Test Catalog

Test Id : HIVP

HIV-1 DNA and RNA Qualitative Detection by PCR, Plasma

Useful For
Suggests clinical disorders or settings where the test may be helpful

Virologic detection of HIV-1 infection in infants younger than 2 years of age (an age group for which serologic tests are unreliable) born to HIV-1-infected mothers

 

Early detection of acute HIV-1 infection in children and adults who may be receiving combination antiretroviral prophylaxis or preemptive treatment

 

Determining eradication of HIV-1 in individuals receiving combination highly active antiretroviral therapies

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

Special Instructions
Library of PDFs including pertinent information and forms related to the test

Method Name
A short description of the method used to perform the test

Real-Time Polymerase Chain Reaction (PCR)

NY State Available
Indicates the status of NY State approval and if the test is orderable for NY State clients.

No

Reporting Name
Lists a shorter or abbreviated version of the Published Name for a test

HIV-1 DNA / RNA Qualitative, P

Aliases
Lists additional common names for a test, as an aid in searching

Acquired Immune Deficiency Syndrome (AIDS)

AIDS (Acquired Immune Deficiency Syndrome)

Human Immunodeficiency Virus

HIV

HIV DNA Detection

HIV-1 DNA Qualitative

HIV-1 Proviral DNA

HIV-1 RNA Detection

HIV-1 RNA Qualitative

HIV-1 Qualitative

HIV-1 NAT

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

Specimen Type
Describes the specimen type validated for testing

Plasma EDTA

Ordering Guidance

This assay should not be used as a screening test or primary diagnostic test for HIV-1 infection, except in infants younger than 2 years of age born to HIV-1-infected mothers. For other age groups, order HVCOP / HIV-1 and HIV-2 Antigen and Antibody Routine Screen, Plasma as the screening test.

Shipping Instructions

1. Ship plasma on ice packs if arrival at Mayo Clinic Laboratories is expected within 5 days of plasma separation.

2. If shipment will be delayed for more than 5 days, freeze plasma specimen -20 to -80 degrees C  until shipment on dry ice.

Specimen Required
Defines the optimal specimen required to perform the test and the preferred volume to complete testing

Supplies: Aliquot Tube, 5 mL (T465)

Collection Container/Tube: Lavender top (EDTA)

Submission Container/Tube: Plastic vial

Specimen Volume: 1 mL

Collection Instructions: 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).

Additional Information: This test can be used for detection and diagnosis of HIV-1 infections, including in children younger than 2 years of age when serologic tests are not useful (due to presence of maternal HIV antibodies).

Special Instructions
Library of PDFs including pertinent information and forms related to the test

Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the Testing Laboratory

0.5 mL

Reject Due To
Identifies specimen types and conditions that may cause the specimen to be rejected

Gross hemolysis OK
Gross lipemia OK

Specimen Stability Information
Provides a description of the temperatures required to transport a specimen to the performing laboratory, alternate acceptable temperatures are also included

Specimen Type Temperature Time Special Container
Plasma EDTA Frozen (preferred) 35 days
Refrigerated 5 days

Useful For
Suggests clinical disorders or settings where the test may be helpful

Virologic detection of HIV-1 infection in infants younger than 2 years of age (an age group for which serologic tests are unreliable) born to HIV-1-infected mothers

 

Early detection of acute HIV-1 infection in children and adults who may be receiving combination antiretroviral prophylaxis or preemptive treatment

 

Determining eradication of HIV-1 in individuals receiving combination highly active antiretroviral therapies

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

Clinical Information
Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test

Human immunodeficiency virus (HIV)-1 infection is usually confirmed by detection of HIV-1-specific antibodies in serum. However, serologic testing may not reliably identify HIV-1 infection in neonates with passively acquired maternal HIV-1 antibodies or with incompletely developed immune systems, individuals with early HIV-1 infection (<30 days from infection), or individuals with "indeterminate" HIV-1 antibody results by supplemental serologic assays. In these situations, detection of HIV-1 nucleic acids (RNA or proviral DNA) by PCR can provide definitive, early evidence of HIV-1 infection (approximately 10 to 14 days after infection), when results of routine diagnostic assays may be inconclusive.

 

Upon entry into human cells (including peripheral blood mononuclear cells), the HIV-1 RNA is converted into complementary DNA (cDNA) by reverse transcription. These linear cDNA strands are then integrated into the host cell genome, thus representing the proviral form of HIV-1. mRNA, transcribed from the proviral DNA, is used to synthesize the proteins required to make new viral particles. These proteins and viral RNA are packaged in the host's cytoplasm and released from the cell, completing the life cycle of the virus.

