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Specimen Collection Guide: Test Name Monogram Test #Labcorp Test #Clinical Use Viral Load Requirement Specimen

The document provides guidance on collecting and testing samples for various hepatitis C virus assays. It lists several tests for determining viral load, genotyping, and assessing drug susceptibility. It also provides requirements for sample type, volume, and storage for each test.

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69 views2 pages

Specimen Collection Guide: Test Name Monogram Test #Labcorp Test #Clinical Use Viral Load Requirement Specimen

The document provides guidance on collecting and testing samples for various hepatitis C virus assays. It lists several tests for determining viral load, genotyping, and assessing drug susceptibility. It also provides requirements for sample type, volume, and storage for each test.

Uploaded by

quantanglement
Copyright
© © All Rights Reserved
Available Formats
Download as PDF, TXT or read online on Scribd
Download as pdf or txt
Download as pdf or txt
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HCV Specimen Collection Guide

Test Name

Monogram LabCorp
Test N
Test N

HCV, Quantitative,
Real-Time PCR
(Graphical or Nongraphical)

Graphical:
C1000G
Nongraphical:
C1000N

Graphical:
550070
Nongraphical:
550080

HCV Genotyping
(Subtype)

C1200

550475

HCV, Quantitative,
Real-Time PCR
(Graphical or Nongraphical)
with Reflex to Genotyping (Subtype) (C1200)

Graphical:
C1200G
Nongraphical:
C1200N

Graphical:
550100
Nongraphical:
550090

Clinical Use
Determine the number of international units (IU) of
hepatitis C virus (HCV) RNA per milliliter in serum or plasma
in known HCV-positive patients.

Viral Load
Requirement

Specimen
Volume

N/A

2.5 mL serum
or plasma

1000 IU/mL

3.0 mL serum
or plasma

N/A

3.0 mL serum
or plasma

2000 IU/mL
This assay requires
an HCV genotype of
1a or 1b.

2.0 mL plasma

The quantifiable range of the assay is 15 IU/mL to


100,000,000 IU/mL.
Genotyping of the six major HCV types and their most
common subtypes.
Quantification of HCV with reflex to HCV genotype (at
additional charge) if viral load is >1000 IU/mL.
The quantifiable range of the assay is 15 to 100,000,000
IU/mL.

HCV GenoSure NS3/4A


(Genotype 1a/1b)

C5000

550540

Assessment of drug susceptibility by nucleic acid


sequencing of a patients hepatitis C virus (HCV) to the
NS3/4A protease inhibitors. Detects Q80K polymorphism.
Assay should be used for patients with documented HCV
genotype 1.

HCV, Quantitative, RT-PCR (Graphical or


Nongraphical) with reflex to HCV GenoSure
NS3/4A (C5000)

Graphical:
C5000G
Nongraphical:
C5000N

Graphical:
550066
Nongraphical:
550072

Quantification of HCV with reflex to HCV GenoSure NS3/4A


drug resistance (at additional charge) if 2000 IU/mL.
Detects Q80K polymorphism.

N/A

6.0 mL serum
or plasma

550555

Genotyping of the six major HCV types and their most


common subtypes. Assessment of drug susceptibility by
nucleic acid sequencing of a patients hepatitis C virus
(HCV) to the NS3/4A protease inhibitors. Detects Q80K
polymorphism.

2000 IU/mL

3.0 mL serum
or plasma

500 IU/mL
This assay requires
an HCV genotype of
either 1a or 1b.

2.0 mL plasma

Hepatitis C Virus (HCV) Genotyping With


1a Subtype Reflex to Hepatitis C Virus
(HCV) GenoSure(R) NS3/4A

C6020G

Hepatitis C Virus (HCV) NS5A Drug


Resistance Assay (Genotype 1a/1b)

C6200

550325

Assessment of drug susceptibility by nucleic acid


sequencing of a patients hepatitis C virus (HCV) to the
NS5A inhibitors. Assay should be used for patients with
documented HCV genotype 1.

Hepatitis C Virus (HCV), Quantitative, RNA


PCR (Graphical or Nongraphical) With
Reflex to Hepatitis C Virus (HCV) NS5A
Drug Resistance Assay

Graphical:
C6200G
Nongraphical:
C6200N

Graphical:
550333
Nongraphical:
550349

Quantification of HCV with reflex to HCV NS5A Drug


Resistance Assay (at additional charge) if > 500 IU/mL.

N/A

4.0 mL plasma

1000 IU/mL

3.0 mL plasma
(preferred) or
serum

Hepatitis C Virus (HCV) Genotyping With


1a Subtype Reflex to Hepatitis C Virus
(HCV) NS5A Drug Resistance Assay

C6200G

550615

Genotyping of the six major HCV types and their most


common subtypes. Assessment of drug susceptibility by
nucleic acid sequencing of a patients hepatitis C virus
(HCV) to the NS5A inhibitors. Detects resistance-associated
variants at positions 28, 30, 31 and 93 in genotype 1a HCV.

Hepatitis C Virus (HCV) GT1a NS5A Profile

C6200RG

550705

Intended for baseline determination of HCV viral load,


HCV genotype and NS5A drug resistance in patients with
documented HCV infection and HCV genotype 1a.

N/A

4.0 mL plasma
(preferred) or
serum

550603

Assessment of drug susceptibility by nucleic acid


sequencing of a patients hepatitis C virus (HCV) to the
NS5A inhibitors. Assay should be used for patients with
documented HCV genotype 3.

500 IU/mL
This assay requires
an HCV genotype
of 3.

2.0 mL plasma

1000 IU/mL
This assay requires
an HCV genotype of
either 1a or 1b.

2.0 mL plasma

N/A

4.0 mL plasma

Hepatitis C Virus (HCV) Genotype 3 NS5A


Drug Resistance Assay

C6220

Hepatitis C Virus (HCV)NS5B Drug


Resistance Assay (Genotype 1a/1b)

C6300

550505

Assessment of drug susceptibility by nucleic acid


sequencing of a patients hepatitis C virus (HCV) to the
NS5B inhibitors. Assay should be used for patients with
documented HCV genotype 1.

Hepatitis C Virus (HCV), Quantitative, RNA


PCR (Graphical or Nongraphical) With
Reflex to Hepatitis C Virus (HCV) NS5B
Drug Resistance Assay**

Graphical:
C6300G
Nongraphical:
C6300N

Graphical:
550554
Nongraphical:
550577

Quantification of HCV with reflex to HCV NS5B Drug


Resistance Assay (at additional charge) if > 1000 IU/mL.

Visit the online Test Menu at www.LabCorp.com for full test information, including CPT codes and specimen collection requirements.
Contact Monogram customer service at 800-777-0177 6:30 am 5:00 pm Pacific time (9:30 am 8:00 pm Eastern time) with any questions.

Sample Collection and Preparation for Hepatitis C Assays


1. Collect whole blood by venipuncture.

For tests with sample volumes of 2.0 - 4.0 mLs plasma either:
Two 5.0 mL PPT (pearl-top) tubes
OR
Two EDTA (lavender-top) tubes

For tests with sample volumes of 6.0 mLs plasma either:
Three 5.0 mL PPT (pearl-top) tubes
OR
Three EDTA (lavender-top) tubes

2. Centrifuge within 6 hours of collection.

3. Remove plasma, and transfer to polypropylene screw-cap tube (if using EDTA).

4. Freeze immediately at or below -20C. Sample should be frozen solid before shipping.

2016 Laboratory Corporation of America Holdings. All Rights Reserved. L12160-0416-5

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