Opti Medical Systems

Business Name: Opti Medical Systems
Business Genre:
Business Description:

Diagnostic company specializing in “manufacturing and marketing portable analyzers for the measurement of time sensitive diagnostics tests” [1]

City: Georgia
State: AL
Country: USA
Data/Evidence of Effectiveness: “Sputum: PPA = 100%, NPA = 100% ; NP Swab: PPA = 100%, NPA = 100%; LoD was confirmed to be 0.7 copies/µL in sputum (20/20) and 0.9 copies/ µL in NP swab samples (19/20) with both extraction methods [3]”
Complimentary Products Needed to Perform Test: “Thermo Scientific Applied Biosystems® 7500 FAST Applied Biosystems® QuantStudio 5 or Agilent Mx3005P™ or Bio Molecular Systems Mic qPCR or Roche LightCycler® 480, Magnetic Bead Kit, Thermo Scientific™ KingFisher™ Flex [3]”
Setting of Care: CLIA certified laboratories [2]
Current Status / Clinical Development Stage / Expected Milestones: FDA-EUA approved [4] ; CE-marked [6]
Funding & Ownership : Private [1] ; subsidiary of IDEXX Laboratories [5]
Business Model: Opti Medical Systems offers OPTI CCA-TS2 Analyzer (a blood gas analyzer), OPTI LION Electrolyte Analyzer (electrolyte analyzer), ComfortSampler Collection Kit (sample collection)
History & Origins : The company was founded in 1967 and offers products to analyze blood gas, electrolyte and metabolyte analysis. It’s products are distrubuted through medical distributor partners [1]
Date EUA Issued: 5/6/2020 [2]
Sources: [1]; [2]; [3]; [4]; [5]; [6]
Organization: P.F. Olivier te Boekhorst (Corporate Vice President), Bryan Briggs (General Manager), Theron Gober (Director, Regulatory Affairs, Quality Assurance, and Quality Control)
Time to Result: 2-3.5 hours including RNA extraction [4]
Test Sample Type: “nasal, nasopharyngeal, oropharyngeal swabs, sputum, lower respiratory tract aspirates, bronchoalveolar lavage, and nasopharyngeal wash/aspirate or nasal aspirate [2]”
Technology Overview: “””Real-time fluorescent reverse transcription polymerase chain reaction test for the qualitative detection of nucleic acid from the SARS-CoV-2″” [2]”
Testing Type: qualitative in vitro detection of nucleic acid from SARS-CoV-2 [2]
Test Category: RT-PCR
Test Name: OPTI SARS-CoV-2 RT PCR Test
Clinical Application & Need: acute infection [2]

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