A sample is reported to contain a HCV genotype when the CN threshold is exceeded, and when the genotype-specific CN value is within a predetermined number of cycles of the HCV-All CN value for the same specimen. Multiple genotypes can be detected simultaneously (see Interpretation of Results below).

INTERPRETATION OF RESULTS

If the controls are valid, then proceed to results and interpretations. The Abbott m2000rt instrument

automatically reports the genotype result on the Abbott m2000rt workstation. Assay results and interpretations will look similar to the following examples:

Location Sample ID Sample Type Result Interpretation

Flags Error Code A1 HCV-GT_NEG Control Passed B1 HCV-GT_POS Control Passed a C1 Patient1 1 1ab D1 Patient2 1 1bb

E1 Patient3 HCV not detectedc

F1 Patient4 2

G1 Patient5 2, 3d

H1 Patient6 HCVDetectede

a No Genotype Resultf The results log will indicate amplification curves for GT 1 and GT 4 based on the use of 5′ UTR RNA sequences. If the negative or positive controls are invalid, refer to Quality Control Procedures, Negative and Positive Control section of this package insert.

b Genotype 1a and genotype 1b results may be reported without genotype 1.

c The assay did not detect HCV. Ensure HCV concentration is at least 500 IU/mL and repeat RealTime HCV Genotype II assay. d When reporting multiple genotypes, consider inclusion of this statement: Multiple genotype assay results may be caused by a mixed genotype infection, recombination of HCV genotypes, or assay probe cross-reactivity. e,f The assay detected HCV but did not produce a genotype result. Ensure HCV concentration is at least 500 IU/mL and repeat RealTime HCV Genotype II assay. If repeat testing generates the same result, consider an alternative HCV genotype method.

For more information about error codes and flags, refer to the Abbott m2000rt Operations Manual.

LIMITATIONS OF THE PROCEDURE

FOR IN VITRO DIAGNOSTIC USE.

Optimal performance of this test requires appropriate specimen collection, handling, preparation, storage, and transport to the test site (refer to the SPECIMEN COLLECTION, STORAGE, AND

TRANSPORT TO THE TEST SITE section of this package insert).

Human serum or plasma (ACD-A, CPD, potassium EDTA, or sodium EDTA) specimens may be used with the Abbott RealTime HCV Genotype II assay. The use of other anticoagulants has not been

validated with the Abbott RealTime HCV Genotype II assay.

Use of the Abbott RealTime HCV Genotype II assay is limited to personnel who have been trained in the procedures of a molecular diagnostic assay and the Abbott m2000sp and m2000rt instruments.

The instruments and assay procedures reduce the risk of contamination by amplification product.

However, nucleic acid contamination from the positive control or specimens must be controlled by good laboratory practice and careful adherence to the procedures specified in this package insert.