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Oct . 27, 2025 10:30 Back to list

Transferrin Rapid Test Cassette – Fast, Accurate POCT

Transferrin Rapid Test Cassette Tumor Marker TF Card: a quick read on GI bleeding, minus the drama

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.

Transferrin Rapid Test Cassette – Fast, Accurate POCT

Product snapshot and why labs keep asking for it

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

How it’s built and how it’s used

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.

Transferrin Rapid Test Cassette – Fast, Accurate POCT

Where it fits (and where it shines)

  • Primary care triage for suspected GI bleeding
  • ED/urgent care “rule-in” signal before endoscopy scheduling
  • Community screening programs where FIT alone misses upper-GI bleeding
  • Resource-limited clinics needing non-invasive markers

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.

Field data, standards, and trends

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.

Transferrin Rapid Test Cassette – Fast, Accurate POCT

Vendor comparison (quick take)

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

Customization and deployment

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.

Two quick cases

• 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.

Citations:

  1. CLSI. EP12-A2: User Protocol for Evaluation of Qualitative Test Performance. Clinical and Laboratory Standards Institute.
  2. ISO 13485:2016 Medical devices—Quality management systems—Requirements for regulatory purposes.
  3. Strate LL et al. ACG Clinical Guideline: Management of Patients With Acute Lower GI Bleeding. Am J Gastroenterol. 2016.
  4. Tokunaga T et al. Immunochemical detection of fecal transferrin for GI bleeding screening. J Gastroenterol. 1993;28:481–486.
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