Only use Uracil-N-Glycosylase (UNG) List No. 08L21-66 when performing the Uracil-N-Glycosylase protocol. Do not use kits or reagents beyond expiration date.

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. Do not import the test order onto the Abbott m2000rt.

The appropriate PCR plate must be selected when samples are loaded into the Abbott m2000rt instrument. NOTE: The Abbott m2000rt protocol must be started within 90 minutes of the initiation of the Master Mix Addition protocol (Assay Protocol Step 12).

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.

Safety Precautions

Refer to the Abbott m2000sp Operations Manual, Hazards Section and the Abbott m2000rt Operations Manual, Hazards Section for instructions on safety precautions.

CAUTION: The Control Kit and Internal Control contain human sourced and/or potentially infectious components. Components sourced from human blood have been tested and found to be nonreactive by FDA licensed tests for antibody to HCV, antibody to HIV-1, antibody to HIV-2, and HBsAg. The

material is also tested and found to be negative by FDA licensed PCR methods for HIV-1 RNA and

HCV RNA. No known test method can offer complete assurance that products derived from human

sources will not transmit infection. Therefore, all human sourced materials should be considered

potentially infectious. It is recommended that these reagents and human specimens be handled as if

infectious, using safe laboratory procedures, such as those outlined in Biosafety in Microbiological and Biomedical Laboratories,9 OSHA Standard on Bloodborne Pathogens,10 CLSI Document M29-A3,11

and other appropriate biosafety practices.11,12 Therefore, all human sourced materials should be

considered potentially infectious.

The Abbott RealTime HCV Genotype II Control Kit, Internal Control, HCV Oligonucleotide Reagents A, B, and C, and Activation Reagent contain a 3:1mixture of 5-chloro-2- methyl-4-isothiazolin-3-one and 2-methyl-4-isothiazolin-3-one which are components of ProClin.

H319

H317

P261

P264

P280

P272

P305+P351+P338

P302+P352

P333+P313

P337+P313

P363

P501 Causes serious eye irritation. May cause an allergic skin reaction. Avoid breathing mist / vapors / spray. Wash hands thoroughly after handling. Wear protective gloves / protective clothing / eye protection. Contaminated work clothing should not be allowed out of the workplace. IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. IF ON SKIN: Wash with plenty of water. If skin irritation or rash occurs: Get medical advice / attention. If eye irritation persists: get medical advice / attention. Wash contaminated clothing before reuse. This material and its container must be disposed of in a safe way.

These precautions include, but are not limited to, the following:

Wear gloves when handling specimens or reagents.

Do not pipette by mouth.