Dealing with patient executed testing
How do PHAs expect to have the results of the patient performed new FDA approved test Lucira resported?
Here is the link to the package insert: https://www.fda.gov/media/143809/download
How would you expect to indicate that this was not generated at a lab = no CLIA number etc?
Riki
Here is the link to the package insert: https://www.fda.gov/media/143809/download
How would you expect to indicate that this was not generated at a lab = no CLIA number etc?
Riki
* CLIA
* EIN
* State Bureau of Labs ID# (all facilities must be PA licensed so they should not be testing any PA resident without a license)
this sample is collected by the patient and the test could be performed BY THE PATIENT.
Riki
Someone owns this process. I don’t care, personally who performs the test. Whatever entity distributes the test then is chain of custody. They initiated it. They own it. And if these half-baked companies do not collect good, usable data, we are calling THEM for details. Patient or no patient test and result, the distributor/doc-for-hire, whatever, owns the problem. it is then the distributor/data holder of whatever amount of information that must be identified in some manner.
I would prefer CSTE firmly say “NO!” to these tests in all forms. Simply not trust worthy.
I don't know what our contact tracing folks will want, but in my humble opinion it would be impossible for PH to collect this info. There is nothing that compels a person to consult with a provider, and lots of asymptomatic people will use these tests to be able to 'justify' their activities. I would not even try to shoe horn this into a lab report. If a person with a positive test consulted their provider, that provider could report that on our case report form.
It would be helpful to get some sort of consensus on these types of tests. Before our state governments impose yet more unrealistic expectations on us to collect data that may well be difficult to use or meaningless for positivity rates.
Riki