• Print
  • Download PDF

Dengue Virus IgM

Test Code: 5219229

Performed at multiple locations.

Cpt Code:

86790 (x1)

Clinical Utility

The DENV DetectTM IgM CAPTURE ELISA is for the qualitative detection of IgM antibodies to DENV recombinant antigens (DENRA) in serum for the presumptive clinical laboratory diagnosis of Dengue virus infection. The assay is intended for use only in patients with clinical symptoms consistent with either dengue fever or dengue hemorrhagic fever. Positive results must be confirmed by Plaque Reduction Neutralization Test (PRNT), or by using the current CDC guidelines for diagnosis of this disease.

Procedure

Biological matrix is diluted in buffer and incubated in microtiter wells coated with monoclonal antibody bound to recombinant Dengue antigen (DENRA) and normal cellular antigen (NCA) separately. Wells are then treated with a human IgG-specific monoclonal antibody labeled with horseradish peroxidase. After a second incubation, the wells are incubated with tetramethylbenzidine. An acidic stopping solution is then added and the degree of enzymatic turnover of the substrate is measured by absorbance at 450 nanometers. The ratio of each sample's paired DENRA and NCA absorbances are used to calculate the Immune Status Ratio (ISR). Compared to threshold points, the ISR value determines whether antibodies to Dengue virus are present. This test has been cleared or approved for diagnostic use by the U.S. Food and Drug Administration.

Specificity

Serological cross-reactivity across the flavivirus group is common. Certain sera from patients infected with Japanese Encephalitis, West Nile, and/or Saint Louis Viruses may give false positive results.

Assay Range

Less than 1.65 ISR: Negative - No significant level of detectable dengue fever virus IgM antibody.

1.65-2.84 ISR: Equivocal - Questionable presence of antibodies. Repeat testing in 10-14 days may be helpful.

Greater than 2.84 ISR: Positive - IgM antibody to dengue fever virus detected, which may indicate a current or recent infection.

However, low levels of IgM antibodies may occasionally persist for more than 12 months post-infection.

 

Causes For Rejection

Specimen types other than serum. Grossly lipemic or hemolyzed.

Turnaround Time

2-3 days from receipt of specimen, Monday through Saturday.

Shipping

Lee's Summit Lab: Ship Monday through Friday.
Ship specimens FedEx Priority Overnight® to:

Viracor-IBT Laboratories
1001 NW Technology Dr
Lee's Summit, MO 64086
Ph: (800) 305-5198

Los Angeles Lab: Ship Monday through Friday.
Ship specimens FedEx Priority Overnight® to:

Viracor-IBT Serology
2100 West 3rd Street, Suite 301
Los Angeles, CA 90057
Ph: (213)229-3654

Label Friday shipments with Saturday delivery. All specimens must be labeled with patients name and collection date. A Viracor-IBT test requisition form must accompany each specimen. Multiple tests can be run on one specimen.

Specimen Information

serum

NY approved. Whole blood should be collected in serum tube, allowed to clot for a minimum of 30 minutes, centrifuged and 1 mL serum removed. Serum samples should be frozen immediately (-70°C). Ship frozen in dry ice Monday through Friday.

Disclaimer

Specimens are approved for testing in New York only when indicated in the Specimen Information field above.

The CPT codes provided are based on Viracor-IBT's interpretation of the American Medical Association's Current Procedural Terminology (CPT) codes and are provided for informational purposes only. CPT coding is the sole responsibility of the billing party. Questions regarding coding should be addressed to your local Medicare carrier. Viracor-IBT assumes no responsibility for billing errors due to reliance on the CPT codes illustrated in this material.

References

1. Monath TP . Flaviviruses. In: Fields BN, et al. Fields Virology, 2nd ed. Vol 1, New York: Raven Press, 1990, 763-814.

2. Henchal EA, Putnak JR. The dengue viruses. Clin Microbiol Rev 1990; 3(4):376-96.

3. Effler PV, Halstead SB. Immune enhancement of viral infection. Progress in Allergy 1982; 31:301-64.

4. Halstead SB. Neutralization and antibody-dependent enhancement of dengue viruses. Advances in Virus Research 2003; 60:421-67.

5. Gubler DJ, Dengue and dengue hemorrhagic fever. Clin Microbiol Rev 1998; 11(3):480-496.

6. The Dengue Update, CDC, Vol. 3 No. 1 2011

7. Effler PV, Pang L, Kitsutani P, Vorndam V, Nakata M, Ayers T, Elm J, Tom T, Reiter P, Rigau-Perez JG, Hayes JM, Mills K, Napier M, Clark GG, Gubler DJ; Hawaii Dengue Outbreak Investigation Team. Dengue fever, Hawaii, 2001-2002. Emerg Infect Dis 2005; 11(5):742-8.

8. Innis BL, Nisalak A, Nimmannitya S, Kusalerdchariya S, Chongswasdi V, Suntayakorn S, Puttisri P, Hoke CH. An enzyme linked immunosorbent assay to characterize dengue infections where dengue and Japanese encephalitis co-circulate. Am J Trop Med Hyg 1989; 40: 418–427.

9. World Health Organization. Dengue hemorrhagic fever: diagnosis, treatment, prevention and control, 2nd ed. World Health Organization, Geneva, Switzerland 1997.

<< Back to list