Sona Nanotech Inc C.SONA

RE:Interesting #'s on new NON LAB Antigen Tests

[shoosh22]

I moved this up so anyone new here that does not know what the FDA is requiring for Test Results...and to the trolls who try to say SONA does not cut it.  WE DO  FDA wants 90% PPA we have 96%.. NPA  they want 95% we have 96%.  I bet when all said and done.. we will be closer to 99%  Once more and more tests are used and the numbers are greater we will be very high... Darren would not have it any other way... Finiky Scientist!

shoosh22 wrote: I was surprised to see there is a difference in percent requirements of PPA NPA in the Antigen Test, depending if testing for Symptomic or Asymptomic patients.  

This may have been posted but I can't recall seeing it..
This is from the new July 29 template.

We have it in the bag.. with PPA & NPA being 96%   GLTA  Exciting times ahead...And I'm posting this to counter other posts which said NPA must be 100%.. 

10. Alternative Clinical Study Approaches:

 

• • 1. 1. Adding Asymptomatic Testing Post-Authorization

If your assay is already authorized for non-laboratory use without an asymptomatic claim, you may request the addition of asymptomatic testing through a post-authorization study. For a post-authorization study we generally recommend testing a minimum of 20 consecutively collected asymptomatic positive specimens and at least 100 consecutively collected negative specimens based on the results of the candidate test. All specimens should then be tested with another EUA authorized molecular assay. Using estimates of the predictive values and the percentage of positive results, this study can be used to establish the sensitivity (PPA) and specificity (NPA) of your test in an asymptomatic population, as this is an important performance metric for tests intended for asymptomatic screening of large populations. The FDA generally expects that PPA should be >95% and NPA should be ≥98% (with a lower bound of the two-sided 95% confidence interval >95%). 

 

• • 1. 2. Symptomatic Patient Testing (prescription use only)

If you wish to limit your assay to symptomatic individuals you may do this by offering your test by prescription only. Since there is no mechanism to limit OTC testing to symptomatic individuals, FDA recommends developers requesting an OTC claim consider the clinical study and performance recommendations for asymptomatic testing, as described above.

 

For a Prescription Non-Laboratory Test for symptomatic patients, you should follow the study design above with the recommended changes to Study Size and Performance below.

 

Study Size For Prescription Non-Laboratory Use Only

 

• • Testing in symptomatic individuals should be continued until 30 positives and 30 negatives are obtained. (a population size of 150, in a prospective study, would be expected to yield 30 positive results if prevalence is 20%).

Lower PPA and NPA may be acceptable for prescription non-laboratory use assays for symptomatic patients because the inclusion of symptoms as a requirement for testing increases the pre-test probability of a positive result (higher prevalence) and therefore increases the Positive Predictive Value of the test. FDA believes that a Positive Predictive Value of a test with below 90% PPA would be insufficient without this mitigation (confirming symptoms).

 

Performance For Symptomatic Use Only

 

For symptomatic use only tests, FDA recommends that the test have a PPA and NPA as follows:

 

• • Positive Percent Agreement (PPA) ≥80% for symptomatic

  • Negative Percent Agreement (NPA) ≥99% (LB >95%)