Hard-hit Peru's costly bet on cheap COVID-19 antibody tests

BOGOTA, Colombia (AP) - In the early days of the coronavirus pandemic, rushed Peru health officials faced a dilemma. They knew molecular testing for COVID-19 was the best option to detect the virus - but they didn't have the laboratories, nor the supplies, or the technicians to get it working.
But there was a cheaper alternative - antibody tests, mainly from China, which flooded the market at a fraction of the price and could give a positive or negative result in minutes with a simple fingerstick.
In March, President Martin Vizcarra announced that he had completed a massive purchase of 1.6 million tests - almost all for antibodies.
Interviews with experts, public orders, import records, government decisions, patients, and COVID-19 health reports now show the country's bet on rapid antibody tests is dangerously off course.
Unlike almost every other nation, Peru relies heavily on rapid antibody blood tests to diagnose active cases - a purpose they were not designed for. The tests cannot detect early COVID-19 infections, making it difficult to quickly identify and isolate sick people. Epidemiologists surveyed by The Associated Press say their abuse produces a significant number of false positives and negatives, contributing to one of the world's worst COVID-19 outbreaks.
In addition, a number of the antibody tests purchased for use in Peru were rejected by the US after independent analysis found they did not meet standards for accurate detection of COVID-19.
Today, according to John Hopkins University, the South American nation has the highest COVID-19 death rate per capita of any country in the world - and doctors there believe the country's flawed testing approach is one reason.
"This was a multisystem failure," said Dr. Víctor Zamora, Peru's former Minister of Health. "We should have stopped the rapid tests now."
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When COVID-19 cases surfaced around the world, low- and middle-income nations found themselves in a dilemma.
The World Health Organization urged authorities to step up testing to prevent the virus from spreading out of control. One particular test - a polymerase chain reaction test - was seen as the best option. Using a sample taken deep inside the nose, the test is developed on special machines that can detect the genetic material of the virus within days of infection.
If COVID-19 cases are detected early, the sick can be isolated, their contacts tracked and the chain of infection broken.
Within weeks of the first outbreak in China, genomic sequences for the virus were made available and specialists in Asia and Europe were able to create their own tests. But in parts of the world like Africa and Latin America there was no such option. They had to wait for the tests to become available - and when they did, the incredible demand meant most were unable to secure the number they needed.
"The collapse of global cooperation and the failure of international solidarity have pushed Africa out of the diagnostic market," wrote Dr. John Nkengasong, director of Africa CDC, in Nature magazine in April when the hunt began.
Nations that had an early start to preparation or already had a relatively robust health system in place did the best. Two weeks after Colombia identified its first case, the country registered 22 private and public laboratories for PCR testing. Peru, on the other hand, relied on just one laboratory that could run 200 tests a day.
For years, Peru has invested a smaller proportion of its GDP in public health than others in the region. As COVID-19 approached, obvious flaws became apparent in Peru. Only 100 intensive care beds were available for COVID-19 patients, said Dr. Víctor Zamora, who was appointed head of the Peruvian Ministry of Health in March. Corruption scandals had interrupted numerous hospital construction projects. Peru also faced a significant shortage of doctors, forcing the state to launch a massive hiring campaign.
Even now, months later, Peru's needs are far from being met. To date, the country has fewer than 2,000 intensive care beds compared to over 6,000 in the state of Florida, which officially has 10 million fewer people.
High levels of poverty and people dependent on daily wages for informal work hampered the government's efforts to impose strict quarantine and further challenged Peru's ability to respond effectively to the virus.
When Zamora arrived, he said the government had already decided that molecular testing was not a viable option. The nation did not have the infrastructure to run the tests, and it acted too slowly to try to preserve what was little available in the market.
"Peru didn't buy in time," he said. "Everyone in Latin America has bought before us - even Cuba."
Antibody tests that detect proteins made by the immune system in response to a virus have had numerous drawbacks. They had not been fully tested and their accuracy was questionable. If taken too soon, most people with the virus are negative. This could lead those infected to believe they did not have COVID-19. False positives can be just as dangerous and lead people to mistakenly believe they are immune.
