OPTI Medical Systems  

235 Hembree Park Drive
Roswell,  GA  30076

United States
https://www.optimedical.com

• Booth: 631

OPTI Medical, a subsidiary of IDEXX, specializes in the design and manufacturing of point-of-care and laboratory diagnostic solutions. OPTI Medical leverages advanced technologies to develop reliable, cost-effective products that combine accuracy with convenience, ease of use, and clinical flexibility to support infectious disease diagnostics as well as point-of-care blood gas and electrolyte analysis using optical fluorescence technology. Our products are FDA, ISO and CE certified, and are distributed in over 100 countries worldwide. OPTI Medical's critical care analyzers measure time sensitive diagnostic assays including blood gas, electrolytes, ionized calcium, measured SO2, tHb, lactate and glucose. Their unique technology eliminates the need for costly electrode maintenance. OPTI Medical's COVID-19 and COVID-19/Flu PCR testing solutions bring labs a reduced cost and simplified workflow without compromising diagnostic sensitivity. For more information, please visit optimedical.com.

 Press Releases

• OPTI Medical Systems COVID-19/Flu test obtains FDA Emergency Use Authorization (Jun 10, 2022)

  Roswell, Georgia - 27 April 2022 - The US Food and Drug Administration granted OPTI Medical Emergency Use Authorization for the OPTI® SARS-CoV-2/Influenza A/B RT-PCR Test on April 21st. The test simultaneously detects and differentiates between SARS-CoV-2, influenza A and influenza B in a single reaction. It uses an internal sample control targeting human RNase P and minimizes impact of viral mutation with detection of two targets in the N region of SARS-CoV-2.

  "This test will be an important tool for the influenza seasons for several years to come, helping healthcare professionals manage and control COVID-19" 

  said Bryan Briggs, Director and General Manager of OPTI Medical Systems.

  The OPTI® SARS-CoV-2/Influenza A/B RT-PCR Test is authorized for use by high-complexity labs and has been verified to detect all SARS-CoV-2 variants of concern. In addition to the FDA EUA, it has also received CE marking. This test compliments the COVID-19 test portfolio of OPTI Medical, which also includes the OPTI® SARS-CoV-2 RT-PCR Test (FDA EUA, CE-IVD) and the OPTI® SARS-CoV-2 Total Antibody Test (CE-IVD). Manufacturing of the assay takes place at IDEXX's state-of-the-art PCR production facilities in Montpellier, France, along with other PCR products for COVID-19.

  About OPTI Medical: Roswell, Georgia-based OPTI Medical Systems, a subsidiary of IDEXX Laboratories, specializes in the design and manufacturing of point-of-care and laboratory diagnostic solutions. OPTI Medical Systems leverages advanced technologies to develop reliable, cost-effective products that combine accuracy with convenience, ease of use, and clinical flexibility to support infectious disease diagnostics as well as point-of-care blood gas and electrolyte analysis using optical fluorescence technology.  

• Extraction-free PCR testing for SARS-CoV-2 (Jun 10, 2022)

  Roswell, Georgia - 21 April 2021 - The OPTI® SARS-CoV-2 RT-PCR Test has received FDA Emergency Use Authorization and CE-IVD for sample handling using the OPTI® Rapid Lysis Buffer. The OPTI Rapid Lysis Buffer protocol eliminates the need for magnetic bead or spin column extraction and prepares the samples for PCR testing using a simple heating protocol. This protocol has shown a diagnostic sensitivity and specificity of 100% when compared to magnetic bead extraction.

  The OPTI SARS-CoV-2 RT-PCR Test is authorized for use by high-complexity labs and has been verified to detect all SARS-CoV-2 variants of concern. It uses an internal sample control targeting human RNase P and minimizes impact of viral mutation with detection of two targets in the N region of SARS-CoV-2. Manufacturing of the assay and the sample preparation buffer takes place at IDEXX's state-of-the-art PCR production facilities in Montpellier, France, along with other PCR products for COVID-19.

  About OPTI Medical: Roswell, Georgia-based OPTI Medical Systems, a subsidiary of IDEXX Laboratories, specializes in the design and manufacturing of point-of-care and laboratory diagnostic solutions. OPTI Medical Systems leverages advanced technologies to develop reliable, cost-effective products that combine accuracy with convenience, ease of use, and clinical flexibility to support infectious disease diagnostics as well as point-of-care blood gas and electrolyte analysis using optical fluorescence technology.  

• OPTI Medical Systems obtains FDA EUA for pooled testing and asymptomatic screening with the OPTI SARS-CoV-2 RT-PCR Test (Jun 10, 2022)

  Roswell, Georgia - 21 April 2021 - The OPTI® SARS-CoV-2 RT-PCR Test has received FDA Emergency Use Authorization and CE-IVD for pooled testing and asymptomatic screening. This authorization supports the guidance from the U.S. Centers for Disease Control and Prevention (CDC) to expand COVID-19 testing to include people without symptoms to reduce the spread of the virus. The test is designed for the detection of SARS-CoV-2 RNA extracted from upper respiratory samples collected from any individual, including from individuals without symptoms or other reasons to suspect COVID-19 infection. In addition, it has been validated on nucleic acid extracts for the use of 5-specimen pool testing without compromising sensitivity or efficacy.

