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Test Code HCV Qual by NAAT Hepatitis C Virus Qualitative by NAAT

Useful For

The Aptima HCV Quant Dx assay is indicated for use as an aid in the diagnosis of active HCV infection in the following populations: individuals with antibody evidence of HCV infection with evidence of liver disease, individuals suspected to be actively infected with HCV antibody evidence, and individuals at risk for HCV infection with antibodies to HCV. Detection of HCV RNA indicates that the virus is replicating and, therefore, is evidence of active infection. Detection of HCV RNA does not discriminate between acute and chronic states of infection

Patient Preparation

No special patient preparation required

Collection Method

Venous collection

Minimum Volume

3 mL

Container

Pink Top EDTA

Preferred Specimen

Frozen Plasma from whole blood collected in a Pink Top EDTA tube

Acceptable Specimens

EDTA Whole blood collected within 6 hours

Reference or Target Ranges

Not Detected

 

Lower Limit of Detection IU/mL, 1.00 Log10

 

Reportable Units

Detected/Not Detected/Invalid

Critical Value

Not defined for this assay

Reasons for Rejection

Hemolysis Threshold N/A
Icterus Threshold N/A
Lipemia Threshold N/A
Interfering Subtances/Other
  • Plasma not separated and frozen within 6 hours of collection
  • Leakage or contamination of specimen, improper collection, container or transport, questionable patient or specimen identification, insufficient quantity

Specimen Stability

Ambient Whole Blood: 6 Hours
Plasma: 24 Hours
Refrigerated (4°C to 8°C) Plasma: 5 Days
Frozen(-20°C or below) Plasma: 60 Days

Performance Information

Days and Time Performed Batched once weekly
Expected Turn Around Time 1 – 7 Days
Stat Availabilty No
Performing Bench Molecular Pathology
Methodology/Method Description Hologic Panther – Nucleic Acid Amplification

Special Handling

Handle all specimens as if they are capable of transmitting infectious agents.

CPT Codes

87521

Reflex Testing

Test does not automatically reflex. Additional testing available off of original sample for HCV genotyping by contacting the Molecular laboratory.