Women's Health
Rubella IgG/IgM Rapid Test
Detects Rubella virus IgG/IgM antibodies. colloidal-gold. Specimen: WB / Serum / Plasma.
| Target / Analyte | Rubella virus IgG/IgM antibodies |
|---|---|
| Disease / Indication | Rubella (TORCH) |
| Series | Women's Health |
| Method | colloidal-gold |
| Specimen | WB / Serum / Plasma |
| 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 Rubella virus IgG/IgM antibodies in WB / Serum / Plasma to support Rubella (TORCH). 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 Rubella virus IgG/IgM antibodies.
Clinical Context
Rubella IgG indicates immunity — critical before pregnancy; IgM indicates recent infection.
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
Rubella immunity testing is standard in antenatal screening.
Procurement
Specimen: WB / Serum / Plasma. 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 |
Available SKUs (this series)
| Cat. No. | Product | Specimen | Format | Kit Size | Status |
|---|---|---|---|---|---|
| ICGM-302 | CMV IgG/IgM Rapid Test Cassette | S / P | Cassette | 40 T | Non-CE |
| ICGM-325 | CMV IgG/IgM Combo Rapid test Cassette | S / P | Cassette | 25 T | Non-CE |
| ICGM-402 | CMV IgG/IgM Rapid Test Cassette | WB/S/P | Cassette | 40 T | Non-CE |
| ICGM-425 | CMV IgG/IgM Combo Rapid test Cassette | WB/S/P | Cassette | 25 T | Non-CE |
| IRG-302 | Rubella IgG Rapid Test Cassette | S / P | Cassette | 40 T | Non-CE |
| IRG-402 | Rubella IgG Rapid Test Cassette | WB/S/P | Cassette | 40 T | Non-CE |
| IRM-302 | Rubella IgM Rapid Test Cassette | S / P | Cassette | 40 T | CE0123 |
| IRM-402 | Rubella IgM Rapid Test Cassette | WB/S/P | Cassette | 40 T | Non-CE |
| IRGM-302 | Rubella IgG/IgM Rapid Test Cassette | S / P | Cassette | 40 T | Non-CE |
| IRGM-325 | Rubella IgG/IgM Combo Rapid Test Cassette | S / P | Cassette | 25 T | Non-CE |
| IRGM-402 | Rubella IgG/IgM Rapid Test Cassette | WB/S/P | Cassette | 40 T | Non-CE |
| IRGM-425 | Rubella IgG/IgM Combo Rapid Test Cassette | WB/S/P | Cassette | 25 T | Non-CE |
Technical Evidence
| Analytical performance | Sensitivity, specificity, cut-off and precision are documented per product line in the datasheet and validation report. |
|---|---|
| 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