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COVID 19 Testing Kits

ExProbe SARS-CoV-2 Surveillance Testing Station

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. 

Specifications

ExProbe SARS-CoV-2 Surveillance Testing Station (68040TS)

  • Surveillance Testing Station Includes: TBG Q6000 Real Time PCR System, centrifuge, Reagent Freezer, and transfer pipette, Quick user guide, and optional UPS station. 

  • Consumables required and purchased separately: Sample collection pack (See details below), ExProbe surveillance testing kits (See details below), transfer pipette tips, disposable trashbin, and station cleaning set.

  • Operating conditions: Indoor use only. Operate between 10C to 45C.  Require 110 volt AC outlet unless UPS is provided 


ExProbe Surveillance Testing Kits (Cat.No. 68040TK, 96 tests/kit)
  • Station Contents: PCR reagents, pos/neg controls, and IFU.​

  • Storage: -20±5°C for 6 months. ​

  • Compatible real time PCR systems: TBG Q6000, ABI7500, Roche 480
     

Saliva Collection Pack (Cat.No. 68040SCP, 96 prep/pack)
  • Pack Contents: 1.5ml collection vial, collection straw, saliva storage buffer, disposable transfer pipette

  • Storage: Room Temperature for 6 months. 


Surface Swab Sampling Pack (Cat.No. 68040SCP, 96 preps/pack)
  • Pack Contents: 1.5ml collection vial, surface swab, disposable transfer pipette.

  • Storage: Room Temperature for 6 months. ​

Ordering Information

Product Name Cat.No. Format
ExProbe SARS-CoV-2 Surveillance Test Station 68040TS 1 System
ExProbe SARs-CoV-2 Surveillance Testing Kit 68040TK 96 Tests/kit
Saliva Collection Pack 68040SCP 96 Preps/Pack
Surface Sample Swab Pack 68040SWP 96 Preps/Pack

Regulations

This Test Station is FOR SURVEILLANCE USE only. It is NOT intended for diagnostics or individual screening use. Please refer 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) for more information. 

Product Documents

Name / Version Description Size
v1.0 DM 4.02MB