Test Code HBV Quant Hepatitis B Viral Load

Useful For

Intended for use as an aid in the management of patients with chronic HBV infections undergoing HBV antiviral drug therapy.

No special patient preparation required

Venous collection

3 mL

K₂EDTA (Pink Top)

Frozen plasma from whole blood collected in K₂EDTA

K₂EDTA Whole Blood (less than 24 hours of collection)

Lower Limit of Detection: 5.58IU/mL (plasma) 4.29IU/mL (Serum)

Reported Aptima HBV Quant Assay Result
IU/mL	Log₁₀ Value	Interpretation
Not Detected	Not Detected	HBV DNA Not Detected
<10 detected	<1.00	HBV DNA is detected but at a level below the lower limit of quantification (LLoQ)
10 to 1,000,000,000	1.00 to 9.00	HBV DNA concentration is within the quantitative range between LLoQ to ULofQ
>1,000,000,000	>9.00	HBV DNA Concentration is above the upper limit of quantification (ULoQ)
Invalid*	Invalid*	There was an error in the generation of the result. Specimen should be retested.
*Invalid results are displayed in blue-colored font.

IU/mL and Log₁₀

Hemolysis Threshold	N/A
Icterus Threshold	N/A
Lipemia Threshold	N/A
Interfering Subtances/Other	Leakage/contamination of specimen. Improper collection, container, or transport. Questionable patient or specimen identification. Insufficient quantity.

Ambient	Whole Blood within 24 hours of collection
Refrigerated (2°C to 8°C)	5 Days
Frozen( ≤0°C)	Plasma: 60 Days

Days and Time Performed	Tues, Fri
Expected Turn Around Time	1-4 Days
Stat Availabilty	No
Performing Bench	Molecular Pathology
Methodology/Method Description	Hologic Panther® Single tube assay utilizing target capture, target amplification by transcription-mediated amplification (TMA), and detection of the amplification products by fluorescent labeled probes.

Centrifuged and separated plasma within 24hrs of collection.

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