Human Immunodeficiency Virus 1 (HIV-1) by Qualitative PCR
0093061
Ordering Recommendation
 
Mnemonic
HIV DNA
Methodology
Qualitative Polymerase Chain Reaction
Performed
Tue-Sat
Reported
2-5 days  
New York DOH Approval Status
This test is New York DOH approved.
Submit With Order
Specimen Required
Patient Preparation
  
Collect
Lavender (EDTA) or pink (K2EDTA).  
Specimen Preparation
Do not freeze specimen. Transport 1 mL whole blood. (Min: 0.5 mL)  
Storage/Transport Temperature
Refrigerated.  
Unacceptable Conditions
Heparinized specimens. Frozen specimens.  
Remarks
  
Stability
Ambient: 12 hours; Refrigerated: 5 days; Frozen: Unacceptable  
Reference Interval
Not detected  
Interpretive Data
This test detects human immunodeficiency virus type 1 (HIV-1) DNA and RNA. The 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).


See Compliance Statement D: www.aruplab.com/CS
Statement D: 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.
 
Note
 
CPT Code(s)
87535
Components
Component Test Code*Component Chart NameLOINC
0093062HIV-1 PCR, Qualitative44871-2
* Component test codes cannot be used to order tests. The information provided here is not sufficient for interface builds; for a complete test mix, please click the sidebar link to access the Interface Map.
Aliases
  • HIV 1 DNA and RNA
  • HIV Qualitative
  • HIV-1 DNA
  • HIV-1 proviral DNA
  • HIV1 detection
  • Nucleic Acid Amplification Test (NAAT)