Test Catalog

Test Id : HPS12

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HIV-1/HIV-2 RNA Detection Prenatal, Serum

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Overview

Test Catalog

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

Diagnosis of HIV-1 and/or HIV-2 infection in pregnant individuals with indeterminate or inconclusive HIV serologic test results

 

Diagnosis of HIV-1 and/or HIV-2 infection in pregnant individuals in the acute or early phase of HIV-1 and/or HIV-2 infection

Highlights

This test is to be used for qualitative detection and differentiation of HIV-1 and HIV-2 infection in a pregnant individual with indeterminate or inconclusive HIV serologic test results or who are suspected to be in the acute / early HIV infection stage (ie, "window period").

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

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

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

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

Yes

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

HIV-1/HIV-2 RNA Detect Prenatal, S

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

Acquired Immune Deficiency Syndrome (AIDS)

AIDS (Acquired Immune Deficiency Syndrome)

HIV (Human Immunodeficiency Virus)

HIV Prenatal

HIV-1 Detection

HIV-1 PCR

HIV-1 RNA

HIV-2 Detection

HIV-2 PCR

HIV-2 RNA

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

Serum SST

Ordering Guidance

This test is indicated for qualitative detection and differentiation of HIV-1 and HIV-2 infection in pregnant individuals with indeterminate or inconclusive HIV serologic test results or who are suspected to be in the acute / early HIV infection stage (ie, "window period"). If serologic testing has not yet been performed on the patient, order either HVPRS / HIV Antigen and Antibody Prenatal Routine Screen, Serum or HVPPS / HIV-1 and HIV-2 Antibody Confirmation and Differentiation Prenatal, Serum, where this test will automatically be added on depending on the results of the serologic test.

Shipping Instructions

1. Ship specimen frozen on dry ice.

2. If shipment will be delayed for more than 24 hours, freeze serum specimen at -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: Sarstedt Aliquot Tube, 5 mL (T914)

Collection Container/Tube: Serum gel

Submission Container/Tube: Plastic vial

Specimen Volume: 1.5 mL

Collection Instructions:

1. Within 2 hours of collection, centrifuge and aliquot serum into plastic vial.  .

2. Freeze aliquoted serum for shipment.

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

Forms

If not ordering electronically, complete, print, and send a Microbiology Test Request (T244) with the specimen.

Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the testing laboratory. The minimum volume is sufficient for one attempt at testing.

0.8 mL

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

Gross hemolysis Reject
Gross lipemia Reject
Gross icterus 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
Serum SST Frozen (preferred) 40 days
Refrigerated 6 days

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

Diagnosis of HIV-1 and/or HIV-2 infection in pregnant individuals with indeterminate or inconclusive HIV serologic test results

 

Diagnosis of HIV-1 and/or HIV-2 infection in pregnant individuals in the acute or early phase of HIV-1 and/or HIV-2 infection

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

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 or AIDS-related complex, and from 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 overall genomic structure and ability to cause AIDS, but viral load tends to lower in HIV-2 than HIV-1 infection.

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 indicates that the presence of RNA of the specific virus in the plasma specimen tested, consistent with the presence of this viral infection. For example, a "Detected" result for HIV-1 RNA by this assay is indicative of HIV-1 infection in the tested individual. A follow-up plasma specimen should be collected from this individual to both verify the diagnosis and quantify the HIV RNA prior to initiation of antiviral therapy.

 

An "Undetected" result indicates that the assay was unable to detect RNA of the specific virus in the plasma specimen tested.

 

An "Inconclusive" result indicates that the presence or absence of viral RNA could not be determined with certainty after repeat testing in the laboratory, possibly due to presence of inhibitory substances in the plasma specimen tested. Collection of a new plasma 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 test is not licensed by the US Food and Drug Administration as a screening test for HIV-1 infection in donors of blood, human cells, tissues, or tissue products.

 

A single "Undetected" result may not rule out the presence of HIV infection, if the plasma specimen is collected and tested too early after exposure (ie, less than 10 days from exposure) or if patient is infected with a rare HIV variant. Improper storage or processing (ie, incorrect temperature) of the plasma specimen for transport to the testing laboratory may lead to falsely negative viral RNA result.

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

1. Centers for Disease Control and Prevention. 2018 Quick reference guide: Recommended laboratory HIV testing algorithm for serum or plasma specimens. CDC; January 2018. Accessed July 22, 2024. Available at https://stacks.cdc.gov/view/cdc/50872

2. Branson BM, Owen SM, Wesolowski LG, et al. Laboratory testing for the diagnosis of HIV infection: Updated recommendations. Centers for Disease Control and Prevention; June 27, 2014. Accessed July 22, 2024. Available at https://stacks.cdc.gov/view/cdc/23447

3. Duncan D, Duncan J, Kramer B, et al. An HIV diagnostic testing algorithm using the cobas HIV-1/HIV-2 Qualitative Assay for HIV type differentiation and confirmation. J Clin Microbiol. 2021;59(7):e03030-20. doi:10.1128/JCM.03030-20

4. U.S. Department of Health and Human Services, Panel on Treatment of HIV During Pregnancy and Prevention of Perinatal Transmission: Recommendations for the use of antiretroviral drugs during pregnancy and interventions to reduce perinatal HIV transmission in the United States. HHS; January 31, 2024. Accessed July 22, 2024. Available at https://clinicalinfo.hiv.gov/en/guidelines/perinatal/whats-new

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

This test is a US Food and Drug Administration approved, real-time polymerase chain reaction (PCR) assay performed on the cobas 5800/6800/8800 Systems for fully automated sample preparation (including extraction and purification of viral nucleic acid), amplification, detection, and differentiation of HIV-1 and HIV-2 RNA. It utilizes a multi-target approach to amplify 2 highly conserved gag and long terminal repeat (LTR) regions of the HIV-1 genome and the LTR region of the HIV-2 genome for detection by target sequence-specific TaqMan probes. A non-HIV, RNA internal control is introduced into each specimen during sample preparation to assess substantial failures during the sample preparation and PCR amplification processes, while HIV-1 and HIV-2 positive controls and a negative control are used as assay run controls. The assay generates individual results for the presence or absence of HIV-1 RNA and HIV-2 RNA.(Package insert:  HIV-1/HIV-2 Qualitative - nucleic acid test for use on the cobas 5800/6800/8800 Systems, Roche Molecular Systems, Inc; Doc rev. 5.0, 05/2023)

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.

Monday through Saturday

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.

1 to 3 days

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

30 days

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 account representative. 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 has been cleared, approved, or is exempt by the US Food and Drug Administration and is used per manufacturer's instructions. Performance characteristics were verified by Mayo Clinic in a manner consistent with CLIA requirements.

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

87538

LOINC® Information
Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the order and results codes of this test. LOINC values are provided by the performing laboratory.

Test Id Test Order Name Order LOINC Value
HPS12 HIV-1/HIV-2 RNA Detect Prenatal, S 96557-4
Result Id Test Result Name Result LOINC Value
Applies only to results expressed in units of measure originally reported by the performing laboratory. These values do not apply to results that are converted to other units of measure.
616346 HIV-1 RNA 25835-0
616347 HIV-2 RNA 69353-1

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

Test Update Resources

Change Type Effective Date
New Test 2023-05-09