Intended Use

Based on the information provided on the US FDA website (https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/covid-19-test-uses-faqs-testing-sars-cov-2) and the FAQ for Surveillance (https://www.cms.gov/files/document/06-19-2020-frequently-asked-questions-covid-surveillance-testing.pdf). 

    "Surveillance for COVID-19 includes ongoing systematic activities, including collection, analysis, and interpretation of health-related data, essential to planning, implementing, and evaluating public health practice. It is generally used to monitor for an occurrence, such as an infectious disease outbreak, in a population or community, or to characterize the occurrence once detected, such as looking at the incidence and prevalence of the occurrence. Surveillance testing is primarily used to gain information at a population level, rather than an individual level."

   "During this COVID-19 Public Health Emergency, facilities performing SARS-CoV-2 surveillance testing using a pooled sampling procedure to report non patient-specific SARS-CoV-2 cohort results will not require CLIA certification."

   For patient specific and individual testing, please refer to the ExProbe SARS-CoV-2 Testing Kit that has received US EUA and CE marked for futher information. 

   The ExProbe SARS-CoV-2 Surveillance Test Station is intended for Surveillance Use Only (Please refer to the FDA Links above for detailed information about its recommended use). It is a work station that contains all the components necessary for performing a real time PCR based test in the detection of SARS-CoV-2, the virus that is responsible for the spread of COVID19. This test can be done using saliva samples and surface sampling swabs. Using an extraction free protocol, the entire process takes less than 2 hours. Please refer the IFU link below for detailed description of the test kit and its protocols. 


 

Feature and Benefits

• All in one testing station with all consumables, reagents and equipment included. Just plug and start. 

• Extraction free protocol with results within 2 hours

• High sensitvitiy with an LOD of 100 copies/ul 

• Open PCR system with 4 color multiplex capability.  Enable future use in monitoring for other infectious diseases, cancer, and other genetic testing reagents.