Infectious Disease

Dengue NS1 + IgG/IgM Combo

Detects Dengue NS1 + IgG/IgM. colloidal-gold. Specimen: WB / S / P.

Dengue NS1 + IgG/IgM Combo rapid diagnostic test — Progene Bio
Target / AnalyteDengue NS1 + IgG/IgM
Disease / IndicationDengue
SeriesInfectious Disease
Methodcolloidal-gold
SpecimenWB / S / P
Test time10–15 min (product-specific)
Storage2–30 °C, sealed pouch with desiccant
Shelf life24 months (product-specific)
RegulatoryCE (IVDD 98/79/EC)
OEM/ODMAvailable — private label & custom panel

Direct Answer

This rapid test detects Dengue NS1 + IgG/IgM in WB / S / P to support Dengue. It is a colloidal-gold screening test — a reactive result is presumptive and should be confirmed per the intended use.

Intended Use

Combined detection of Dengue NS1 antigen and IgM/IgG antibodies in a single device.

Clinical Context

The NS1 + IgM/IgG combo widens the diagnostic window — capturing early (NS1) and later (IgM/IgG) phases in one test, improving case detection across the illness course.

Test Principle

Colloidal-gold immunochromatography (lateral flow). The device captures the target analyte (antigen or antibody) on a membrane via labeled antibodies, producing a visible test line within minutes. Qualitative or semi-quantitative, intended as a screening/triage aid — not a replacement for confirmatory laboratory testing.

Limitations

Same flavivirus cross-reactivity caveats as serology; combo results still require clinical correlation.

Procurement

Specimen: whole blood / serum / plasma. Format: cassette, 25 T. CE-marked line.

Interpretation

ResultLinesMeaning
PositiveTest + control lineTarget detected (presumptive positive)
NegativeControl line onlyBelow cut-off / not detected
InvalidNo control lineRepeat with a new device

Common misconception

A negative rapid test does not always exclude infection — timing, specimen and pathogen load all matter. Follow up clinically where suspicion is high.

Sources

Screening results are presumptive, not diagnostic. Confirmatory testing follows WHO, CDC and national regulatory guidance — see screening vs confirmatory.

Available SKUs (this series)

Cat. No.ProductSpecimenFormatKit SizeStatus
IRAC-625 Rotavirus and Adenovirus Combo Rapid Test Cassette Feces Cassette 25 T CE
INRA-635 Norovirus, Rotavirus and Adenovirus Combo Rapid Test Cassette Feces Cassette 10T CE
IMVD-645 Norovirus, Rotavirus, Adenovirus and Astrovirus Combo Rapid Test Cassette Feces Cassette 10T CE
ICDT-625 Clostridium difficile Toxin A +Toxin B Combo Rapid Test Cassette Feces Cassette 10 T CE
ICD-635 Clostridium difficile GDH+ Toxin A +Toxin B Combo Rapid Test Cassette Feces Cassette 10 T CE
ICGC-625 Cryptosporidiumand Giardia LambliaCombo Rapid Test Cassette Feces Cassette 10T CE
IEGC-635 Entamoeba/Giardia/Crypto Combo Rapid Test Cassette (3 Windows) Feces Cassette 10T CE
ICHI-302 Chikungunya IgG/IgM Rapid Test Cassette S/P Cassette 40 T CE
ICHI-402 Chikungunya IgG/IgM Rapid Test Cassette WB/S/P Cassette 40 T CE
IDEN-402 Dengue IgG/IgM Rapid Test Cassette WB/S/P Cassette 10 T CE
IDES-402 Dengue NS1 Rapid Test Cassette WB/S/P Cassette 10 T CE
IDEC-425 Dengue IgG/IgM And NS1 Combo Rapid Test Cassette WB/S/P Cassette 25 T CE

Technical Evidence

Analytical performanceSensitivity, specificity, cut-off and precision are documented per product line in the datasheet and validation report.
Average accuracy≥96% (overall agreement rate, manufacturer-validated). Per-product sensitivity and specificity are documented in the datasheet.
Clinical performanceEvaluation data (study population, reference method, agreement) available on request.
Cross-reactivityDocumented per analyte — see limitations above.
DocumentsIFU · Datasheet · Certificate · Declaration of Conformity — request below.

Buyer Information

MOQProduct-dependent — low MOQ available on specialty assays
OEM / private labelCustom branding, cut-off, panel and packaging
SamplesAvailable for evaluation — request via RFQ
Lead timeOn request
DocumentsIFU · Datasheet · COA · Validation report · CE files · Registration support

Documentation & quotation — datasheet, IFU, certificate, MOQ and OEM/ODM options on request.

Request IFU / Spec Sheet Request Datasheet Request Certificate

Last reviewed: 2026-09-12