Use of artificial intelligence in clinical laboratory testing could improve the diagnosis of cancer worldwide
In a proof of concept study, scientists at Shanghai Jiao Tong University in China have developed a clinical laboratory test that utilizes artificial intelligence (AI) to diagnose three types of cancer from a single drop of dried blood. The paper-based test was able to identify patients with colorectal, gastric, and pancreatic cancers and distinguish between patients with and without cancer.
The team’s goal was to develop a way to diagnose cancer while the disease is still in the earlier stages, especially in rural areas.
“Over a billion people across the world experience a high rate of missed disease diagnosis, an issue that highlights the need for diagnostic tools showing increased accuracy and affordability. In addition, such tools could be used in ecologically fragile and energy-limited regions, pointing to the need for developing solutions that can maximize health gains under limited resources for enhanced sustainability,” the researchers wrote in an article published in the journal Nature Sustainability titled, “A Sustainable Approach to Universal Metabolic Cancer Diagnosis.”
The researchers determined that by using less than 0.05 millimeters of dried blood, their test could accurately and quickly identify if a patient had cancer between 82% to 100% of the time.
According to Chaoyuan Kuang, MD, PhD (above), an oncologist at Montefiore Health System and assistant professor at the Albert Einstein College of Medicine, unlike liquid blood, dried serum can be “collected, stored, and transported at much lower cost and with much simpler equipment,” Live Science reported. “This could help democratize the availability of cancer early detection testing across the world,” he added. A paper-based clinical laboratory test that can detect and distinguish one cancer type from another would be a boon to cancer diagnosis worldwide. (Photo copyright: Albert Einstein College of Medicine.)
Improving Cancer Screening in Rural Areas
An earlier study conducted in China in 2022 examined results from 1,570 cancer survivors from both urban and rural areas of China. That study showed that 84.1% of the patients were diagnosed with cancer only after developing symptoms and that urban patients were more likely to be diagnosed in the early stages of cancer. In addition, rural patients also had less screening and treatment options available to them.
The researchers in this latest Chinese study tested their AI model on blood donors with and without cancer and compared the results to traditional liquid-blood biopsy tests.
“Based on modeling they performed, they reported the new tool could reduce the estimated proportion of undiagnosed cases of pancreatic, gastric, and colorectal cancers by about 20% to 50% if it was used for population-level cancer screening in rural China,” Live Science reported.
The scientists used dried serum spots (DSS) and machine learning to perform the research. According to their Nature Sustainability paper, DSS can be challenging in cancer research because sensitive biomarkers in the samples are often degraded or have inadequate amount of blood for proper analysis. To circumvent these issues, the researchers used nanoparticle-enhanced laser desorption/ionization mass spectrometry (NPELDI MS) to increase reliability and sensitivity. Inorganic nanoparticles were applied to the samples to strengthen selectivity and refine metabolic compounds from the samples.
However, the study authors noted that “the adaptation of NPELDI MS to dried spot analysis has not been validated,” Interesting Engineering reported.
A ‘Great Start’
The machine learning algorithm the Chinese scientists created demonstrates that DSS samples can be used to preserve important biological markers and could be beneficial in the diagnosis of cancer.
Their research indicated an overall reduction rate of undiagnosed cancers in the range of 20.35% to 55.10%. The researchers estimated the implementation of their AI tool could reduce the proportion of specific undiagnosed cancer cases in rural China by:
84.30% to 29.20% for colorectal cancer,
77.57% to 57.22% for gastric cancer, and
34.56% to 9.30% for pancreatic cancer.
It’s a “great start,” Chaoyuan Kuang, MD, PhD, an oncologist at Montefiore Health System and assistant professor at the Albert Einstein College of Medicine told Live Science. “This cancer test won’t enter use for a long time,” he said. Nevertheless, the potential of the tool is “immense,” he added, but that “we are still years away from being able to offer this test to patients.
“With further development, it could theoretically be used for the early detection of other types of cancer or for other diseases, or to monitor the progression of disease in patients who have already been diagnosed,” he noted.
Further research and clinical trials are needed before this AI tool can be used in a clinical diagnostic setting. This study is another example of researchers looking for cancer biomarkers in specimen types that are not tissue and further supports the hope that machine learning may one day detect cancer in earlier stages, increase survival rates, and save healthcare costs.
One factor motivating this type of research in China is the fact that the nation has more than 36,000 hospitals and approximately 20,000 anatomic pathologists. Of this total, only a minority of these pathologists have been trained to the standards of North America and Northern Europe.
