Page History

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 original IS example 5 in the SDTMIG 3.4: IS Example 5

In the published examples where NHOID is used, observations are made and tests are run on the bug itself - the result tells you something about the bug:

• 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 the observations/assessments tell you something about the microbe, but not necessarily the host/subject.

In the below example, this is measuring the subject/host immune response (in antibody quantification/titer) toward a vaccine-delivered viral antigen, the observation is about the study subject and how he responses responds 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 in this example 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/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?

Question: Can we expand the scope of NHOID in this case? Why was the variable scope so limited in the first place, where were/are the concerns?

Without NHOID. Where do you map the info that the antibody targets (HUMAN RESPIRATORY SYNCYTIAL VIRUS-PROTEIN B, HUMAN RESPIRATORY SYNCYTIAL VIRUS-PROTEIN Z) are actually from two different strains of RSV virus?

• HUMAN RESPIRATORY SYNCYTIAL VIRUS-PROTEIN B is from Human respiratory syncytial virus MinA    
• HUMAN RESPIRATORY SYNCYTIAL VIRUS-PROTEIN Z is from Human respiratory syncytial virus (strain RSP112/Sweden/02-03)   

With NHOID, but this is stretching the scope of this variable.