HIV-1 RNA, Qualitative, Real-Time PCR

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Test Name: HIV-1 RNA, Qualitative, Real-Time PCR
Reference Lab: QNI
Test Code: 16185
Shipping Temp: Frozen
Specimen Type: 1.6 mL serum or EDTA plasma
TAT: 2 days
CPT Code: 87535
Cost: _
Additional Comments: _
FDA Approved Test: YES_ NO_ LDT_
Medical Director/Pathologist: approved by
Billing Completed by_ Date_ Time_


Test Code
QNI FLEXI 16185


Quest Code
16185


CPT Codes
87535

Preferred Specimen
1.6 mL serum or plasma collected in an EDTA (lavender-top) tube or potassium EDTA (white-top) tube


Minimum Volume
0.8 mL


Instructions
Separate plasma or serum from the cells by centrifugation within 24 hours after collection. Transfer the specimen to a transport tube. Separated plasma or serum can be sent in the PPT/SST® but cannot be shipped frozen.


Transport Temperature
Frozen


Specimen Stability
Room temperature: 72 hours
Refrigerated: 5 days
Frozen: 42 days


Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Whole blood • Unspun PPT • Frozen plasma in PPT (white-top) tube in situ • Frozen serum in Serum Separator Tube (SST®) in situ


Methodology
Real-Time Polymerase Chain Reaction

Setup Schedule
A.M.


Report Available
Reports in 2 days.


Reference Range
Not detected


Clinical Significance
HIV-1 Qualitative is an in vitro nucleic acid amplification test for the qualitative detection of human immunodeficiency virus type 1 (HIV-1) RNA in human serum and plasma by PCR. The test is intended to be used as an aid in diagnosis of HIV-1 infection. Detection of HIV-1 nucleic acid is indicative of HIV-1 infection. The presence of HIV-1 nucleic acid in the plasma or serum of individuals without antibodies to HIV-1 is indicative of acute or primary HIV-1 infection. The HIV-1 Qualitative PCR may also be used as an additional test to confirm the presence of HIV-1 infection in an individual with specimens reactive for HIV-1 antibodies or antigens. The assay may also be used as an aid in the diagnosis of infection with HIV-1 in pediatric subjects and pregnant women. This assay is not intended to be used for monitoring patient status, or for screening donors of blood, plasma, or human cells, tissues, and cellular and tissue-based products (HCT/Ps) for HIV.


Performing Laboratory
Quest Diagnostics Nichols Institute-San Juan Capistrano, CA
33608 Ortega Highway
San Juan Capistrano, CA 92675-2042




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.