Test Catalog

Test Id : DENGS

Dengue Virus, Molecular Detection, PCR, Serum

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

Aiding in the diagnosis of acute infection caused by dengue virus

Highlights

Detection of dengue virus nucleic acid in serum is suggestive of recent exposure and acute infection with dengue virus.

 

The presence of dengue virus nucleic acid in serum can be used as a marker for acute-phase infection. Patients with a history of symptoms for more than 1 week may be negative by molecular tests (ie, real-time PCR) and may require serologic testing to confirm the diagnosis of dengue virus infection.

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

See Mosquito-borne Disease Laboratory Testing in Special Instructions.

Special Instructions
Library of PDFs including pertinent information and forms related to the test

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

Real-Time Polymerase Chain Reaction (PCR)

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

Dengue Virus, PCR, Serum

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

Dengue fever

Break Bone Fever

Flavivirus

Mosquito-borne infection

Arbovirus

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

See Mosquito-borne Disease Laboratory Testing in Special Instructions.

Specimen Type
Describes the specimen type validated for testing

Serum

Ordering Guidance

The presence of dengue virus nucleic acid in serum overlaps with the presence of dengue virus nonstructural protein 1 (NS1) antigen (DNSAG / Dengue Virus NS1 Antigen, Serum). Patients with a history of symptoms for more than 1 week may be negative by molecular tests (ie, real-time PCR) and may require serologic testing (DENVP / Dengue Virus Antibody/Antigen Panel, Serum) to confirm the diagnosis of dengue virus infection.

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

Collection Container/Tube:

Preferred: Serum gel

Acceptable: Red top

Submission Container: Sterile container

Specimen Volume: 0.5 mL

Collection Instructions:

1. Collect whole blood in a serum gel tube.

2. Centrifuge and aliquot the serum into a sterile container within 6 hours of collection.

3. Label specimen as serum.

Special Instructions
Library of PDFs including pertinent information and forms related to the test

Forms

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
Heat-inactivated specimen 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
Serum 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 acute infection caused by dengue virus

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

See Mosquito-borne Disease Laboratory Testing in Special Instructions.

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

Dengue virus (DV) is a globally distributed flavivirus with 4 distinct serotypes (DV-1, -2, -3, -4) and is primarily transmitted by the Aedes aegypti mosquito, found throughout the tropical and subtropical regions of over 100 countries. DV poses a significant worldwide public health threat with approximately 2.5 to 3 billion people residing in DV endemic areas, among whom 100 to 200 million individuals will be infected and approximately 30,000 patients will succumb to the disease, annually.

 

Following dengue infection, the incubation period varies from 3 to 7 days and while some infections remain asymptomatic, the majority of individuals will develop classic dengue fever. Symptomatic patients become acutely febrile and present with severe musculoskeletal pain, headache, retro-orbital pain, and a transient macular rash most often observed in children. Fever defervescence signals disease resolution in most individuals. However, children and young adults remain at increased risk for progression to dengue hemorrhagic fever and dengue shock syndrome, particularly during repeat infection with a new DV serotype.

 

Detection of DV nucleic acid in serum is a marker of acute infection with this virus. Importantly, the period of time that the virus can be detected in serum is brief and, therefore, molecular testing should be performed within the first week following onset of symptoms. After this time, serologic testing is the preferred method for diagnosis of DV infection.

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

Positive:

The detection of dengue virus nucleic acid in serum is consistent with acute-phase infection.

 

Dengue virus nucleic acid may be detectable during the first 1 to 7 days following the onset of symptoms.

 

Negative:

The absence of dengue nucleic acid in serum is consistent with the lack of acute-phase infection.

 

Dengue virus nucleic acid may not be detected if the serum specimen is collected immediately following dengue virus infection (<24-48 hours) and is rarely detectable following 7 days of symptoms.

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

Results should be used in conjunction with clinical presentation and exposure history.

 

Negative dengue virus (DV) PCR results may occur if the specimen was collected more than 7 days following symptom onset. Serologic testing for the presence of IgM and IgG antibodies to DV is recommended in such cases.

Supportive Data

Assay Inclusivity:

The Altona RealStar Dengue virus RT-PCR assay was tested using control strains of each of the 4 dengue serotypes and was able to detect serotypes 1, 2, 3 and 4.

 

Accuracy:

A commercial panel (SeraCare) of known-positive samples for dengue virus serotypes 1, 2, 3, and 4 was tested. Each member of the panel was tested in triplicate, and all replicates were positive by the Altona RealStar Dengue assay.

 

Thirty analyte-negative serum samples were spiked (1:10 dilution) with plasma samples collected in South America during an outbreak of dengue virus and determined to be positive for the virus. Of the 30 spiked serum samples, 29 (97%) were positive by the Altona RealStar Dengue RT-PCR assay.

 

Limit of Detection (LoD):

The LoD in serum was determined to be the following:

 

Dengue serotype 1:14 genomic targets/mcL (7000 genomic targets/mL)

Dengue serotype 2: 2 genomic targets/mcL (1000 genomic targets/mL)

Dengue serotype 3: 1.6 genomic targets/mcL (800 genomic targets/mL)

Dengue serotype 4: 13 genomic targets/mcL (6500 genomic targets/mL)

 

Reference Range (Analytical Specificity):

A total of 20 serum samples collected from normal donors were analyzed by the Altona RealStar Dengue RT-PCR assay and all 20 were negative.

 

A cross-reactivity panel of bacteria (n=12), viruses (n=15), and parasites (n=2) was tested, and all were negative by the Altona Dengue RT-PCR assay.

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

1. Bhatt S, Gething PW, Brady OJ, et al: The global distribution and burden of dengue. Nature 2013;496:504-507

2. Dengue--an infectious disease of staggering proportions. Lancet 2013 Jun 22;381(9884):2136

3. Rigau-Perez JG, Clark GG, Gubler DJ, et al: Dengue and dengue haemorrhagic fever. Lancet 1998;352:971-977

4. Tang KF, Ooi EE: Diagnosis of dengue: an update. Expert Rev Anti Infect Ther 2012;10:895-907

5. Guzman MG, Kouri G: Dengue diagnosis, advances and challenges. Int J Infect Dis 2004;8:69-80

Special Instructions
Library of PDFs including pertinent information and forms related to the test

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

The Altona Real Star (ARS) DENV is a qualitative, reverse transcription-PCR (RT-PCR) assay targeting the 3' UTR polyprotein gene. The assay includes a heterologous amplification system (internal control) to identify possible RT-PCR inhibition and to confirm the integrity of the reagents of the kit. Specimens are run on the LightCycler 480 following nucleic acid extraction using the NucliSENS EasyMag (BioMerieux). Real-time RT-PCR technology utilizes reverse-transcriptase (RT) reaction to convert RNA into complementary DNA (cDNA), PCR for the amplification of specific target sequences and target specific probes for the detection of the amplified DNA. The probes are labelled with fluorescent reporter and quencher dyes. Probes specific for DENV RNA are labelled with the fluorophore FAM. The probe specific for the Internal Control (IC) is labeled with the fluorophore JOE. Using probes linked to distinguishable dyes enables the parallel detection of DENV specific RNA and the internal control in corresponding detector channels of the real-time PCR instrument.(Package insert: RealStar Dengue RT-PCR Kit 2.0. Altona Diagnostics, Hamburg. 01/2017)

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.

Tuesday, Thursday

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.

5 to 8 days

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

7 days

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