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Donor, Hepatitis B Surface Antigen with Reflex to Confirm
MessageTest Code
CPT Codes
87340
Includes
Preferred Specimen
3 mL plasma collected in an EDTA (lavender-top) tube
Minimum Volume
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 Temperature
Specimen Stability
Refrigerated: 14 days
Frozen: 90 days
Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Methodology
Immunoassay (IA)
Setup Schedule
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