HIV 1 Proviral DNA PCR, Qualitative


Sunquest Code:HIVQL  
Epic Code:LAB6055Epic Name:HIV 1 Proviral DNA PCR Qualitative
Synonyms:Human Immunodeficiency Virus 1
Methodology:Polymerase chain reaction
CPT Code:----------CPTCODES HERE----------
Turnaround Time:Specimens are sent to reference laboratory Mon-Sat; results are reported in 2-5 days.
Compliance:

This test was developed and its performance characteristics determined by ARUP Laboratories. The U.S. Food and Drug Administration has not approved or cleared this test; however FDA clearance or approval is not currently required for clinical use. The results are not intended to be used as the sole means for clinical diagnosis or patient management decisions.



Collection Instructions

Specimen:Blood
Optimal Volume:1 mL
Minimum\Peds Volume:0.5 mL
Causes for Rejection:Frozen or heparinized specimens.


Processing and Shipping

Specimen Processing:Do not process; send 1 mL, 0.5 mL minimum whole blood.
Shipping Instructions:Ship at refrigerated temperature.
Test Performed at or Referral Lab Lab Sendouts  (ARUP)
Referral Lab number:93061


Interpretive

Reference Range:Not detected
Use:This test detects human immunodeficiency virus type 1 (HIV-1) DNA and RNA. This assay methodology is polymerase chain reaction (PCR) using the COBAS AmpliPrep/COBAS TaqMan HIV-1 Qual Test. This test is optimized to yield equivalent amplification of Group M subtypes of HIV-1. A result of "Not Detected" does not rule out HIV-1 nucleic acid concentrations below the limit of detection of the assay or the presence of PCR inhibitors in the patient specimen. Improper specimen handling can cause false negatives. PCR may not detect infection in the first months of life. The diagnosis of HIV-1 infection should be made based on clinical presentation and results from additional diagnostic tests. Diagnosis should not be made based solely on a single HIV-1 test. False positives can be caused by PCR contamination. This assay should not be used for blood donor screening, associated re-entry protocols, or for screening Human Cell, Tissues and Cellular Tissue-Based Products (HCT/P).


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