Qualitative Detection of Dengue Virus NS1 Antigen in 15 Minutes — All 4 Serotypes
Dengue NS1 (non-structural protein 1) is a glycoprotein secreted by Dengue virus into the bloodstream during active viral replication. Detection of antigens released during virus replication in an infected patient enables diagnosis from the first day after the onset of fever up to around day 9, once the acute clinical phase of the disease is over — allowing treatment to be initiated promptly, well before a serological antibody response (IgM/IgG) has fully developed.
Dengue viruses comprise four distinct serotypes — Den-1, Den-2, Den-3, and Den-4 — single-stranded, enveloped, positive-sense RNA viruses transmitted by daytime-biting Stegomyia mosquitoes, principally Aedes aegypti and Aedes albopictus. More than 2.5 billion people living in tropical Asia, Africa, Australia, and the Americas are at risk of Dengue infection, with an estimated 100 million cases of Dengue fever and 250,000 cases of life-threatening Dengue hemorrhagic fever occurring annually worldwide.
Because the antibodies used in the Sekbio Dengue NS1 Rapid Test Device recognize NS1 antigen shared across all four serotypes, a single test line detects Dengue infection regardless of which serotype is circulating — an important feature in regions where multiple serotypes co-circulate or shift seasonally.
The Sekbio Dengue NS1 Rapid Test Device (REF SEK-G103) is a single-use, qualitative, lateral flow chromatographic immunoassay for the detection of Dengue virus NS1 antigen in human whole blood, serum, or plasma. It is intended for use as a screening test and as an aid in the diagnosis of Dengue virus infection; any reactive specimen must be confirmed with an alternative testing method and clinical findings.
The test cassette contains a burgundy-colored conjugate pad with mouse anti-Dengue NS1 antibody conjugated to colloidal gold, and a nitrocellulose membrane with one Test line (T) pre-coated with rabbit anti-Dengue NS1 antibody, and one Control line (C) pre-coated with goat anti-mouse IgG antibody. When specimen containing Dengue NS1 antigen migrates across the membrane, the antigen-conjugate immunocomplex is captured at the T line, producing a visible burgundy band. The C line captures the conjugate regardless of specimen reactivity, confirming assay validity.
Results are read visually at 15 minutes. No laboratory equipment, reader, cold chain, or electrical supply is required during testing.
Suitable for febrile-patient triage in clinics, emergency departments, and community outbreak-response settings.
Bring the specimen and test components to room temperature if refrigerated or frozen. Open the pouch and place the test device on a clean, flat surface. Label with the specimen ID.
For whole blood: add 2 drops (~80 µL) of specimen plus 2 drops of buffer. For serum/plasma: add 1 drop (~40 µL) of specimen plus 2 drops of buffer. Avoid air bubbles. Start the timer.
Read results at 15 minutes. Any shade of color at the Test line (T) is positive. Do not read results after 30 minutes; discard the device after interpretation.
Use only clear, non-hemolyzed serum or plasma specimens. Fingerstick whole blood should be tested immediately after collection.
The cassette has two lines: Control (C) and Test (T). The Control line must always appear for a valid test.
Control line (C) visible. Test line (T) absent. Dengue NS1 antigen was not detected at or above the assay's detection threshold.
Both Control (C) and Test (T) lines visible. Dengue NS1 antigen detected. Any shade of color at T is positive. Confirmatory testing with an alternative method and clinical correlation is recommended.
Control line (C) absent. The result is invalid regardless of the test line. Review the procedure and repeat with a new device. If the problem persists, contact your distributor.
Important: This device is a screening test intended for professional in vitro diagnostic use only. The intensity of the test line does not correlate linearly with Dengue antigen titer, and a negative result does not preclude the possibility of Dengue virus infection. Any reactive specimen must be confirmed with alternative testing methods and clinical findings.
