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Test ID HIS12 HIV-1/HIV-2 RNA Detection, Serum


Ordering Guidance


This test is indicated for qualitative detection and differentiation of HIV-1 and HIV-2 infection in a person with indeterminate or inconclusive HIV serologic test results or who is 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 HIVSS / HIV-1 and HIV-2 Antigen and Antibody Routine Screen, Serum; and HIVDS / HIV-1 and HIV-2 Antigen and Antibody Diagnostic Evaluation, 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° C until shipment on dry ice.



Specimen Required


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. Centrifuge blood collection tube and aliquot serum 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 serum for shipment.


Secondary ID

615816

Useful For

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

 

Diagnosis of HIV-1 and/or HIV-2 infection in individuals with acute or early HIV-1 and/or HIV-2 infection

 

Diagnosis of HIV-1 and/or HIV-2 infection in infants under 18 months of age who are born to HIV-infected mothers

Method Name

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

Reporting Name

HIV-1/HIV-2 RNA Detect, S

Specimen Type

Serum SST

Specimen Minimum Volume

0.8 mL

Specimen Stability Information

Specimen Type Temperature Time
Serum SST Frozen (preferred) 40 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 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

Undetected

Cautions

This test is not licensed by the FDA 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 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 specimen for transport to the testing laboratory may lead to falsely negative viral RNA result.

Day(s) Performed

Monday through Saturday

Report Available

1 to 3 days

Performing Laboratory

Mayo Clinic Laboratories in Rochester

Test Classification

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

87535

87538

NY State Approved

Yes