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Hepatitis C Virus Test Menu TM Screening Test Name Test Code Hepatitis C Antibody w/reflex to Hepatitis C RNA Quantitative, RT-PCR 8587 Specimen Requirements Clinical Use Summary 4 mL refrigerated serum in a serum separator tube (SST) (3 mL minimum). Centrifuge as soon as possible after clot formation. Detect HCV antibody and confirm active HCV infection; establish baseline viral load for treatment monitoring; If Hepatitis C Antibody is reactive or equivocal, then Hepatitis C RNA, Quantitative, RT-PCR will be performed at an additional charge Specimen Requirements Clinical Use Summary Disease Progression Test Name Test Code Hepatitis C Virus RNA, Quantitative, RT-PCR 905541 3 mL frozen EDTA plasma from 2 lavender-top tubes (2.5 mL minimum). Centrifuge and transfer plasma to a plastic, screw-cap polypropylene vial within 24 hours of collection. Useful in monitoring response to therapy and/or disease progression; Reportable range is 15-100,000,000 IU/mL (1.18-8.00 Log IU/mL) Hepatitis C Viral RNA, Qualitative, TMA 901153 2 mL frozen EDTA plasma in a PPT white-top tube (0.6 mL minimum). Centrifuge and freeze entire tube within 2 hours of collection. Useful in confirming HCV infection and to assess response to therapy; Limit of detection for this assay is 5.3 IU/mL Liver Fibrosis, FibroTest-ActiTest Panel 906531 3.5 mL frozen serum (2 mL minimum) from a serum separator tube (SST) or plain red-top tube. Serum should be separated from the cells as soon as possible after visible clot formation (usually 15-30 minutes after collection). Avoid freezing and thawing. FibroTest and ActiTest permit the non-invasive evaluation of Hepatitis C (or B) individuals for the presence of liver fibrosis and liver inflammation, respectively. The FibroTest and ActiTest scores are calculated based on patient age, gender and in serum concentrations of y-glutamyl transferase (GGT), total bilirubin (TB), a-2 microglobulin, haptoglobin, apolipoprotein A1 and alanine aminotransferase (ActiTest). FibroTest and ActiTest Scores, on a scale of 0.0 to 1.0, are assigned a Metavir scale indicating the level of fibrosis or inflammation present. Please note that this test is not available for patients <2 years old. Tests on this chart may change periodically. Hepatitis C Virus Test Menu TM Pre-treatment and Treatment Response Test Name Test Code Specimen Requirements Clinical Use Summary Hepatitis C Viral RNA Genotype, LiPA® 15294 2 mL frozen EDTA plasma from a PPT white-top tube or lavender-top tube (0.6 mL minimum). Centrifuge and transfer plasma to a plastic, screw-cap polypropylene vial within 24 hours of collection. Determine whether to begin antiviral therapy in patients with chronic HCV infection; Determine duration and dosage of treatment; Predict response to therapy; Minimum viral load of ≥300 IU/mL; If viral load is <300 IU/mL or has not been quantified in the last 1-2 months, test code 901398 - HCV RNA, Quantitative, RT-PCR w/rflx Genotype, LiPA® is recommended Hepatitis C Viral RNA, Quantitative, RT-PCR, w/rflx Genotype, LiPA® 901398 3 mL frozen EDTA plasma from a lavender-top tubes (1.5 mL minimum). Centrifuge and transfer plasma to a plastic, screw-cap polypropylene vial within 24 hours of collection. Confirm the presence of virus on HCV Ab positive patients; Establish baseline HCV viral load for monitoring response to treatment; Determine treatment duration based on the HCV genotype; Reflex at additional charge to Genotype LiPA® if viral load >300 IU/mL Hepatitis C Viral RNA NS3 Genotype 906415 2 mL refrigerated or frozen EDTA plasma from a lavender-top tube or PPT white-top tube (0.6 mL minimum). Used to detect boceprevir, simeprevir and paritaprevir resistance-associated NS3 mutations in NS3 protease inhibitor treatment-experienced patients and also the Q80K polymorphism in patients being considered for a simeprevir-containing regimen. Hepatitis C Viral RNA Genotype 1 NS5A Drug Resistance 906678 2 mL frozen EDTA plasma from a lavender-top tube (0.6 mL minimum). Detect mutations or polymorphisms for genotype 1a or 1b in the NS5A gene associated with NS5A inhibitor treatment failure Hepatitis C Viral RNA Genotype 1 NS5B Drug Resistance 906679 2 mL frozen EDTA plasma from a lavender-top tube (0.6 mL minimum). Detect mutations or polymorphisms for genotype 1a or 1b in the NS5B gene associated with NS5B inhibitor treatment failure Hepatitis C Viral RNA Genotype 3 NS5A Drug Resistance 906677 2 mL frozen EDTA plasma from a lavender-top tube (0.6 mL minimum). Detect daclatasvir resistance associated polymorphisms, particularly Y93H for genotype 3 in the NS5A gene associated with NS5A inhibitor treatment failure Hepatitis C Viral RNA Genotype, LiPA® w/Reflex to HCV NS5a Drug Resistance 906685 3 mL frozen EDTA plasma from a lavender-top tube (1.2 mL minimum). Genotype used to guide treatment selection and duration; If HCV Genotype, LiPA® is "GENOTYPE 1", "GENOTYPE 1a", or "GENOTYPE 1a or 1b" then reflex Hepatitis C Viral RNA Genotype 1 NS5a Drug Resistance will be performed at additional charge Hepatitis C Viral RNA Quantitative Real-Time PCR w/Reflexes 906684 3 mL frozen EDTA plasma from a lavender-top tube (1.8 mL minimum). Used to obtain HCV viral load, HCV genotype and NS5a resistance testing when considering treatment with ZepatierTM or in other circumstances where all three tests are warranted; If HCV RNA, PCR QT is ≥300 IU/mL HCV Genotype, LiPA® will be performed at an additional charge; If HCV Genotype, LiPA® is "GENOTYPE 1", "GENOTYPE 1a", or "GENOTYPE 1a or 1b" then reflex Hepatitis C Viral RNA Genotype 1 NS5a Drug Resistance will be performed at additional charge Tests on this chart may change periodically. 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