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Order Code HCVL Hepatitis C Virus Antibody Confirmation, Serum

Useful For

Confirming the presence of hepatitis C virus (HCV)-specific IgG antibodies in serum specimens that are reactive by HCV antibody screening tests

 

Distinguishing between true- and false-reactive HCV antibody screening test results

 

This test is not intended for use as an HCV antibody screening test for blood or human cells/tissue donors.

 

This assay is not useful for detection of early or acute hepatitis C (<2 months from exposure) as immunocompromised patients may not develop detectable HCV antibodies in blood until 6 months after infection.

 

This assay is not useful for differentiating between past (resolved) and chronic hepatitis C.

Testing Algorithm

This test is available as a confirmatory test for reactive Hepatitis C virus (HCV) antibody screening test results.

 

For more information see Hepatitis C: Testing Algorithm for Screening and Diagnosis

Reporting Name

HCV Ab Confirmation, S

Specimen Type

Serum


Ordering Guidance


This test does not differentiate between past (resolved) and chronic hepatitis C. To distinguish between past (resolved) and chronic hepatitis C, order HCVQN / Hepatitis C Virus (HCV) RNA Detection and Quantification by Real-Time Reverse Transcription-PCR (RT-PCR), Serum.

 

For screening of asymptomatic individuals for HCV, order HCSRN / Hepatitis C Virus (HCV) Antibody Screen with Reflex to HCV RNA, PCR, Asymptomatic, Serum.

 

For detection of HCV in symptomatic at-risk individuals, order HCVDX / Hepatitis C Virus (HCV) Antibody with Reflex to HCV RNA, PCR, Symptomatic, Serum.



Necessary Information


Date of collection is required.



Specimen Required


Collection Container/Tube:

Preferred: Serum gel

Acceptable: Red top

Submission Container/Tube: Plastic vial

Specimen Volume: 0.4 mL

Collection Instructions:

1. Centrifuge blood collection tube per collection tube manufacturer's instructions (eg, centrifuge and aliquot within 2 hours of collection for BD Vacutainer tubes).

2. Aliquot serum into plastic vial.


Specimen Minimum Volume

0.1 mL

Specimen Stability Information

Specimen Type Temperature Time
Serum Frozen (preferred) 30 days
  Refrigerated  7 days

Reject Due To

Gross hemolysis Reject
Gross lipemia OK
Gross icterus OK

Reference Values

Negative

Method Description

The MP Diagnostics Hepatitis C Virus (HCV) Blot 3.0 is a line immunoassay that utilizes a nitrocellulose strip containing 4 bands corresponding to recombinant HCV proteins derived from the capsid (C), NS3, NS4, and NS5 regions of the HCV genome. The HCV proteins are expressed as glutathione-S-transferase (GST) fusion proteins, so a GST control band is also present on each strip to indicate reactivity to native GST. Each strip also contains an IgG control band and an anti-IgG band. Individual strips are incubated with either diluted clinical serum specimens or assay controls. Specific antibodies to HCV, if present in the specimen, will bind to the HCV proteins on the strips. The strips are washed to remove unbound materials and then incubated with affinity purified antihuman IgG conjugated with alkaline phosphatase. The conjugated antibody will bind to any antigen-antibody complexes formed on the strips. Unbound conjugate is removed by washing. A BCIP/NBT (5-bromo-4-chloro-3-indolyl-phosphate/nitro blue tetrazolium) substrate is added to visualize reactive protein bands on the strips.(Unpublished Mayo method)

Day(s) Performed

Tuesday

Performing Laboratory

Mayo Clinic Laboratories in Rochester

CPT Code Information

86804

Method Name

Line Immunoassay (LIA)

Forms

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

-Gastroenterology and Hepatology Test Request (T728)

-Infectious Disease Serology Test Request (T916)