Test Details
Methodology
Immunochemiluminometric assay (ICMA) (HBV components) and chemiluminescence immunoassay (HDV component)
Result Turnaround Time
1 - 5 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) if Hepatitis B Core Antibody, Total is positive; and reflexes to Hepatitis D Virus (HDV) Antibody, IgG and IgM if positive for HBsAg.
Use
This is an HBV triple test panel intended for screening and diagnosis of hepatitis B virus (HBV) infection with reflex of Hepatitis B surface antigen (HBsAg) positive samples to Hepatitis D virus (HDV) antibody testing to identify HDV coinfections. This panel can be used to identify different phases of HBV infection and to determine whether a patient has acute or chronic HBV infection, is immune to HBV as a result of prior infection or vaccination or is susceptible to infection. Additionally, this panel identifies HBV-HDV coinfections.
Special Instructions
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 HBV assays included in this panel has not been established with cadaveric specimens, heat-inactivated specimens or body fluids other than serum and EDTA plasma. HDV antibody reactive specimens should be further tested for HDV RNA to differentiate between active and resolved HDV infection. A nonreactive test result for HDV antibodies does not exclude the possibility of exposure to or infection with HDV. Further investigations with alternative HDV-specific tests are suggested in case of suspected infection despite the negative finding.
The performance of the HBV assays included in this panel has not been established with cadaveric specimens, heat-inactivated specimens or body fluids other than serum and EDTA plasma. HDV antibody reactive specimens should be further tested for HDV RNA to differentiate between active and resolved HDV infection. A nonreactive test result for HDV antibodies does not exclude the possibility of exposure to or infection with HDV. Further investigations with alternative HDV-specific tests are suggested in case of suspected infection despite the negative finding.
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The performance of the HBV assays included in this panel has not been established with cadaveric specimens, heat-inactivated specimens or body fluids other than serum and EDTA plasma. HDV antibody reactive specimens should be further tested for HDV RNA to differentiate between active and resolved HDV infection. A nonreactive test result for HDV antibodies does not exclude the possibility of exposure to or infection with HDV. Further investigations with alternative HDV-specific tests are suggested in case of suspected infection despite the negative finding.
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Custom Additional Information
| HBV and HDV Serology Interpretation Chart | |||||
|---|---|---|---|---|---|
| Interpretation | HBsAg | antiHBs | antiHBc | IgM anti-HBc | HDV IgG/IgM |
| Susceptible to HBV/no evidence of infection | - | - | - | TNI | TNI |
| Immune to HBV due to natural resolved infection | - | + | + | - | TNI |
| Immune to HBV due to vaccination | - | + | - | TNI | TNI |
| Acute HBV infection, no evidence of HDV infection | + | - | + | + | - |
| Acute HBV infection and evidence of HDV infection | + | - | + | + | + |
| Chronic HBV infection, no evidence of HDV infection | + | - | + | - | - |
| Chronic HBV infection and evidence of HDV infection | + | - | + | - | + |
| Interpretation unclear* | - | - | + | +/- | TNI |
| Key: Analyte present: + Analyte absent: - Test not indicated: TNI | |||||
| *Multiple possibilities: resolved infection (most common); false-positive anti-HBc (susceptible); “low-level” chronic infection; resolving acute infection | |||||
Specimen Requirements
Specimen
Serum
Volume
5.5 mL
Minimum Volume
2.7 mL (Note: This volume does not allow for repeat testing.)
Container
Gel-barrier tube or serum transfer tube
Collection Instructions
Centrifuge sample within 24 hours of collection. If tube other than a gel-barrier tube is used, or if sample will be shipped frozen, transfer separated serum to a screw-cap polypropylene transport tube. Do not freeze gel-barrier tube (pour off serum first).
