- One-step lateral flow immunoassay for direct detection of Campylobacter antigen from stool specimens.
- Detects C. jejuni and C. coli; results in ~20 minutes.
- Acceptable specimen: fresh stool or stool in Cary-Blair–based transport media (see insert).
- Box contains test devices, sample diluent, negative control, positive control and transfer pipettes — 30 tests per box.
- SKU:
- 775356
- QTY Per Sell:
- 30
- Number of Tests:
- 30 Tests
- Reading Type:
- Visual Read
- Sample Type:
- Stool Sample
- CLIA Classification:
- CLIA Moderate Complexity (non‑waived).
- Time to Results:
- 20 minutes
- Detectable Analytes:
- Campylobacter antigen (C. jejuni and C. coli)
- Sensitivity & Specificity:
- 98.1% sensitivity; 95.9% specificity (manufacturer data).
- Storage Instructions:
- Refrigerate per package insert; follow insert for shelf-life and dating.
- Shelf Life:
- See package insert for lot-specific expiry; typical shelf life ~12-18 months.
- Packaging Details:
- 30 tests/box
- Includes positive & negative controls
- Transfer pipettes & sample diluent
- CPT / Billing Code:
- CPT: 87899 (per distributor/manufacturer guidance).
- Regulatory / Certification:
- CE‑IVD indicated by some distributors; refer to package insert for region-specific clearance.
- Country of Origin:
- Manufacturer-listed: Germany / United Kingdom or Germany depending on distributor — see manufacturer lot labeling.
- Manufacturer Link:
- Meridian Bioscience product & support pages (see Meridian for package insert).
- Contents (concise):
- Test devices
- Sample diluent
- Positive & negative controls
- Specimen Transport Note:
- If transport >2 hours, preserve in Cary‑Blair based media (per insert).
- Clinical Use / Application:
- Rapid triage of patients for Campylobacter infection; complements culture methods.
- SKU:
- 775356
- QTY Per Sell:
- 30
- Number of Tests:
- 30 Tests
- Reading Type:
- Visual Read
- Sample Type:
- Stool Sample
- ic__sync_id:
- 1
- ic__id:
- 1272
- CLIA Classification:
- CLIA Moderate Complexity (non‑waived).
- Time to Results:
- 20 minutes
- Detectable Analytes:
- Campylobacter antigen (C. jejuni and C. coli)
- Sensitivity & Specificity:
- 98.1% sensitivity; 95.9% specificity (manufacturer data).
- Storage Instructions:
- Refrigerate per package insert; follow insert for shelf-life and dating.
- Shelf Life:
- See package insert for lot-specific expiry; typical shelf life ~12-18 months.
- Packaging Details:
- 30 tests/box
- Includes positive & negative controls
- Transfer pipettes & sample diluent
- CPT / Billing Code:
- CPT: 87899 (per distributor/manufacturer guidance).
- Regulatory / Certification:
- CE‑IVD indicated by some distributors; refer to package insert for region-specific clearance.
- Country of Origin:
- Manufacturer-listed: Germany / United Kingdom or Germany depending on distributor — see manufacturer lot labeling.
- Manufacturer Link:
- Meridian Bioscience product & support pages (see Meridian for package insert).
- Contents (concise):
- Test devices
- Sample diluent
- Positive & negative controls
- Specimen Transport Note:
- If transport >2 hours, preserve in Cary‑Blair based media (per insert).
- Clinical Use / Application:
- Rapid triage of patients for Campylobacter infection; complements culture methods.
