If the Abbott m2000rt instrument run 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.

Decontaminate and dispose of all specimens, reagents, and other potentially biohazardous materials in accordance with local, state, and federal regulations.15,16 All materials should be handled in a manner that minimizes the chance of potential contamination of the work area. NOTE: Autoclaving the sealed Abbott 96-Well Optical Reaction Plate will not degrade the amplified product and may contribute to the release of the amplified product by opening the sealed plate. The laboratory area can become contaminated with amplified product if the waste materials are not carefully handled and contained before and after processing.

Aerosol Containment

To reduce the risk of nucleic acid contamination due to aerosols formed during manual pipetting, aerosol barrier pipette tips must be used for all manual pipetting. The pipette tips must be used only one time. Clean and disinfect spills of specimens and reagents as stated in the Abbott m2000sp and Abbott m2000rt Operations Manuals.

Contamination and Inhibition

The following precautions should be observed to minimize the risks of RNase contamination, cross-

contamination between samples, and inhibition:

Wear appropriate personal protective equipment at all times.

Use powder-free gloves.

Change gloves after having contact with potential contaminants (such as specimens, eluates, and/or amplified product).

To reduce the risk of nucleic acid contamination due to aerosols formed during pipetting, pipettes with aerosol barrier tips must be used for all sample and IC reagent pipetting. The length of the tip should be sufficient to prevent contamination of the pipette barrel. While pipetting, care should be taken to avoid touching the pipette barrel to the inside surface of the sample tube or container. The use of extended

aerosol barrier pipette tips is recommended.

Change aerosol barrier pipette tips between ALL manual liquid transfers.

Clean and disinfect spills of specimens and reagents as stated in the Abbott m2000sp and the Abbott m2000rt Operations Manuals, Hazards section.

Replace any empty or partially used 200 μL and 1000 μL disposable tip trays with full trays before every run.

The Abbott mSample Preparation System (4 x 24 Preps) reagents are single use only. Use new reagent vessels, reaction vessels, and newly opened reagents for every new Abbott RealTime HCV Genotype II assay run. At the end of each run, discard all remaining reagents from the Abbott m2000sp worktable as stated in the Abbott m2000sp Operations Manual and the Abbott mSample Preparation System

(4 x 24 Preps) product information sheet.

Contamination From External dU-Containing Amplified Product

Laboratories that use or have used HCV amplification assays that include post-PCR processing of the amplified product may be contaminated by dU-containing amplified product. Such contamination may cause inaccurate results in the Abbott RealTime HCV Genotype II assay. Refer to the Monitoring the Laboratory for the Presence of Amplification Product section of this package insert.

When negative controls persistently generate a HCV genotype result, are invalid or where contamination with dU containing HCV amplified product is likely to have occurred, it is recommended that the laboratory use the Uracil-N-Glycosylase (UNG) (List No. 08L21-66) contamination control procedure if decontamination of the laboratory is unsuccessful.