PrEP Use Only: HBV Screening and Diagnosis (Triple Panel)
Also known as: Pre-exposure prophylaxis screening for hepatitis B virus
Use
This test is used for HBV screening and diagnosis in patients administered HIV PrEP. This is a triple test panel intended for screening and diagnosis of hepatitis B virus (HBV) infection. This panel can be used to identify different phases of HBV infection and to determine whether a patient has acute or chronic HBV as a result of prior infection or vaccination or is susceptible to infection. This panel aligns with current CDC recommendations for HBV screening and testing.
Special Instructions
The test is intended for PrEP use only and contains a CPT code modifier for the CARES Act. If a reflex test is performed, additional charges or CPT codes may apply. The test may show interference when samples are collected from individuals taking high doses of biotin. Patients should stop taking biotin at least 72 hours prior to sample collection.
Limitations
The assays included in this panel have not been validated with cadaveric specimens, heat-inactivated specimens, or body fluids other than serum and EDTA plasma. There may be interference when samples are collected from individuals consuming biotin supplements. The test may not be valid in specimens outside the specified collection criteria.
Methodology
Immunoassay (ECLIA)
Biomarkers
LOINC Codes
- 77190-7
- 5196-1
- 22322-2
- 13952-7
- 77202-0
- 56850-1
Result Turnaround Time
1-2 days
Related Documents
For more information, please review the documents below
Specimen
Serum
Volume
5 mL
Minimum Volume
2.5 mL
Container
Gel-barrier tube, red-top tube or serum transfer tube
Collection Instructions
If a tube other than a gel-barrier tube is used, transfer separated serum to a screw-cap polypropylene transport tube. Do not freeze gel-barrier tube (pour off serum first).
Patient Preparation
Patients should stop biotin consumption at least 72 hours prior to the collection of a sample.
Storage Instructions
Room temperature
Causes for Rejection
Specimens other than serum or EDTA plasma; PST gel-barrier tube; specimens with visible gross microbial contamination
Stability Requirements
| Temperature | Period |
|---|---|
| Room Temperature | 14 days |
| Refrigerated | 14 days |
| Frozen | 14 days |