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Epic Test Code LAB782 Adenovirus DNA Detection and Quantification, Plasma

Additional Codes

MAYO CODE: ADVQU


Ordering Guidance


Request this test only in at-risk individuals, such as organ or hematopoietic stem cell transplant recipients, suspected of developing disseminated adenoviral infection.



Shipping Instructions


1. Ship specimen frozen on dry ice only.

2. If shipment will be delayed for more than 24 hours, freeze plasma at -20 to -80° C (up to 30 days) until transport and ship on dry ice.



Specimen Required


Supplies: Sarstedt Aliquot Tube, 5 mL (T914)

Collection Container/Tube: Lavender top (EDTA)

Submission Container/Tube: Plastic vial

Specimen Volume: 1.5 mL (plasma)

Collection Instructions:

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

2. Aliquot plasma into plastic vial.


Useful For

Aiding in the diagnosis of disseminated adenovirus infections in at-risk individuals

 

Measuring adenoviral load in plasma to monitor disease progression and antiviral response in individuals with disseminated infection

Method Name

Real-Time (Quantitative) Polymerase Chain Reaction (rt-qPCR)

Reporting Name

Adenovirus DNA Detect/Quant, P

Specimen Type

Plasma EDTA

Specimen Minimum Volume

0.8 mL

Specimen Stability Information

Specimen Type Temperature Time Special Container
Plasma EDTA Frozen (preferred) 30 days
  Refrigerated  6 days

Reject Due To

Gross hemolysis OK
Gross lipemia Reject
Gross icterus OK

Clinical Information

Human adenoviruses (ADV) are ubiquitous, nonenveloped, double-stranded DNA viruses capable of infecting humans. ADV are classified into 7 species (A through G), and over 100 types based on serological and genetic analysis.(1) While infections can be asymptomatic, a variety of clinical presentations can occur following infection, in part due to differences in cell tropism across ADV types.(2) The most common clinical presentations include respiratory, gastrointestinal, and ocular infections.

 

Adenovirus infections are commonly acquired in early childhood, but infections and outbreaks have been reported in adult populations as well.(3) In immunocompetent individuals, infections are typically self-limiting and do not require medical intervention. However, there is a higher risk of more severe infection, including disseminated disease, in immunocompromised patients such as solid organ and hematopoietic stem cell transplant recipients.

 

In individuals at risk for severe disease, the most common diagnostic method is detection of the ADV DNA with various molecular assays, which have been developed to detect and quantify various ADV species and types associated with human disease.(2) Additionally, plasma specimens are used for diagnostic screening in high-risk transplant patients as a marker of dissemination. However, presence of ADV in non-blood specimens is not a definitive marker of disease, as it can be shed in urine, saliva, tears, or stool of asymptomatic patients.(3,4) Therefore, serial quantitative measurement of ADV viral load in plasma of high-risk patients is recommended to guide clinical management strategies, but there is no consensus on a definitive ADV viral load thresholds to guide therapeutic intervention.(3,4) Currently, the primary use of quantitative plasma ADV DNA assays is to monitor the trend of viral load over time as a surrogate for disease progression.

Reference Values

Undetected

Interpretation

The quantification range of this assay is 30 to 10,000,000 IU/mL (1.48 log to 7.00 log IU/mL), with a limit of detection (at 95% detection rate) at 30 IU/mL.

 

An "Undetected" result indicates that ADV DNA is not detected in the plasma specimen (see Cautions). In at-risk individuals, follow-up serial weekly testing is recommended.

 

A result of "<30 IU/mL" indicates that the ADV DNA level present in the plasma specimen is below 30 IU/mL (1.48 log IU/mL), and the assay cannot accurately quantify the ADV DNA present below this level.

 

A quantitative value (reported in IU/mL and log IU/mL) indicates the ADV DNA level (ie, viral load) present in the plasma specimen.

 

A result of ">10,000,000 IU/mL" indicates that the ADV DNA level present in the plasma specimen is above 10,000,000 IU/mL (7.00 log IU/mL), and this assay cannot accurately quantify the ADV DNA present above this level.

 

An "Inconclusive" result indicates that the presence or absence of ADV DNA in the plasma specimen could not be determined with certainty after repeat testing in the laboratory, possibly due to polymerase chain reaction inhibition or presence of interfering substance. Submission of a new specimen for testing is recommended if clinically indicated.

Cautions

Adenovirus (ADV) DNA test results should be used as an aid in diagnosis and should not be considered diagnostic in themselves.

 

Although the reference range is generally considered to be "Undetected” for this assay, adenovirus DNA may be detected from asymptomatic individuals in certain settings. This assay should only be used to test at-risk patients with clinical history and symptoms consistent with disseminated adenovirus disease and is not used to screen otherwise healthy individuals.

 

Only EDTA-plasma specimens are acceptable for testing with this assay. Visibly lipemic plasma specimens are not acceptable, as ADV DNA may be undetectable or under-quantified due to possible complete or partial polymerase chain reaction inhibition.

 

Due to differences in design and analytical performance for different assays detecting and quantifying ADV DNA in human plasma specimens, serial testing for ADV load in plasma of a given patient over time should be performed using the same molecular assay.

Day(s) Performed

Tuesday, Friday

Report Available

1 to 4 days

Specimen Retention Time

30 days

Performing Laboratory

Mayo Clinic Laboratories in Rochester

CPT Code Information

87799

NY State Approved

Yes