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Posted On: 06/10/2020 3:07:52 PM
Post# of 9146
Re: thanksmuch #6441
The following part of the report is revealing from a competitive standpoint.
With this test, human antibodies found in oral fluid would be collected via a wand and pad and eluted into the OraSure® oral fluid specimen collection device buffer for storage and transport, and later dispensed onto the ELISA microplate for testing in a laboratory. The assay, in conjunction with the collection device, would be utilized under FDA’s Emergency Use Authorization (EUA).
Under the initial EUA, if obtained, the collection device would be available for specimen collection in a physician's office, a lab or a testing facility.
The EUA subsequently could be amended to permit an in-home or self-collection option. Being able to collect samples at home would promote social distancing and minimize healthcare workers' exposure to patients who potentially are infected.
The distinction I see is that:
1. Initially it is something to be sent to a lab and tested and would be taken in a specific location and facility but not immediately tested.
2. At home testing is not going to be available at this time.
3. There is no mention of whether the test would be limited to COVID-19 or applicable to other other viruses, as is suggested with the NNLX test.
This clearly is not the NNLX tech that could be used at a medical office, or at home and have results in 30-60 minutes or so. For workplace, school, etc. testing of COVID-19 infection it is critical that rapid results are achieved at POC or Point of Testing in order to be able to isolate and provide rapid initial reaction, treatment and prevention of spread.
With this test, human antibodies found in oral fluid would be collected via a wand and pad and eluted into the OraSure® oral fluid specimen collection device buffer for storage and transport, and later dispensed onto the ELISA microplate for testing in a laboratory. The assay, in conjunction with the collection device, would be utilized under FDA’s Emergency Use Authorization (EUA).
Under the initial EUA, if obtained, the collection device would be available for specimen collection in a physician's office, a lab or a testing facility.
The EUA subsequently could be amended to permit an in-home or self-collection option. Being able to collect samples at home would promote social distancing and minimize healthcare workers' exposure to patients who potentially are infected.
The distinction I see is that:
1. Initially it is something to be sent to a lab and tested and would be taken in a specific location and facility but not immediately tested.
2. At home testing is not going to be available at this time.
3. There is no mention of whether the test would be limited to COVID-19 or applicable to other other viruses, as is suggested with the NNLX test.
This clearly is not the NNLX tech that could be used at a medical office, or at home and have results in 30-60 minutes or so. For workplace, school, etc. testing of COVID-19 infection it is critical that rapid results are achieved at POC or Point of Testing in order to be able to isolate and provide rapid initial reaction, treatment and prevention of spread.
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