Like other nations, China’s demand for subspecialist pathology services outstrips its supply of such pathologists. This is the reason why researchers in that country want to develop diagnostic assays for cancer and other diseases that are faster, cheaper, and comparable to a human pathologist in accuracy.
Bioeasy stands behind the accuracy of its coronavirus test kits and, in a statement, questioned whether they were being used correctly
How accurate are the SARS-CoV-2 test kits being offered by different in vitro diagnostics companies, as well as the internally-developed COVID-19 tests developed by individual medical laboratories, both here in the United States and in other countries? It’s a question that has not been addressed by the news media nor by healthcare regulators.
That
is why a recent news story reported complaints by authorities in several
European countries that COVID-19 tests they had purchased were “unreliable.”
The source of the COVID-19 test kits was a Chinese company.
On Wednesday, government officials in China announced that manufacturers of test kits for SARS-CoV-2, the novel coronavirus that causes the COVID-19 illness, can no longer export their tests unless China’s National Medical Products Administration (NMPA) has licensed and registered those tests, the South China Morning Post (SCMP) reported.
China issued the new rules after receiving complaints from buyers in Europe about the quality and accuracy of tests kits and other products, including personal protective equipment (PPE), ventilators, and infrared thermometers, SCMP wrote. Previously, Chinese exporters were required only to have CE certification to indicate that their goods conformed to the health and safety standards required for sale in the European Economic Area, SCMP added.
In a joint statement issued March 31, China’s Ministry of Commerce, General Administration of Customs (GAC), and the National Medical Products Administration said the new rule applies to all companies seeking to export test kits, face masks, protective clothing, ventilators, and infrared thermometers.
Spain
Discontinues Use of Rapid Diagnostic Tests from Bioeasy
The new rules came after health authorities in Spain stopped using a rapid diagnostic test (RDT) kit that required a nasopharyngeal (NP) swab to collect specimens to diagnose patients for the SARS-CoV-2 virus, saying the test kits from Shenzhen Bioeasy Biotechnology were unreliable. Turkey also rejected the Shenzen Bioeasy test kits after finding similar problems, according to The Middle East Eye. Ukraine and Georgia also bought kits from Bioeasy, according to published reports.
The low accuracy rate of the Bioeasy coronavirus test kits raises questions about the rapid rate of development for new tests in the United States and worldwide, said Michael Noble, MD, FRCPC, Chair of the University of British Columbia (UBC) Clinical Microbiology Proficiency Testing program and the UBC Program Office for Laboratory Quality Management, in Vancouver.
“There’s
an inherent problem with building a test during a crisis,” Noble said in an
interview with Dark Daily. “Clinical laboratory test developers are
being forced into building tests in a hurry, and the highest likelihood is that
they will fail because these tests take a lot of time if the aim is to get them
right.
“When
a company or a lab feels the need to go too fast, it is likely to take
shortcuts,” he added. “And every time a shortcut is taken, an opportunity for
error is created.
“Also,
the federal Food and Drug Administration (FDA) may be going too fast to issue
emergency use authorizations (EUAs). If laboratory test developers and the FDA
go too fast, then both could make mistakes,” Noble noted.
“The lesson for labs in the United States and everywhere is you can’t go too fast and you don’t want to go too slow either,” Michael Noble, MD (above), Chair of the University of British Columbia Clinical Microbiology Proficiency Testing Program, told Dark Daily. “Instead, you need to proceed as quickly as you can, but also take as long as you need to ensure you follow all the steps accurately.” (Photo copyright: The Dark Report.)
Bioeasy
Questions Whether Tests are Being Used Correctly
On
March 27, SCMP reported that Shenzhen Bioeasy would send new kits to
ensure that “patients get the best diagnostics” and to “ensure the test kits’
sensitivity and specificity.” The company also raised questions about whether
the tests were used properly and promised to send a video explaining how those
administering the tests should collect specimens using NP swabs.
“As
it [is a] rapid test kit, following the protocol is very important,” the
company added, according to SCMP.
Last
week, Zhu Hai, a manager at
Shenzen Bioeasy, said reports that the test kits had a low accuracy rate were
untrue, SCMP reported. A more detailed explanation would be given via
official Chinese government channels, he added.
Shenzen
Bioeasy also issued a statement about the tests, saying, “The production export
of our CE products to Spain has been done according [to] regulations. All
Bioeasy COVID-19 rapid test [kits] are officially CE-IVD approved, so we are free
to [export] and sell in [the EU],” SCMP reported.
The company exported 337,000 tests to South Korea and more than 420,000 test kits to at least 10 countries, including Italy, Qatar, and Ukraine, the company added. It had five million such kits under production, the company said.
