TEST CATALOG ORDERING & RESULTS SPECIMEN HANDLING CUSTOMER SERVICE EDUCATION & INSIGHTS
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

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