Useful For
Suggests clinical disorders or settings where the test may be helpful
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
Highlights
This assay detects and quantifies the adenoviral (ADV) DNA present in the plasma of at-risk individuals, such as organ or hematopoietic stem cell transplant recipients, for developing disseminated ADV infection. The assay is calibrated to the First World Health Organization International Standard for human ADV for nucleic acid amplification techniques (NIBSC code: 16/234; adenovirus species C, type 2), and results are reported in IU/mL.
Method Name
A short description of the method used to perform the test
Real-Time (Quantitative) Polymerase Chain Reaction (rt-qPCR)
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
Adenovirus DNA Detect/Quant, P
Aliases
Lists additional common names for a test, as an aid in searching
ADV
Adenovirus
Disseminated ADV
Disseminated adenovirus
Specimen Type
Describes the specimen type validated for testing
Plasma EDTA
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 degrees C (up to 30 days) until transport and ship 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: 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.
Forms
If not ordering electronically, complete, print, and send an 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 OK
Thawing Cold OK if <7 days; Warm reject
Gross lipemia Reject
Gross icterus OK
| Specimen Type |
Temperature |
Time |
Special Container |
|
Plasma EDTA |
Refrigerated |
6 days |
|
|
|
Frozen (preferred) |
30 days |
|
Useful For
Suggests clinical disorders or settings where the test may be helpful
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
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
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
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
Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances
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.
Clinical Reference
Recommendations for in-depth reading of a clinical nature
1. Lion T. Adenovirus infections in immunocompetent and immunocompromised patients. Clin Microbiol Rev. 2014;27(3):441-462. doi:10.1128/cmr.00116-13
2. Hiwarkar P, Kosulin K, Cesaro S, et al. Management of adenovirus infection in patients after haematopoietic stem cell transplantation: state-of-the-art and real-life current approach. Rev Med Virol. 2018;28(3):e1980. doi:10.1002/rmv.1980
3. Florescu DF, Schaenman JM. AST Infectious Diseases Community of Practice. Adenovirus in solid organ transplant recipients: guidelines from the American Society of Transplantation Infectious Diseases Community of Practice. Clin Transplant. 2019;33(9):e13527. doi:10.1111/ctr.13527
4. Shirley JD, Yao JD. Laboratory diagnosis of adenoviral infections in transplant recipients. Clin Microbiol News. 2023;45(22):189-199. doi:10.1016/j.clinmicnews.2024.01.003
Method Description
Describes how the test is performed and provides a method-specific reference
This laboratory-developed, real-time, polymerase chain reaction (PCR) assay is performed on the cobas 5800 system. It amplifies and detects a 53-base pair (bp) sequence (77-bp long when including the 5' flap on the PCR primers) within the adenoviral hexon protein-encoding gene and uses an MGB-TaqMan hydrolysis probe labeled with FAM fluorophore (emission wavelength of 521 nm) for real-time detection of the amplified adenoviral sequences. The cobas 5800 assay-specific Utility Channel Analysis Package program analyzes the amplified target fluorescence signal to determine positivity and adenovirus DNA concentrations in individual PCR. The assay is calibrated to the First World Health Organization International Standard for human adenovirus for nucleic acid amplification techniques (NIBSC code: 16/234; adenovirus species C, type 2), and results are reported in IU/mL.(Package insert: cobas omni Utility Channel Reagent Kit for use on the cobas 5800/6800/8800 Systems. Roche Molecular Systems, Inc.; Doc. Rev. 3.0; 11/2022)
PDF Report
Indicates whether the report includes an additional document with charts, images or other enriched information
No
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.
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
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 was developed and its performance characteristics determined by Mayo Clinic in a manner consistent with CLIA requirements. It has not been cleared or approved by the US Food and Drug Administration.
87799
| Test Id |
Test Order Name |
Order LOINC Value
|
| ADVQU |
Adenovirus DNA Detect/Quant, P |
106727-1 |
| 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.
|
| 622150 |
Adenovirus DNA Detect/Quant, P |
106727-1 |