Other Rapid Tests

TSH Rapid Test

Detects Thyroid-stimulating hormone. colloidal-gold. Specimen: WB / S / P.

TSH Rapid Test rapid diagnostic test — Progene Bio
Target / AnalyteThyroid-stimulating hormone
Disease / IndicationThyroid disorder
SeriesOther Rapid Tests
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 Thyroid-stimulating hormone in WB / S / P to support Thyroid disorder. It is a colloidal-gold screening test — a reactive result is presumptive and should be confirmed per the intended use.

Intended Use

Detection of thyroid-stimulating hormone (TSH) for thyroid screening.

Clinical Context

TSH is the first-line thyroid function test.

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

POC qualitative TSH is screening-grade; quantitative lab TSH is reference.

Procurement

Specimen: WB/S/P. Format: cassette. 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

Technical Evidence

Analytical performanceSensitivity, specificity, cut-off and precision are documented per product line in the datasheet and validation report.
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