Test Catalog

Test Id : LADV

Adenovirus, Molecular Detection, PCR, Varies

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

Aiding in the diagnosis of adenovirus infections

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

Real-Time Polymerase Chain Reaction (PCR)/DNA Probe Hybridization

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 PCR

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

ADV (Adenovirus)

Specimen Type
Describes the specimen type validated for testing

Varies

Necessary Information

Specimen source is required.

Specimen Required
Defines the optimal specimen required to perform the test and the preferred volume to complete testing

Submit only 1 of the following specimens:

 

Specimen Type: Body fluid

Sources: Pleural, peritoneal, ascites, pericardial, or amniotic

Container/Tube: Sterile container

Specimen Volume: 0.5 mL

Collection Instructions: Do not centrifuge.

 

Specimen Type: Respiratory

Sources: Bronchial washing, bronchoalveolar lavage, nasopharyngeal aspirate or washing, sputum, or tracheal aspirate

Container/Tube: Sterile container

Specimen Volume: 1 mL

 

Specimen Type: Spinal fluid

Container/Tube: Sterile vial

Specimen Volume: 0.5 mL

Collection Instructions: Do not centrifuge.

 

Specimen Type: Stool

Supplies: Stool Collection Kit, Random (T635)

Container/Tube: Sterile container

Specimen Volume: 1 g

 

Specimen Type: Swab

Supplies:

-M4-RT (T605)

-Bartels FlexTrans VTM-3 mL (T892)

-Jiangsu VTM-3 mL (T891)

Sources: Nasal, throat, respiratory, genital, or ocular

Container/Tube: Multimicrobe media (M4-RT) and Eswabs

Specimen Volume: Entire specimen

Collection Instructions: Place swab back into a multimicrobe media (M4-RT, M4, or M5).

 

Specimen Type: Tissue

Supplies:

-M4-RT (T605)

-Bartels FlexTrans VTM-3 mL (T892)

-Jiangsu VTM-3 mL (T891)

Container/Tube: Sterile container containing 1 mL to 2 mL of sterile saline or multimicrobe medium (M4-RT, M4, or M5)

Specimen Volume: Entire collection

Collection Instructions: Collect fresh tissue specimen.

 

Specimen Type: Urine

Container/Tube: Sterile container

Specimen Volume: 1 mL

Collection Instructions: Collect a random urine specimen.

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

Body Fluid, Respiratory Specimen, Spinal Fluid, or Urine: 0.3 mL

Stool: 0.5 g

Swab or Tissue: NA

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

Other Calcium alginate-tipped swab Wood swab Transport swab containing gel

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
Varies Refrigerated (preferred) 7 days
Frozen 7 days

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

Aiding in the diagnosis of adenovirus infections

Clinical Information
Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test

Human adenoviruses cause a variety of diseases including pneumonia, cystitis, conjunctivitis, diarrhea, hepatitis, myocarditis, and encephalitis. In humans, adenoviruses have been recovered from almost every organ system. Infections can occur at any time of the year and in all age groups. Currently, there are 57 adenovirus serotypes that have been grouped into 6 separate subgenera.

 

Culture is the gold standard for the diagnosis for adenovirus infection. However, it can take up to 3 weeks to achieve culture results (Mayo Clinic's shell vial culture provides more rapid results, reported at 2 and 5 days). Serological tests have faster turnaround times, but can be less sensitive compared to culture. PCR offers a rapid, specific, and sensitive means of diagnosis by detecting adenovirus DNA.

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.

Negative

Interpretation
Provides information to assist in interpretation of the test results

A positive result indicates the presence of adenovirus DNA in the clinical sample.

 

A negative result does not rule out the presence of adenovirus because viral DNA may be present at levels below the detection limits of this assay.

Cautions
Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances

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 "Negative" for this assay, adenovirus DNA may be detected from asymptomatic individuals in certain settings. This assay should only be used to test patients with clinical history and symptoms consistent with adenovirus disease, and is not used to screen healthy patients.   

Supportive Data

The following support the use of this assay for clinical testing.

