Question 1

One of the problems with performing conventional quality control (QC)testing on a single-use disposable POCT device is that:&#10;A) it is a waste of time and product.&#10;B) qualitative devices will not give appropriate values when tested in this way.&#10;C) it does not assess the competency of each operator.&#10;D) only that single testing unit is monitored.

Accepted Answer

Performing conventional QC testing on a single-use disposable POCT device would only monitor that one particular unit, but it would not assess the consistency or quality of the entire batch of devices. Additionally, QC testing on a disposable device is not always practical or cost-effective, as it is designed to be used only once. Therefore, monitoring the manufacturing process and ensuring good manufacturing practices is more important to ensure overall quality and consistency of the POCT devices.

Question 2

To assess the presence of (not the concentration of)a specific cardiac marker,such as myoglobin in a blood sample,the best POCT analysis to use would be a(n):&#10;A) immunochromatographic technique that is part of a single-use qualitative cartridge test strip.&#10;B) reflectance spectrophotometric technique that is part of a single-use quantitative cartridge with a reader.&#10;C) electrochemical technique that is part of a panel of tests in a multiple-use quantitative bench top device.&#10;D) single use,colorimetric dipstick that is read visually.

Accepted Answer

An immunochromatographic technique in a single-use cartridge test strip is the best option for assessing the presence of a specific cardiac marker, such as myoglobin, as it provides a quick and qualitative result without the need for expensive equipment or specialized skills. Reflectance spectrophotometric techniques require a quantitative cartridge with a reader, which may not be available in all settings, while electrochemical techniques are part of a panel of tests in a multiple-use quantitative benchtop device, which may not be cost-effective or practical for point-of-care testing. A single-use colorimetric dipstick is also not as sensitive or specific as an immunochromatographic technique.

Question 3

One of the most important benefits of connectivity between a POCT device and information systems is:&#10;A) the reduction of time that a laboratorian has to spend transcribing results.&#10;B) the ability of any user to interface with their physician or healthcare provider.&#10;C) the ease of comparing POCT device results with routine laboratory methods.&#10;D) facilitation of the transfer and capture of patient POCT and quality-related data into permanent medical records.

Accepted Answer

The facilitation of the transfer and capture of patient POCT and quality-related data into permanent medical records is a critical benefit of connectivity between a POCT device and information systems. This allows for accurate and complete documentation of a patient's health status and history, improves coordination between healthcare providers, and enables informed medical decision-making. Connectivity also reduces the risk of transcription errors and enhances the efficiency of the diagnostic process.

Question 4

The Connectivity Industry Consortium (CIC)developed a:&#10;A) set of management standards for the whole process of delivering a high quality POCT service.&#10;B) standard that requires all personnel associated with the delivery of diagnostic results demonstrate their competence.&#10;C) set of standards that ensures POCT devices meet critical user requirements such as interfacing between POCT devices and information systems.&#10;D) standard for quality control that allows POCT devices to use a docking station to assess the quality of that device's results.

Accepted Answer

The Connectivity Industry Consortium (CIC) developed a set of standards that ensures POCT devices meet critical user requirements such as interfacing between POCT devices and information systems. This standard is known as the POCT1-A2 standard.

Question 5

An example of in vivo POCT technology would be:&#10;A) optical fluorescence.&#10;B) lateral flow immunoassay.&#10;C) light scattering such as nephelometry.&#10;D) spectrophotometry.

Accepted Answer

Optical fluorescence is an in vivo POCT technology as it can be used directly within the body to measure biological markers, unlike the other options which are typically used in vitro.

Question 6

To document that an individual has satisfactorily completed training and been found competent in the use of a point-of-care testing (POCT)device,it is important to:&#10;A) use a multiple choice test that is completely objective in nature and record the results.&#10;B) assess a practical demonstration of skill through performance of parallel sample analysis.&#10;C) have the individual present a demonstration seminar and quiz the participants.&#10;D) prepare a computer-assisted learning program that provides testing and recordkeeping.

Accepted Answer

The best way to document an individual's competency in using a POCT device is by assessing a practical demonstration of skill through performance of parallel sample analysis. This ensures that the individual can actually use the device properly and accurately, rather than just memorizing information for a multiple-choice test or giving a presentation. It also allows for real-time feedback and corrections to be made if needed. Option D may be used in addition to practical demonstrations, but should not be the sole method of assessment.

Question 7

Regarding internal quality control (QC)for a bench top analyzer:&#10;A) it is safe to assume that the manufacturer has performed all necessary QC.&#10;B) at least one QC sample should be run a minimum of once per shift.&#10;C) one QC sample should be analyzed whenever there is a change to the testing system.&#10;D) QC samples can be assessed once a day for frequently used devices.

Accepted Answer

Internal QC should be performed regularly to ensure the accuracy and precision of the instrument. A minimum of once per shift is recommended to detect any potential issues early on. It cannot be assumed that the manufacturer has performed all necessary QC, and QC should be run whenever there is a change to the testing system. While daily assessments may be sufficient for some devices, it is not a one-size-fits-all approach and should be tailored to the specific analyzer and its usage.

Question 8

The final step in the documentation of satisfactory training of an individual in the use of a POCT device is:&#10;A) observation of that individual's performance of the entire procedure on three different occasions.&#10;B) submission of a certificate of completion of training to an appropriate accrediting agency.&#10;C) performance by that individual of correlation studies using the POC test and a complex piece of lab equipment.&#10;D) the formal designation of that individual as &#34;POCT-competent.&#34;

Accepted Answer

Observing the individual's performance on multiple occasions is the most thorough way to ensure competency and proficiency in using a POCT device. This allows for identification and correction of any errors or misunderstandings during the training process. The other options listed may be useful for record-keeping or accreditation purposes, but they do not necessarily provide a direct assessment of the individual's ability to perform the test correctly.

Question 9

The component of a point-of-care testing (POCT)system that detects the reaction of the analyte with a binding molecule or some other type of recognition element is the:&#10;A) reaction cell.&#10;B) sensor.&#10;C) sample delivery system.&#10;D) user interface.

Accepted Answer

The sensor is the component that detects the reaction of the analyte with a binding molecule or some other type of recognition element. The reaction cell contains the sample and reagents, the sample delivery system delivers the sample to the reaction cell, and the user interface allows the user to interact with and interpret the results of the system.

Question 10

In the design of a POCT device,the component that coordinates all the other systems and ensures that all the required processes for an analysis take place in the correct order is referred to as the:&#10;A) reaction cell.&#10;B) sensor.&#10;C) control subsystem.&#10;D) sample delivery system.

Accepted Answer

The component that coordinates all the other systems and ensures that all the required processes for an analysis take place in the correct order is referred to as the control subsystem. It is responsible for controlling the actions of other components such as the sample delivery system, reaction cell, and sensor. Therefore, the best choice is C, control subsystem.

Deck 17: Point-Of-Care Instrumentation