HCV Viral Load, PCR

CPT: 86803, 87522

Expected Turnaround Time

24 Hours

Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary.

Specimen Requirements

Specimen

Serum

Volume

5 ml

Minimum Volume

1 ml

Container

SST (Serum)

Storage Instructions

Room Temp., Refrigerated (2-8 C)

Stability Requirements

Room temp. & Refrigerated 7 days

Causes for Rejection

Mislabeled specimen, grossly hemolyzed specimen, sample collected expired tubes, QNS

Test Details

Use

This test is use for the quantification of HCV RNA in a patient’s blood and is a key parameter for diagnosing active infection.

Methodology

PCR

Reference Interval

Not Detected

Additional Information

Hepatitis C Virus (HCV) viral load refers to the quantification of HCV RNA in a patient’s blood and is a key parameter for diagnosing active infection, monitoring disease progression, and evaluating response to antiviral therapy. Quantitative HCV RNA testing is performed using nucleic acid amplification techniques such as real-time reverse transcription polymerase chain reaction (RT-PCR). Results are expressed in international units per milliliter (IU/mL), and the lower limit of quantification (LLOQ). HCV viral load is not correlated with disease severity but is essential for determining treatment eligibility and confirming sustained virologic response (SVR), defined as undetectable HCV RNA 12 weeks after completing therapy.

References

Ghany, M. G., Morgan, T. R., & AASLD-IDSA HCV Guidance Panel. (2020). Hepatitis C guidance 2020 update: AASLD-IDSA recommendations for testing, managing, and treating hepatitis C virus infection. Hepatology, 71(2), 686–721. https://doi.org/10.1002/hep.31060

Chevaliez, S., & Pawlotsky, J. M. (2018). HCV genome and life cycle, diagnosis and treatment. Clinical Microbiology and Infection, 24(10), 1027–1031. https://doi.org/10.1016/j.cmi.2018.03.032

Lok, A. S., & McMahon, B. J. (2009). Chronic hepatitis B: Update 2009. Hepatology, 50(3), 661–662. https://doi.org/10.1002/hep.23190

Footnotes

Statement on Medical Necessity
All ordered tests should be medically necessary for the diagnosis or detection of disease, illness, impairment, symptom, syndrome, or disorder and the results should be used in the medical management and treatment decisions for the patient. Solaris requires ICD-10 codes with each order for lab testing and both the tests ordered and the diagnosis should be documented in the provider’s medical record for the patient. The United States Department of Health and Human Services, Office of Inspector General, takes the position that a provider who orders medically unnecessary tests may be subject to civil penalties.

Panels and Profiles
Solaris offers Providers the convenience of ordering test combinations in a group at times with the flexibility to choose appropriate test(s) for individual patients. Providers should only order those tests that he or she believes are medically necessary for each patient, and a lesser inclusive profile or individual tests should be ordered if not all tests in the test combination/profile are medically necessary. All tests offered in a test combination/profile may be ordered separately as individual tests. Solaris encourages clients to contact their Solaris representative if the testing configurations shown do not meet individual needs for any reason, or if some other combination of procedures is needed.

CPT Codes
CPT Codes listed are in accordance with Current Procedural Terminology, a publication of the American Medical Association. CPT codes are the responsibility of the billing party and are listed here for informational purposes. Correct coding may vary from one carrier to another. Solaris may bill specific carriers using codes other than what is shown.

Questions?

For questions or inquiries related to testing please reach out to
customerservice@solarisdx.com or contact us by phone at (844) 550-0308.