Application of the Rules - Flow Diagram Part 2
Use with respect to Transmissible Agents
An IVDD used for donor screening to detect transmissible agents is Class IV.
An IVDD used to determine disease or immune status from transmissible agents is Class II unless:
- It is used for detection of HIV, HTLV, HBV, HCV or HDV - then it is a Class IV;
- It is used to determine disease or immune status for transmissible agents that cause a serious disease where there is a risk of propagation in the Canadian population (M. Tuberculosis, agents causing nosocomial infections) - then it is Class III;
- It detects presence of/exposure to sexually transmitted agents - then it is Class III;
- There is risk an erroneous result would cause death or severe disability (prenatal, neonatal screening) - then it is Class III;
- It detects agents in the blood/CSF - then it is Class III.
An IVDD used to detect transmissible agents for patient management is Class II unless:
- It is used for management of Patients suffering from a life-threatening disease (ie HIV, Hepatitis), then it is Class III;
- An erroneous result would lead to patient management decisions resulting in an imminent life threatening situation, and then it is Class III.
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