Test Catalog

Test Id : DNSAG

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Dengue Virus NS1 Antigen, Serum

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Overview

Test Catalog

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

Aiding in the diagnosis of dengue virus infection

Highlights

Detection of the dengue virus nonstructural protein 1 (NS1) antigen is suggestive of recent exposure and/or acute infection with dengue virus.

 

This test should be used for diagnostic purposes only.

 

Dengue NS1 antigenemia overlaps with dengue virus viremia and can be used as an acute phase marker for infection.

Profile Information
A profile is a group of laboratory tests that are ordered and performed together under a single Mayo Test ID. Profile information lists the test performed, inclusive of the test fee, when a profile is ordered and includes reporting names and individual availability.

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

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

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

Enzyme-Linked Immunosorbent Assay (ELISA)

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 NS1 Ag, S

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

Dengue Fever

Break Bone Fever

Flavivirus

Mosquito-borne infection

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

Specimen Type
Describes the specimen type validated for testing

Serum

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/Tube: Plastic vial

Specimen Volume: 0.5 mL

Collection Instructions: Centrifuge and aliquot serum into plastic vial.

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

Forms

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

Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the testing laboratory. The minimum volume is sufficient for one attempt at testing.

0.4 mL

Reject Due To
Identifies specimen types and conditions that may cause the specimen to be rejected

Gross hemolysis Reject
Gross lipemia Reject
Gross icterus 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) 14 days
Frozen 14 days

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

Aiding in the diagnosis of dengue virus infection

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

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). It is primarily transmitted by the Aedes aegypti mosquito, which is 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 the DV nonstructural protein 1 (NS1) has emerged as an alternative biomarker to both serologic and molecular based techniques for diagnosis of acute DV infection. NS1 antigenemia is detectable within 24 hours and up to 9 days following symptoms onset. This overlaps with the DV viremic phase, and NS1 is often detectable prior to IgM seroconversion. Concurrent evaluation for the NS1 antigen alongside testing for IgM- and IgG-class antibodies to DV (DENGM / Dengue Virus Antibody, IgG and IgM, Serum) provides optimal diagnostic potential for both early and late dengue disease.

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

Reference values apply to all ages.

Interpretation
Provides information to assist in interpretation of the test results

Positive:

The presence of dengue nonstructural protein 1 (NS1) antigen is consistent with acute-phase infection with dengue virus.

 

The NS1 antigen is typically detectable within 1 to 2 days following infection and up to 9 days following symptom onset.

 

NS1 antigen may also be detectable during secondary dengue virus infection, but for a shorter duration of time (1-4 days following symptom onset).

 

Negative:

The absence of dengue NS1 antigen is consistent with the lack of acute-phase infection.

 

The NS1 antigen may be negative if specimen is collected immediately following dengue virus infection (<24-48 hours) and is rarely detectable following 9 to 10 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.

 

Though uncommon, false-positive nonstructural protein 1 (NS1) results may occur in individuals with active infection due to other flaviviruses, including West Nile virus and yellow fever virus.

 

Negative NS1 antigen results may occur if the specimen was collected greater than 7 days following symptom onset. Serologic testing for the presence of IgM and IgG antibodies to dengue virus is recommended in such cases.

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%

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 Apr 25;496(7446):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, Reiter P, Sanders EJ, Vorndam AV: Dengue and dengue haemorrhagic fever. Lancet. 1998 Sep 19;352(9132):971-977

4. Tang KF, Ooi EE: Diagnosis of dengue: an update. Expert Rev Anti Infect Ther. 2012 Aug;10(8):895-907

5. Guzman MG, Kouri G: Dengue diagnosis, advances and challenges. Int J Infect Dis. 2004 Mar;8(2):69-80

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

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 01/18/2019)

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

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.

Same day/1 to 7 days

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

14 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 account representative. 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 has been cleared, approved, or is exempt by the US Food and Drug Administration and is used per manufacturer's instructions. Performance characteristics were verified by Mayo Clinic in a manner consistent with CLIA requirements.

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.

86790

LOINC® Information
Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the order and results codes of this test. LOINC values are provided by the performing laboratory.

Test Id Test Order Name Order LOINC Value
DNSAG Dengue Virus NS1 Ag, S 75377-2
Result Id Test Result Name Result LOINC Value
Applies only to results expressed in units of measure originally reported by the performing laboratory. These values do not apply to results that are converted to other units of measure.
DENS1 Dengue NS1 Ag, S 75377-2
DNAGI Dengue Ag Interpretation 69048-7

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