E2: Clinical Biochemistry CH7 & CH10

Which analyzer is used for assaying drugs, specific proteins, tumor markers, and hormones? Instruments use fluorescence polarization immunoassay, nephelometry, and immunoassay with chemiluminescent detection.

Immunochemistry Analyzers

Much operator skill and decision making is needed in which type of testing?

Highly complex testing

When handling a request for new or additional POCT, indicate the following. - How is the test requested? - How is test request evaluated? - What should be considered?

- Document request via standardized request form. - Evaluate request using program structure. - Consider whether comparable testing is available in central clinical lab.

What are the accuracy requirements for quality management?

-Comparisons to central laboratory -Harmonization and standardization -Daily QC -Proficiency testing -User competency testing -Management of user records

What are the types of POC analyzers?

-Glucose (highest volume POC test) -Blood chemistry -Coagulation -Cardiac markers -HbA1c -Others

What are the forms or reagent in systems and delivery?

-Liquid: available in bulk volume containers or unit doses -Dry (Bottled as lyophilized powder, requiring reconstitution OR Multilayered dry chemistry slide) -Preservation: refrigeration, reconstitution of dry tablet, or combination of two stable components -Dispensed via tubing from bulk containers, syringes that pipette reagents into reaction containers, piston-driven pumps connected by tubing, or pressurized reagent bottles

What 4 issues should you consider when implementing POCT?

1. Average turnaround time and cost for testing in lab versus POCT 2. Impact on length of stay or patient satisfaction 3. Impact on operational efficiency for department 4. Options for achieving objectives other than POCT

Indicate the 3 types of specimen preparation.

1. Can be automated by robotics. 2. Can be skipped, if whole blood is used for analysis. 3. Plasma separator tube can be used and primary tube sampling performed with heparin plasma

Indicate the steps for specimen measurement and delivery.

1. Circular carousels or rectangular racks hold specimen containers. 2. Primary collection tubes or microsample tubes are placed in carousels or racks. 3. Aliquot is measured through aspiration of sample into a probe. 4. Probe and tubing are cleaned after each dispensing to minimize carryover, unless disposable probes or tips are used.

Identify the 5 driving forces towards automation.

1. Higher volume of testing, faster turnaround time 2. Fewer, more centralized core labs 3. Regulatory standards requiring greater accuracy and precision 4. Intense competition among instrument manufacturers 5. Decreased operating budgets for labs, ability to "walk away"

Identify the 5 advantages to automation.

1. Increases number of tests performed in a lab 2. Decreases labor and cost per test 3. Minimizes variation in results among laboratorians 4. Eliminates potential errors of manual analyses 5. Instruments use very small amounts of samples and reagents

What are the 6 systems for measurement?

1. Ultraviolet, fluorescent, and flame photometry 2. Ion-specific electrodes 3. Gamma counters 4. Luminometers 5, Visible and ultraviolet light spectrophotometry (most common) 6. Fluorescence polarization, chemiluminescence, bioluminescence

What is essential to obtaining accurate information?

Accurate calibration

The following characteristics apply to which phase? - Ever-smaller microsampling - Expanded onboard and total test menus - Accelerated reaction times - Higher-resolution optics - Improved flow through electrodes - Enhanced user-friendly interactive software for quality control, maintenance, and diagnostics - Ergonomic and physical design improvements

Analytic phase (Chemical analyses)

When considering cost, consider not only cost of actual instrument, but all __________.

Associated consumables

Which analyzer has the following characteristics? - First automated analyzer -Introduced by Technicon in 1957 - A continuous flow, single-channel, sequential batch analyzer - Capable of providing a single test result on about 40 samples/h

Autoanalyzer

Which analyzer has the following characteristics? - First noncontinuous flow, discrete analyzer - First instrument to have random access capabilities - Unique features: plastic test packs, positive patient identification, infrequent calibration

Automatic Clinical Analyzer

How is a specimen identified in automated analysis?

Bar code label affixed to primary collection tube

What analysis should be performed on relationship of fixed costs, variable costs, and profits?

Break-even analysis

All testing, including POCT, falls within scope of what agency?

CLIA

Level of testing complexity being performed is regulated by which agency?

CLIA

Multiple instruments that measure the same constituent in a lab should be...

Calibrated so that results are compatible

What has force of centrifugation transfers and contains liquids? It is capable of batch analysis.

Centrifugal analysis

Liquids are pumped through system of continuous tubing and samples are introduced in a sequential manner in what?