 

For infants born to HIV-1-infected mothers, HIV-1 DNA or RNA tests are recommended at 0 to 2 days, 14 days, 1 to 2 months, and 4 to 6 months after birth. Two consecutive positive HIV-1 virologic test results (HIV-1 DNA and/or RNA) are necessary for confirming the diagnosis of HIV-1 infection in infants younger than 2 years of age.

Reference Values
Describes reference intervals and additional information for interpretation of test results. May include intervals based on age and sex when appropriate. Intervals are Mayo-derived, unless otherwise designated. If an interpretive report is provided, the reference value field will state this.

Undetected

Interpretation
Provides information to assist in interpretation of the test results

A "Detected" result is consistent with HIV infection (see Cautions). Per CDC and US Public Health Services recommendations, a second specimen should be collected from any patient with first-time detectable HIV-1 DNA or RNA result and tested to verify the diagnosis of HIV-1 infection.

 

An "Undetected" result indicates that neither HIV-1 DNA nor RNA is detected in the specimen (see Cautions). Repeat testing is recommended at 0 to 2 days, 14 days, 1 to 2 months, and 4 to 6 months after birth in infants born to HIV-1 infected mothers. For at-risk individuals older than 2 years of age, repeat testing in 1 to 2 months is recommended. The lower limits of detection (based on 95% detection rate) of this assay in plasma are 311 copies/mL for HIV-1 DNA and 75 copies/mL for HIV-1 RNA.

 

An "Inconclusive" result indicates that the absence or presence of HIV-1 DNA or RNA could not be determined with certainty after repeat testing of the clinical specimens in the laboratory, possibly due to PCR inhibition. Submission of a new specimen for testing is recommended.

Cautions
Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances

This assay is optimized for the detection of HIV-1 groups M (subtypes A to H), N and O, but it may not detect all HIV-1 group N or O strains.

 

Diagnosis of HIV-1 infection should not rely solely upon a "Detected" result for HIV-1 DNA and/or RNA. Such a result should be considered in conjunction with patient's clinical presentation, physical findings, and other diagnostic laboratory tests prior to establishing the diagnosis. An "Undetected" result indicates only the absence of HIV-1 DNA and RNA in the specimen tested and does not exclude the diagnosis of HIV-1 infection. "Undetected" results should be interpreted with caution, considering the patient's risk factors for HIV-1 infection, the analytical sensitivity of the assay, and the group of the infecting HIV-1 strain. Follow-up testing is recommended for high-risk patients with initially "Undetected" test results. Individuals on prophylactic or therapeutic antiretroviral therapy may have "Undetected" results.

 

"Undetected" results together with repeatedly positive HIV-1 antibody supplemental test results may be observed in HIV-2-infected individuals. For such patients with risk factors for HIV-2 infection, specific testing for HIV-2 antibodies (serologic) and HIV-2 DNA and/or RNA is recommended.

Clinical Reference
Recommendations for in-depth reading of a clinical nature

1. Huang S, Erickson B, Mak WB, et al: A novel real-time HIV-1 qualitative assay for the detection of HIV-1 nucleic acids in dried blood spots and plasma. J Virol Meth 2011;178:216-224

2. Burgard M, Blanche S, Jasseron C, et al: Performance of HIV-1 DNA or HIV-1 RNA tests for early diagnosis of perinatal HIV-1 infection during anti-retroviral prophylaxis. J Pediatr  2012;160:60-66

3. Nelson JAE, Hawkins JT, Schanz M, et al: Comparison of the Gen-Probe Aptima HIV-1 and Abbott HIV-1 qualitative assays with the Roche Amplicor HIV-1 DNA assay for early infant diagnosis using dried blood spots. J Clin Virol 2014;60:418-421

4. HHS Panel on Treatment of HIV-Infected Pregnant Women 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. Accessed January 5, 2018. Available at https://aidsinfo.nih.gov/guidelines/html/3/perinatal/0

5. HHS Panel on Antiretroviral Therapy and Medical Management of HIV-Infected Children: Guidelines for the use of antiretroviral agents in pediatric HIV infection. Accessed January 5, 2018. Available at https://aidsinfo.nih.gov/guidelines/html/2/pediatric-arv/0

Special Instructions
Library of PDFs including pertinent information and forms related to the test

Method Description
Describes how the test is performed and provides a method-specific reference

The Abbott mSample Preparation System kit is used with the automated Abbott m2000sp sample preparation system to extract and purify viral nucleic acids from human plasma specimens, based on magnetic particle technology. An internal control (IC) is incorporated in the nucleic acid extraction and purification procedure for processing the assay controls and clinical specimens. After capture of nucleic acids on magnetic microparticles, the microparticles are washed to remove unbound sample components. Then, the bound nucleic acids are eluted from the microparticles and the eluates are transferred to a 96-well microtiter plate containing PCR master mix reagents for amplification and detection.

