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22748 HIV RNA, Quantitative, NAM

HIV RNA, Quantitative, NAM
Test Code: HIVPCR
Synonyms/Keywords
​HIV 1 Quantitative NAM, Viral Load, HIV 1
Useful For

Not useful for diagnosis of HIV-1 in adults or infants.

​This test is intended for use in conjunction with clinical presentation and other laboratory markers of disease progress for the clinical management of HIV-1 infected patients. The test can be used to assess patient prognosis by measuring the baseline HIV-1 RNA level or to monitor the effects of antiretroviral therapy by measuring changes in EDTA plasma HIV-1 RNA levels during the course of antiretroviral treatment. This test is not intended for use as a screening test for the presence of HIV-1 in blood or blood products or as a diagnostic test to confirm the presence of HIV-1 infection.  Consenting process change July 2010 - consent form is no longer required.

Specimen Requirements
Fasting Required Specimen Type Preferred Container/Tube Acceptable Container/Tube Specimen Volume Specimen Minimum Volume
(allows for 1 repeat)
Pediatric Minimum Volume
(no repeat)
No​ ​ Plasma ​EDTA Pink Top Tube (PTT) EDTA Lavender Top Tube (LTT)​ ​2.5 mL 2.5 mL​ 1.5 mL​
Collection Processing Instructions
​Centrifuge and separate plasma from whole blood within 24 hours of collection. Transfer plasma to a polypropylene tube dedicated to HIV Viral Load testing. Aliquot should not be a shared sample.
 
To ensure specimen integrity, testing will not be performed on add-on requests. Direct aliquots from primary tubes are required.
Specimen Stability Information
Specimen Type Temperature Time
Plasma​ ​Ambient ​24 hrs
​Refrigerate ​5 days
Frozen @ -20 to -80 deg. C.​ > 5 days​
Rejection Criteria
Anticoagulants other than EDTA
​Plasma not separated from Whole Blood within 24 hours of collection
​Previously opened tubes
Performing Laboratory Information
Performing Location Day(s) Test Performed Analytical Time Methodology/Instrumentation
​Marshfield Monday
6-8 hours*
Nucleic Acid Amplification (NAM)​
*Testing performed once/week.
Sample must be received in the lab by 0700 Monday to be tested same day. ​ ​ ​ ​
Test Information
The Panther HIV-1 Test is an FDA approved in-vitro nucleic acid amplification test for the quantitation of Human Immunodeficiency Virus Type 1 (HIV-1) RNA in human plasma. The test can quantitate HIV-1 RNA in human plasma over the range of 30 - 10,000,000 copies/mL. One copy of HIV-1 RNA is equivalent to 1.7 +/- 0.1 International Units (IU) based on the WHO 1st International Standard for HIV-1 RNA for Nucleic Acid-Based Techniques (NAT) (NIBSC 97/656).​
Reference Range Information
Performing Location Reference Range
​Marshfield ​No HIV-1 RNA detected.
Interpretation
​Positives are reported as 30 - 10,000,000 copies/mL.
Qualitative detection of HIVRNA below 30 copies/mL is reported as <30 copies/mL with the following interpretive comment: HIVRNA is detected but is below the lower limit of quantitation (30 copies/mL).
Outreach CPTs
CPT Modifier
(if needed)
Quantity Description Comments
​87536
Synonyms/Keywords
​HIV 1 Quantitative NAM, Viral Load, HIV 1
Ordering Applications
Ordering Application Description
​Centricity HIV RNA, Quantitative, NAM
​Cerner HIV RNA, Quantitative, NAM
​COM HIV RNA, Quantitative, NAM
If the ordering application you are looking for is not listed, contact your local laboratory for assistance.
Specimen Requirements
Fasting Required Specimen Type Preferred Container/Tube Acceptable Container/Tube Specimen Volume Specimen Minimum Volume
(allows for 1 repeat)
Pediatric Minimum Volume
(no repeat)
No​ ​ Plasma ​EDTA Pink Top Tube (PTT) EDTA Lavender Top Tube (LTT)​ ​2.5 mL 2.5 mL​ 1.5 mL​
Collection Processing
​Centrifuge and separate plasma from whole blood within 24 hours of collection. Transfer plasma to a polypropylene tube dedicated to HIV Viral Load testing. Aliquot should not be a shared sample.
 
To ensure specimen integrity, testing will not be performed on add-on requests. Direct aliquots from primary tubes are required.
Specimen Stability Information
Specimen Type Temperature Time
Plasma​ ​Ambient ​24 hrs
​Refrigerate ​5 days
Frozen @ -20 to -80 deg. C.​ > 5 days​
Rejection Criteria
Anticoagulants other than EDTA
​Plasma not separated from Whole Blood within 24 hours of collection
​Previously opened tubes
Useful For

Not useful for diagnosis of HIV-1 in adults or infants.

​This test is intended for use in conjunction with clinical presentation and other laboratory markers of disease progress for the clinical management of HIV-1 infected patients. The test can be used to assess patient prognosis by measuring the baseline HIV-1 RNA level or to monitor the effects of antiretroviral therapy by measuring changes in EDTA plasma HIV-1 RNA levels during the course of antiretroviral treatment. This test is not intended for use as a screening test for the presence of HIV-1 in blood or blood products or as a diagnostic test to confirm the presence of HIV-1 infection.  Consenting process change July 2010 - consent form is no longer required.

Reference Range Information
Performing Location Reference Range
​Marshfield ​No HIV-1 RNA detected.
Interpretation
​Positives are reported as 30 - 10,000,000 copies/mL.
Qualitative detection of HIVRNA below 30 copies/mL is reported as <30 copies/mL with the following interpretive comment: HIVRNA is detected but is below the lower limit of quantitation (30 copies/mL).
For more information visit:
Performing Laboratory Information
Performing Location Day(s) Test Performed Analytical Time Methodology/Instrumentation
​Marshfield Monday
6-8 hours*
Nucleic Acid Amplification (NAM)​
*Testing performed once/week.
Sample must be received in the lab by 0700 Monday to be tested same day. ​ ​ ​ ​
For billing questions, see Contacts
Outreach CPTs
CPT Modifier
(if needed)
Quantity Description Comments
​87536
For most current information refer to the Marshfield Laboratory online reference manual.