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Specimen Collection Manual and Test Catalog

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HIV-1 RNA QUANTITATIVE, PCR

Geisinger Epic Procedure Code:  LAB5182    Geisinger Epic ID:  196056

SPECIMEN COLLECTION
Specimen type: 

Plasma


Preferred collection container: 
Specimen required: 

Two 6 ml pink-top K2 EDTA tubes must be collected. Aliquot 3-4 mL of plasma in two (2) separate aliquot tubes; minimum 2.0 mL of plasma in each aliquot.



SPECIMEN PROCESSING
Processing instructions: 

Separate plasma from EDTA whole blood within 24 hours of collection. Centrifuge for 15 mins at 2000-3000g, room temperature. Using a sterile pipet, transfer 3-4 mL of plasma from each 6 ml pink top K2 EDTA tubes into two separate, labeled, sterile, aliquot tubes.


Transport temperature: 

Plasma frozen, -20 to -80°C (preferred). Plasma may also be transported at 2-8°C. Transport EDTA whole blood specimens at 2-8°C.


Specimen stability: 

Plasma specimens may be stored at 2-8°C for up to 6 days, or frozen at -20°C to -80°C for up to 12 weeks (preferred). EDTA whole blood specimens can be stored at 2-8°C up to 24 hours prior to centrifugation.


Rejection criteria: 

Whole blood specimens must be collected in EDTA tubes. Specimens must be separated within 24 hours, or they will be rejected. Plasma must be stored at 2-8°C for up to 6 days and at -20°C to -80°C up to 12 weeks. Stability limits exceeded. Shared or comingled specimens.



TEST DETAILS
Reference interval: 

Negative copies/mL.


Additional information: 

Normal volume of specimen tested is 650 uL of plasma. When 650 uL of plasma is tested, the linear range of the assay is 20 copies/mL to 10,000,000 copies/mL. Positive results less than 20 copies/mL will be reported as: HIV RNA detected but not quantified. The calculated titer is below the lower limit of quantification (LLoQ) of the assay. 

Low volume of specimen may be tested using 350 uL of plasma (i.e., neonatal setting, hard stick). When 350 uL of plasma is tested, the linear range of the assay is 50 copies/mL to 10,000,000 copies/mL. Positive results less than 50 copies/mL will be reported as: HIV RNA detected but not quantified. The calculated titer is below the lower limit of quantification (LLoQ) of the assay.


CPT code(s):  87536
Note: The billing party has sole responsibility for CPT coding.  Any questions regarding coding should be directed to the payer being billed.
The CPT codes provided by GML are based on AMA guidelines and are for informational purposes only.

Test includes: 

Quantitative HIV RNA.


Methodology: 
Real-time Reverse Transcription Polymerase Chain Reaction (RT-PCR)
Synonyms: 

HIVRNA, HIV 1 RNA Quant Viral Load, HIV Viral Load, Quantitative HIV, HIV Quant, Human immunodeficiency virus quantitative


Clinical significance: 

The HIV-1 quantitative test offers a direct measure of viral RNA in an individual's plasma. This test is intended to monitor disease progression and monitor the effects of antiretroviral therapy in HIV-1-infected individuals. This test is NOT intended for use as a screening test for the presence of HIV in blood or as a diagnostic test to confirm HIV-1 infection. This test detects HIV-1 Groups M, N and O.


Doctoral Director(s): 
Yi Ding MD, PhD
Review Date:  03/20/2025

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