Test ID: LADV
Adenovirus, Molecular Detection, PCR
Secondary ID 
A test code used for billing and in test definitions created prior to November 2011
NY State Approved Indicates the status of NY State approval and if the test is orderable for NY State clients.
Useful For Suggests clinical disorders or settings where the test may be helpful
As an aid in diagnosing adenovirus infections
Method Name A short description of the method used to perform the test
Real-Time Polymerase Chain Reaction (PCR)/DNA Probe Hybridization
(PCR is utilized pursuant to a license agreement with Roche Molecular Systems, Inc.)
Reporting Name A shorter/abbreviated version of the Published Name for a test; an abbreviated test name
Aliases Lists additional common names for a test, as an aid in searching
Specimen Type Describes the specimen type needed for testing
Specimen Required Defines the optimal specimen. This field describes the type of specimen required to perform the test and the preferred volume to complete testing. The volume allows automated processing, fastest throughput and, when indicated, repeat or reflex testing.
Forms: If not ordering electronically, submit a Microbiology Request Form (Supply T244) with the specimen.
Specimen source is required.
Submit only 1 of the following specimens:
Specimen Type: Body or ocular fluid
Container/Tube: Sterile container
Specimen Volume: 0.5 mL
Collection Instructions: Do not centrifuge.
Specimen Stability Information: Refrigerated (preferred)/Frozen
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 Stability Information: Refrigerated (preferred)/Frozen
Specimen Type: Spinal fluid
Container/Tube: Sterile vial
Specimen Volume: 0.5 mL
Collection Instructions: Do not centrifuge.
Specimen Stability Information: Refrigerated (preferred)/Frozen
Specimen Type: Stool
Container/Tube: Sterile container
Specimen Volume: 1 g
Specimen Stability Information: Refrigerated (preferred)/Frozen
Specimen Type: Swab
Sources: Nasal, throat, respiratory, or ocular
Container/Tube: Culture transport swab-If a culture transport swab is not available, M4 or M5 media is acceptable
Specimen Volume: Entire specimen
Collection Instructions: Place swab back into swab cylinder.
Specimen Stability Information: Refrigerated (preferred)/Frozen
Specimen Type: Tissue
Container/Tube: Sterile container with 1 to 2 mL of sterile saline or multi-microbe medium (M5) (Supply T484)
Specimen Volume: Entire collection
Collection Instructions: Collect fresh tissue specimen.
Specimen Stability Information: Refrigerated
Specimen Type: Urine
Container/Tube: Sterile container
Specimen Volume: 1 mL
Collection Instructions: Collect a random urine specimen.
Specimen Stability Information: Refrigerated (preferred)/Frozen
Specimen Minimum Volume Defines the amount of specimen required to perform an assay once, including instrument and container dead space. Submitting the minimum specimen volume makes it impossible to repeat the test or perform confirmatory or perform reflex testing. In some situations, a minimum specimen volume may result in a QNS (quantity not sufficient) result, requiring a second specimen to be collected.
Reject Due To Identifies specimen types and conditions that may cause the specimen to be rejected
| Hemolysis | NA |
| Lipemia | NA |
| Icterus | NA |
| Other | Calcium alginate-tipped swab, wood swab, or transport swab containing gel |
Specimen Stability Information Provides a description of the temperatures required to transport a specimen to the laboratory. Alternate acceptable temperature(s) are also included.
| Specimen Type | Temperature | Time |
|---|---|---|
| Varies | Varies | 7 days |
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). 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.
Not applicable
Interpretation Provides information to assist in interpretation of the test results
A positive result indicates the presence of adenoviruses.
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 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 51 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/L). 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 non-spiked specimens were negative.
Analytical Sensitivity/Limit of Detection (LoD):
The lower limit of detection of this assay is 10 targets/L in specimen matrix.
Analytical Specitificty:
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:
Inter-assay precision was 100% and intra-assay precision was 100%.
Reference Range:
The reference range is 'negative' for this assay.
Reportable Range:
This is a qualitative assay and results are reported as negative or positive for targeted Adenovirus DNA.
Clinical Reference Provides recommendations for further in-depth reading of a clinical nature
1. 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
2. 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
3. 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
4. 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
5. Thavagnanam S, Christie SN, Doherty GM, et al: Respiratory viral infection in lower airways o asymptomatic children. Acta Paediatr Mar;99(3):394-398
6. 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, swabs, stools, tissues, 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)
Day(s) and Time(s) Test Performed Outlines the days and times the test is performed. This field reflects the day and time the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time required before the test is performed. Some tests are listed as continuously performed, which means assays are performed several times during the day.
Monday, Wednesday, Friday; 6 a.m.
Analytic Time Defines the amount of time it takes the laboratory to setup and perform the test. This is defined in number of days. The shortest interval of time expressed is "same day/1 day," which means the results may be available the same day that the sample is received in the testing laboratory. One day means results are available 1 day after the sample is received in the laboratory.
Maximum Laboratory Time Defines the maximum time from specimen receipt at Mayo Medical Laboratories until the release of the test result
Specimen Retention Time Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded
Performing Laboratory Location The location of the laboratory that performs the test
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's instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR), Investigation Use Only (IUO) product, or a Research Use Only (RUO) product.
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 Medical Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.
87798
LOINC® Code Information Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the result codes returned for this test or profile.
| Result ID | Reporting Name | LOINC Code |
|---|---|---|
| SRC65 | Specimen Source | 31208-2 |
| 89074 | Result | 21055-9 |
| 29295 | Special Information | 48767-8 |
| 29296 | Report Status | N/A |
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