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Is it appropriate to use NHOID in this example where you are testing anti-RSV epitope IgG antibody in the patient? The bug is not the subject of the observation, this is measuring host/subject immune response.

This example is been tweaked to include NHOID, see the orginal original IS example 5 in the SDTMIG 3.4: IS Example 5

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• is it susceptible to an antibiotics? (MS)
• does it have some mutations in its genome or sequence changes? (GF)
• can the antibody stop it from infecting cells? (IS)
• For all of the above, you are running tests that directly impact the microbe, and tells the observations/assessments tell you something about the microbe.

In the below example, this is measuring the subject/host immune response toward a vaccine-delivered antigen, the observation is about the study subject , not about and how he responses to the vaccine stimulation. It technically has nothing to do with the bug, it doesn't tell me anything about the bug. Having NHOID here is beyond the scope of how this variable is defined and used. I wonder in this instance it is even current to use the OI domain.

If you want to know which strain of the virus is used to make and /generate the vaccine or vaccine components, is it appropriate to use OI and NHOID? or is that actually device domain information? really more like manufacturing information and details?

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