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Alphabetical Index
HCV Quantitative Assay by NAAT (8000100164)
Test Mnemonic:

HCV-NAAT
Specimen Requirements:
Collection:

Plasma preparation tube (PPT)

Serum separator tube (SST)

Red Top serum tube
Container:

Plasma preparation tube (PPT) 

Serum separator tube (SST)

Red Top serum tube
Minimum Volume:

Original Tube - 2 mL of plasma or serum

13 x 100 Specimen Aliquot Tube - 1.5 mL of plasma or serum
Storage/Transport:

Refrigerate (2-8ºC) up to 5 days; Samples should be frozen (-20ºC) and tested within 60 days.
Stability:

Refrigerate (2-8ºC) up to 5 days; Samples should be frozen (-20ºC) and tested within 60 days.
Causes for Rejection:

Improper collection. Specimen container unlabeled or labeled incorrectly. No date and time of collection or collector information on order.
Specimen Preparation:

 Within 24 hours of collection, centrifuge.
Methodology:

Nucleic acid amplification by transcription-mediated amplification, target capture, and dual kinetic assay.
Performed:
Lab:

Clinical Microbiology
Turnaround Time:

5 days
Reference Range:

HCV Not Detected

HCV Detected: 10-100,000,000 IU/mL
CPT 4 Code:

87522
Note:

The Aptima HCV Quant Dx assay is an FDA-approved real-time transcription mediated amplification (TMA) test used for both detection and quantification of hepatitis C virus (HCV) RNA in human serum and plasma from HCV-infected individuals. It is intended for use as an aid in the diagnosis of active HCV infection and the management of HCV-infected patients undergoing HCV antiviral drug therapy. It is not approved for use as a screening test for the presense of HCV RNA in blood or blood products. 

The quantitative range of this assay is 1.00-8.00 log IU/mL or 10 - 100,000,000 IU mL.

An interpretation of "Not Detected" does not rule out the presence of inhibitors in the patient specimen of HCV  RNA concentration below the level of detection of the test. Care should be taken when interpreting any single viral load determination.

Detected, not Quantifiable: HCV RNA detected, but at a level below 10 IU/mL (1.0 log IU/mL). HCV RNA concentration is below the lower limit of quantitation of the assay. 

Indeterminate: Error indicated in the generation of the result. Please submit a new specimen for repeat testing if clinically indicated.
Synonyms:

HCV Viral Load; HCV Quantitative; Hepatitis C Quantitative test
Patient Preparation :

Routine venipuncture for blood.
Clinical Indication:

Detection of HCV in serum or plasma specimens.
Effective Date: 10/12/2021
Reviewed By/Date: 0 - 01/01/1900
Approved By/Date: Williams-Bouyer, Natalie - 10/24/2024
When ordering tests for which Medicare or Medicaid reimbursement will be sought, physicians should only order tests that are medically necessary for the diagnosis or treatment of the patient. Components of the organ or disease panels may be ordered individually. The diagnostic information must substantiate all tests ordered and must be in the form of an ICD-10 code or its verbal equivalent.

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