Donor, HIV-1/HBV/HCV NAT Procleix® with Reflex to HIV-1/HBV/HCV Discriminatory [19854X]

Message

For Specimen Integrity during Extreme Weather see the “Lockbox Usage in Extreme Weather” document at the top of this page.

Test Code

DNRPRF

Alias/See Also

19854

CPT Codes
87801

Includes

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

Preferred Specimen

3 mL plasma collected in EDTA (lavender-top) tube

Minimum Volume

2 mL plasma • 5 mL whole blood

Other Acceptable Specimens

Plasma collected in: an PPT potassium EDTA (white-top) • 7 mL EDTA whole blood collected in: (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.

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.

This test is FDA-Approved (HIV RNA, HBV RNA, and HCV RNA) for the screening of DONORS of human cells, tissues, and cellular and tissue-based products for infectious diseases. It is not intended to be used for routine diagnostic testing.

For Shipper collection please see detailed instructions in Test Resources.

Transport Container

Plastic screw-cap vial and original collection tube

Transport Temperature

Refrigerated (cold packs)

Specimen Stability

Plasma
Room temperature: 72 hours
Refrigerated: 7 days
Frozen: 6 months

Whole blood
Room temperature: 72 hours
Refrigerated: 72 hours
Frozen: Unacceptable

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

Sample not marked as plasma/serum

Methodology
Nucleic Acid Amplification (NAT)

FDA Status
This test is FDA Approved/Cleared for the screening of DONORS of human cells, tissues and cellular and tissue-based products for infectious diseases. It is not intended to be used for routine diagnostic testing.

Setup Schedule

Set up: Mon, Wed-Sat; Report available: 3 days

Reference Range

Non-Reactive

Clinical Significance

This test is for the eligibility determination of Donors of blood and blood components and human cells, tissues, and cellular tissue based products (HCT/Ps). This test is not intended to be used for routine clinical or routine diagnostic evaluation.

Performing Laboratory

Quest Diagnostics Nichols Institute

14225 Newbrook Drive

Chantilly, VA 20153

Last Updated: November 29, 2021

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.