Evidence-Based Medicine in Point-of-Care Testing

EBM offers fact-based support for medical decision-making, reducing subjectivity and practice variability

Evidence-based medicine (EBM) is the conscientious, explicit and judicious use of current best evidence in making decisions about the care of individual patients. It is the integration of best research evidence with clinical expertise and patient values. Best research evidence includes both clinically relevant studies and research in the basic sciences.

It is important that the practice of POCT is evidence-based. EBM offers fact-based support for medical decision-making, reducing subjectivity and practice variability. It is also important to separate the facts from conjecture when implementing and utilizing POCT devices, and to define the mechanisms and strategies for optimizing health outcomes.

Read more:
The Importance of Evidence-Based Medicine in Point-of-Care Testing

Source: Alere

Point-of-care testing for blood cell count

With the arrival of the 21. Century we have witnessed automatisation on the market. Bringing machines and informatics to workplaces with a lot of people and/or samples circulating, we have made it both easier and faster to get the necessary results. That is the very reason the automatisation had to come to the laboratories. Even though in the laboratories there is laboratory staff specifically educated for maneuvering with machines designed for preanalytical and analytical parts of the analisis, today there are machines operating on laboratory samples outside of the laboratory. Glucometers and different opium detecting tests are very common these days, however, is there a way of detecting leukemias and infections from the ones home?

The answer has been brought to us by Athelas. Athelas is the first ever in – home blood diagnostic platform. Its base is counting white blood cells and facilitating the control over the progress of the disease of chemo patients, immunocompromised patients and ones submissive to different infections. The way Athelas works is similar to glucometers. Take a simple prick of blood with lancet, press against the Test Strip, and stick it into the system. Within a few minutes an integrated cell counting app will appear on your monitor.

From the Athelas Company they explain that Athelas is built on deep learning technology that uses machine vision to rapidly analyze blood cells and generate diagnostic reports. Instead of traditional coulter counting or flow based techniques (such as flow cytometry) Athelas is able to maintain a high degree of precision on drop samples; performing with greater accuracy than other existing technologies.

Blood cell counts enable a rapid analysis of a patient's various immune, hematological, and general conditions. Athelas is primary made for immunocompromised patients who aim to monitor their white blood cell counts more often and it forces them to visit the doctor and the laboratory frequently. With Athelas they'd be provided with technology to monitor their WBCs at home and better determine when it is really necessary to visit a doctor. WBCs offer a unique insight as to this - indicating anything from inflammatory response, all the way to leukemia based on cell count ranges.

However, Athelas is not providing us only with white blood cell counters, it also has the ability to count the erythrocytes, diagnosing the anemias and polycythemias; it offers differential blood count and hematocrit as well. In the Athelas Company they are working on the ability to analise UTI (urine tract infections) and pyurias from a single drop of urine.

Athelas is regulated as a Class 1 Exempt Device under Product Codes GHO and KPA by the FDA. They are in filing process for the a range of tests under the 510(k) product code GLK and GKZ. [1]

Athelas is currently still in the testing phase, it has been tested by 25 clinics, of which the first one was FEMAP (First Episode Mood and Anxiety Program) hospital. It has been approved for the in – home testing and people who decide to test it at home can do it for the price of 99$. The Athelas staff promises a 24 hour online support. You can get it on the Athelas official website: http://getathelas.com/index.html .

Author: Ines Poljak,  cand. for bacc. med. lab. diagn.
Images: Athelas


[1] http://getathelas.com/fda/index.html

A new biosensor test system based on magnetic nanoparticles suitable for POCT

Researchers from the General Physics Institute of the Russian Academy of Sciences (GPI RAS) and Moscow Institute of Physics and Technology (MIPT) have developed a new biosensor test system based on magnetic nanoparticles. It is designed to provide highly accurate measurements of the concentration of protein molecules (e.g. markers, which indicate the onset or development of a disease) in various samples, including opaque solutions or strongly coloured liquids.

At molecular level, the magnetic nanoparticles "link" with antibodies to the required protein and then they are placed on a porous plate close to the intended point of contact with the test solution. The liquid, which spreads along the plate due to capillary action, captures the magnetic particles. It then meets two lines - the test line and the control line. The test line contains antibodies that capture the protein in question and also the magnetic markers that became attached to molecules of the protein due to the fact that the nanoparticles are also "linked" to the antibodies. The control line only captures the antibodies with magnetic markers, and it will be activated in any case, if the test strip is usable. The control line serves as an indicator as to whether the test is suitable for use, the protein antibodies in it have not been destroyed due to improper storage, and the test liquid has been applied correctly.