 

Accuracy/Diagnostic Sensitivity and Specificity:

A study of 715 clinical specimens compared shell vial culture and this PCR assay. Included in the study were 286 swab specimens (nasal, throat, rectal, skin), 49 eye specimens, 221 respiratory specimens (bronchial washings, sputa, bronchioalveolar lavage, tracheal secretions), 55 fresh tissue specimens, 72 stools, and 27 body fluids/other specimens. Specimens were inoculated into culture tubes and examined for cytopathic effects over a period of 14 days, and subsequently assayed with this LightCycler assay. Comparison of cell culture with LC PCR yielded the following: total specimens positive by LC PCR was 60 (stool=9; respiratory=4; tissue=4; swabs=24; eye specimens=14; and urine=4) and total specimens by culture were 52 (stool=8; respiratory=3; tissue=3; swabs=23; eye specimens=13; and urine=2). Of the 60 total positive specimens, PCR produced a 13.5% increased rate of detection of adenovirus compared with culture. This assay detected all 57  serotypes of adenovirus tested.

 

Supplemental Data (Spiking Studies):

To supplement the above data, 30 negative specimens of various types (CSF, ocular, respiratory, stool, urine, and plasma) were spiked with adenovirus positive control plasmid at the limit of detection (approximately 10 targets/microliter). The 30 spiked specimens were run in a blinded manner with 30 negative (nonspiked) specimens. One hundred percent of the spiked specimens were positive and 100% of the nonspiked specimens were negative.

 

Analytical Sensitivity/Limit of Detection (LoD):

The LoD of this assay is 10 targets per microliter in specimen matrix.

 

Analytical Specificity:

No PCR signal was obtained from extracts of 150 bacterial, viral, parasitic, and fungal isolates that could cause similar disease or could be found as normal flora in sites normally tested for this organism.

 

Precision:

Interassay precision was 100% and intra-assay precision was 100%.

 

Reportable Range:

This is a qualitative assay and results are reported as negative or positive for targeted adenovirus DNA.

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

1. Buckwalter SP, Teo R, Espy MJ, et al: Real-time qualitative PCR for 57 human adenovirus types from multiple specimen sources. J Clin Microbiol2011;50(3):766-771 doi:10.1128/jcm.05629-11

2. Ebner K, Pinsker W, Lion T: Comparative sequence analysis of the hexon gene in the entire spectrum of human adenovirus serotypes: phylogenetic, taxonomic, and clinical implications. J Virol 2005;79:12635-12642

3. Ebner K, Suda M, Watzinger F, Lion T: Molecular detection and quantitative analysis of the entire spectrum of human adenoviruses by a two-reaction real-time PCR assay. J Clin Microbiol 2005;43:3049-3053

4. Jothikumar N, Cromeans TL, Hill VR, et al: Quantitative real-time PCR assays for the detection of human adenoviruses and identification of serotypes 40 and 41. Appl Environ Microbiol 2005;71:3131-3136

5 . Robinson C, Echavarria M: Adenovirus. In Manual of Clinical Microbiology. Edited by PR Murray, EJ Baron, JH Jorgensen, et al: Ninth edition. Washington, DC, ASM Press, 2007, pp 1589-1600

6. Thavagnanam S, Christie SN, Doherty GM, et al: Respiratory viral infection in lower airways o asymptomatic children. Acta Paediatr Mar;99(3):394-398

7. Kaneko H, Maruko I, Iida T, et al: The possibility of human adenovirus detection in the conjunctiva in asymptomatic cases during a nosocomial infection. Cornea Jun 2008;27(5):527-530

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

Respiratory, swab, stool, tissue, and urine samples were processed according to specimen source. Viral nucleic acid is extracted by the MagNA Pure automated instrument (Roche Applied Science). Primers and fluorescence resonance energy transfer (FRET) probes target a relatively conserved 185-base pair region of the adenovirus penton gene. The LightCycler instrument (Roche Applied Science) amplifies and monitors the development of target nucleic acid sequences after the annealing step during PCR cycling. This automated PCR system rapidly detects amplicon development through stringent air-controlled temperature cycling in capillary cuvettes. The detection of amplified products is based on the FRET principle. For FRET product detection, a hybridization probe with a donor fluorophore, fluorescein, on the 3'-end is excited by an external light source and emits light that is absorbed by a second hybridization probe with an acceptor fluorophore, LC-Red 640, at the 5'-end. The acceptor fluorophore then emits a light of a different wavelength that can be measured with a signal that is proportional to the amount of specific PCR product.(Unpublished Mayo method)

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 Friday

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.

2 to 5 days

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

1 week

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 Regional Manager. 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. This test has not been cleared or approved by the US Food and Drug Administration.

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.

87798

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