RE:RE:RE:RE:RE:RE:Field testsThis is a tough one especially the Flex Studies has to be done to failure.. Nothing like this was ever published by SONA from the MRI results. So is manual easier or harder.??
J. PERFORMANCE EVALUATION
We recommend including the studies listed below (as applicable) in your EUA request. Please note that, particularly for new technologies, FDA may request additional studies so we can adequately assess the risks and benefits associated with the device:
1) Limit of Detection (LoD) - Analytical Sensitivity
Please provide information consistent with the recommendations in the Antigen Template for Manufacturers or Molecular Diagnostic Template for Manufacturers.
2) Inclusivity (analytical sensitivity)
Please provide information consistent with the recommendations in the Antigen Template for Manufacturers or Molecular Diagnostic Template for Manufacturers.
3) Cross-reactivity (Analytical Specificity)
Please provide information consistent with the recommendations in the Antigen Template for Manufacturers or Molecular Diagnostic Template for Manufacturers. For all tests intended for use in a non-laboratory setting (e.g., a complete home test), FDA recommends wet testing of Cross-reactivity and Microbial Interference in addition to in silico analysis.
a. Cross-reactivity (organisms tested in the absence of SARS-CoV-2)
b. Microbial Interference Studies (organisms tested in the presence of SARS-CoV-2)
c. Endogenous Interference Substances Studies (including common household items such as cleaners, lotions, soap etc.)
4) High-dose Hook Effect Study for antigen tests
Please provide information consistent with the recommendations in the Antigen Template for Manufacturers.
5) Biotin interference, if applicable
Please provide information consistent with the recommendations in the Antigen Template for Manufacturers.
6) Flex Studies
Flex studies assess the robustness of an assay performed with the device in its final design/format and should be performed in-house by staff who have been trained in the use of the test. The flex studies should evaluate the most common or likely sources of error based on the use locations and test procedure. Flex studies should be conducted by testing a negative sample and a low positive sample (at 1.5x - 2x LoD) for each condition being evaluated. In general, the flex studies should be conducted to the point of failure to determine the maximum deviation that will allow for generating accurate results. We recommend 3 replicates per condition per sample concentration. Data for each condition evaluated (i.e., line data) should be provided. If erroneous results are observed during studies evaluating the robustness of the device, adequate mitigation(s) should be provided. Each study should be performed using a pre-defined study protocol that includes the following:
i. The objective of the study
ii. Detailed test procedure
iii. Materials used
An example of some conditions that may be evaluated as potential user errors and anticipated environmental stresses (temperature and humidity extremes) are shown below:
iv. 40°C and 95% RH (mimicking hot and humid climates)
v. Delay in sample testing
vi. Delay in operational steps
vii. Delay in reading results
viii. Sample volume variability (if applicable)
ix. Buffer volume variability (if applicable)
x. Mixing/swab expression variability (if applicable)
xi. Disturbance during analysis
xii. Placement on non-level surface
xiii. Impact of different light sources (if applicable)
xiv. If hand-held, positioning at 90° angle (simulating placing device in pocket or lifting to see result display screen)