Lecture 1

Question 1

What additional aims does NPT

Answer 1

1.Medical outcome- quicker response, reduced complications. satisfaction

2.Economic- optimised drug, reduced hospital stay,

3.rapid response- earlier treatment, improved patient outcome, less reliance

Question 2

What stimulates demand for NPT?

Answer 2

1.Aging demographics, 2.chronic disease 3.personalized medicine, 4.long-term savings, 5.improvements technology,
6.improved care

Question 3

Why has POCT/NPT became so topical

Answer 3

1. Emphasis on patient-focused care,

2.changes in healthcare practices,

3.advances in POCT technology

4.connectivity of modern POC test systems.

Question 4

What does the Medical Devices Directive (93/42/EEC) define as a medical device (MD)?

Answer 4

Any instrument or article used for diagnosis, prevention, monitoring, treatment, or alleviation of disease, among other purposes for human beings.

Question 5

What does Regulation (EU) 2017/746 (IVDR) define as an in-vitro diagnostic (IVD) medical device?

Answer 5

Any device used in vitro for examining specimens derived from the human body to provide information on various physiological or pathological processes.

Question 6

Category I NPT devices

Answer 6

Small handheld devices for qualitative or quantitative analyte determination, such as glucose biosensor strips.

Question 7

Category II NPT devices

Answer 7

Larger bench-top devices, like critical care analyzers, often using molecular techniques for infectious disease testing.

Question 8

Where is NPT used outside of hospital and community settings?

Answer 8

Disaster management, extreme environments, military operations, and space research.

Question 9

Other settings NPT used

Answer 9

disaster management
extreme enviroments
military
space research