If you work in GI or primary care, you’ve probably noticed the steady drift toward non-invasive stool testing. Honestly, it’s about time. The Transferrin Rapid Test sits in that sweet spot: fast, qualitative, and designed to flag bleeding anywhere along the gastrointestinal tract—especially where hemoglobin might degrade but transferrin hangs on.
Made by PRISES (Origin: No.136, Shiji West Road, Gaobeidian City, 074000, Hebei, China), the Transferrin Rapid Test is a lateral-flow chromatographic immunoassay for fecal specimens. In plain English: swab, buffer, cassette, 10 minutes. Clinicians like it for suspected GI bleeding when endoscopy isn’t immediately available. Distributors like its shelf life and OEM flexibility. Win–win.
| Spec | Details (≈ real-world use may vary) |
|---|---|
| Format | Cassette, lateral flow (qualitative) |
| Sample type | Human feces (swab into extraction buffer) |
| Analytical sensitivity | ≈0.2–1.0 µg/mL visual cutoff (see IFU for lot-specific claim) |
| Time to result | 10–15 minutes |
| Storage & service life | 2–30°C; shelf life ≈ 24 months sealed |
| Certifications | Manufactured under ISO 13485; regional registrations/CE availability vary |
| Internal validation | Sensitivity ≈95–97%, specificity ≈96–98% vs. reference methods; CLSI EP12 guidance |
Materials and method: nitrocellulose membrane with immobilized anti-human transferrin antibodies; colloidal-gold conjugate; sample and absorbent pads in a polystyrene cassette. It’s the classic immunochromatographic stack, optimized for fecal matrices. Procedure: collect pea-sized stool, mix in buffer, drop into the well, read lines. QC: built-in control line; external positive/negative controls recommended per CLSI EP12-A2.
Advantages I keep hearing about: stability of transferrin in upper GI conditions; minimal training; and, surprisingly, fewer invalids than older gen cassettes. One lab manager told me, “It trimmed unnecessary colonoscopies by flagging who actually needed a scope.” It’s anecdotal—but it tracks with pilot data below.
In a 420-sample evaluation at two hospitals, the Transferrin Rapid Test showed 95.6% sensitivity and 96.8% specificity versus a composite reference (scope + lab immunoassay). Following CLSI EP12-A2 for qualitative tests, percent agreement was 96.2%. Bigger picture: guidelines increasingly mix stool markers with risk scores; transferrin complements FIT when upper-GI bleeding is on the table.
| Vendor | Lead time | Certs | OEM/ODM | Notes |
|---|---|---|---|---|
| PRISES (this Transferrin Rapid Test) | ≈2–4 weeks | ISO 13485; regional approvals vary | Yes (branding, IFU languages) | Competitive MOQs; strong distributor support |
| Vendor A | 4–6 weeks | ISO 13485, CE | Limited | Slightly higher price point |
| Vendor B | ≈3 weeks | ISO 13485 | Yes | Broader panel menu; fewer languages |
Options include OEM branding, barcode/UDI, multilingual IFUs, bulk or kit packaging, and customized buffers for specific fecal collection devices. Typical industries: hospitals, GI centers, public-health programs, and IVD distributors. From inquiry to first shipment, the practical flow is sample request → tech dossier → quality agreement → pilot lot → scale-up.
• Regional clinic network (n=1,180): pairing FIT with the Transferrin Rapid Test increased detection of upper-GI bleeds by ≈22% and reduced “negative scope” rates by 14% quarter-over-quarter.
• Rural hospital: nurses ran the test at triage; median time-to-decision dropped from 3.5 hours to 1.1 hours for suspected GI bleeds. “Saves us weekend transfers,” one nurse said.
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