The anti-NS1 antibody pair recognizes epitopes conserved across all four Dengue serotypes, enabling a single test to screen for infection regardless of which serotype is circulating locally.
| Dengue Serotype | Virus Family | NS1 Detected by This Assay | Primary Vector |
|---|---|---|---|
| Den-1 | Flavivirus (Dengue) | ✓ Detected | Aedes aegypti / Ae. albopictus |
| Den-2 | Flavivirus (Dengue) | ✓ Detected | Aedes aegypti / Ae. albopictus |
| Den-3 | Flavivirus (Dengue) | ✓ Detected | Aedes aegypti / Ae. albopictus |
| Den-4 | Flavivirus (Dengue) | ✓ Detected | Aedes aegypti / Ae. albopictus |
| Global Burden | ~2.5 billion at risk | 4 of 4 serotypes | ~100M fever cases / 250K severe cases annually |
| The assay uses a single test line (T) — a positive result does not identify which specific serotype is present. Serotype identification requires RT-PCR or other molecular methods. Epidemiological figures per the product's package insert and cited literature. | |||
NS1 antigen circulates in blood from the first day of fever, well before IgM/IgG antibodies become detectable — enabling diagnosis and treatment decisions earlier than antibody-only tests.
A single test line detects Dengue NS1 antigen from all four circulating serotypes, removing the need to know which serotype is locally dominant before testing.
From whole blood, serum, or plasma to visual result in 15 minutes. No laboratory equipment, electricity, or specialist technician required — suitable for clinics, ERs, and mobile outbreak-response teams.
95.7% relative sensitivity and 95.6% relative specificity against a commercial EIA reference method across 114 clinical samples, with 95.6% overall agreement.
Accepts whole blood (venipuncture or fingerstick), serum, or plasma — supporting both laboratory-based testing and decentralized point-of-care and community screening.
Available for OEM and private label supply. Custom branding, multilingual IFU, and packaging design supported. Contact info@sekbio.com for a quotation.
Data summarized from the product package insert: 114 patient samples from subjects with suspected Dengue infection, compared against a commercial EIA reference method.
Samples from susceptible subjects were tested in parallel by the Dengue NS1 Rapid Test and a commercial Dengue Ag EIA.
| Dengue NS1 Rapid Test | EIA Positive | EIA Negative | Total |
|---|---|---|---|
| Positive | 66 | 3 | 69 |
| Negative | 2 | 43 | 45 |
| Total | 68 | 46 | 114 |
Relative Sensitivity: 95.7% · Relative Specificity: 95.6% · Overall Agreement: 95.6%
Per the product's package insert, the following limitations should be understood before using this test clinically.
REF SEK-G103 — 25 Tests / Kit
| Component | Quantity | Description |
|---|---|---|
| Test Device | 25 pcs | Colloidal gold LFA cassette, individually sealed in foil pouch |
| Buffer | 1 vial | Sample buffer added after specimen to initiate chromatographic migration |
| Disposable Specimen Dropper | 25 pcs | For transferring specimen to the sample well |
| Package Insert (IFU) | 1 pc | Instructions for Use — multilingual available for OEM orders |
Not included: specimen collection containers, timer, centrifuge (for plasma preparation only). Positive and negative controls available upon request.
Support rapid differential diagnosis of acute febrile illness in clinics and emergency departments during the first 1–9 days of fever, when NS1 antigen is most detectable.
Point-of-care format with no laboratory equipment required supports community screening and outbreak-response testing during seasonal Dengue transmission peaks.
Rapid screening of febrile patients returning from Dengue-endemic regions, supporting early clinical decision-making ahead of confirmatory laboratory testing.
Available for private label and OEM supply with custom branding, IFU localization, and packaging. Competitive MOQ for established IVD distributors and brands in dengue-endemic markets.
Export-ready components for IVD distributors and kit assemblers across Southeast Asia, Latin America, South Asia, and Africa — the tropical and subtropical regions bearing the highest Dengue disease burden.
Certificate of Analysis (CoA), MSDS, and lot traceability records are provided with every OEM shipment to support customs clearance and local registration filings.
Ambient storage (2–30 °C, no freezing) simplifies logistics to community clinics, mobile outbreak-response units, and primary care facilities outside major urban centers.
Instructions for Use and packaging available in English, French, Spanish, and Arabic, supporting distributor markets across Southeast Asia, Latin America, and Africa.
OEM order quantities scaled for regional distributors and kit assemblers building out a local rapid test portfolio, rather than requiring institutional-tender volumes.
Local regulatory registration remains the responsibility of the importing distributor. Sekbio provides the underlying technical file and clinical evaluation data to support that process.
Active OEM and export supply capability for distributors across Vietnam, Thailand, Indonesia, the Philippines, Brazil, Colombia, and Sub-Saharan Africa. See our full rapid test portfolio.
IFU, clinical performance report, quality documentation, and OEM pricing available on request.