Cardiac & Tumor Markers
D-Dimer Rapid Test
Detects D-dimer. colloidal-gold. Specimen: WB / P.
| Target / Analyte | D-dimer |
|---|---|
| Disease / Indication | Thrombosis / VTE |
| Series | Cardiac & Tumor Markers |
| Method | colloidal-gold |
| Specimen | WB / 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 D-dimer in WB / P to support Thrombosis / VTE. It is a colloidal-gold screening test — a reactive result is presumptive and should be confirmed per the intended use.
Intended Use
Detection of D-dimer for fibrinolysis/thrombosis assessment.
Clinical Context
D-dimer is a fibrin-degradation product; a negative result helps rule out venous thromboembolism (VTE) in low-risk patients.
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
Positive D-dimer is non-specific (elevated in many conditions); used for exclusion, not diagnosis.
Procurement
Specimen: whole blood / plasma. Format: cassette / strip, 25 T. 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.
Available SKUs (this series)
| Cat. No. | Product | Specimen | Format | Kit Size | Status |
|---|---|---|---|---|---|
| CDM-402 | D-dimer Rapid Test Cassette | WB / P | Cassette | 10 T | 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