Abstract

GCI #270 v4.1 is an open‑hardware, home‑deployable diagnostic for Mycoplasma pneumoniae and S. pneumoniae (walking pneumonia). Uses extraction‑free one‑pot Cas12a‑LAMP‑CRISPR (1 copy/µL LoD, 98–100% sensitivity/specificity) in a Vortex‑HT microfluidic disc with sonication lysis, photo‑gated activation, and PCM incubation (10–20 min total). 16‑channel multiplex, smartphone AI readout. 3–6x faster, 20–80x cheaper than Alethia/BioFire RP2.1. TRL 8–9; validated chemistry (CHAMP, ERA‑Cas12a trials). BOM $1.20/test; 4‑step workflow. CERN‑OHL‑P licensed for global manufacture. Requires wet‑lab validation for clinical deployment.

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