Product 1
  • Fast & Precise: 120 tests/hour, results in 30 minutes, <3.5% CV accuracy
  • Flexible: 36 analytes, 24 at once, STAT-ready, non-stop loading
  • Versatile: Oncology to neurology, CE-marked, FDA-pending assays
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TechnologyChemiluminescent Enzyme Immunoassay (CLEIA)
Throughput120 tests per hour (true throughput)
Time to First Result~30 minutes; subsequent results every minute
Sample Capacity36 analytes on board; 24 measurable simultaneously per sample
Assay TypeMono-test cartridge system
FlexibilityContinuous access for samples, reagents, consumables; STAT priority loading
ConnectivityBi-directional LIS integration; compatible with specimen conveyor lines
User FeaturesDisposable pipette tips, master calibration, replenishable wash/substrate solutions
Operating Temperature15–30°C (typical laboratory conditions)
Assay MenuOncology (e.g., CA125, HE4), Infectious Diseases (e.g., SARS-CoV-2 Ag), Endocrinology, Metabolic, Neurology
Intended UseQuantitative/qualitative IVD measurement in human specimens (serum, plasma, CSF)
PrecisionTotal imprecision <3.5% CV (e.g., HBV markers, aldosterone)
Regulatory StatusCE-marked (Europe); select assays FDA-approved/pending (e.g., pTau 217, filed Sept 2024)
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