Continuous flow

Which support staff is indicated by the following? Responsibilities: facilitate efficient POCT program, serve as link between coordinator and staff, ease training

Designated contacts or trainers in nonlaboratory departments

Which support staff is indicated by the following? - PhD, MD, or DO laboratory scientist or pathologist - Responsibilities: policy, admin, financial, and technical decisions

Director

Which analyzer has the following characteristics? - Ion-selective electrodes, fiberoptics, polychromatic analysis - Sophisticated computer hardware and software for data handling Larger test menus

Discrete Analyzers

Which has separation of each sample and reagent in a separate container and is the most popular type? It can run multiple tests on one sample at a time or multiple samples one test at a time.

Discrete analysis

In preliminary selection of devices/methods, what are some criteria for selection?

Ease of use, cost, test menu, comparability to clinical lab instrumentation, buying group contracts, software features, data management, connectivity

What oversee and enforce CLIA 88?

FDA and CMS

True or false: Computerized monitoring is available for only some parameters.

False. It is available for many parameters.

Which analyzer has the following characteristics? - Spin-off technology from NASA space research - Developed by Dr. Norman Anderson at Oak Ridge National Laboratory - An alternative to continuous flow technology

First Commercial Centrifugal Analyzer

What are the following a component of? - Perform literature search for data on performance of method/instrument. - Contact other users for references, sharing of validation data. - Perform preliminary, limited validation, including mini-correlation. - Select method/instrument.

Implementation: Preliminary Selection of Devices/Methods

In which step is a heating bath used (water or air) to maintain required temperature of reaction mixture?

Incubation

Which analyzer has the following characteristics? - First instrument to use microsample volumes and reagents on slides for dry chemistry analysis - First instrument to incorporate computer technology extensively into its design and use

Kodak Ektachem Analyzer

POCT analyzers usually connected to what?

LIS system

Automated instruments, once calibrated, provide what?

Long-term stability of standard curve; require only monitoring.

The following are components of what? - Coiled tubing (continuous flow analyzers) - Rapid start-stop of reaction tray (RA1000) - Rapid start-stop of rotation or bubbling of air (centrifugal)

Mixing

The chemical reaction phase includes what 4 things?

Mixing, separation, incubation, and reaction time

75% of 12,000 test methods are considered which type of testing?

Moderately complex testing

Which analyzer is a combination of chemistry and immunoassay?

Modular Analyzers

What are some future trends in automation?

More integration and miniaturization of operating systems - More sophisticated portable analyzers - New tests for expanded menus - Spectral-mapping, multiple wavelength monitoring, with high-resolution photometers in analyzers - Extensive use of mass spectrometry and capillary electrophoresis - System and workflow integration with robotics and data management

What utilizes the following methodologies? -Reflectance -Electrochemistry -Immunoturbidity -Lateral flow, flow-through, solid phase -Spectrophotometry -Fluorescence -Polymerase chain reaction

POC Applications

What is usually administered by the lab and testing often performed by nonlaboratory personnel?

POCT

Certain patient information should always accompany what?

Patient result

Which support staff is indicated by the following? Responsibilities: implementing and coordinating POCT, facilitating compliance with procedures, policies, regulations

Point of Care Coordinator

Which analyzers are small, portable, easy to operate, and used in primary in physician office laboratories, surgical and critical care units?

Point-of-Care Benchtop Analyzers

The following characteristics apply to which phase? - Bidirectional communication between analyzers and host computer - Integration of work station managers into communication system - Automated management of quality control data - User-defined perimeters for many values - Need for a "gap-filler" between instrument and laboratory information system

Postanalytic Phase (Data Management)

In which phase, does the automated process replace manual handling?

Preanalytical (sample processing)

The following key components are associated with which phase? - Conveyance system - Bar-coded specimens - Computer software package to control specimen movement - Coordination of robots with instruments as work cells - Automated sorting, centrifugation, uncapping, sample archiving, aliquoting

Preanalytical phase

Which type of testing has special requirements?

Provider-performed microscopy

What depends on rate of transport through system and timed reagent additions?

Reaction time

Advanced automated instruments have method of?

Reporting printed results

Undesirable substances are removed from sample in which step?

Separation

Which analyzer has the following characteristics? - Multiple channels working synchronously - Produced 6 to 12 test results simultaneously at rate of 360 to 720 tests/h

Simultaneous Multiple Analyzer

Define POCT.

Those analytical patient-testing activities provided within the institution, but performed outside the physical facilities of the clinical laboratories.

True or false: Some instruments are self calibrating.

True

Simple tested are considered to be?

Waived tests