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HelpTest Code HBVVL Hepatitis B Quant PCR
Additional Test Codes
Epic Order Name: Hepatitis B Quant PCR Sunquest order Code: HBVVL Epic Px Code: LAB10929
Specimen Collection Type
Preferred: Pearl EDTA Plasma Acceptable: Lavender EDTA Plasma
Minimum Collection Volume
2 mL Plasma
Additional Information / Notes
N/A
Reference Range
Not Detected
Critical Value
N/A
Specimen Availability for Add-on Testing
20 hours
Specimen Stability
Prior to centrifugation: 24 hours room temp. (15-30°C), 3 days refrigerated (2-8°C) After centrifugation: 20 hours room temp. (15-30°C), 3 days refrigerated (2-8°C)
Day(s) Performed
Batched twice per week. Report available in 1-4 days.
Performing Lab - Department
TUKHS-BH-Molecular Microbiology
CPT Code
87517
LOINC Code
42595-9, 48398-2
Performing Lab- Department
TUKHS-BH-Molecular Microbiology
Clinical Indications
The HBV Quant assay is intended for use as an aid in the management of patients with chronic HBV infections undergoing HBV antiviral drug therapy. The assay can be used to measure HBV DNA levels at baseline and during treatment to aid in assessing viral response to treatment. The results from the HBV Quant assay must be interpreted within the context of all relevant clinical and laboratory findings. Assay performance for determining the clinical stage of HBV infection has not been established. This assay is not intended to be used as a screening blood, blood products, or cell, tissue, and cellular and tissue-based products (HCT/Ps), or as a diagnostic test to confirm the presence of HBV infection.
Interpretation
This assay is FDA-cleared to quantitate HBV from 10 to 1,000,000,000 IU/mL (1.00 to 9.00 log IU/mL). The limit of detection for this assay is 10 IU/mL (1.00 log IU/mL). A “Not Detected” result indicates that HBV DNA was not detected. Negative test results do not preclude viral infection or tissue invasive viral disease. Test results must not be the sole basis for patient management decisions.
A result of <10 IU/mL (<1.00 log IU/mL) indicates that HBV DNA is detected, but the HBV DNA level present cannot be quantified accurately below this lower limit of quantification of this assay. A numerical result is reported when HBV DNA is detected. If detected, quantitative results will be reported in IU/mL and log IU/mL.
Test Alias
HBV PCR HBV PCR Quant QHBV Hepatitis B Virus (HBV) Viral Load HBV Viral Load
Rejection Criteria
Any unspun sample outside of specimen stability
Any plasma sample outside of specimen stability
Samples that do not comply with TUKHS Lab specimen requirements.