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Dengue Virus IgG

Test Code: 5219239

Cpt Code:

86790 (x1)

Clinical Utility

The DENV DetectTM IgG ELISA test for exposure to Dengue Virus (DENV) is an ELISA assay system for the detection of IgG antibodies in human serum to Dengue-derived recombinant antigen (DENRA). This test is to aid in the diagnosis of human exposure to the Dengue virus.

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.

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 IgG 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 - IgG antibody to dengue fever virus detected, which may indicate a current or past 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

Ship Monday through Friday. Label Friday shipments for Saturday delivery. All specimens must be labeled with patient's name and collection date. A Viracor-IBT test requisition form must accompany each specimen. Multiple tests can be run on one specimen. Ship specimens FedEx Priority Overnight® to: Viracor-IBT Laboratories, 1001 NW Technology Dr, Lee's Summit, MO 64086.

Specimen Information

serum

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.

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