotype II Amplification Reagent Packs A, B, and C to support processing up to 24 samples.

Abbott m2000sp Procedure

4. Gently invert the Abbott mSample Preparation bottles to ensure a homogeneous solution. If crystals are observed in any of the reagent bottles upon opening, allow the reagent to equilibrate at room temperature until the crystals disappear. Do not use the reagents until the crystals have dissolved. Ensure bubbles or foam is not generated; if present, remove with a sterile pipette tip, using a new tip for each bottle.

5. Vortex each IC three times for 2 to 3 seconds before use. Ensure bubbles or foam is not generated; if present, remove with a sterile pipette tip, using a new tip for each vial.

6. Using a calibrated precision pipette DEDICATED FOR INTERNAL CONTROL USE ONLY, add 2000 μL of IC to one bottle of mLysis Buffer. Mix by gently inverting the container 5 to 10 times to minimize foaming.

7. Place the negative control, the positive control, and the patient specimens into the Abbott m2000sp sample rack.

8. Place the 5 mL Reaction Vessels into the m2000sp 1 mL subsystem carrier.

9. Load the carrier racks containing the Abbott mSample Preparation System reagents and the Abbott 96-Deep-Well Plate on the Abbott m2000sp worktable as described in the Abbott m2000sp Operations Manual, Operating Instructions.

10. From the Run Sample Extraction screen, select and initiate the sample extraction protocol as described in the m2000sp Operations Manual, Operating Instruction.

Following completion of the Sample Extraction protocol, proceed to Step 11 for master mix preparation or processed samples may be stored in the Abbott 96-Deep-Well Plate prior to initiating the Abbott m2000sp Master Mix Addition protocol:

At 2 to 30°C for up to 4 hours

At –20°C or colder for up to 7 days

Thaw processed samples prior to initiating the Master Mix Addition Protocol

NOTE: Change gloves before handling the amplification reagents.