Credo Vita

Summary

VitaPCR is an ultra-portable, cartridge-based real-time PCR system for decentralized testing that integrates a simple 4-step workflow (collect → lyse → transfer/start → result). It reports Ct and fluorescence curves on-screen and delivers results in about 20 minutes with <1 minute hands-on time. Designed for minimal setup (no extra equipment) and room-temperature kit storage, it supports NP/OP swabs and offers validated respiratory and Strep A assays, plus a combined Flu A&B/SARS-CoV-2 panel. The platform includes connectivity via VitaDataLink™ for HL7/LIS integration and is CE-marked (IVDR).

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Main features

• Rapid sample-to-answer: ~20 min turnaround; <1 min hands-on.
  
  

• Easy use & interpretation: on-screen real-time fluorescence curves and Ct values; intuitive UI.
  
  

• Portable form factor: 1.2 kg, 15.5 × 16.5 × 20.5 cm; 4" capacitive touchscreen.
  
  

• Optics: 3 + 1 fluorescence channels (internal control), 450–750 nm detection range.
  
  

• Specimens: nasopharyngeal or oropharyngeal swabs.
  
  

• Assay menu (examples): SARS-CoV-2 Gen2 (N1/N2), Flu A&B (M/NS genes), Flu A&B/SARS-CoV-2, Flu A&B/RSV (N gene), Strep A (spy1258).
  
  

• Reagents & logistics: kit storage 5–25 °C; 20 tests/box; room-temperature transport/storage noted.
  
  

• Connectivity: VitaDataLink™ transfers HL7 to LIS/HIS; built-in ID/barcode support.
  
  

• Operating/storage env.: operate 10–38 °C, 10–80% RH; store 15–40 °C.
  
  

• Regulatory: CE-marked (IVDR).
  
  

Variant coverage statement: ongoing monitoring of SARS-CoV-2 and Influenza A variants/subtypes with assays designed not to be impacted by listed VOIs/VUMs (as of Sept-2024).