Drug of Abuse (DOA)

Carfentanyl (CFYL) Rapid Test

Detects Carfentanyl. colloidal-gold. Specimen: Urine.

Carfentanyl (CFYL) Rapid Test rapid diagnostic test — Progene Bio
Target / AnalyteCarfentanyl
Disease / IndicationDrug of abuse screening
SeriesDrug of Abuse (DOA)
Methodcolloidal-gold
SpecimenUrine
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 Carfentanyl in Urine to support Drug of abuse screening. 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 Carfentanyl in urine for drug screening.

Clinical Context

Carfentanyl is an ultra-potent synthetic opioid. Cut-off typically 5.

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

Screening result — a presumptive positive requires confirmatory testing (GC-MS/LC-MS).

Procurement

Specimen: urine. Format: cassette / dipstick / panel. 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 reactive drug-screen result is presumptive — it does not indicate impairment, timing of use or a diagnosis. Confirm positives by GC-MS/LC-MS.

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
DCFY-102 Carfentanyl(CFYL) Rapid Tests Cassette Urine Cassette 40 T CE
DCFY-114 Carfentanyl(CFYL) Rapid Tests Panel Urine Panel 40 T CE
DCFY-101 Carfentanyl(CFYL) Rapid Tests Dipstick Urine Dipstick 50 T CE
DCFY-802 Carfentanyl(CFYL) Rapid Test Cassette Oral Fluid Cassette 25 T CE
DCFY-803 Carfentanyl(CFYL) Rapid Test Midstream Oral Fluid Midstream 25 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