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Test Code DNSAG Dengue Virus NS1 Antigen, Serum

Useful For

Aiding in the diagnosis of dengue virus infection

Profile Information

Test ID Reporting Name Available Separately Always Performed
DENS1 Dengue NS1 Ag, S No Yes
DNAGI Dengue Ag Interpretation No Yes

Reporting Name

Dengue Virus NS1 Ag, S

Specimen Type

Serum


Specimen Required


Supplies: Sarstedt Aliquot Tube 5 mL (T914)

Collection Container/Tube:

Preferred: Serum gel

Acceptable: Red top

Submission Container/Tube: Plastic vial

Specimen Volume: 0.5 mL

Collection Instructions: Centrifuge and aliquot serum into plastic vial.


Specimen Minimum Volume

0.4 mL

Specimen Stability Information

Specimen Type Temperature Time
Serum Refrigerated (preferred) 14 days
  Frozen  14 days

Reject Due To

Gross hemolysis Reject
Gross lipemia Reject
Gross icterus Reject

Reference Values

Negative

Reference values apply to all ages.

Supportive Data

The presence of nonstructural protein 1 (NS1) antigen overlaps with the dengue virus (DV) viremic phase for the first 4 to 5 days following infection and therefore, the performance characteristics of the InBios DV NS1 enzyme-linked immunosorbent assay (ELISA) were compared to the Focus Diagnostics DV real-time polymerase chain reaction (RT-PCR), which detects RNA from all 4 DV serotypes. Seventy-seven serum samples previously evaluated by the Focus Diagnostics RT-PCR assay were also tested by the InBios DV NS1 ELISA and the results are compared in the Table. Discordant samples were also tested by the PlateliaTM NS1 Ag enzyme immunoassay (EIA) (BioRad Laboratories).

 

Table. Comparison of the InBios NS1 EIA to RT-PCR for DV detection

InBios DV NS1 EIA

Focus Diagnostics DV RT-PCR

 

Positive

Negative

Positive

24

7(b)

Negative

1(a)

43

Equivocal

0

2(c)

 

a. This sample was negative by the Platelia NS1 EIA

b. Five samples were also positive by the Platelia NS1 EIA

c. One sample was negative, and one sample was indeterminate by the Platelia NS1 EIA

 

Sensitivity: 96% (24/25); 95% CI: 79.1%-100%

Specificity: 82.7% (43/52); 95% CI: 70.1%-90.9%

Overall Agreement: 87.1% (67/77); 95% CI: 77.6%-93%

Method Description

The InBios NS1 enzyme-linked immunosorbent assay (ELISA) is a 2-step sandwich-format colorimetric immunoassay for qualitative detection of nonstructural protein 1 (NS1) antigen in serum. Diluted patient samples and controls are incubated in wells coated with purified capture antibody, specific for the dengue NS1 antigen. Following incubation, wells are washed, incubated with a horseradish peroxidase-conjugated polyclonal antibody specific to NS1 antigen and re-incubated. Wells are subsequently washed and 3,3',5,5'-tetramethlbenzidine substrate is added and incubated at room temperature in the dark. Stop solution is added next and the optical density (OD) of the reaction is measured at 450/620 nm. The immune status ratio for each sample is calculated from the ratio of the OD obtained with the test sample divided by the OD from the calculated cutoff value (determined by the cutoff control sample).(Package insert: InBios DENV DetectTM NS1 ELISA. InBios International, Inc; Revision 01/2019)

Day(s) Performed

Tuesday

Report Available

Same day/1 to 7 days

Performing Laboratory

Mayo Clinic Laboratories in Rochester

CPT Code Information

86790

LOINC Code Information

Test ID Test Order Name Order LOINC Value
DNSAG Dengue Virus NS1 Ag, S 75377-2

 

Result ID Test Result Name Result LOINC Value
DENS1 Dengue NS1 Ag, S 75377-2
DNAGI Dengue Ag Interpretation 69048-7

Forms

If not ordering electronically, complete, print, and send Infectious Disease Serology Test Request (T916) with the specimen.

Specimen Retention Time

14 days