Indications and Limitations of Use

Intended Use
 

The Abbott RealTime HCV Genotype II 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 qualitative identification of hepatitis C virus (HCV) genotypes 1, 1a, 1b, and 2 -5 in plasma or serum from individuals chronically infected with HCV. The Abbott RealTime HCV Genotype II is intended for use as an aid in the management of HCV-infected individuals and in guiding the selection of therapeutic treatment indicated for the above listed genotypes. The assay is intended for use on patients who are chronically infected with HCV, are being considered for antiviral treatment, and are positive for HCV RNA. The Abbott RealTime HCV Genotype II assay is not for screening blood, plasma, serum or tissue donors for HCV.
 

Limitations of the Procedure
 

• FOR IN VITRO DIAGNOSTIC USE ONLY.
• Optimal performance of this test requires appropriate specimen collection, handling, preparation, storage, and transport to the test site (refer to the SPECIMEN COLLECTION, STORAGE, ANDTRANSPORT 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.
• A specimen with an interpretation of “No Genotype Result” cannot be presumed to be negative for the tested genotypes.
• Multiple genotype assay results may be caused by a mixed genotype infection, recombination of HCV genotypes, or assay probe cross-reactivity.
• The Abbott RealTime HCV Genotype II assay is capable of detecting both genotypes in a genotype mixture when the concentrations of both genotypes are near equal; however, the assay may not detect the lower concentration genotype.
• Performance has not been established with the Abbott RealTime HCV Genotype II assay for HCV genotype 6 specimens.
• HCV genotype 6 specimens may generate a HCV genotype 1 result with the Abbott RealTime HCV Genotype II assay based on probe cross-reactivity of the HCV genotype 1 probe.
• As with any diagnostic test, results from the Abbott RealTime HCV Genotype II assay should be interpreted in conjunction with other clinical and laboratory findings. A specimen with a result of "HCV not detected" cannot be presumed to be negative for HCV RNA.
• 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.
   

CAUTION: United States Federal law restricts this device to sale and distribution to or on the order of a physician or to a clinical laboratory; and use is restricted to, by, or on the order of a physician.
 

To learn more about RealTime HCV Genotype II please visit: https://www.molecular.abbott/us/en/products/infectious-disease/realtime-hcv-genotype-II