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Donor, Hepatitis B Core Total Antibody
Test Code17378
CPT Codes
86704
Preferred Specimen
2 mL serum, or
2 mL plasma collected in an EDTA (lavender-top) tube
2 mL plasma collected in an EDTA (lavender-top) tube
Minimum Volume
1 mL
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 is 24 hours for unspun serum or plasma and (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 diseases.
For Shipper collection please see detailed instructions in Test Resources.
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 is 24 hours for unspun serum or plasma and (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 diseases.
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: 24 hours for unspun, 7 days for spun (See Collection Instructions)
Refrigerated: 10 days
Frozen: 28 days
Refrigerated: 10 days
Frozen: 28 days
Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Sample not marked serum/plasma • Specimens other than serum or EDTA plasma • Heat-treated specimens
Methodology
Immunoassay (IA)
Setup Schedule
Set up: Daily; Report available: 24 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.
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.
