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Test ID HIQNP HIV-1 RNA Detection and Quantification, Prenatal, Plasma


Ordering Guidance


For detection and quantification of HIV-1 RNA in plasma before and during antiretroviral therapy in pregnant individuals only. For nonpregnant individuals, order HIVQN / HIV-1 RNA Detection and Quantification, Plasma.



Shipping Instructions


1. Ship specimen frozen on dry ice.

2. If shipment will be delayed for >24 hours, freeze plasma specimen at -20 to -80° C until shipment on dry ice.



Specimen Required


Supplies: Aliquot Tube, 5 mL (T465)

Collection Container/Tube: Lavender top (EDTA)

Submission Container/Tube: Plastic vial

Specimen Volume: 1.5 mL

Collection Instructions:

1. Centrifuge blood collection tube and aliquot plasma into plastic vial per collection tube manufacturer's instructions(eg, centrifuge and aliquot within 2 hours of collection for BD Vacutainer tubes).

2. Freeze aliquoted plasma for shipment.


Useful For

Diagnosis of HIV-1 infection in pregnant individuals with acute or early HIV-1 infection

 

Quantifying plasma HIV-1 RNA levels (viral load) in pregnant individuals living with HIV-1:

-Before initiating anti-HIV-1 drug therapy (baseline viral load)

-Who may have developed HIV-1 drug resistance while on anti-HIV-1 therapy

-Who may be noncompliant with anti-HIV-1 drug therapy

 

Monitoring HIV-1 disease progression before or during antiretroviral drug therapy in pregnant individuals

Method Name

Real-Time Reverse Transcription-Polymerase Chain Reaction (RT-PCR)

Reporting Name

HIV-1 RNA Detect/Quant Prenatal, P

Specimen Type

Plasma EDTA

Specimen Minimum Volume

0.8 mL

Specimen Stability Information

Specimen Type Temperature Time Special Container
Plasma EDTA Frozen (preferred) 84 days
  Refrigerated  6 days

Clinical Information

Currently, 2 types of HIV, HIV type 1 (HIV-1) and HIV type 2 (HIV-2), are known to infect humans. HIV-1 has been isolated from patients with AIDS, AIDS-related complex, and asymptomatic infected individuals at high-risk for AIDS. Accounting for more than 99% of HIV infection in the world, HIV-1 is transmitted by sexual contact, by exposure to infected blood or blood products, from an infected pregnant woman to fetus in utero or during birth, or from an infected mother to infant via breast-feeding. HIV-2 has been isolated from infected patients in West Africa and it appears to be endemic only in that region. However, HIV-2 also has been identified in individuals who have lived in West Africa or had sexual relations with individuals from that geographic region. HIV-2 is similar to HIV-1 in its morphology, overall genomic structure, and ability to cause AIDS.

 

Multiple clinical studies of plasma HIV-1 viral load (expressed as HIV-1 RNA copies/mL of plasma) have shown a clear relationship of HIV-1 RNA copy number to stage of HIV-1 disease and efficacy of anti-HIV-1 therapy. Quantitative HIV-1 RNA level in plasma (ie, HIV-1 viral load) is an important surrogate marker in assessing the risk of disease progression and monitoring response to anti-HIV-1 drug therapy in the routine medical care of HIV-1-infected patients.

Reference Values

Undetected

Interpretation

This assay has a plasma HIV-1 RNA quantification result range of 20 to 10,000,000 copies/mL (1.30-7.00 log copies/mL).

 

An "Undetected" result indicates that the assay was unable to detect HIV-1 RNA in the plasma specimen tested.

 

A result of "<20 copies/mL" indicates that HIV-1 RNA is detected, but the level present is less than the lower quantification limit of this assay. Due to the increased sensitivity of this assay, patients with previously low or undetectable HIV-1 viral load may show increased or detectable viral load with this assay. However, the clinical implications of a viral load less than 20 copies/mL remain unclear. Possible causes of such a result include very low plasma HIV-1 viral load present (eg, in the range of 1-19 copies/mL), very early HIV-1 infection (ie, <3 weeks from time of infection), or absence of HIV-1 infection (ie, false-positive).

 

A result of ">10,000,000 copies/mL" with the result comment of "HIV-1 RNA level is >10,000,000 copies/mL (>7.00 log copies/mL). This assay cannot accurately quantify HIV-1 RNA above this level" indicates that HIV-1 RNA is detected, but the level present is above the upper quantification limit of this assay.

 

For the purpose of monitoring patient's response to antiretroviral therapy, the United States Department of Health and Human Services Panel on Antiretroviral Guidelines for Adults and Adolescents defines virologic failure as a confirmed viral load of above 200 copies/mL, which eliminates most cases of viremia resulting from isolated blips or assay variability. Confirmed viral load rebound (ie, >200 copies/mL) on 2 separate tests obtained at least 2 to 4 weeks apart should prompt a careful evaluation of patient's tolerance of current drug therapy, drug-drug interactions, and patient adherence.

Clinical Reference

1. Centers for Disease Control and Prevention and Association of Public Health Laboratories. Laboratory testing for the diagnosis of HIV infection: Updated recommendations. June 27, 2014. Available at http://stacks.cdc.gov/view/cdc/23447

2. Gunthard HF, Saag MS, Benson CA, et al: Antiretroviral drugs for treatment and prevention of HIV infection in adults: 2016 recommendations of the International Antiviral Society-USA Panel. JAMA. 2016 Jul 12;316(2):191-210

3. Panel on Treatment of Pregnant Women with HIV Infection and Prevention of Perinatal Transmission: Recommendations for the Use of Antiretroviral Drugs in Pregnant Women with HIV Infection and Interventions to Reduce Perinatal HIV Transmission in the United States. US Department of Health and Human Services. October 26, 2016. Updated February 10, 2021. Accessed May 13, 2021. Available at https://clinicalinfo.hiv.gov/en/guidelines/perinatal/whats-new-guidelines

Day(s) Performed

Monday through Saturday

Report Available

1 to 3 days

Test Classification

This test has been modified from the manufacturer's instructions. Its performance characteristics were determined by Mayo Clinic in a manner consistent with CLIA requirements. This test has not been cleared or approved by the US Food and Drug Administration.

CPT Code Information

87536

LOINC Code Information

Test ID Test Order Name Order LOINC Value
HIQNP HIV-1 RNA Detect/Quant Prenatal, P 70241-5

 

Result ID Test Result Name Result LOINC Value
65567 HIV-1 RNA Detect/Quant Prenatal, P 70241-5