lecture 1 Flashcards
According to The College of American Pathologists (CAP) (2015), what is a defining characteristic of POCT/NPT?
A. Requires a permanent dedicated space within a clinical laboratory
B. Designed for use at the patient’s location
C. Must be performed by a certified medical laboratory scientist
D. Involves complex laboratory procedures that require specialized equipment
b)Designed for use at the patient’s location.
The College of American Pathologists (CAP) (2015) defines POCT/NPT as “Tests designed to be used at the site where the patient is located…”
Which of the following is NOT considered an alternative descriptive for Near Patient Testing?
A. Physician’s office testing
B. Centralized laboratory testing
C. Decentralised testing
D. Point of Care testing
Centralized laboratory testing.
The sources list alternative descriptives for Near Patient Testing including physician’s office testing, extra laboratory testing, decentralized testing, off-site, ancillary and alternative testing, and point-of-care testing.
Based on the HSE, PSI, AMLS, ACBI, IMB, RCPI (2010) definition, what is a key feature of a POCT service?
A. It must be performed in a traditional clinical laboratory setting
B. It utilizes analytical devices provided near the patient
C. It focuses on research and development of new diagnostic technologies
D. It prioritizes cost-effectiveness over patient outcomes
It utilizes analytical devices provided near the patient.
A POCT service is defined as “a quality-assured pathology service using analytical devices provided near to the patient rather than in the traditional environment of a clinical laboratory.”
Price & St John (2005) define POCT in terms of its impact on patient care. What is the central aspect of their definition?
A. Testing performed in a centralized laboratory with fast turnaround time
B. Testing that leads to an immediate decision and action improving health outcome
C. Testing that primarily focuses on disease diagnosis rather than treatment monitoring
D. Testing that is solely used in emergency situations requiring rapid results
Testing that leads to an immediate decision and action improving health outcome.
Price & St John (2005) define POCT as: “Any test that is performed at the time at which the test result enables a decision to be made and an action taken that leads to an improved health outcome.”
Which of the following is NOT a primary goal of NPT?
A. Minimizing patient involvement in the healthcare process
B. Reducing hospital visits and length of stay
C. Improving patient adherence to treatment
D. Optimizing drug treatment strategies
Minimizing patient involvement in the healthcare process.
The sources state that a primary goal of NPT is to have the “Patient at the centre of the healthcare process”.
What is a potential economic outcome associated with NPT?
A. Increased reliance on complex and expensive medical procedures
B. Delayed initiation of treatment due to the need for on-site testing
C. Reduced use of staff, equipment, and healthcare facilities
D. Higher healthcare expenditures due to the widespread adoption of NPT
Reduced use of staff, equipment, and healthcare facilities.
The sources list “Reduced use of staff, equipment, estate” as a medical outcome of NPT.
The demand for NPT is stimulated by several factors. Identify the factor that is NOT directly mentioned in the lecture excerpts.
A. Advancements in telemedicine technologies
B. Rising prevalence of chronic diseases
C. Growing emphasis on personalized medicine
D. The aging population and increasing life expectancy
Advancements in telemedicine technologies.
The lecture excerpts mention several factors that stimulate the demand for NPT, including the aging population, chronic disease, personalized medicine, long-term savings, improved technology, and improved care. Advancements in telemedicine technologies are not mentioned.
What is a key distinction between a Medical Device (MD) and an in-vitro diagnostic (IVD) medical device?
A. MDs are used for treatment, while IVDs are used for diagnosis.
B. MDs are regulated by different authorities than IVDs.
C. MDs are typically more complex and sophisticated than IVDs.
D. MDs are used directly on the patient, while IVDs examine specimens derived from the body.
MDs are used directly on the patient, while IVDs examine specimens derived from the body.
A medical device is defined as being used “by human beings” for the purpose of diagnosis, prevention, etc. An in-vitro diagnostic medical device is defined as being used “in vitro for the examination of specimens, including blood and tissue donations, derived from the human body…”
According to Regulation (EU) 2017/746 (IVDR), what is the primary purpose of an in-vitro diagnostic medical device?
A. To replace or modify the anatomy of a physiological process.
B. To provide information for the control of conception.
C. To examine specimens to provide information on physiological or pathological states.
D. To be used as a reagent in chemical synthesis or drug development.
To examine specimens to provide information on physiological or pathological states.
The primary purpose of an in-vitro diagnostic medical device is to examine specimens from the human body “for the purpose of providing information on one or more of the following: a) concerning a physiological or pathological process or state…”
What is a characteristic feature of Category I NPT devices?
A. They are typically large, bench-top devices.
B. They often utilize molecular techniques such as PCR.
C. They are small, handheld devices that may or may not involve a meter.
D. They are primarily used for research purposes in laboratory settings.
They are small, handheld devices that may or may not involve a meter.
The sources define Category I NPT devices as “small handheld devices (with/without meter), providing qualitative or quantitative determination of an increasing range of analytes.”
Category II NPT devices are often distinguished by their size and complexity. What is a typical example of a Category II device?
A. Glucose biosensor strips for blood glucose monitoring.
B. Lateral flow strips for rapid detection of infectious pathogens.
C. Small haematology analyzers for blood cell counts.
D. Home pregnancy tests based on lateral flow assay (LFA) technology.
Small haematology analyzers for blood cell counts.
The lecture states that Category II NPT devices often include “small haematology and immunology analysers.”
The lecture mentions the Pregnancy Test as an example of a specific type of assay. What is the underlying principle of this assay?
A. Amplification of DNA or RNA sequences to detect specific genetic material.
B. Measurement of changes in electrical conductivity due to the presence of an analyte.
C. Binding of antibodies to antigens and visualization of the resulting reaction.
D. Separation of molecules based on their size and charge in an electric field.
Binding of antibodies to antigens and visualization of the resulting reaction.
A pregnancy test is a lateral flow assay (LFA), and the sources describe this as the “Binding of antibodies to antigens and visualising the reaction. Signal correlates with the immunoreaction and allows the detection of the analyte of interest. Chromatographic result shown as coloured lines on the membrane.”
Apart from hospital and community settings, where else are NPTs being utilized?
A. Routine office health check-ups
B. Sports and athletic performance monitoring
C. Disaster management and extreme environments
D. Educational institutions for teaching purposes
Disaster management and extreme environments.
The sources list “Disaster management”, “Extreme environments”, “Military”, and “Space research” as settings where NPT is used.
