RealTime HCV
- Indications and Limitations of Use
- Package Insert For Information Only - Not a Controlled Copy
| Product Name | Quantity | Order # | Additional Information | ||
| Abbott RealTime HCV Amplification Reagent Kit | 96 tests (4 packs, 24 tests/pack) | 01N30-090 |
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| Abbott RealTime HCV Control Kit | 8 vials of low positive controls, 8 vials of high positive controls, 8 vials of negative controls | 01N30-080 |
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| Abbott RealTime HCV Calibrator Kit | 12 vials of calibrator A, 12 vials of calibrator B (4 complete calibration sets) |
01N30-070 |
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| Abbott RealTime HCV m2000 Application CD-ROM | 1 CD-ROM | 04N45-001 |
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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.
| Abbott RealTime HCV Performance* |
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| Limit of Detection (LOD) |
12 IU/mL |
| Limit of Quantitation (LOQ) | 12 IU/mL |
| Linear Range | 12 IU/mL (1.08 log IU/mL) to 100 million IU/mL (8.0 log IU/mL) |
| Target Region | 5' utr |
| Genotype Detection | Accurate quantitation of genotypes 1, 2, 3, 4, 5 and 6 |
| Internal Control | Added to lysis buffer during extraction and detected with all samples |
| Calibration | External two point |
| Specimen Type | Human serum and plasma (EDTA) |
| Input Volume | 0.5mL |
| Precision | SD: less than or equal 0.25 log IU/mL |
| Standardization | Second WHO international standard to HCV RNA (NIBSC 96/798) |
Development Philosophy
Today's clinical molecular diagnostics laboratory must have confidence in the quality of HCV patient results. As a result of our real-time PCR development philosophy, Abbott RealTime HCV is designed to quantify all HCV genotypes (1—6), accurately.
Accurate Quantification is dependent upon a combination of:
- Primer Design
- Probe Design
- Cycling Conditions
| Primers and Probe are Targeted to the 5´UTR Region of the HCV Genome |
The target sequence for the Abbott RealTime HCV assay is in the 5´UTR region of the HCV genome. This region is specific for HCV and is highly conserved. The primers are designed to hybridize to the 5´UTR region with the fewest possible mismatches among HCV genotypes 1-6.
| Single Stranded Linear Probe Design |
In the absence of target, the probe achieves quenching through random coiling.
In presence of target, the probe prefers to hybridize to the target sequence, allowing fluorescent detection; cleavage is not required.
| Cycling Conditions: Low Temperature Read Cycles |
The cycling conditions for Abbott RealTime HCV encompass a low temperature read cycle. This read cycle allows the probe to tolerate mismatches more effectively than a probe required to bind during the extension phase.
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 laboratoryfindings.
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
- 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.
- 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.
- 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 one technology to the next, users perform method correlation studies in their laboratory to quantify technology differences.
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.
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.
