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HelpEpic Test Code LAB101011 Enterovirus, Molecular Detection, PCR, Varies
Additional Codes
MML:LENT
Reporting Name
Enterovirus PCRUseful For
Aiding in diagnosing enterovirus infections
This test should not be used to screen asymptomatic patients.
Performing Laboratory
Mayo Clinic Laboratories in Rochester
Specimen Type
VariesOrdering Guidance
This test will detect enterovirus but will not differentiate viruses in this family or provide serotyping information.
Necessary Information
1. Specimen source is required.
2. Source information should include main anatomical site of collection.
Specimen Required
Submit a raw clinical sample (not a culture isolate) for enterovirus testing.
Submit only 1 of the following specimens:
Specimen Type: Body fluid
Sources: Pericardial, peritoneal
Container/Tube: Sterile container
Specimen Volume: 0.5 mL
Collection Instructions: Do not centrifuge.
Specimen Type: Spinal fluid
Container/Tube: Sterile vial
Specimen Volume: 0.5 mL
Collection Instructions:
1. Submit specimen from collection vial 2.
2. Do not centrifuge.
Specimen Type: Swab
Supplies: Culturette (BBL Culture Swab) (T092)
Sources: Dermal, eye, rectal, genital, nasopharyngeal, oropharyngeal, throat, nasal, or urethral
Container/Tube: Multimicrobe media (M4-RT) or similar viral transport media (M4 or M5) and Eswab
Specimen Volume: Entire specimen
Collection Instructions:
1. Rectal swab must have no visible fecal matter
2. Place swab back into multimicrobe media (M4-RT, M4, or M5)
Specimen Type: Respiratory
Sources: Bronchial washing, bronchoalveolar lavage, nasopharyngeal aspirate or washing, pleural fluid, sputum, or tracheal aspirate
Container/Tube: Sterile container
Specimen Volume: 1.5 mL
Collection Instructions: Do not centrifuge.
Specimen Minimum Volume
Body and Respiratory fluids: 0.5 mL; Spinal fluid: 0.3 mL; Swab: See Specimen Required
Specimen Stability Information
| Specimen Type | Temperature | Time | Special Container |
|---|---|---|---|
| Varies | Refrigerated (preferred) | 7 days | |
| Frozen | 7 days |
Reference Values
Negative
Day(s) Performed
Monday through Sunday
CPT Code Information
87498
Clinical Information
Enteroviruses are positive-sense RNA viruses in the Picornaviridae family. These viruses were initially classified by serotype as polioviruses (3 types), echoviruses (31 types, including types 22 and 23, which are now classified as parechoviruses), coxsackievirus A (23 types), and coxsackievirus B (6 types). However, genomic studies have demonstrated that there is significant overlap in the biological characteristics of different serotypes and more recently isolated enteroviruses are now named with consecutive numbers (eg, EV68, EV69).
The normal site of enterovirus replication is the gastrointestinal tract where the infection is typically subclinical. However, in a proportion of cases, the virus spreads to other organs, causing systemic manifestations, including mild respiratory disease (eg, the common cold); conjunctivitis; hand, foot, and mouth disease; aseptic meningitis; myocarditis; and acute flaccid paralysis. Collectively, enteroviruses are the most common cause of upper respiratory tract disease in children. In addition, the enteroviruses are the most common cause of central nervous system (CNS) disease; they account for almost all viruses recovered in culture from spinal fluid. Differentiation of enteroviruses from other viruses and bacteria that cause CNS disease is important for the appropriate medical management of these patients.
Traditional cell culture methods require 6 days, on average, for enterovirus detection. In comparison, real-time polymerase chain reaction (PCR) allows same-day detection. Detection of enterovirus nucleic acid by PCR is also the most sensitive diagnostic method for the diagnosis of CNS infection caused by these viruses.
Interpretation
A positive result indicates the presence of enterovirus RNA in the specimen.
Cautions
A negative result does not rule out the possibility of enterovirus infection.
This assay may detect virus from a variety of specimen types in asymptomatic individuals, including feces. This assay should only be used for patients with a clinical history and symptoms consistent with enterovirus infection and must be interpreted in the context of the clinical picture.
This is a qualitative assay. Results are reported as either negative or positive for targeted enterovirus RNA.
Supportive Data
Accuracy/Diagnostic Sensitivity and Specificity:
Mayo Clinic Laboratories compared the detection of enteroviruses from spinal fluid by conventional tube cell culture (MCR-5) and by LightCycler polymerase chain reaction (PCR). Of 715 specimens tested, enteroviruses were detected in 65 (9%) by conventional cell culture and 82 (11%) by LightCycler PCR. Twenty-two of 82 (27%) were exclusively positive by PCR, whereas only 5 of 65 (8%) were exclusively positive by conventional cell cultures.
Supplemental Data (Spiking Studies):
To supplement the data above, 30 or more negative specimens of each specimen type (spinal fluid [CSF]/sterile body fluid, dermal/ocular/rectal swabs, plasma, and upper and lower respiratory specimens) were spiked with enterovirus culture control at approximately 10 to 50 targets/mcL (the approximate limit of detection). The spiked specimens were run in a blinded manner along with negative (non-spiked) specimens of each specimen type. Of the spiked specimens, 97% to 100% were positive, and 100% of the non-spiked specimens were negative. A total of 489 spiked and non-spiked specimens were tested.
Assay Inclusivity:
The assay detected all 64 members of an enterovirus panel, consisting of coxsackieviruses, polio viruses, echoviruses, and other enteroviruses. Importantly, the detection of parechovirus serotypes was found to be variable.
Analytical Specificity/Limit of Detection:
The lower limit of detection of this assay is approximately 10 to 50 RNA target copies/mcL. This was confirmed in all specimen types accepted for this assay.
Specificity:
The assay cannot reliably distinguish between enterovirus and rhinovirus. However, no cross-reactivity was observed when a specificity panel was tested, including influenza A/B, respiratory syncytial virus, parainfluenza virus, herpes simplex virus, Epstein-Barr virus, varicella zoster virus, and cytomegalovirus.
Reportable Range:
This is a qualitative assay, and results are reported as either negative or positive for targeted enterovirus RNA.
Report Available
2 to 3 daysSpecimen Retention Time
7 daysReject Due To
| Calcium alginate-tipped swab Wood swab Transport swab containing gel Heat-inactivated specimen |
Reject |
NY State Approved
YesMethod Name
Real-Time Polymerase Chain Reaction (PCR)/RNA Probe Hybridization
Forms
If not ordering electronically, complete, print, and send a Microbiology Test Request (T244) with the specimen.
Testing Algorithm
For more information see Meningitis/Encephalitis Panel Algorithm