Procleix® Ultrio HIV/HCV/HBV Assay
Performed at multiple locations.
The Procleix Ultrio Assay is a qualitative in vitro nucleic acid assay system to screen for human immunodeficiency virus type I (HIV-1) RNA, hepatitis C virus (HCV) RNA and hepatitis B virus (HBV) DNA in plasma and serum specimens from individual human donors, including donors of whole blood, blood components, and source plasma, and from other living donors. It is also intended for use in testing plasma and serum specimens to screen organ donors when specimens are obtained while the donor's heart is still beating, and in testing blood specimens from cadaveric (non-heart beating) donors. 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 assay is not intended for use as an aid in diagnosis of infection with HIV-1, HCV or HBV. The test has been cleared or approved for diagnostic use by the U.S. Food and Drug Administrations.
ProcedureNucleic Acid Amplification (NAT).
SpecificityOverall specificity of the Procleix Ultrio Assay was 99.95%.
Overall specificity of the Procleix HIV-1 Discriminatory Assay was 99.8%.
Overall specificity of the Procleix HCV Discriminatory Assay was 98.1%.
Overall specificity of the Procleix HBV Discriminatory Assay was 99.8%.
Same day (within 8 - 12 hours from receipt of specimen), Monday through Saturday.
| Specimen Type | Test Code | CPT Code | NY Approved | Volume | Assay Range | Special Instructions |
|---|---|---|---|---|---|---|
| plasma | 5218959 | 87801 | Yes | 4 mL (min. 2 mL) | Reactive/NonReactive |
|
Qualitative results (Reactive/Nonreactive).
ShippingLee's Summit Lab: Ship Monday through Friday.
Ship specimens FedEx Priority Overnight® to:
Eurofins Viracor
18000 W 99th St. Ste, #10
Lenexa, KS 66219
Ph: (800) 305-5198
Los Angeles Lab: Ship Monday through Friday.
Ship specimens FedEx Priority Overnight® to:
Eurofins Viracor Serology
2100 West 3rd Street, Suite 301
Los Angeles, CA 90057
Ph: (213)229-3654
Label Friday shipments with Saturday delivery. All specimens must be labeled with patients name and collection date. A Eurofins Viracor test requisition form must accompany each specimen. Multiple tests can be run on one specimen.
Causes for RejectionSpecimens beyond their acceptable length of time from collection as listed in the specimen handling or specimen types other than those listed.
Specimens are approved for testing in New York only when indicated in the Specimen Information field above. The CPT codes provided are based on Eurofins Viracor's interpretation of the American Medical Association's Current Procedural Terminology (CPT) codes and are provided for informational purposes only. CPT coding is the sole responsibility of the billing party. Questions regarding coding should be addressed to your local Medicare carrier. Eurofins Viracor assumes no responsibility for billing errors due to reliance on the CPT codes illustrated in this material.
References1. Procleix® WNV Assay Package Insert.