Do not eat, drink, smoke, apply cosmetics, or handle contact lenses in areas where these materials are handled.

Clean and disinfect spills of specimens by using a tuberculocidal disinfectant such as 1.0% sodium hypochlorite or other suitable disinfectant.13,14

Decontaminate and dispose of all specimens, reagents, and other potentially contaminated materials in accordance with local, state, and federal regulations.15,16

Special Precautions

Handling Precautions

The Abbott RealTime HCV Genotype II assay is only for use with human serum or plasma (ACD-A, CPD, potassium EDTA, or sodium EDTA) specimens that have been handled and stored in capped tubes as described in the SPECIMEN COLLECTION, STORAGE, AND TRANSPORT TO THE TEST SITE section. During preparation of samples, compliance with good laboratory practices is essential to minimize the risk of cross-contamination between samples, and the inadvertent introduction of ribonucleases (RNases) into samples during and after the extraction procedure. Proper aseptic technique should always be used when working with RNA.

Amplification reactions such as PCR are sensitive to accidental introduction of product from previous

amplification reactions. Incorrect results could occur if either the clinical specimen or the RealTime reagents used in the amplification step become contaminated by accidental introduction of even a few molecules of amplification product. Measures to reduce the risk of contamination in the laboratory include physically separating the activities involved in performing PCR and complying with good laboratory practices.

Work Areas

The m2000sp and the m2000rt instruments may be operated in the same location. Use two dedicated areas within the laboratory for performing the Abbott RealTime HCV Genotype II assay.

The Sample Preparation Area is dedicated to processing samples (specimens and Abbott RealTime HCV Genotype II Controls), and to adding processed samples and controls to the Abbott 96-Well

Optical Reaction Plate. All reagents used in the Sample Preparation Area should remain in this

dedicated area at all times. Laboratory coats, pipettes, pipette tips, and vortexers used in the

Sample Preparation Area must remain in this area and not be moved to the Amplification Area. Do not bring amplification product into the Sample Preparation Area.

The Amplification Area is dedicated to the amplification and detection of amplified product.

Laboratory coats and equipment used in the Amplification Area must remain in this area and not be

moved to the Sample Preparation Area.

Components contained within a kit are intended to be used together. Do not mix components from different kit lots. For example, do not use the negative control from control kit lot X with the positive controls from control kit lot Y. Additionally, do not mix and match Amplification Reagent Packs A, B, and C from different amplification kit lots.

Do not use kits or reagents beyond expiration date.

Work areas and instrument platforms must be considered potential sources of contamination. Change gloves after contact with potential contaminants (such as specimens, eluates, and/or amplified product) before handling unopened reagents, negative control, positive controls, or specimens. Refer to the Abbott m2000sp and m2000rt Operations Manuals for instructions on instrument cleaning procedures.

If the Abbott m2000sp instrument run is aborted, dispose of all commodities and reagents according to the Abbott m2000sp Operations Manual. If the Abbott m2000sp master mix addition protocol is aborted, seal the Abbott 96-Well Optical Reaction Plate in a sealable plastic bag and dispose according to the Abbott m2000sp Operations Manual, Hazards Section, along with the gloves used to handle the plate.