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
LOINC® Map
| Order Code | Order Code Name | Order Loinc | Result Code | Result Code Name | UofM | Result LOINC |
|---|---|---|---|---|---|---|
| 144103 | HBV Triple Panel Rfx to HDV Ab | 006510 | HBsAg Screen | 5196-1 | ||
| 144103 | HBV Triple Panel Rfx to HDV Ab | 006408 | Hep B Surface Ab, Qual | 22322-2 | ||
| 144103 | HBV Triple Panel Rfx to HDV Ab | 006718 | Hep B Core Ab, Tot | 13952-7 | ||
| 144103 | HBV Triple Panel Rfx to HDV Ab | 006719 | Rfx to HBc IgM | 77202-0 | ||
| 144103 | HBV Triple Panel Rfx to HDV Ab | 006723 | Interpretation: | 56850-1 | ||
| Order Code | 144103 | |||||
| Order Code Name | HBV Triple Panel Rfx to HDV Ab | |||||
| Order Loinc | ||||||
| Result Code | 006510 | |||||
| Result Code Name | HBsAg Screen | |||||
| UofM | ||||||
| Result LOINC | 5196-1 | |||||
| Order Code | 144103 | |||||
| Order Code Name | HBV Triple Panel Rfx to HDV Ab | |||||
| Order Loinc | ||||||
| Result Code | 006408 | |||||
| Result Code Name | Hep B Surface Ab, Qual | |||||
| UofM | ||||||
| Result LOINC | 22322-2 | |||||
| Order Code | 144103 | |||||
| Order Code Name | HBV Triple Panel Rfx to HDV Ab | |||||
| Order Loinc | ||||||
| Result Code | 006718 | |||||
| Result Code Name | Hep B Core Ab, Tot | |||||
| UofM | ||||||
| Result LOINC | 13952-7 | |||||
| Order Code | 144103 | |||||
| Order Code Name | HBV Triple Panel Rfx to HDV Ab | |||||
| Order Loinc | ||||||
| Result Code | 006719 | |||||
| Result Code Name | Rfx to HBc IgM | |||||
| UofM | ||||||
| Result LOINC | 77202-0 | |||||
| Order Code | 144103 | |||||
| Order Code Name | HBV Triple Panel Rfx to HDV Ab | |||||
| Order Loinc | ||||||
| Result Code | 006723 | |||||
| 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 | 016104 | HBsAg Confirmation Rflx to HDV | 016105 | HBsAg Confirmation | 7905-3 | |
| Reflex 2 | 144104 | HDV Antibody, IgG/IgM | 144013 | HDV Antibody, IgG/IgM | 40727-0 | |
| Reflex 3 | 144015 | Interpretation: | 144015 | Interpretation: | 56850-1 | |
| Reflex 1 | ||||||
| Order Code | 016104 | |||||
| Order Name | HBsAg Confirmation Rflx to HDV | |||||
| Result Code | 016105 | |||||
| Result Name | HBsAg Confirmation | |||||
| UofM | ||||||
| Result LOINC | 7905-3 | |||||
| Reflex 2 | ||||||
| Order Code | 144104 | |||||
| Order Name | HDV Antibody, IgG/IgM | |||||
| Result Code | 144013 | |||||
| Result Name | HDV Antibody, IgG/IgM | |||||
| UofM | ||||||
| Result LOINC | 40727-0 | |||||
| Reflex 3 | ||||||
| Order Code | 144015 | |||||
| Order Name | Interpretation: | |||||
| Result Code | 144015 | |||||
| Result Name | Interpretation: | |||||
| UofM | ||||||
| Result LOINC | 56850-1 | |||||
| Order Code | Order Name | Result Code | Result Name | UofM | Result LOINC | |
|---|---|---|---|---|---|---|
| Reflex 1 | 016104 | HBsAg Confirmation Rflx to HDV | 016105 | HBsAg Confirmation | 7905-3 | |
| Reflex 2 | 144104 | HDV Antibody, IgG/IgM | 144013 | HDV Antibody, IgG/IgM | 40727-0 | |
| Reflex 3 | 144016 | Interpretation: | 144016 | Interpretation: | 56850-1 | |
| Reflex 1 | ||||||
| Order Code | 016104 | |||||
| Order Name | HBsAg Confirmation Rflx to HDV | |||||
| Result Code | 016105 | |||||
| Result Name | HBsAg Confirmation | |||||
| UofM | ||||||
| Result LOINC | 7905-3 | |||||
| Reflex 2 | ||||||
| Order Code | 144104 | |||||
| Order Name | HDV Antibody, IgG/IgM | |||||
| Result Code | 144013 | |||||
| Result Name | HDV Antibody, IgG/IgM | |||||
| UofM | ||||||
| Result LOINC | 40727-0 | |||||
| Reflex 3 | ||||||
| Order Code | 144016 | |||||
| Order Name | Interpretation: | |||||
| Result Code | 144016 | |||||
| Result Name | Interpretation: | |||||
| UofM | ||||||
| Result LOINC | 56850-1 | |||||
| Order Code | Order Name | Result Code | Result Name | UofM | Result LOINC | |
|---|---|---|---|---|---|---|
| Reflex 1 | 016881 | Hep B Core Ab, IgM | 016881 | Hep B Core Ab, IgM | 24113-3 | |
| Reflex 1 | ||||||
| Order Code | 016881 | |||||
| Order Name | Hep B Core Ab, IgM | |||||
| Result Code | 016881 | |||||
| Result Name | Hep B Core Ab, IgM | |||||
| UofM | ||||||
| Result LOINC | 24113-3 | |||||