Donor, Stem Cells Donor Panel

Test Code

93309

Alias/See Also

LAB724

Includes

Donor, HIV-1/-2 plus O Antibody Screen
Donor, Hepatitis B Surface Antigen Reflex to Confirm
Donor, Hepatitis B core Total Antibody
Donor, Hepatitis C Antibody (Anti-HCV)
Donor, HTLV-I/II Antibody Screen
Donor, Cytomegalovirus (CMV) Total Antibodies
Donor, HIV-1/HBV/HCV NAT Procleix® with Reflex to HIV-1/HBV/HCV Discriminatory
Donor, West Nile Virus NAT
Donor, Syphilis IgG Antibody

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

If Donor, HIV-1/HBV/HCV/NAT Procleix® with Reflex is reactive, then the Donor, HIV-1 Discriminatory (CPT code: 87535), Donor, HBV Discriminatory (CPT code: 87516), and Donor, HCV Discriminatory (CPT code: 87521) will be performed at an additional charge.

Preferred Specimen

6 mL serum collected in each of two separate tubes and
6 mL plasma collected in each of two separate EDTA (lavender-top) tubes

Minimum Volume

6 mL serum • 6 mL plasma

Instructions

Note: Please include serum, red-top (no-gel) for CMV portion of testing.

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

See Collection Instructions

Transport Temperature

Refrigerated (cold packs)

Specimen Stability

Room temperature: Unacceptable
Refrigerated: 5 days
Frozen: 28 days

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

Sample not marked serum/plasma • CMV samples submitted in gel tubes (serum separator tube - SST)

Methodology
Immunoassay (IA) • Hemagglutination • Nucleic Acid Amplification

Setup Schedule

Set up: Daily; Report available: 24 hours

Clinical Significance

Blood donors and donors of human cells, tissues and cellular and tissue-based products (HCT/Ps) must be tested for infectious diseases using assay kits that are FDA-approved or FDA-cleared specifically for donor screening.

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.