Donor, Hepatitis B Core Total Antibody

Test Code

17378

Alias/See Also

1230400168 | LAB7026: Allogeneic Donor Panel

LAB7195: Donor, Hepatitis B Core Total Antibody

LAB9018: Autologous Donor Panel | QUEST EAP: 17378

CPT Codes
86704

Preferred Specimen

2 mL serum, or
2 mL plasma collected in an EDTA (lavender-top) tube

Minimum Volume

1 mL

Instructions

For Shipper collection please see detailed instructions in Test Resources.
Please note: This test is to be used for the screening of DONORS of human cells, tissues, and cellular and tissue-based products for infectious diseases.

Label the tubes according to your standard operating procedure, making sure that each tube has at least two unique patient identifiers.

If transport temperature will be frozen, centrifuge the red/lavender top tube and transfer the serum/plasma into a plastic screw cap vial. The plastic screw cap vial (aliquot tube) containing serum or plasma must be labeled with the specimen type (serum or plasma) and at least two unique patient identifiers. Aliquot tubes must be processed and labeled at the original collection site. If aliquot tubes are submitted, do not send the original red/lavender top tube.

Transport Container

Transport tube

Transport Temperature

Room temperature

Specimen Stability

Room temperature: 7 days
Refrigerated: 14 days
Frozen: 90 days

Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)

Gross hemolysis • Sample not marked serum/plasma • Specimens other than serum or plasma • Heat-inactivated specimens • Pooled specimens • Specimens with obvious microbial contamination • Specimens with fungal growth

Methodology
Immunoassay (IA)

Setup Schedule

Set up: Daily; Report available: 36 hours

Reference Range

Non-Reactive

Clinical Significance

This test in intended to be used as a primary screening test for the diagnosis of acute or chronic hepatitis due to hepatitis B virus (HBV) infection. This test has been approved by the FDA for the screening of donors of blood, blood components and human cells, tissues, and tissue-based products (HCT&Ps). It is also intended for use to screen organ donors when specimens are obtained while the donor's heart is still beating. This test is not intended for use on samples of cord blood.

A positive result is indicative of an infection with HBV, and may be used to disqualify a potential cell or tissue donor. This test is not intended to be used for routine clinical diagnostic testing.

Performing Laboratory
Quest Diagnostics Nichols Institute
14225 Newbrook Drive
Chantilly, VA 20153

Last Updated: April 21, 2023

The CPT Codes provided in this document are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed. Any Profile/panel component may be ordered separately. Reflex tests are performed at an additional charge.