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Test Code:
VIRALLOADHCV

Order Name:
Viral Load (HCV RNA), Quantitative method

 
Useful For:
The test is intended for use in the management of patients with chronic HCV in conjunction with clinical and laboratory markers of infection. The test can be used to predict the probability of sustained virologic response (SVR) early during a course of antiviral therapy, and to assess viral response to antiviral treatment (response guided therapy) as measured by changes of HCV RNA levels in serum
 
Methodology:
Real-Time Reverse Transcription polymerase chain reaction (RT-PCR) assay
 
Test List In Profile:
Viral load HCV RNA
Viral load Log equivalence
 
AliasesName:
HCV (RT-PCR) Quantification
HCV RNA
HCV Quantification
HCV RNA Quantification
HCV Viral Load
Hepatitis C RNA Quantitation
Hepatitis C Viral Load
 
 
 
Test Code:
VIRALLOADHCV

Order Name:
Viral Load (HCV RNA), Quantitative method

 
Collection Specimen Or Container:
Blood/ Plain blood (Red top) 6 mL, 1 tube
 
Specimen Testing Type:
Serum, minimum volume 1 mL
Separate plasma within 24 hours of collection.
 
Sub Mission Container:
Plastic tube
 
Rejection Criteria:
Hemolysis: N/A
Lipemia: N/A
Icterus: N/A
Other: Heparin, anticoagulant blood
 
Specimen Stabillity:
Specimen Type Temperature Time
Whole blood At temperature, 2oC to 25oC 24 hours
Serum Refrigerated, 2oC to 8oC 72 hours
Frozen, -20oC to -80oC 6 weeks
 
 
 
Test Code:
VIRALLOADHCV

Order Name:
Viral Load (HCV RNA), Quantitative method

 
Method detail:
Real-Time Reverse Transcription polymerase chain reaction (RT-PCR) assay
 
Schedule:
Monday through Saturday, at 1:00 p.m.and 07:00 p.m.
 
Turnaround Time:
Received specimen to reported within 2 days.
 
Performing Location:
Molecular biology & Genetics, Laboratory Department Tel.14168
 
Specimen Retention Time:
2 months
 
 
 
Test Code:
VIRALLOADHCV

Order Name:
Viral Load (HCV RNA), Quantitative method

 
 
Clinical Information:
Hepatitis C Virus is considered to be the principal etiologic agent responsible for 90 to 95% of the cases of post-transfusion hepatitis. The incidence of HCV infection is highest in association with intravenous drug abuse and to a lesser extent with other percutaneous exposures. Spontaneous viral clearance rates in exposed individuals are highly variable; between 10 and 60% have been reported as measured clinically by normalization of liver enzymes and clearance of plasma HCV RNA. HCV virus particles cannot be cultured from infected blood samples; hence the presence of anti-HCV antibodies in patients infected with HCV has led to the development of immunoserological assays that are specific for these antibodies. The presence of anti-HCV antibodies, however, is a measure of prior exposure to HCV infection, but cannot be considered a marker for current infection. The measurement of alanine aminotransferase levels (ALT) is considered to be a surrogate indicator of HCV infection, but is not a direct measure of viremia. In contrast, quantitation of HCV RNA for measuring baseline viral loads and for on-treatment monitoring has been well established in demonstrating the efficacy of antiviral response to peginterferon plus ribavirin combination therapy. Determining the viral kinetics during therapy has more recently been used to further personalize treatment duration with the novel direct acting antiviral agents for the treatment of chronic HCV infections.
 
Reference Value:
Test Reference Value
Viral load HCV RNA Not detected
Viral load Log equivalence Not detected
 
Interpretation:
This assay has a result range of 15 to 100,000,000 IU/mL (1.18 log to 8.00 log IU/mL) for quantification of hepatitis C virus (HCV) RNA in serum.
An "Not detected" result indicates that the HCV RNA is absent in the patient's serum specimen.
A result of "<15 IU/mL (<1.18 log IU/mL)" indicates that HCV RNA is detected, but the HCV RNA level present cannot be quantified accurately below this lower limit of quantification of this assay. When clinically indicated, follow-up testing with this assay is recommended in 1 to 2 months. To assess response-guided therapy eligibility, an "Not detected" result is required, and a result of "<15 IU/mL mL (<1.18 log IU/mL)" should not be considered equivalent to an "Not detected" result.
A quantitative result expressed in IU/mL and log IU/mL indicates the degree of active HCV viral replication in the patient. Monitoring HCV RNA levels over time is important to assess disease progression and/or monitoring a patient's response to anti-HCV therapy.
A result of ">100,000,000 IU/mL (>8.00 log IU/mL)" indicates the presence of active HCV viral replication, and the HCV RNA level present cannot be quantified accurately above this upper limit of quantification of this assay.
 
Clinical Reference:
Manufacturer’s package insert, COBAS®AmpliPrep/COBAS® TaqMan® HCV Quantitative Test, version 2.0, September 2019, Roche Molecular Systems, NJ 08876 Branchburg, USA.