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Test Code HCVQG Hepatitis C Virus (HCV) RNA Quantification with Reflex to HCV Genotype, Serum

Reporting Name

HCV RNA Detect/Quant Reflex Geno, S

Performing Laboratory

Mayo Clinic Laboratories in Rochester

Useful For

Detection of acute hepatitis C virus (HCV) infection before the appearance of HCV antibodies in serum (ie, <2 months from exposure)

 

Detection and confirmation of chronic HCV infection and determining HCV genotype (1 to 5) to guide antiviral therapy in patients with chronic hepatitis C

 

Quantification of HCV RNA in serum of patients with chronic HCV infection (HCV antibody-positive) before initiating antiviral therapy

 

Determining cure and detection of relapse of HCV infection after completion of antiviral therapy

Method Name

HCVQG: Real-Time Reverse Transcription-Polymerase Chain Reaction (RT-PCR)

HCVG, HCVGR: RT-PCR followed by Hybridization with Sequence-Specific, Fluorescent-Labeled Oligonucleotide Probes


Ordering Guidance


For detection and quantification of hepatitis C (HCV) RNA and genotype in serum before initiating antiviral therapy for chronic hepatitis C.

 

Do not order this test to monitor response and progress during antiviral therapy for chronic hepatitis C.



Shipping Instructions


1. Freeze serum immediately, and ship specimen frozen on dry ice only.

2. If shipment will be delayed for more than 24 hours, freeze serum at -20 to -80° C (up to 42 days) until shipment on dry ice.



Specimen Required


Supplies: Sarstedt Aliquot Tube, 5 mL (T914)

Collection Container/Tube: Serum gel

Submission Container/Tube: Plastic vial

Specimen Volume: 3.5 mL

Collection Instructions: Centrifuge and aliquot serum into plastic vial within 2 hours of collection.


Specimen Type

Serum SST

Specimen Minimum Volume

1.6 mL

Specimen Stability Information

Specimen Type Temperature Time Special Container
Serum SST Frozen (preferred) 42 days
  Refrigerated  72 hours

Reject Due To

Gross hemolysis OK
Gross lipemia OK
Gross icterus OK

Reference Values

Undetected

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. Only those specimens with HCV RNA levels greater than or equal to 500 IU/mL will be tested for HCV genotype (HCVG / Hepatitis C Virus Genotype, Serum or HCVGR / Hepatitis C Virus Genotype Resolution, Serum).

 

An "Undetected" result indicates that the HCV is absent in the patient's serum specimen. Such specimens will not be tested for HCV genotype.

 

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. Such specimens will not be tested for HCV genotype.

 

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.

 

An "Inconclusive" result reported with a comment indicates that testing failed, likely due to the presence of inhibitory substances in the submitted serum specimen. A new specimen should be collected for retesting. Such specimens will not be tested for HCV genotype.

Day(s) Performed

Monday through Saturday

Report Available

1 to 8 days

Test Classification

This test has been cleared, approved, or is exempt by the US Food and Drug Administration and is used per manufacturer's instructions. Performance characteristics were verified by Mayo Clinic in a manner consistent with CLIA requirements.

CPT Code Information

87522

87902 (if appropriate)

87902 (if appropriate)

LOINC Code Information

Test ID Test Order Name Order LOINC Value
HCVQG HCV RNA Detect/Quant Reflex Geno, S 11011-4

 

Result ID Test Result Name Result LOINC Value
603602 HCV RNA Detect/Quant, S 11011-4

Forms

If not ordering electronically, complete, print, and send 1 of the following forms with the specimen:

-Microbiology Test Request (T244)

-Gastroenterology and Hepatology Test Request (T728)

Reflex Tests

Test ID Reporting Name Available Separately Always Performed
HCVG HCV Genotype, S Yes No
HCVGR HCV Genotype Resolution, S No No

Testing Algorithm

Specimens with hepatitis C virus (HCV) RNA levels greater than or equal to 500 IU/mL will be tested for HCV genotype at an additional charge.

 

Specimens either generating indeterminate genotype results or results with multiple or mixed HCV genotypes (eg, 1, 5; 1a, 2; or 3, 5) containing genotype 1 but no subtype will be automatically evaluated with by genotype resolution at an additional charge.

 

For more information see:

-Chronic Hepatitis C Treatment and Monitoring Algorithm: Direct Antiviral Antigen (DAA) Combination

-Hepatitis C: Testing Algorithm for Screening and Diagnosis