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Hepatitis C Virus

Clinical Specimen Submission Guidance

Submit all specimens to 50 Orms St, Providence RI 02904. Open Monday to Friday 8:30 AM to 4:30 PM

Lab

STI & Arbovirus Laboratory 401-222-5591

Analyte Name

Hepatitis C Virus

Disease

Hepatitis C (Hep C/HCV)

Test Description

Hepatitis C virus screening is performed using the FDA cleared ALINITY Anti-HCV Assay (Abbott Diagnostics).

Confirmation testing is performed using  the FDA cleared APTIMA HCV RNA Qualitative Assay (Hologic). 

The performance characteristics of these assays were verified by the Rhode Island State Health Laboratories (RISHL).

The RISHL has validated the accuracy of the HCV Qualitative confirmatory test for specimens held up to 7 days at 4°C prior to confirmation.

Results should be used in conjunction with the patient's clinical symptoms, medical history, and other clinical/laboratory findings to determine an overall clinical diagnosis.

Specimen

Collect minimum 2.5 mL serum or plasma or 5 mL whole blood

COLLECTION TUBES SHOULD BE CENTRIFUGED (SPUN DOWN) WITHIN 6 HOURS OF BLOOD BEING DRAWN.

Refrigerate at 2° - 8°C for up to one week.

Specimen Identification

CLIA regulations require specimens be labeled with at least two patient identifiers. Examples of identifiers are first and last name, date of birth, chart/medical record number. The specimen container must be labeled to match the test requisition or the electronic order.

Form Required

Rhode Island State Health Laboratories (RISHL) test requisition form https://health.ri.gov/forms/LabRequisitionForm.pdf

Test Request

Hepatitis C

Transport

Transport as soon as possible.

Refrigerated: Transport and deliver to the laboratory within 24 hours of collection at 2-8°C in a cooler able to maintain specimen temperature. A plug-in electric cooler is recommended, however, a cooler packed with excess frozen gel packs is acceptable as long as the transport temperature is maintained at 2-8°C. 

Specimens must be packaged & transported in accordance with current federal shipping regulations.

 

Integrity

Non-hemolyzed

Normal Value

Negative

Reporting Requirement

Providers must report patient information on Hepatitis C within 4 days using the RIDOH reportable disease form.

Turnaround Time

Screen: 3 business days

Confirmation: 5 business days

STAT testing may be requested by contacting the STI & Arbovirus Laboratory directly at (401) 222-5591

Kit

Containers specifically labeled for transport of specimens to the RISHL STI & Arbovirus Laboratory are available in all Serology Laboratories and Laboratory Sendout Departments.