Test Catalog

Test Id : LCADP

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Adenovirus, Molecular Detection, PCR, Plasma

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Overview

Test Catalog

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

Aiding in diagnosing adenovirus infections using plasma specimens

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, P

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

ADV (Adenovirus)

Specimen Type
Describes the specimen type validated for testing

Plasma EDTA

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

Collection Container/Tube: Lavender top (EDTA)

Submission Container/Tube: Screw-capped, sterile container

Specimen Volume: 1 mL

Collection Instructions: Spin down promptly.

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

0.3 mL

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

Gross hemolysis Reject

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
Plasma EDTA Refrigerated (preferred) 7 days
Frozen 7 days

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

Aiding in diagnosing adenovirus infections using plasma specimens

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 51 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's shell vial culture provides more rapid results, reported at 2 and 5 days. While 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 nucleic acid.

 

A negative result does not rule out the presence of adenoviruses because organisms 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 data support the use of this assay for clinical testing.

 

Accuracy/Diagnostic Sensitivity and Specificity:

A study of 791 clinical specimens compared shell vial culture and this PCR assay. Included in the study were 288 swab specimens (nasal, throat, rectal, skin), 125 eye specimens, 221 respiratory specimens (bronchial washings, sputa, bronchioalveolar lavage, tracheal secretions), 56 fresh tissue specimens, 72 stools, and 29 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 76 (stool=6; respiratory=7; tissue=3; swabs=28; eye specimens=29; urine=2; miscellaneous = 1) and total specimens by culture were 52 (stool= 8; respiratory=3; tissue=3; swabs=23; eye specimens=13; urine=2). Of the 76 total positive specimens, PCR produced a 13.5% increased rate of detection of adenovirus compared with culture. Analytical sensitivity was assessed by testing dilutions (in triplicate) of the plasmid control down to a level corresponding to 1 target/microliter. The limit of reproducible detection was determined to be 10 targets/microliter. Additionally, the sensitivity of plasma was known to be > or =90% at the concentration of 10 targets/microliter. This assay detected all 51 serotypes of adenovirus tested.

 

Supplemental Data (Spiking Studies):

To supplement the above data, 30 negative samples of various types (cerebrospinal fluid, 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 (non-spiked) specimens. 100% of the spiked specimens were positive and 100% of the nonspiked specimens were negative.

 

Analytical Sensitivity/Limit of Detection (LoD):

The lower limit of detection of this assay is 10 targets/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%.

 

Reference Range:

The reference range for this assay is "Negative."

 

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, et al: Washington, DC, ASM Press, 2007, pp 1589-1600

6. Thavagnanam S, Christie SN, Doherty GM, et al: Respiratory viral infection in lower airways of asymptomatic children. Acta Paediatr 2010 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 2008 Jun;27(5):527-530

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

Respiratory, swabs, stools, tissues, plasma, and urine samples are 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, Wednesday, 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.

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  • 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

LOINC® Information
Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the order and results codes of this test. LOINC values are provided by the performing laboratory.

Test Id Test Order Name Order LOINC Value
LCADP Adenovirus PCR, P 21055-9
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.
56088 Adenovirus PCR, P 21055-9

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