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Specimen Collection Manual and Test Catalog

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HEPATITIS C ANTIBODY WITH REFLEX HCV QUANTITATIVE PCR

Geisinger Epic Procedure Code:  LAB2443    Geisinger Epic ID:  32445

SPECIMEN COLLECTION
Specimen type: 

Serum AND plasma.

Collect two tubes


Alternate collection container: 
6 mL red-top (plain, non-serum separator) tube
Specimen required: 

Serum: 1 mL aliquot, minimum 0.5 mL AND 
Plasma: one 3-4 mL plasma aliquot, minimum 2.0 mL NO SHARED SPECIMENS.



SPECIMEN PROCESSING
Processing instructions: 

Allow serum to clot. Centrifuge to separate serum or plasma within 2 hours of collection. If red-top is drawn, serum must be aliquoted. Separate plasma from EDTA whole blood within 24 hours of collection. Centrifuge for 15 minutes at 2000-3000 g, room temperature. Using a sterile pipet, transfer 3-4 mL of plasma to one (1) labeled, sterile aliquot tube.


Transport temperature: 

Serum: Refrigerated. 
Plasma: Frozen -20 to -80°C (preferred). Plasma may also be transported at 2-8°C. 
EDTA whole blood: 2-8°C up to 24 hours.


Specimen stability: 

Serum: Room temperature: 3 days. Refrigerated: 21 days at 2-8°C. Frozen: 3 months. 
Plasma may be stored at 2-8°C up to 6 days, or frozen at -20 to -80°C up to 12 weeks (preferred). 
EDTA whole blood samples can be stored at 2-8°C up to 24 hours prior to centrifugation.


Rejection criteria: 

For plasma, whole blood specimens must be collected in EDTA tubes. Specimens must be separated with 24 hours of collection, or will be rejected. Improper storage or transport temperature. Stability limits exceeded. Shared or comingled specimens. Add-ons available only to unopened tube..



TEST DETAILS
Reference interval: 

Negative for antibody screen. Negative IU/mL for HCV RNA quantitation.


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 but not quantified. The calculated titer is below the lower limit of quantification (LLoQ) of the assay.


CPT code(s):  86803. When antibody screen is positive, an additional CPT code of 87522 is added for Hepatitis C RNA Quantitative Assay.
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.

Methodology: 
Chemiluminescence Immunoassay
Real-time Reverse Transcription Polymerase Chain Reaction (RT-PCR)
Synonyms: 

Hepatitis C virus antibody screen with progression to HCV RNA Quantitative Viral Load if equivocal or positive screen., HCVPRO


Clinical significance: 

See individual panel members: HEPATITIS C ANTIBODY and HEPATITIS C RNA QUANTITATIVE


Doctoral Director(s): 
Hoi-Ying Elsie Yu, PhD, DABCC, FADLM
Sheng-Ying (Margaret) Lo, PhD, DABCC
Yi Ding, MD,PhD
Review Date:  04/02/2025

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