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Alphabetical Index
HBV Quantitative Assay by NAAT (8000100319)
Test Mnemonic:

HBV-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:

8 days
Reference Range:

HBV Not Detected
HBV Detected: 10 - 1,000,000,000 IU/mL
CPT 4 Code:

87517
Note:

The Aptima HBV Quant assay is an FDA-approved in-vitro nucleic acid amplification test for the quantification of hepatitis B virus (HBV) DNA in human plasma and serum. It is intended for use as an aid in the management of patients with chronic HBV infections undergoing HBV antiviral drug therapy. It is not approved for use as a screening test for the presence of HBV DNA in blood or blood products or as a diagnostic test to confirm the presence of HBV infection. 

The quantitative range of this assay is 1.00 - 9.00 log IU/mL or 10 – 1,000,000,000 IU/mL.

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

Detected, not Quantifiable: HBV DNA detected, but at a level below 10 IU/mL (1.0 log IU/mL). HBV DNA 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:

HBV Viral Load; HBV Quantitative; Hepatitis B Virus, Quantitative test
Patient Preparation :

Routine venipuncture for blood.
Clinical Indication:

Detection of HBV in serum or plasma specimens.
Effective Date: 09/27/2024
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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