雅培RealTime HCV Genotype⒒(11)

the pipette barrel to the inside of the sample tube or container. The use of extended aerosol barrier pipette tips is recommended.

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.

NOTE: The m2000rt protocol must be started within 90 minutes of the initiation of the Master Mix Addition protocol.

If the Abbott m2000rt instrument run is not initiated within 90 minutes, 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.

Monitoring procedures for the presence of amplification product can be found in the QUALITY CONTROL PROCEDURES section in this package insert.

To reduce the risk of nucleic acid contamination, clean and disinfect spills of specimens by including the use of a tuberculocidal disinfectant such as 1.0% sodium hypochlorite or other suitable disinfectant.

The Abbott RealTime HCV Genotype II Controls must be processed in conjunction with specimens to be tested. The use of the Abbott RealTime HCV Genotype II Controls is integral to the performance of the Abbott RealTime HCV Genotype II assay. Refer to the QUALITY CONTROL PROCEDURES section of this package insert for details.

ASSAY PROTOCOL

For a detailed description of how to operate the Abbott m2000sp instrument and Abbott m2000rt instrument, refer to the Abbott m2000sp and m2000rt Operations Manuals, Operating Instructions section.

Laboratory personnel must be trained to operate the Abbott m2000sp and m2000rt instruments. The operator must have a thorough knowledge of the applications run on the instruments and must follow good laboratory practices.

Sample Preparation Area

All specimen preparation must take place in the dedicated Sample Preparation Area. Refer to the Handling Precautions section of this package insert before preparing samples.

1. A maximum of 24 samples or 72 reactions (3 reactions per sample) can be performed per run. A negative control and a positive control are included in each run, therefore allowing a maximum of 22 specimens to be processed per run.

Check sample volume. The Abbott RealTime HCV Genotype II assay minimum sample volume and

associated rack requirements on the Abbott m2000sp are:

Rack Tube Diameter a

13 mm

16 mm

13mm

aMinimum Sample Volume 1.0 mL 1.3 mL 0.8 mL 11.6 to 14.0 mm 15.0 to 16.0 mm Reaction Vessel Refers to sample tube outer diameter

If frozen, thaw specimens at 15 to 30°C or at 2 to 8°C. Once thawed, specimens can be stored at

2 to 8°C for up to 6 hours before processing.

Before use, vortex specimens three times for 2 to 3 seconds. Ensure that bubbles or foam are not created. If found, remove them with a new sterile pipette tip for each tube. Specimens showing

particulate matter or turbidity should be clarified by centrifugation at 2000 g for 5 minutes prior