Spain
Purchased More than Half a Million Bioeasy Test Kits
One
of the first publications to report the inaccuracy problems was El País, a Spanish
language daily newspaper in Madrid.
The
Shenzen Bioeasy tests functioned much like pregnancy tests, the newspaper
wrote. Once the sample is taken, the NP swab is diluted and placed into a
cartridge with a lined test strip showing whether the result is positive,
negative, or invalid. “The tests detect the presence of antigen and the result is obtained in 10
or 15 minutes,” El País wrote.
Based
in part on a claim that the medical laboratory test kits have an 80% accuracy
rate, the government purchased 640,000 kits to screen health workers and the
elderly. If the Chinese tests were of sufficient quality, negative or doubtful
results would require a confirmatory molecular diagnostics test, the
newspaper added.
The
Chinese embassy in Spain also responded, saying on Twitter on March 26 that
the country’s National Medical Products Administration had not approved the
tests, and that they were not included in the medical supplies the Chinese
government sent to Spain, SCMP reported. “The Chinese Ministry of
Commerce offered Spain a list of approved suppliers, in which Shenzhen Bioeasy
Biotechnology was not included,” the embassy added.
After
the low accuracy rates were reported, the Spanish government said it ordered
€432 million (US$468 million) worth of medical supplies from China, 5.5 million
test kits, 550 million face masks, and 950 ventilators, SCMP added. But
none of the kits in this order were from Shenzen Bioeasy, the government said.
SCMP quoted Professor Leo Poon
Lit-man, BSc, MPhil, DPhil, FFPH, an expert in the SARS-CoV-2 coronavirus
who helped design a testing protocol for the COVID-19 illness, and who is a
Professor and Division Head of the Division of Public Health Laboratory
Sciences at The University of Hong Kong. A claim of 80% accuracy
for a test using nasal swabs was perplexing, because such tests are known to be
inaccurate, Poon said. “It would be dangerous if it’s used on a large scale,
since patients who are supposed to be positive might not be detected,” he
added.
Pathologists
and clinical laboratory scientists know there are many reasons why a clinical
laboratory test can be unreliable or inaccurate. For example, during the
production of a batch of tests, one step in the manufacturing process may have
gone awry and that problem was not detected before those tests were shipped to
a medical laboratory.
Unfortunately,
when lab tests are proved to be “unreliable” or inaccurate, the public or the
medical laboratory profession seldom learn the reasons for these problems and
what steps were taken to resolve them.
Violence by patients against physicians in China is a reminder to pathologists and clinical laboratory professionals about the importance of gaining patient trust in local medical laboratory test providers too
Medical errors, inaccurate diagnoses, and poor clinical care by clinicians in China are believed to be the primary reasons why a growing number of Chinese patients are physically attacking their doctors. Hospitals in China are beefing up security to protect physicians from what are often violent attacks.
This trend is a reminder to pathologists and clinical laboratory professionals in the United States and other developed nations of how essential it is maintain patients’ complete confidence and trust in their caregivers. That trust is anchored in accurate medical laboratory testing, precise diagnosis, and high-quality clinical care that is appropriate to a patient’s disease or health problem.
More Chinese Patients Turn Violent on Physicians and Caregivers
What makes this trend particularly noteworthy is that Chinese people are often viewed as patient and obedient. Now, however, when it comes to their healthcare, a growing number of Chinese patients are not patently compliant or meek. Over the last decade, disgruntled patients or family members have turned the nation’s hospitals into scary places for doctors and nurses to work. That’s because violent attacks on caregivers are increasing at an alarming rate.
China’s 1,000 top hospitals have seen a rise in “disputes escalating into violence, as well as random attacks,” stated Sun Haibo, Department Chief at China’s Ministry of Public Security’s Public Security Management Bureau in Bejing, in a recent report published by Bloomberg Businessweek. (more…)
Prenatal testing, the most popular in China, is banned, affecting current projects at providers—another lesson for laboratories in how quickly things change
Genetic testing has been halted in China. This unexpected decree was announced in February. Government officials cited challenges surrounding “ethics, privacy, and the protection of human heredity resources, in a message posted on the China Food and Drug Administration’s website.
Authorities named prenatal DNA tests in particular as an area of concern in genetic testing. This may surprise pathologists and clinical laboratory professionals, who have regularly read about the substantial investments major Chinese companies have made in the field of gene sequencing. (more…)
Telemedicine allows U.S. pathologists and other specialists to boost revenue by consulting with international partners.
Pathology laboratories in the United States are among the first adopters of a trend toward international telemedicine.
Pathologists working at a handful of well-known healthcare organizations here in the United States are forming partnerships with other hospitals and health systems worldwide, particularly in China. (more…)
