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HelpEpic Test Code LAB782 Adenovirus, Molecular Detection, PCR, Plasma
Additional Codes
MML:LCADP
Reporting Name
Adenovirus PCR, PUseful For
Aiding in diagnosing adenovirus infections using plasma specimens
Performing Laboratory
Mayo Clinic Laboratories in Rochester
Specimen Type
Plasma EDTASpecimen Required
Collection Container/Tube: Lavender top (EDTA)
Submission Container/Tube: Screw-capped, sterile container
Specimen Volume: 1 mL
Collection Instructions: Centrifuge and aliquot plasma into a sterile, plastic vial.
Specimen Minimum Volume
0.3 mL
Specimen Stability Information
| Specimen Type | Temperature | Time | Special Container |
|---|---|---|---|
| Plasma EDTA | Refrigerated (preferred) | 7 days | |
| Frozen | 7 days |
Reference Values
Negative
Day(s) Performed
Monday, Wednesday, Friday
CPT Code Information
87798
Clinical Information
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 over 50 adenovirus serotypes that have been grouped into 6 separate subgenera.
Although adenovirus can be recovered in cell culture, it can take up to 3 weeks for the virus to be identified by culture methods (Mayo's shell vial culture provides more rapid results, reported at 2 and 5 days). Polymerase chain reaction assays offer a rapid, specific, and sensitive means of diagnosis by detecting adenovirus DNA.
Interpretation
A positive result indicates the presence of adenovirus nucleic acid in the clinical specimen.
A negative result does not rule out the presence of adenoviruses because viral DNA may be present at levels below the detection limits of this assay.
Cautions
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 polymerase chain reaction (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, 5 urines, and 24 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 (LC) assay. Comparison of cell culture with LC PCR yielded the following: total specimens positive by LC PCR was 83 (stool=7; respiratory=8; tissue=3; swabs=29; eye specimens=30; miscellaneous= 1 and urine=4) and total specimens positive by culture were 76 (stool=6; respiratory=7; tissue=3; respiratory swabs=28; eye specimens=29; and urine=2, miscellaneous = 1). Of the 83 total positive specimens, PCR detected approximately 10% more adenovirus infections compared with culture. This assay detected all 57 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. One hundred percent of the spiked specimens were positive, and 100% of the non-spiked specimens were negative.
Analytical Sensitivity/Limit of Detection:
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.
Report Available
2 to 5 daysSpecimen Retention Time
1 weekReject Due To
| Gross hemolysis | Reject |
NY State Approved
YesMethod Name
Real-Time Polymerase Chain Reaction (PCR)/DNA Probe Hybridization
Forms
If not ordering electronically, complete, print, and send a Microbiology Test Request (T244) with the specimen.