Intended Use
 

The Abbott RealTime HCV assay is an in vitro reverse transcription-polymerase chain reaction (RT-PCR) assay for use with the Abbott mSample Preparation System reagents and with the Abbott m2000sp and m2000rt instruments for the quantitation of hepatitis C viral (HCV) RNA in human serum or plasma (EDTA) from HCV-infected individuals. Specimens containing HCV genotypes 1 – 6 have been validated for quantitation in the assay.
 

The Abbott RealTime HCV assay is intended for use as an aid in the management of HCV-infected patients undergoing antiviral therapy. The assay measures HCV RNA levels at baseline and during treatment and can be utilized to predict sustained and non-sustained virological response to HCV therapy. The results from the RealTime HCV assay must be interpreted within the context of all relevant clinical and laboratory findings.
 

Assay performance characteristics have been established for individuals treated with peginterferon alfa-2a or 2b plus ribavirin. No information is available on the assay’s predictive value when other therapies are used. Assay performance for determining the state of HCV infection has not been established.
 

The Abbott RealTime HCV assay is not for screening blood, plasma, serum or tissue donors for HCV, or to be used as a diagnostic test to confirm the presence of HCV infection.
 

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 and plasma specimens (EDTA) may be used with the Abbott RealTime HCV assay. The use of other anticoagulants has not been validated with the Abbott RealTime HCV assay.

• Though rare, mutations within the highly conserved regions of the viral genome covered by the Abbott RealTime HCV assay primers and/or probe may result in the under-quantitation of or a failure to detect the presence of the virus in this circumstance.

• Use of the Abbott RealTime HCV 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 calibrators, positive controls, or specimens must be controlled by good laboratory practice and careful adherence to the procedures specified in this package insert.

• A specimen with a result of “Not Detected” cannot be presumed to be negative for HCV RNA.

• Precision was established with HCV Genotypes 1 and 3 only.

• Some of the cross-reactivity studies were performed with nucleic acids (DNA and RNA) only. For further detail, refer to the SPECIFIC PERFORMANCE CHARACTERISTICS section of this package insert.

• As with any diagnostic test, results from the Abbott RealTime HCV assay should be interpreted in conjunction with other clinical and laboratory findings.

• Due to inherent differences between technologies, it is recommended that, prior to switching from 1 technology to the next, users perform method correlation studies in their laboratory to quantify technology differences.

• Contamination from HCV positive controls and clinical specimens can be avoided only by good laboratory practices and careful adherence to the procedures specified in this package insert.
   

Warnings and Precautions

The Abbott RealTime HCV assay is not for screening blood, plasma, serum, or tissue donors for HCV, or to be used as a diagnostic test to confirm the presence of HCV infection.

The Abbott RealTime HCV reagents are intended to be used only on the Abbott m2000 System consisting of the Abbott m2000sp for sample processing and the Abbott m2000rt for amplification and detection.
 

Rx Only
 

To learn more about Abbott RealTime HCV please visit: https://www.molecular.abbott/us/en/products/infectious-disease/realtime-hcv-viral-load