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Test Code HCVAB Hepatitis C Antibody with Reflex to Viral Load, Plasma

Biohazard Infectious

Specimen Type

Preferred: Plasma, EDTA

Acceptable: Plasma Li-Heparin, Serum*

 

*Note: Serum, and Plasma Li Heparin sample types will not reflex to viral load

Container

Preferred: Lavender EDTA

Acceptable: Li-Heparin (Mint Green or Dark Green), Red Top tube and Gold STT*

 

*Note: Serum, and Plasma Li Heparin sample types will not reflex to viral load

Preferred Volume

EDTA Plasma: 10 mL

Li Heparin Plasma: 3 mL

Serum: 3 mL

 

*Note: EDTA Plasma required volume is 10 mL for reflex to microbiology. Unacceptable volume will result in cancellation of reflex.

 

UCMC Collection Instructions

1. Samples need to be received in the lab within 2 hours of collection at room temperature.

2. Greater than 2 hours must be refrigerated at 2-8°C for serum and Li-Heparin plasma.

3. Greater than 6 hours refrigerated specimens must be centrifuged and aliquoted.

4. If above criteria are not met, specimen will be rejected.

5. EDTA plasma must be sent room temperature.

 

Availability

24/7

Turnaround Time

4 hours

STAT Availability

Not Available

Test Usage

The assay may be used in conjunction with other serological and clinical information to aid in the diagnosis of individuals with symptoms of hepatitis and in individuals at risk for hepatitis C infection.

Test Methodology

Electrochemiluminescence Immunoassay (ECLIA)

Additional Information

The Supplemental testing algorithm is described in the Guidelines for Laboratory Testing and Result Reporting of Antibody to Hepatitis C Virus, MMWR 2003: 52(RR03) from the Centers for Disease Control.

CPT Code

86803

Minimum Volume

EDTA Lavender 10 mL tube: minimum of 8 mL needed to reflex to Microbiology

 

Serum and Plasma: 0.5 mL

Test Limitations

The results from this or any other diagnostic kit should be used and interpreted only in the context of the overall clinical picture. A negative test result does not exclude the possibility of exposure to hepatitis C virus. 
 

The performance of the assay has not been established for populations of immunocompromised, immunosuppressed, infants, children, or adolescent patients.
 

A reactive anti-HCV result does not exclude co-infection by another hepatitis virus.

Critical Results

None

Reference Range

Non-reactive

 

Borderline

 

Reactive
 

Reactive results should be confirmed by separately requesting that supplemental testing (HCV-RIBA and/or HCV RNA nucleic acid testing) be performed following CDC recommendations (MMWR 2003:52 RR03). Physicians are responsible for evaluating results and requesting supplemental testing when appropriate. Reactive tests drawn in a EDTA plasma tube will automatically reflex to hepatitis Viral Load, HCVL.
 

The results from this or any other diagnostic kit should be used and interpreted only in the context of the overall clinical picture.

 

A negative test result does not exclude the possibility of exposure to hepatitis C virus.

Fee Code

43095

Offsite collection Instructions

1. Serum or Plasma tubes should be centrifuged and aliquoted within 2 hours of collection.

2. Aliquoted EDTA Plasma samples should be room temperature at 25°C prior and during transportation.

3. Aliquoted Serum or Li-Heparin Plasma samples should be refrigerated at 2-8°C prior and during transportation.

3. If above criteria are not met, specimen will be rejected.

Test Includes

Qualitative determination of antibodies to hepatitis C virus (HCV) in human serum or plasma