Cardiac & Tumor Markers

Myoglobin Rapid Test

Detects Myoglobin. colloidal-gold. Specimen: WB / S / P.

Myoglobin Rapid Test rapid diagnostic test — Progene Bio
Target / AnalyteMyoglobin
Disease / IndicationMyocardial injury
SeriesCardiac & Tumor Markers
Methodcolloidal-gold
SpecimenWB / S / P
Test time10–15 min (product-specific)
Storage2–30 °C, sealed pouch with desiccant
Shelf life24 months (product-specific)
RegulatoryNon-CE / registration in progress
OEM/ODMAvailable — private label & custom panel

Direct Answer

This rapid test detects Myoglobin in WB / S / P to support Myocardial injury. It is a colloidal-gold screening test — a reactive result is presumptive and should be confirmed per the intended use.

Intended Use

Detection of myoglobin for early myocardial injury.

Clinical Context

Myoglobin rises earliest after myocardial injury but has low cardiac specificity; used as an early marker in some multi-marker panels.

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

Low specificity (elevated in skeletal muscle injury/renal failure); not used alone.

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 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.ProductSpecimenFormatKit SizeStatus
CMY-402 Myoglobin Rapid Test Cassette WB/S/P Cassette 10 T CE
CMA-435 Myoglobin/CK-MB/Troponin I Combo Rapid Test Cassette WB/S/P Cassette 10 T CE
CMA-445 H-FABP and Myoglobin/CK-MB/Cardiac Troponin I Combo Rapid Test Cassette WB/S/P Cassette 10 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