雅培RealTime HCV Genotype⒒(9)

STORAGE INSTRUCTIONS

Abbott RealTim

e HCV Genotype II Amplification Reagent Kit (List No. 08L21-90)

The Abbott RealTime HCV Genotype II Amplification Reagent Packs and Internal

Control vials must be stored at –25 to –15°C when not in use. Care must be taken to separate the Abbott RealTime HCV Genotype II Amplification Reagent Packs that are in

use from direct contact with samples and controls.

Abbott RealTim

e HCV Genotype II Control Kit (List No. 08L21-80)

The Abbott RealTime HCV Genotype II Negative and Positive Controls must be stored

at –25 to –15°C.

INDICATION OF INSTABILITY OR DETERIORATION OF REAGENTS

When a positive or negative control value is out of the expected range, it may indicate deterioration of the reagents. Associated test results are invalid and samples must be retested.

SPECIMEN COLLECTION, STORAGE, AND TRANSPORT TO THE TEST SITE Specimen Collection and Storage

Human serum or plasma (ACD-A, CPD, potassium EDTA, or sodium EDTA) specimens may be used with the Abbott RealTime HCV Genotype II assay. Follow the manufacturer’s instructions for processing collection tubes.

Freshly drawn specimens (whole blood) may be held at 2 to 30°C for up to 6 hours

At 15 to 30°C for up to 24 hours At 2 to 8°C for up to 3 days At –25 to –15°C for up to 60 days At –70°C for up to 60 days priorto centrifugation. After centrifugation, remove serum or plasma from cells. Serum or plasma specimens may be stored:

Multiple freeze/thaw cycles should be avoided. If frozen, thaw specimens at 15 to 30°C or at 2 to 8°C. Once thawed, if specimens are not being processed immediately, they can be stored at 2 to 8°C for up to 6 hours. Specimens showing particulate matter or turbidity should be clarified by centrifugation at 2000 g for 5 minutes prior to testing.

Specimen Transport

Ship specimens frozen on dry ice. Specimens should be packaged and labeled in compliance with applicable state and federal regulations covering the transport of clinical specimens and etiologic agents/infectious substances.

INSTRUMENT PROCEDURE

The Abbott RealTime HCV Genotype II application file must be installed on the Abbott m2000sp and Abbott m2000rt instruments from the Abbott RealTime HCV Genotype II m2000 System Combined Application CD-ROM prior to performing the assay. For detailed information on application file installation, refer to the Abbott m2000sp and m2000rt Operations Manuals, Operating Instructions section.

ABBOTT REALTIME HCV GENOTYPE II ASSAY PROCEDURE

Materials Provided

Abbott RealTime HCV Genotype II Amplification Reagent Kit (List No. 08L21-90)