Patients at a clinic in a rural area could get lipid screening with point of care devices under a partnership between AACC and CDC

Cardiovascular disease (CVD), including heart disease and stroke, is the leading cause of death globally, and more than three-quarters of deaths are in low- and middle-income countries. Early detection, typically through lipid screening, is critical in preventing complications and deaths, especially in underserved areas. However, access to reliable lipid screening varies greatly.

In 2020, AACC launched a partnership with the Centers for Disease Control and Prevention (CDC) and the CDC Foundation to reduce the high mortality rate from CVD in resource-limited countries by expanding access to quality point-of-care (POC) lipid screening. The AACC-CDC collaboration focuses on training clinical laboratorians to administer and manage a POC lipid screening program in their communities.

“Point-of-care testing devices are a very successful model for delivering clinical laboratory services because their portability lets you bring the lab to the patient,” said James Nichols, PhD, DABCC, FADLM, professor of pathology at Vanderbilt University Medical Center in Nashville, and an AACC member who worked on designing the training curriculum. “But in financially strapped regions the quality of that testing, including technician training, lags behind what’s accepted in advanced economy countries.”

Lipid Screening and POC Technology

Lipid screening plays a critical role in early CVD detection. A lipid screen performed by a clinical laboratorian can identify individuals at high risk of developing CVD, prompting them to get additional testing with their physician.

However, in low- and middle-income countries, well-equipped and well-organized laboratories often exist alongside those with out-of-date instruments and technicians who have not received adequate training. And some areas do not have access to laboratory testing at all.

“As a result, CVD detection can be very late in the course of the disease, and people can die at a younger age, often in their most productive years,” said Hubert Vesper, PhD, director of clinical standardization programs for CDC. “Identifying those at highest risk of CVD and ensuring they receive appropriate treatment can prevent premature deaths.”

AACC and CDC are working together with local laboratory medicine societies to improve both access and quality. Ultimately, the goal is to identify people at high risk of developing CVD and channel them further into the healthcare system where they can have their risk investigated before they develop serious health problems.

Designing a Custom POC Curriculum

AACC’s point-of-care testing subject matter experts and representatives from CDC worked together to design the POC lipid screening curriculum, with the Philippines as the first site for deployment.

The curriculum has three main parts: training on quality management for POC lipid testing, training on country-specific rules and regulations for POC testing, and manufacturer-led training on how to use the actual device.

“We designed the training modules to have a strong focus on total quality management and on practical exercises,” Nichols said.

This includes quality management for testing as well as for acquiring and storing reagents and ensuring patient and physician satisfaction. The original modules for this part of the program include live, 2-day on-site training for laboratorians by two AACC lecturers with expertise in cardiology, POC testing, and quality control and assurance.

Also integral to the program is engagement with local subject matter experts. The AACC-CDC team joined with local experts through the Philippine Association of Medical Technologists (PAMET) to tailor the content to the country.

“We want a program that is the best fit, that considers feedback from local expertise combined with our programmatic expertise,” said Bill Clarke, PhD, DABCC, FADLM, director of clinical toxicology and professor of pathology at Johns Hopkins Hospital in Baltimore. Clarke worked with Nichols on developing the curriculum.

The PAMET partnership is led by the organization’s past president Leila Lany Florento, PhD. “We all know that point-of-care testing has had a great impact on the clinical laboratory. The technology is helpful not only because it is cost-effective and fast—it also guides doctors on what to do next,” said Florento. “The use of this point-of-care device will better identify which patients need more diagnostic investigation.”

Florento and her PAMET colleagues chose the South Luzon region as a starting point for the program, but they plan to use the materials and train additional laboratory practitioners in other regions of the country in the future.

Program assessment is scheduled to take place 2−3 months post-training.

With COVID-19, Training Goes Virtual

The goal of the pilot phase of the POC lipid screening program, which began in early 2020, was to train 20 laboratorians in the Philippines. However, like many plans for 2020, COVID-19 threw that agenda out the window.

The pandemic halted travel, making in-person training impossible, so the Philippines team adapted the training modules to virtual platforms. In hindsight, this may make the training modules easier to share and implement in areas where live instruction, for whatever reason, is not an option.

The U.S.-based training team will travel to the Philippines and visit several participants in their healthcare settings to assess their use of the device and device performance.

Next Stop, Bolivia

An AACC team is working concurrently to prepare a POC lipid screening program for Santa Cruz, Bolivia, with national clinical chemistry society partner La Sociedad Boliviana de Bioquímica Clínica (SOBOBIOCLI).

One of the people leading this effort is Veronica Luzzi, PhD, DABCC, FADLM, section chief and medical director of the Tricore Research Institute in Albuquerque, New Mexico. The Bolivia program will use some of the virtual training modules developed by the Philippines team.

“The training the laboratorians will receive is very important, because lack of training and education may lead to inadequate use of the devices and perhaps inappropriate patient treatment,” Luzzi said. “Our group is going to be teaching laboratory professionals how to maintain a quality program for monitoring the use of the POC devices, as well as testing accuracy and risk management.”

The Bolivia program is aiming to start an in-person training workshop by mid-September 2022.

Leveraging Advantages of POC Testing

POC testing devices are known for offering low cost, portable testing. But in this case the benefits go beyond mere convenience.

“As the testing volumes increase, we expect that the clinical laboratory specialists that go through this training program will be facilitating or overseeing the testing. That’s why we are spending so much time on training,” said Clarke. “We want to share with them our experience in not just the testing protocol, but also in how to ensure quality in testing and in patient and physician satisfaction in less controlled environments outside the hospital or clinical lab.”

Looking beyond the AACC-CDC collaboration, advancements in POC technology are creating more opportunities for better patient outcomes in all healthcare settings.

“A similar strategy could be used here in the United States,” Nichols said, “to help address disparities in access to care that occur because of race and economic status.”

Sarah Michaud is a freelance writer who lives in London. Email: [email protected]