Test: HIV RNA Quantitation, Ultrasensitive 
  Synonym: HIV Viral Load Ultrasensitive 
  Method: Quantitative Nucleic Acid Amplification 
  Availability: Test performed at least once/week; results within 1 week 
  Specimen: Blood 
  Collection Device: 7.0 mL EDTA (Lavender) tube 
  Volume: 3.0 mL plasma minimum 
  Storage/Transport: Frozen; centrifuge and aliquot plasma to a clean tube within 6 hours of collection, labeling with patient name, date of birth and "EDTA Plasma." 
  Specimen Stability: Specimen stable frozen 
  Reference Interval: HIV-1 RNA not detected, < 50 copies/mL 
  Reportable Disease:  
  Comments: This test is intended for use in conjunction with clinical presentation and other laboratory markers as an indicator of disease prognosis. This test is also used as an aid in assessing viral response to antiretroviral treatment as measured by changes in plasma HIV-1 RNA levels. The analytic measurement range of this assay is 1.7 - 7.0 log copies (50 - 10,000,000 copies/mL). The clinical significance of changes in HIV-1 RNA measurement has not been fully established; however, a threefold (0.5 log) change in copies/mL may be significant. False positive results may occur. Care should be taken when interpreting results, especially for seronegative patients. 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). 
  Revised: 7/11/2011