Every few months I tour a diagnostics line, and I’m reminded how much work hides inside a small plastic shell. The lateral flow plastic cassette for the FOB Fecal Occult Blood Rapid Test Kit is a good example—simple on the outside, a tight choreography of membranes, antibodies, and manufacturing discipline on the inside.
Rapid diagnostics are shifting from lab-centric to near-patient settings—physicians’ offices, community clinics, even mobile units. For FIT/FOB screening in particular, speed and simplicity are everything. Manufacturers that prove lot-to-lot consistency and practical usability win tenders; to be honest, buyers these days are also probing sustainability and private-label flexibility more than ever.
| Intended use | Qualitative detection of fecal occult blood in laboratories or physicians’ offices |
| Format | lateral flow plastic cassette, colloidal gold immunoassay |
| Specimen | Stool sample diluted in buffer |
| Time to result | ≈ 5–10 minutes (real-world use may vary) |
| Analytical sensitivity | Around 50 ng/mL human hemoglobin equivalence, typical for FIT cassettes |
| Shelf life | 18–24 months sealed at 2–30°C (per ISO 23640 principles) |
| Certifications | Manufactured under ISO 13485; risk managed per ISO 14971 |
| Origin | No.136, Shiji West Road, Gaobeidian City, 074000, Hebei, P.R. China |
Procedure is straightforward: collect stool with the provided device, vortex or mix in buffer, add drops to the sample well, and read within the indicated window. Analytical verification typically follows CLSI EP12-A2 for qualitative tests, with stability validated along ISO 23640. Many buyers ask about lot traceability—good vendors keep membrane roll maps, conjugate batch IDs, and incoming QC certs. It sounds nerdy, but it matters for recalls and audits.
| Vendor | Certs | Customization | MOQ | Lead time |
|---|---|---|---|---|
| Prises Bio (FOB FIT) | ISO 13485; design files available for audit | Cassette color, labeling, IFU languages, barcodes | ≈ 5k–10k | ≈ 3–5 weeks (forecast-driven) |
| Generic A | ISO 13485 | Label + pouch only | ≈ 20k | 6–8 weeks |
| Generic B | ISO 13485, CE IVD listed | Broader, but higher tooling fees | ≈ 10k | 4–6 weeks |
Note: values are indicative; real-world use may vary by forecast and region.
A clinic network in Southeast Asia rolled out 15,000 kits over a quarter; they reported fewer invalids after switching to buffered collection vials with clearer fill lines. Another lab director told me, “control lines are crisp even with somewhat mucky samples,” which, admittedly, is what you want to hear in FOB testing.
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