Donor, Hepatitis B Surface Antigen Reflex to Confirmation

Test Code

17375

CPT Codes
87340

Includes

If Donor Hepatitis B Surface Antigen is reactive, then Donor, Hepatitis B Surface Antigen Confirmation will be performed at an additional charge (CPT code(s): 87341).

Preferred Specimen

2 mL serum

Minimum Volume

1 mL

Other Acceptable Specimens

Plasma collected in: EDTA (lavender-top) tube

Instructions

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.

Room temperature stability for serum or plasma (transport only) 7 days for spun.

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 disease.

For Shipper collection please see detailed instructions in Test Resources.

Transport Container

Plastic screw-cap vial

Transport Temperature

Refrigerated (cold packs)

Specimen Stability

Room temperature: See Collection Instructions
Refrigerated: 7 days
Frozen: 30 days

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

Sample not marked serum/plasma

Methodology
Immunoassay (IA)

Setup Schedule

Set up: Daily; Report available: 24 hours (Reflex: 2-3 days)

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

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.