Cardiac & Tumor Markers
CEA Rapid Test
Detects Carcinoembryonic antigen. colloidal-gold. Specimen: WB / S / P.
| Target / Analyte | Carcinoembryonic antigen |
|---|---|
| Disease / Indication | Colorectal cancer |
| Series | Cardiac & Tumor Markers |
| Method | colloidal-gold |
| Specimen | WB / S / P |
| 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 Carcinoembryonic antigen in WB / S / P to support Colorectal cancer. It is a colloidal-gold screening test — a reactive result is presumptive and should be confirmed per the intended use.
Intended Use
Detection of carcinoembryonic antigen (CEA) for colorectal cancer monitoring support.
Clinical Context
CEA is a tumor marker used in colorectal cancer monitoring and, with other markers, in screening support.
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
Not diagnostic alone; elevated in benign conditions and smoking. Imaging/confirmatory testing required.
Procurement
Specimen: WB/S/P. 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 single negative troponin does not rule out myocardial infarction — serial testing and clinical context are required. Elevated tumor markers are not diagnostic of cancer.
Sources
Screening results are presumptive, not diagnostic. Confirmatory testing follows WHO, CDC and national regulatory guidance — see screening vs confirmatory.
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