 

During the amplification reaction on the Abbott m2000rt system, target DNA is amplified by the DNA polymerase activity of the thermostable rTth DNA polymerase. The target RNA present is first converted to cDNA by the reverse transcriptase activity of the enzyme and subsequently amplified. Amplification of HIV-1 and IC targets takes place simultaneously in the same reaction. The target sequence for this assay is in the pol integrase region of the HIV-1 genome and it is highly conserved. The IC sequence is derived from the hydroxypyruvate reductase gene of the pumpkin plant, Cucurbita pepo, and is delivered in an Armored RNA particle that has been diluted in negative human plasma.

 

During the read cycles of amplification on the Abbott m2000rt, the temperature is lowered to allow fluorescent detection of amplification products as the HIV-1 and IC probes anneal to their respective targets (real-time fluorescent detection). The HIV-1 probe has a fluorescent moiety that is covalently linked to the 5' end. A short quencher oligonucleotide is complementary to the 5' end of the HIV-1 probe and has a quencher moiety at its 3' end. In the absence of HIV-1 target, the HIV-1 probe fluorescence is quenched through hybridization to the quencher oligonucleotide. In the presence of the HIV-1 target sequence, the HIV-1 probe preferentially hybridizes to the target sequence, dissociating from the quencher oligonucleotide, allowing fluorescent detection. The IC probe is a single stranded DNA oligonucleotide with a fluorophore at the 5' end and a quencher at the 3' end. In the absence of IC sequences, the IC probe adopts a series of random conformations, some of which bring the quencher close enough to the excited fluorophore to absorb its energy before it can be fluorescently emitted. When the IC probe binds to its complementary sequence in the target, the fluorophore and the quencher are held apart, allowing fluorescent emission and detection by the Abbott m2000rt. The HIV-1 and IC specific probes are each labeled with a different fluorophore, thus allowing for simultaneous detection of both amplified products.(Package insert: Abbott RealTime HIV-1 Qual; Abbott Molecular, Inc., Des Plaines, IL. 10/2014)

PDF Report
Indicates whether the report includes an additional document with charts, images or other enriched information

No

Day(s) Performed
Outlines the days the test is performed. This field reflects the day that the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time before the test is performed. Some tests are listed as continuously performed, which means that assays are performed multiple times during the day.

Varies

Report Available
The interval of time (receipt of sample at Mayo Clinic Laboratories to results available) taking into account standard setup days and weekends. The first day is the time that it typically takes for a result to be available. The last day is the time it might take, accounting for any necessary repeated testing.

3 to 10 days

Specimen Retention Time
Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded

2 months

Performing Laboratory Location
Indicates the location of the laboratory that performs the test

Rochester

Fees
Several factors determine the fee charged to perform a test. Contact your U.S. or International Regional Manager for information about establishing a fee schedule or to learn more about resources to optimize test selection.

  • Authorized users can sign in to Test Prices for detailed fee information.
  • Clients without access to Test Prices can contact Customer Service 24 hours a day, seven days a week.
  • Prospective clients should contact their Regional Manager. For assistance, contact Customer Service.

Test Classification
Provides information regarding the medical device classification for laboratory test kits and reagents. Tests may be classified as cleared or approved by the US Food and Drug Administration (FDA) and used per manufacturer instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR) product.

This test was developed, and its performance characteristics 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
Provides guidance in determining the appropriate Current Procedural Terminology (CPT) code(s) information for each test or profile. The listed CPT codes reflect Mayo Clinic Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.

CPT codes are provided by the performing laboratory.

87535

Test Setup Resources

Setup Files
Test setup information contains test file definition details to support order and result interfacing between Mayo Clinic Laboratories and your Laboratory Information System.

Excel | Pdf

Sample Reports
Normal and Abnormal sample reports are provided as references for report appearance.

Normal Reports | Abnormal Reports

SI Sample Reports
International System (SI) of Unit reports are provided for a limited number of tests. These reports are intended for international account use and are only available through MayoLINK accounts that have been defined to receive them.

SI Normal Reports | SI Abnormal Reports