Clinics and Departments

Laboratory Services

Lab Dept:

Microbiology/Virology

Test Name:

HIV-1 DNA QUALITATIVE PCR

General Information

Lab Order Codes:

HIVD

Synonyms:

HIV-1 DNA by PCR, Qualitative

CPT Codes:

87535 – HIV-1, amplified probe technique

Test Includes:

HIV-1 reported as negative, positive or indeterminate.

Logistics

Test Indications:

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

Early detection of HIV-1 infection in children and adults prior to the appearance of HIV-1 RNA, HIV-1 p24 antigen, or HIV-1 antibodies in blood.

Determining eradication of HIV-1 in individuals receiving investigational highly active anti-retroviral therapies.

Lab Testing Sections:

Microbiology/Virology – Sendouts

Referred to:

Mayo Medical Laboratories (MML Test: 88635/PHIV)

Phone Numbers:

MIN Lab: 612-813-6280

STP Lab: 651-220-6550

Test Availability:

Daily, 24 hours

Turnaround Time:

5 days

Special Instructions:

N/A

Specimen

Specimen Type:

Whole blood

Container:

Lavender top (EDTA) tube

Draw Volume:

2 mL (Minimum: 0.6 mL) blood

Processed Volume:

Same as Draw Volume

Collection:

Routine venipuncture, invert tube several times to mix so no clots form. Send to Children’s laboratory as soon as possible for shipping to the reference lab facility.

Special Processing:

Lab Staff: Do Not centrifuge or process. Submit specimen in a screw-capped, round-bottom, plastic vial. Store and ship at frozen temperatures. Forward promptly.

Patient Preparation:

None

Sample Rejection:

Warm specimens; specimens other than EDTA whole blood; mislabeled or unlabeled specimens

Interpretive

Reference Range:

Negative

A positive result is consistent with HIV infection (See Limitations). Two serially positive HIV-1 virologic test results (HIV-1 proviral DNA or HIV-1 RNA) are necessary for the diagnosis of HIV-1 infection in infants <2 years of age.

A negative result indicates that HIV-1 DNA was not detected in the specimen (See Limitations). The lower limit of detection is 66 copies/mL (95% confidence interval).

Indeterminate results indicate that the presence or absence of HIV-1DNA could not be determined with certainty after repeat testing of clinical samples in the laboratory, possibly due to PCR inhibition. Submission of a new sample for testing is recommended.

Critical Values:

N/A

Limitations:

This assay should not be used as a screening test or primary diagnostic test for HIV-1 infection (except in infants <2 years of age born to HIV-1 infected mothers).

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

Diagnosis of HIV-1 infection should not rely solely upon the result of an HIV-1 proviral DNA assay. A positive result should be considered in conjunction with clinical presentation and additional established diagnostic tests prior to establishing a diagnosis. A negative result indicates only the absence of HIV-1 proviral DNA in the sample tested and does not exclude the diagnosis of disease. Negative results should be interpreted with caution, considering the patient’s risk factors for HIV infection, the analytical sensitivity of the assay (95% detection limit of 66 copies/mL), and genotype of the infecting HIV-1 strain. Follow-up testing is recommended for high-risk patients with initially negative results.

Methodology:

Polymerase Chain Reaction (PCR)

References:

Mayo Medical Laboratories Web Page (August 2013)

Updates:

4/21/2004: Test moved from Fairview Diagnostic Laboratories to Mayo Medical Laboratories forward to Focus Technologies, Inc.

3/18/2005: Change in MML test code, previously listed as 90345.

9/25/2006: Test brought in-house at MML on 8/15/2006. Method previously listed as Roche AMPLICOR/Polymerase Chain Reaction (PCR). Specimen volume previously listed 5 mL and sent refrigerated.



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