Patient Preparation

No special patient preparation is necessary

Collect

Human serum or plasma isolated from whole blood collected in EDTA (purple top) tubes or in Serum Separator Tubes (SST).

Volume requirements: 1.5mL preferred 1.0mL minimum

Specimen Preparation

Separate serum or plasma from whole blood within 24 hours of collection by centrifugation at 800-1600 x g for 20 minutes at room temperature.
Transfer serum or plasma to a sterile polypropylene tube.

Unacceptable Conditions

Heparinized specimens.

Storage/Transport Temperature

Refrigerated

Stability (from collection to initiation)

Serum and plasma specimens may be stored at 2-8°C for up to 3 days or frozen at -70°C for up to 6 weeks. Serum or plasma specimens may be frozen and thawed up to five times without a loss of HCV RNA.

Cerner Orderable(s)

Hepatitis C Viral Load w/ reflex Genotype

Performed

Hepatitis C PCR Quantitative: 2-3 days

Hepatitis C Virus Genotype (SENDOUT): Performed by LabCorp Burlington, test code 550475

Ordering Recommendations

Preferred reflex test to confirm active HCV infection following positive HCV screen. Reflex to genotype aids in prognosis and treatment selection.

Methodology

Polymerase Chain Reaction

Reported

Hepatitis C PCR Quantitative TAT:  24 - 48 hours

Hepatitis C Virus Genotype (SENDOUT):  Report available 5-7 days

Synonyms

  • HCV treatment decision
  • HCV-PCR
  • HCV-RNA
  • Hepatitis C Viral Load
  • Genotype reflex
  • HCV confirmation
  • HCV genotype
  • HCV quantitative

Reference Interval

ComponentsReference Interval
Hepatitis C Virus by Quantitative PCRNot Detected
Hepatitis C Virus Genotype (SENDOUT)By report

Interpretive Data

The Limit of Detection (LOD) of the assay is 15 IU/mL for HCV genotypes 1-6. The Linear range of the assay is 15-100,000,000 IU/mL. The HCV viral load is performed with the FDA-approved Ampliprep COBAS TaqMan HCV v2.0 test. The test is intended for use as an aid in the management of HCV-infected individuals undergoing anti-viral 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 this test must be interpreted within the context of all relevant clinical and laboratory findings.




CPT Codes

87522; if reflexed, add 87902
Collection

Patient Preparation

No special patient preparation is necessary

Collect

Human serum or plasma isolated from whole blood collected in EDTA (purple top) tubes or in Serum Separator Tubes (SST).

Volume requirements: 1.5mL preferred 1.0mL minimum

Specimen Preparation

Separate serum or plasma from whole blood within 24 hours of collection by centrifugation at 800-1600 x g for 20 minutes at room temperature.
Transfer serum or plasma to a sterile polypropylene tube.

Unacceptable Conditions

Heparinized specimens.

Storage/Transport Temperature

Refrigerated

Stability (from collection to initiation)

Serum and plasma specimens may be stored at 2-8°C for up to 3 days or frozen at -70°C for up to 6 weeks. Serum or plasma specimens may be frozen and thawed up to five times without a loss of HCV RNA.
Ordering

Cerner Orderable(s)

Hepatitis C Viral Load w/ reflex Genotype

Performed

Hepatitis C PCR Quantitative: 2-3 days

Hepatitis C Virus Genotype (SENDOUT): Performed by LabCorp Burlington, test code 550475

Ordering Recommendations

Preferred reflex test to confirm active HCV infection following positive HCV screen. Reflex to genotype aids in prognosis and treatment selection.

Methodology

Polymerase Chain Reaction

Reported

Hepatitis C PCR Quantitative TAT:  24 - 48 hours

Hepatitis C Virus Genotype (SENDOUT):  Report available 5-7 days

Synonyms

  • HCV treatment decision
  • HCV-PCR
  • HCV-RNA
  • Hepatitis C Viral Load
  • Genotype reflex
  • HCV confirmation
  • HCV genotype
  • HCV quantitative
Result Interpretation

Reference Interval

ComponentsReference Interval
Hepatitis C Virus by Quantitative PCRNot Detected
Hepatitis C Virus Genotype (SENDOUT)By report

Interpretive Data

The Limit of Detection (LOD) of the assay is 15 IU/mL for HCV genotypes 1-6. The Linear range of the assay is 15-100,000,000 IU/mL. The HCV viral load is performed with the FDA-approved Ampliprep COBAS TaqMan HCV v2.0 test. The test is intended for use as an aid in the management of HCV-infected individuals undergoing anti-viral 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 this test must be interpreted within the context of all relevant clinical and laboratory findings.




Administrative

CPT Codes

87522; if reflexed, add 87902

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