  The OPTI SARS-CoV-2 RT-PCR Test is authorized for use by high-complexity labs and has been verified to detect all SARS-CoV-2 variants of concern. It uses an internal sample control targeting human RNase P and minimizes impact of viral mutation with detection of two targets in the N region of SARS-CoV-2. Its low limit of detection enables pooling without reducing detection rate. Manufacturing of the assay and the sample preparation buffer takes place at IDEXX's state-of-the-art PCR production facilities in Montpellier, France, along with other PCR products for COVID-19.

  About OPTI Medical: Roswell, Georgia-based OPTI Medical Systems, a subsidiary of IDEXX Laboratories, specializes in the design and manufacturing of point-of-care and laboratory diagnostic solutions. OPTI Medical Systems leverages advanced technologies to develop reliable, cost-effective products that combine accuracy with convenience, ease of use, and clinical flexibility to support infectious disease diagnostics as well as point-of-care blood gas and electrolyte analysis using optical fluorescence technology.  

• OPTI Medical’s next generation of blood gas and electrolyte analyzer at AACC 2022 (Jun 10, 2022)

  Roswell, Georgia - 10 June 2022 – OPTI Medical Systems will be displaying their next generation of blood gas and electrolyte analyzer at the 2022 AACC Clinical Lab Expo (booth #631). The OPTI® CCA-TS2 Blood Gas and Electrolyte Analyzer provides fast accurate results for blood gases, acid-base balance, electrolytes, ionized calcium, glucose, BUN/urea, lactate and additional blood parameters such as total hemoglobin concentration (direct measurement) and oxygen saturation (sO2). The instrument runs samples of whole blood, plasma, and serum on single-use disposable cassettes.

  The OPTI CCA-TS2 uses OPTI Medical’s optical fluorescence technology. This unique, patented technology does not use electrodes or contact points, which eliminates the need for costly electrode maintenance. A disposable, single-use cassette contains all the elements needed for calibration, sample measurement and waste containment. The instrument comes with automated sample aspiration, which reduces the risk of pre-analytical errors, and includes a measuring chamber heated to 37°C (98.6°F), allowing for a wide operating temperature range to meet the needs of colder environments. The OPTI CCA-TS2 uses ready-to-use single-use cassettes that let you test for a range of blood gas parameters:

  

  About OPTI Medical: Roswell, Georgia-based OPTI Medical Systems, a subsidiary of IDEXX Laboratories, specializes in the design and manufacturing of point-of-care and laboratory diagnostic solutions. OPTI Medical Systems leverages advanced technologies to develop reliable, cost-effective products that combine accuracy with convenience, ease of use, and clinical flexibility to support infectious disease diagnostics as well as point-of-care blood gas and electrolyte analysis using optical fluorescence technology.  

• OPTI Medical presents its B-Lac Cassette as an important diagnostic tool for severe cases of COVID-19 (Jun 10, 2022)

  Roswell, Georgia - 10 June 2022 - OPTI Medical Systems B-Lac Cassette measures lactate, pH, PCO₂, PO₂, tHb, and SO₂ in whole blood. An individually wrapped, disposable, single-use cassette contains all the elements needed for calibration, sample measurement, and waste containment. The OPTI® B-Lac Cassette can be used exclusively on the OPTI® CCA-TS2 portable blood gas and electrolyte analyzer.

  Clinical conditions where a lactate blood test is important:

  • Sepsis and septic shock
  • Cardiogenic, obstructive, and haemorrhagic shock
  • Cardiac arrest
  • Severe lung disease, respiratory failure, or pulmonary edema
  • Trauma
  • Burns and smoke inhalation

  OPTI Medical experienced a significant increase in the demand for the OPTI B-Lac Cassette through the pandemic given its high importance for the diagnosis of severe cases of COVID-19. Being a useful marker of sepsis, elevated lactate levels can indicate how serious the septic shock is. An early diagnosis of sepsis has a substantial impact on the patient’s outcome and continuous measurement of lactate levels provides useful information about the individual's condition when treating sepsis with a concomitant COVID-19 infection.

  

  About OPTI Medical: Roswell, Georgia-based OPTI Medical Systems, a subsidiary of IDEXX Laboratories, specializes in the design and manufacturing of point-of-care and laboratory diagnostic solutions. OPTI Medical Systems leverages advanced technologies to develop reliable, cost-effective products that combine accuracy with convenience, ease of use, and clinical flexibility to support infectious disease diagnostics as well as point-of-care blood gas and electrolyte analysis using optical fluorescence technology.  

 Additional Info