The combination of reliability, accessibility, and high accuracy and sensitivity of the new method means that it is likely to make a rapid transition from a laboratory prototype to mass production.

Read more:
Scientists have put a high precision blood assay into a simple test strip

Source: EurekAlert! Science News

Simple point-of-care tests are error proof, right?

As a laboratory professionals, we struggle with the concept of point-of-care testing. The majority of point-of-care tests are performed by non-laboratorians who may not appreciate the nuances of lab testing. Laboratory testing matters whoever is performing the test. In our quest to deliver rapid, actionable test results, have we lost the essential emphasis on quality? Just because a test is simple to perform doesn’t mean it should be done in a cavalier way. Every test, every time, for every patient no matter how simple the test may be should be done with attention to quality, competency and learning from errors.

Why does lab testing matter? Because patient care decisions are frequently based on lab test results. Quality is not just important; it’s essential. Our patients deserve nothing less.

Read more:
Simple Tests are Error Proof, Right?

How many RBC transfusions have been ordered based on an erroneous fingerstick hemoglobin result?

Clinical Laboratory professionals know that point of care test results performed on a fingerstick sample of blood are often less accurate and precise than results performed on a central laboratory analyzer using a venous sample. Improvements in point of care technology have greatly improved the analytical performance of point of care devices. A recent study published in the American Journal of Clinical Pathology convincingly demonstrated that much of the variability in point of care testing occurs during the preanalytical phase of collecting a fingerstick sample of blood.

Compared to tests on venous blood, the coefficient of variation for successive drops of fingerstick blood exceeded venous blood by 3.4 times for hemoglobin, 5.7 times for WBC count, 3.0 times for lymphocyte count, 7.7 times for granulocyte count, and 4.0 times for platelet count. In some individuals, hemoglobin concentration differed by more than two g/dL between two successive drops of blood.

Read more:
Questionable Accuracy of Point of Care Tests Performed on Fingerstick Blood Samples 

Source: ClinLab Navigator

POCT ring can diagnose sexually transmitted diseases in a minute

A ring with the ability to diagnose sexually transmitted diseases like syphilis, gonorrhea, chlamydia and trichomoniasis was designed by the Mexican Ernesto Rodríguez Leal. The portable medical device called Hoope is a ring that is placed in the thumb, contains a disposable cartridge with a retractable needle for single use and sends the data to a smartphone in less than a minute.

The ring functions as a home diagnostic tool that distributes blood into four microfluidic channels. There are antigens specifically synthesized to catch antibodies for each of the diseases, their interaction functions as a lock and key mechanism. If antibodies for any of the conditions exists, the antigens trap them and produce an electrochemical reaction. After, these data is wirelessly transmitted to a smartphone or tablet, where an app gives results in less than a minute

Read more:
New ring can diagnose sexually transmitted diseases in a single test

Source: Investigación y Desarrollo

Point-of-Care Asthma and Tuberculosis Diagnostics

A device to mix liquids utilizing ultrasonics is the first and most difficult component in a miniaturized system for low-cost analysis of sputum from patients with pulmonary diseases such as tuberculosis and asthma. The device, developed by engineers at Penn State in collaboration with researchers at the National Heart, Lung, and Blood Institute (NHLBI), part of the National Institutes of Health, and the Washington University School of Medicine, will benefit patients in the U.S., where 12 percent of the population, or around 19 million people, have asthma, and in undeveloped regions where TB is still a widespread and often deadly contagion.

Stewart J. Levine, a Senior Investigator and Chief of the Laboratory of Asthma and Lung Inflammation in the Division of Intramural Research at NHLBI, said “This on-chip sputum liquefier is a significant advance regarding our goal of developing a point-of-care diagnostic device that will determine the type of inflammation present in the lungs of asthmatics. This will allow health care providers to individualize asthma treatments for each patient and advance the goal of bringing precision medicine into clinical practice.”

