Women's Health
Gonorrhea Rapid Test
Detects Neisseria gonorrhoeae antigen. colloidal-gold. Specimen: Swab / Urine.
| Target / Analyte | Neisseria gonorrhoeae antigen |
|---|---|
| Disease / Indication | Gonorrhea (STI) |
| Series | Women's Health |
| Method | colloidal-gold |
| Specimen | Swab / Urine |
| Test time | 10–15 min (product-specific) |
| Storage | 2–30 °C, sealed pouch with desiccant |
| Shelf life | 24 months (product-specific) |
| Regulatory | Non-CE / registration in progress |
| OEM/ODM | Available — private label & custom panel |
Direct Answer
This rapid test detects Neisseria gonorrhoeae antigen in Swab / Urine to support Gonorrhea (STI). It is a colloidal-gold screening test — a reactive result is presumptive and should be confirmed per the intended use.
Intended Use
Qualitative detection of Neisseria gonorrhoeae antigen.
Clinical Context
Gonorrhea antigen detection supports STI screening.
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
Culture/molecular confirmation recommended.
Procurement
Specimen: Swab / Urine. Format: cassette. CE-marked line.
Interpretation
| Result | Lines | Meaning |
|---|---|---|
| Positive | Test + control line | Target detected (presumptive positive) |
| Negative | Control line only | Below cut-off / not detected |
| Invalid | No control line | Repeat with a new device |
Common misconception
A negative pregnancy test before a missed period can be false — retest if the period is delayed.
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. | Product | Specimen | Format | Kit Size | Status |
|---|---|---|---|---|---|
| IGO-502 | Gonorrhea Rapid Test Cassette | Swab | Cassette | 20 T | CE |
| IGC-525 | Gonorrhea and Chlamydia Combo Rapid Test Cassette | Swab | Cassette | 10 T | Non-CE |
Technical Evidence
| Analytical performance | Sensitivity, 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 performance | Evaluation data (study population, reference method, agreement) available on request. |
| Cross-reactivity | Documented per analyte — see limitations above. |
| Documents | IFU · Datasheet · Certificate · Declaration of Conformity — request below. |
Buyer Information
| MOQ | Product-dependent — low MOQ available on specialty assays |
|---|---|
| OEM / private label | Custom branding, cut-off, panel and packaging |
| Samples | Available for evaluation — request via RFQ |
| Lead time | On request |
| Documents | IFU · Datasheet · COA · Validation report · CE files · Registration support |
Related knowledge
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