Frequently Asked Questions
Do you have combined rt-PCR COVID-19 test available? YES
a. Are the kits EUA/FDA approved for home/self-collect? YES
You can see our EUA here: https://www.fda.gov/media/138295/download, https://www.fda.gov/media/138293/download
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
Do you have a COVID-19 antibody test? NO
We do not have COVID-19 Antibody tests.
Can the kits be used for research use only? NO
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
Are kits COVID-19 only or do you also have combined tests? YES.
We do have combined test kits. Ask your physician to order the P23 Respiratory ONE
Does P23 Labs report positive results to Health authorities? YES
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
What are the costs associated with test kits and shipping?
Through our website, right now COVID-19 tests are $75 + $13 shipping, or $99 with shipping included both ways (to you and return to us).
What is the shelf life for the COVID-19 test?
The shelf life of the TaqPath SARS-CoV-2 Assay is 6 months.