Read more:
On-Chip Processor the First Step in Point-of-Care Asthma and Tuberculosis Diagnostics

Source: The Pennsylvania State University
Image credits: Journal Lab on a Chip

Point of Care Flow Cytometry

Biological and medical scientists have been using flow cytometry to count cancer cells for the past 40 years. But the large instruments are expensive and can only be operated by trained personnel. By contrast the PoCyton cytometer developed by Fraunhofer researchers is cheap to produce, no bigger than a shoebox, and automated.

Existing flow cytometers are capable of measuring the quantity of tumor cells circulating in the bloodstream but they often cost up to 300,000 euros and take up a huge amount of space – equivalent to two washing machines. Moreover, each test cycle lasts several hours. All in all, such techniques are too expensive and time-consuming for everyday clinical practice. A further downside of these cytometers is that they can only be operated by trained specialists and require daily recalibration. An alternative is the PoCyton device developed by researchers at the micro-engineering branch of the Fraunhofer Institute for Chemical Technology in Mainz (IMM). As Dr. Michael Baßler, research scientist at ICT-IMM, explains: “Our flow cytometer enables such tests to be carried out around twenty times faster. Their cost is also lower by several magnitudes, which takes us into a new dimension that makes these devices much more affordable for clinical applications.” Another advantage of the new flow cytometer is the use of miniaturized components that have reduced its size to that of a shoebox. Measurements are carried out automatically, and no calibration is necessary.

Read more:
Automated counting of tumor cells in blood

 Source: Fraunhofer

HIV home test kit

An early diagnosis allows people to get treatment quickly and can prevent serious complications. And individuals successfully treated for HIV are less likely to pass the infection on. This new "do-it-yourself" test is made by company Bio Sure UK and can be bought online.

It works in a similar way to a pregnancy test, measuring levels of antibodies - proteins made in response to the virus - in a person's blood. The device analyses a small droplet of blood, taken from the finger-tip using a lancet. Two purple lines appear if it is positive. The company recommends attending sexual health clinics for advice and further blood tests if both lines appear.

Read more:
HIV home test kit goes on sale in UK

Source: BBC

No-Blood Glucose Monitor Watch

This device uses non-invasive spectrometric process as well as electrical sampling that has been well published recently but advanced by our engineers to determine Sp02 levels and Glucose using low-cost wavelength specific transmitters and receptors. Systolic pressure is calculated by comparing an ECG waveform to the spectroscopic waveform using the Pulse Transit Time Method (PTT).

Infra V is also testing sensors for kidney function such as creatinine, urea and lactic acid levels for many other issues and also close monitoring for intensive physical training and EEG add-on.

Read more:
InfraV No-Blood, Glucose Vital Signs Monitor Watch

 Source: Indiegogo

Medical Lab On Your Smartphone

Health tech startup Scanadu is working on the cutting-edge of a new type of medical technology that could one day put the hospital in the palm of our hands.  It just started shipping its first product Scout, a device that can detect your temperature, blood pressure and other biological phenomenon and then upload that information into an app.

Scanadu is now in the testing phase with Scanaflo. This is an iPhone-ready urinalysis strip and application to read the strip results.

Read more:
New Pee Stick Puts The Medical Lab On Your Smartphone 

Source: TechCrunch

Lab-on-paper for rapid, inexpensive medical diagnostics

A team of University of Rhode Island engineers led by Professor Mohammad Faghri has created a new paper-based platform for conducting a wide range of complex medical diagnostics. The key development was the invention of fluid actuated valves embedded in the paper that allow for sequential manipulation of sample fluids and multiple reagents in a controlled manner to perform complex multi-step immune-detection tests without human intervention.

Faghri said that the platform technology can potentially be applied to a wide variety of medical diagnostics, from Lyme disease and HIV to Ebola and malaria.

A number of diagnostics companies are currently evaluating this lab-on-paper microfluidics technology as the industry moves from lab-based testing to point-of-care rapid, autonomous diagnostics

Read more:
News - University of Rhode Island

Source: University of Rhode Island

Angry Birds Glucose Meter for Kids

When CEO of Modz, Vesa Kemppainen scanned the blood glucose meter market, all he saw was a sea of grey. "All the products and the tech [for these meters] looked grey and unappealing," and "People who had these devices were embarrassed to show anyone else."

