Geisinger Medical Laboratories/Geisinger Proven Diagnostics Test Catalog

Order Display Name: Geisinger Epic Procedure Code Or ID CPT Code:  

HEPATITIS C RNA QUANTITATIVE

ORDERING INFORMATION:
Geisinger Epic Procedure Code: LAB2446         Geisinger Epic ID: 18867

SPECIMEN COLLECTION
Specimen type:
Plasma
Preferred collection container:
Specimen required:
3-4 mL of plasma in one (1) aliquot tube; minimum 2.0 mL of plasma in aliquot. NO SHARED SPECIMENS.
Special notes:
Separate plasma from whole blood within 24 hours of collection. Each molecular test ordered requires its own aliquot tube (e.g. HEPCR requires one 3-4 mL aliquot tube and HIVRNA requires one 3-4 mL aliquot tube).

SPECIMEN PROCESSING
Specimen processing instructions:
Separate plasma from whole blood within 24 hours of collection. Centrifuge for 10 minutes at 3000 rpm, room temperature. Using a sterile pipet, transfer 3-4 mL of plasma to one (1) labeled, sterile, aliquot tube. 
Transport temperature:
Plasma frozen, -20 to -80°C (preferred). Plasma may also be transported at 2-8°C. Transport EDTA whole blood at 2-8°C.
Specimen stability:
Plasma specimens may be stored at 2-8°C for up to 6 days, or frozen at -20 to -80°C up to 12 weeks (preferred). EDTA whole blood specimens can be stored at 2-8°C up to 24 hours prior to centrifugation.
Rejection criteria:
Whole blood specimens must be collected in EDTA tubes. Specimens must be separated within 24 hours, or they will be rejected. Plasma must be stored at 2-8°C for up to 6 days and at -20 to -80°C up to 12 weeks. Stability limits exceeded. Shared or comingled specimens.

TEST DETAILS
Reference interval:
Negative IU/mL.
Additional information:
Linear range of the assay is 15 IU/mL to 100 million IU/mL. Positive results less than 15 IU/mL will be reported as HCV RNA detected, not quantifiable. The lower level of detection (LLoD) of this assay is 12 IU/mL from plasma specimens.
CPT code(s):
87522
Note: The billing party has sole responsibility for CPT coding.  Any questions regarding coding should be directed to the payer being billed.  The CPT codes provided by GML are based on AMA guidelines and are for informational purposes only.
Test includes:
Quantitative HCV RNA.
Methodology:
Real-time Reverse Transcription Polymerase Chain Reaction (RT-PCR)
Synonyms:
HCV RNA Quant Viral Load, HCV Viral Load, Quantitative
Hepatitis C Viral Load, HCV PCR, Hepatits C virus PCR
HCV RNA Quant, HEPCR
HCV RNA Quantitative
Hepatitis C virus RNA Quantitative
Clinical significance:
The hepatitis C quantitative test offers a measures of active viremia in antibody-positive chronic HCV-infected individuals undergoing antiviral therapy. The current FDA guidelines support the importance of measuring HCV RNA levels at baseline prior to treatment, at intervals during treatment to assess viral response, and after treatment is completed to assess the efficacy of treatment. Also, this assay is intended for use as an aid in the diagnosis of HCV infection in the following populations: individuals with antibody evidence of HCV infection with evidence of liver disease, individuals suspected to be actively infected with HCV antibody evidence, and individuals at risk for HCV infection with antibodies to HCV.
Doctoral Director(s:)
Yi Ding MD, PhD    
Review Date: 08/17/2020

Performing Locations

Geisinger Medical Center

Performing laboratory: Molecular Diagnostics
Technical Lead: Lisa Scicchitano
Frequency: Daily, Monday-Friday, 1st shift
Performed stat? No
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