Test Details
Methodology
Immunochemiluminometric assay (ICMA)
Result Turnaround Time
1 - 2 days
Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary.
Test Includes
Hepatitis B Surface Antigen (HBsAg) Screen, Hepatitis B Surface Antibody (anti-HBs), Hepatitis B Core Antibody, Total (anti-HBc); reflexes to Hepatitis B Core Antibody, IgM (IgM anti-HBc) when indicated.
Reflex criteria: If Hepatitis B Core Antibody, Total [006718] is positive and Hepatitis B Surface Antibody, Qualitative [006395] is nonreactive (NR), the test reflexes to Hepatitis B Core Antibody, IgM [016881].
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
PrEP use only. Contains CPT code modifier for CARES Act.
If reflex test is performed, additional charges/CPT code(s) may apply.
This test may exhibit interference when sample is collected from a person who is consuming a supplement with a high dose of biotin (also termed as vitamin B7 or B8, vitamin H, or coenzyme R). It is recommended to ask all patients who may be indicated for this test about biotin supplementation. Patients should be cautioned to stop biotin consumption at least 72 hours prior to the collection of a sample.
Limitations
The performance of the assays included in this panel has not been established with cadaveric specimens, heat-inactivated specimens or body fluids other than serum and EDTA plasma.
Custom Additional Information
Interpretation | HBsAg | anti-HBs | anti-HBc | IgM anti-HBc |
|---|---|---|---|---|
* Multiple possibilities: resolved infection (most common); false-positive anti-HBc (susceptible); "low-level" chronic infection; resolving acute infection. | ||||
Susceptible/no evidence of infection | - | - | - | TNI |
Immune due to natural resolved infection | - | + | + | TNI |
Immune due to vaccination | - | + | - | TNI |
Acute infection | + | - | + | + |
Chronic infection | + | - | + | - |
Interpretation unclear* | - | - | + | ± |
Specimen Requirements
Specimen
Serum or EDTA plasma
Volume
5 mL
Minimum Volume
2.5 mL (Note: This volume does not allow for repeat testing.)
Container
Gel-barrier tube, red top tube or lavender-top (EDTA) tube
Collection Instructions
If tube other than a gel-barrier tube is used, transfer separated serum or plasma to a plastic transport tube.
Stability Requirements
Temperature | Period |
|---|---|
Room temperature | 14 days |
Refrigerated | 14 days |
Frozen | 14 days |
Freeze/thaw cycles | Stable x3 |
Storage Instructions
Room temperature
Causes for Rejection
Specimens other than serum or EDTA plasma; PST gel-barrier tube; specimens with visible gross microbial contamination
References
LOINC® Map
| Order Code | Order Code Name | Order Loinc | Result Code | Result Code Name | UofM | Result LOINC |
|---|---|---|---|---|---|---|
| 144696 | PrEP: HBV Screening and Dx | 77190-7 | 006510 | HBsAg Screen | 5196-1 | |
| 144696 | PrEP: HBV Screening and Dx | 77190-7 | 006408 | Hep B Surface Ab, Qual | 22322-2 | |
| 144696 | PrEP: HBV Screening and Dx | 77190-7 | 006718 | Hep B Core Ab, Tot | 13952-7 | |
| 144696 | PrEP: HBV Screening and Dx | 77190-7 | 144721 | Rfx to HBcIgM | 77202-0 | |
| 144696 | PrEP: HBV Screening and Dx | 77190-7 | 006720 | Interpretation | 56850-1 | |
| Order Code | 144696 | |||||
| Order Code Name | PrEP: HBV Screening and Dx | |||||
| Order Loinc | 77190-7 | |||||
| Result Code | 006510 | |||||
| Result Code Name | HBsAg Screen | |||||
| UofM | ||||||
| Result LOINC | 5196-1 | |||||
| Order Code | 144696 | |||||
| Order Code Name | PrEP: HBV Screening and Dx | |||||
| Order Loinc | 77190-7 | |||||
| Result Code | 006408 | |||||
| Result Code Name | Hep B Surface Ab, Qual | |||||
| UofM | ||||||
| Result LOINC | 22322-2 | |||||
| Order Code | 144696 | |||||
| Order Code Name | PrEP: HBV Screening and Dx | |||||
| Order Loinc | 77190-7 | |||||
| Result Code | 006718 | |||||
| Result Code Name | Hep B Core Ab, Tot | |||||
| UofM | ||||||
| Result LOINC | 13952-7 | |||||
| Order Code | 144696 | |||||
| Order Code Name | PrEP: HBV Screening and Dx | |||||
| Order Loinc | 77190-7 | |||||
| Result Code | 144721 | |||||
| Result Code Name | Rfx to HBcIgM | |||||
| UofM | ||||||
| Result LOINC | 77202-0 | |||||
| Order Code | 144696 | |||||
| Order Code Name | PrEP: HBV Screening and Dx | |||||
| Order Loinc | 77190-7 | |||||
| Result Code | 006720 | |||||
| Result Code Name | Interpretation | |||||
| UofM | ||||||
| Result LOINC | 56850-1 |
| Order Code | Order Name | Result Code | Result Name | UofM | Result LOINC | |
|---|---|---|---|---|---|---|
| Reflex 1 | 016105 | HBsAg Confirmation | 016105 | HBsAg Confirmation | 7905-3 | |
| Reflex 1 | ||||||
| Order Code | 016105 | |||||
| Order Name | HBsAg Confirmation | |||||
| Result Code | 016105 | |||||
| Result Name | HBsAg Confirmation | |||||
| UofM | ||||||
| Result LOINC | 7905-3 | |||||
| Order Code | Order Name | Result Code | Result Name | UofM | Result LOINC | |
|---|---|---|---|---|---|---|
| Reflex 1 | 144722 | PrEP: Hep B Core Ab, IgM | 016881 | Hep B Core Ab, IgM | 24113-3 | |
| Reflex 1 | ||||||
| Order Code | 144722 | |||||
| Order Name | PrEP: Hep B Core Ab, IgM | |||||
| Result Code | 016881 | |||||
| Result Name | Hep B Core Ab, IgM | |||||
| UofM | ||||||
| Result LOINC | 24113-3 | |||||