POST PROCESSING PROCEDURES

1. Remove the Abbott 96-Deep-Well Plate, Reaction Vessels, Reagent Vessels, Amplification Reagent Packs, and Master Mix Vials from the worktable and dispose of according to the Abbott m2000sp Operations Manual.

2. Place 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.

3. Clean the Splash-Free Support Base before next use, according to the Abbott m2000rt Operations Manual. QUALITY CONTROL PROCEDURES

Abbott m2000rt Optical Calibration

Refer to the Calibration Procedures section in the Abbott m2000rt Operations Manual for a detailed description of how to perform an Abbott m2000rt Optical Calibration. Optical calibration of the Abbott m2000rt instrument is required for the accurate measurement and discrimination of dye fluorescence during the Abbott RealTime HCV Genotype II assay.

The following Abbott m2000rt Optical Calibration Plates are used to calibrate the Abbott m2000rt instrument for the Abbott RealTime HCV Genotype II assay:

FAM Plate (Carboxyfluorescein)

ROX Plate (Carboxy-X-rhodamine)

VIC® Plate (Proprietary dye)

NED Plate (Proprietary dye)

Cy5® Plate (Cyanine)

Detection of Inhibition

A defined, consistent quantity of IC nucleic acid is introduced into each specimen and control at the beginning of sample preparation and measured on the Abbott m2000rt to demonstrate proper specimen processing and assay validity. The IC is comprised of a RNA sequence unrelated to the HCV target sequences.

The median amplification cycle at which the IC target sequence fluorescent signal is detected in the negative and positive control samples establishes an IC validity range to be met by all subsequent processed specimens on that run.

An error is displayed when a specimen or control fails to meet their respective IC specification. Specimens whose IC CN value exceeds the established range must be retested starting with sample preparation. Refer to RESULTS section of this package insert and the Abbott m2000rt System Operations Manual for a list of error codes and flags.

Negative and Positive Controls

A negative control and a positive control ( are included in each test order to evaluate run validity. An error is displayed when a control result is invalid. Refer to the Abbott m2000rt Operations Manual for an explanation of the corrective actions for the error. If the negative or positive controls are invalid, all of the specimens and controls from that run must be reprocessed, beginning with sample preparation.

The presence of HCV must not be detected in the negative control. HCV detected in the negative control is indicative of contamination by other samples or by amplified product introduced during sample preparation or during preparation of the Abbott 96-Well Optical Reaction Plate. To avoid contamination, clean the Abbott m2000sp instrument and the Abbott m2000rt instrument according to the Operations Manuals and repeat the sample processing for controls and specimens following the Procedural Precautions section of this package insert. If negative controls are persistently reactive, contact Abbott Molecular Customer Service.