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HelpTest Code HIVPCR HIV RNA, Quantitative, NAM
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.
Synonyms/Keywords
HIV 1 Quantitative NAM, Viral Load, HIV 1
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 |
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).
Interpretations
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).
Reference Range Information
| Performing Location | Reference Range |
|---|---|
| Marshfield | No HIV-1 RNA detected. |
Marshfield Labs Performing Department
Marshfield Labs Molecular Pathology
Performing 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. | |||
CPT Codes
| CPT | Modifier (if needed) |
Quantity | Description | Comments |
|---|---|---|---|---|
| 87536 |
Outreach CPT Codes
| CPT | Modifier (if needed) |
Quantity | Description | Comments |
|---|---|---|---|---|
| 87536 |
Ordering Applications
| Ordering Application | Description |
|---|---|
| Centricity | HIV RNA, Quantitative, NAM |
| Cerner | HIV RNA, Quantitative, NAM |
| COM | HIV RNA, Quantitative, NAM |