So Kemppainen and his team at the Finland based health technology company took action. After talking with children and healthcare specialists, they came up with Modz -- the world's first motivational, Angry Birds themed blood glucose meter, which launches 9 February, 2015 in the UK and Europe.

Read more:
Modz diabetes self-care device gives kids back their freedom

Using Glucose Meters in Intensive Care Units

How should I approach evaluating a glucose meter for use in the ICU?

The answer to this question has both patient care and regulatory considerations. For patient care purposes, the choice of sample type may be as important as the choice of device: arterial whole blood offers the most accurate measurement in the ICU, while capillary sampling may lead to erroneous results in patients with poor tissue perfusion. Venous catheter sampling can lead to overestimation of glucose at higher concentrations depending on meter technology. The ideal approach to evaluating a meter is to collect nearly simultaneously whole blood glucose meter samples and plasma or serum laboratory samples. Using the actual end users to perform bedside measurement—and the intended sample type from ICU patients—allows observation of the variables most likely to impact glucose meter accuracy, such as hematocrit effect, medication interferences, and user errors.

To complement a patient-based assessment of meter accuracy, residual serum or plasma specimens can be spiked with medications used in the ICU to detect interferences. While accuracy (bias) and interferences are the most important factors, meter precision at normal, high, and low glucose concentrations is also important. Fortunately, precision of most hospital-use glucose meters is quite good, with a coefficient of variation <5%.

Read more:
Ask the Expert 

Source: AACC
Image: Drahomira Springer

False negative pregnancy tests

False negative pregnancy tests can result in undesirable outcomes (including loss of pregnancy) if inappropriate treatment is given. In a recent study evaluating the performance of devices used in a hospital setting, 9 of 11 devices were found to be susceptible to false negative results when used to test urine solutions containing hCGβcf concentrations observed in normal pregnancy.

Read more:
False negative pregnancy tests: the story continues 

Source: The Pregnancy Lab

This New Ebola Test Is As Easy As a Pregnancy Test, So Why Aren’t We Using It?

New test consists of a small white lancet, which requires just a small drop of blood. In 15 minutes or less, a positive or negative line will appear on the test, indicating Ebola positive or negative.

Dr. Bob Garry and his team are prepped and ready to have hundreds of thousands, “even millions,” of the rapid tests ready to send to West Africa. But without 100 percent proof that it works, they’re at a standstill.

Read more:
This New Ebola Test Is As Easy As a Pregnancy Test, So Why Aren’t We Using It?

Source: The Daily Beast

The Value of POCT

On a day-to-day basis, laboratory professionals work with an unprecedented number of samples. Both to improve efficiency and protect patient anonymity, these samples are carefully labeled, numbered and processed - ensuring that each sample is examined in a scientific manner. But what happens when things become personal for the laboratorians?

Read more:
The Value of Rapid Tests

Source: Advance

POCT - Self-monitoring of Chronic Anemia

The disposable self-testing device analyzes a single droplet of blood using a chemical reagent that produces visible color changes corresponding to different levels of anemia. The basic test produces results in about 60 seconds and requires no electrical power. A companion smartphone application can automatically correlate the visual results to specific blood hemoglobin levels.

Because of its simplicity and ability to deliver results without electricity, the device could also be used in resource-poor nations.

Read more:
One-minute point-of-care anemia test shows promise in new study

Source: Georrgia Tech

Continuous Monitoring of Glucose

The researchers developed a new continuous glucose monitoring material that changes color as glucose levels fluctuate, and the wavelength shift is so precise that doctors and patients may be able to use it for automatic insulin dosing – something not possible using current point measurements like test strips.

Read more:
A glucose meter of a different color provides continuous monitoring 

Source: University of Illinois

Thinking of Introducing POCT – Things to Consider

The aim of the IFCC Task Force for Point of Care Testing is to promote quality in the use, performance, interpretation and reporting of point of care testing across the full spectrum of clinical chemistry and laboratory medicine; to create a forum for high level discussion on a wide range of related topics; and to provide international leadership for developing the clinical practice of POCT in Laboratory Medicine. The PoCT Satellite Meeting held in Istanbul in June 2014 brought together international experts in the field to discuss the concept of PoCT Enabling Patient-Centred Care. Presentations from this meeting are now available for those who were unable to attend this event.

Read more and view the presentations from IFCC meeting:
Point of Care Testing Resources

Source: IFCC