a. Are the kits EUA/FDA approved for home/self-collect? YES
b. What platform is used? QuantStudio5, ThermoFisher
c. Can you please share updated data on user error rates for the tests? User error rates are less than 1%
d. Can you share any data on sensitivity/specificity using the overall process (self-collection and PCR testing)? 99% and 98%, respectively
e. Can your team direct ship to participants nationwide? YES
f. Turnaround time on results? 48-72 hours
g. What format are results reported? PDF
h. How do we access to results for research team and for participants? Patient Portal
i. What is the method for exporting results? N/A, you may download the PDF
j. Do you analyze the kits in house or is this done through a 3rd party lab? In house at P23 Labs
For safety reasons for our clients, patients, and staff, we do not allow drop offs to the lab under any circumstances.
The lab contains active COVID-19 virus. If you are a visitor, you could expose yourself to unnecessary risks to COVID-19 from travel and the lab environment. You also put our lab staff at risk if you are unknowingly dropping off a positive test. We ask that you kindly follow our instructions within your test kit and send in your samples.
Per our EUA from the FDA, all sales of COVID-19 test kits are final. We cannot issue refunds, nor accept returns.
Arriving in 2021.
a. Does this require any of the following: being a patient, doctor’s order, or issues with potential insurance billing. NO
b. Must a treating physician order the “home kit” for each study participant? Yes, or the P23 house physician can be used for the order
We do have combined test kits. Ask your physician to order the P23 Respiratory ONE
a. Can you please explain the logistics of the process and any liability that may be involved? We report the information we have. For most of our studies, we do not have any patient demographics. Each participant is given a study number. If we do not have names and date of births, there is nothing for us to report and that would be up to the study PI/owner to report. This language would go into your lab services agreement.
b. Do you offer language to add to a research consent form? Yes
Through our website our COVID-19 tests are $129.
We do not provide our TIN to patients. The TIN is considered PHI, proprietary information, and it should be treated as a social security number. Patients can inform the payor to contact our customer services line and make the request for someone to contact them.
The shelf life of the TaqPath SARS-CoV-2 Assay is 6 months.