Antibody testing did not require highly skilled training or a laboratory. Community workers without medical training could then be trained in administration.
"It was the right decision for the time we were in," said Zamora. "We didn't know today what we knew about the virus."
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Ernesto Canayo, a 44-year-old father and city cleaner in Peru's capital, first wiped away the fever and headache that would not go away.
As a member of the Shipibo-Conibo indigenous community, he lived in a hut on a hill about 10 blocks from the Presidential Palace and Parliament. The one-room house that he shared with his fiancé and his 2-year-old son is held together by wood and plastic sheeting.
In early April, urged to see relatives outside of Lima, his family believed they could better avoid the virus. The symptoms did not start long afterwards. On the phone, he told his sister that he had chest pain. He went to work where he got a quick test.
"Nothing came up," he told her.
Concerned about the loss of his job, he continued to work, rode public transport and even joined members of his community to empty their shared toilets. The Cantagallo district - cock crow in English - has neither normal water nor electricity. Since 2013 officials have pledged improvements. Two city mayors who had promised housing were involved in Latin America's largest transplant tube.
Weeks later, Canayo was still feeling bad and getting worse and worse. Health ministry officials arrived in Cantagllo in early May with 120 rapid tests.
Half of the test subjects were positive - but not Canayo.
"How can you say I don't have it?" he asked his sister later. "I feel all the symptoms."
The test caused confusion and alarm throughout Cantagallo. People who appeared to have no symptoms came back positive, while others were convinced they had tested negative for COVID-19. Those who were positive were quarantined, while those who were negative were told not to have the virus.
"The tests lied," said Harry Pinedo, an artist and teacher in Cantagallo, who said he had numerous symptoms but had tested negative. "You betrayed us."
Canayo's fiancée Evelyn Reyes said he told her that maybe he was just feeling the effects of the weather. At night a cold breeze crept into their unprotected hut. He hardly ever got sick. Two negative COVID-19 tests raise doubts.
"He told me," I'm fine, "she said," I'll take a rest from it. "
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Antibody tests are intended to be used as serological tests to give health officials an indication of how widespread the virus is in a community. Some doctors believe that they can also be a useful tool if a patient with severe COVID-19 has repeatedly taken a negative molecular test but has symptoms. In this case, the virus may no longer be in the airways, but antibodies can be detected.
In Peru, on the other hand, the test is often used for diagnosis.
"We are not using them appropriately," said Dr. Rubén Espinoza, former director of the Peruvian Medical Regulation Agency. "Rapid test results are mentioned as if they were diagnostic results - which just confuses people."
According to public records, the Peruvian central government bought nearly six million antibody tests from four different brands in the first few months of the pandemic. At least one imported from China by Core Technology Co. does not have approval from China's medical regulatory agency. It is unclear whether the company has applied for Chinese approval. Not having it is not necessarily an indicator of quality. The tests can be sold within the European Union as there is no regulatory body to evaluate them before placing them on the market.
Another company of the South Korean company SD Biosensor was subjected to an audit in the USA.
The Group's standard Q antibody test has not been used by the US Food and Drug Administration. The agency does not disclose why tests are being pulled from distribution. This may be due, among other things, to insufficient data being provided or to the fact that it was found not to meet the Agency's standards. An independent analysis of the test, sponsored by the National Cancer Institute, found that it only had a 76.7% overall chance of correctly identifying a positive case.
The Peruvian government claims the standard Q-test they bought is different in that it uses one test strip instead of two, although an FDA spokeswoman said the two were "very similar".
The state of Rhode Island purchased 20,000 SD biosensor antibody tests in April but returned them and received a refund after the FDA banned their use.
The SD biosensor test, which, according to import records compiled by one of the country's leading diagnostic companies and shared with The Associated Press, imported around 5 million to Peru, is still used there. Authorities used it both in the Cantagallo indigenous community and in at least one food market in August.
SD Biosensor and Core Technology did not respond to repeated requests for comment.
Dr. Víctor Suárez, sub-director of the Peruvian National Health Institute, said that qualitative studies were conducted on all tests purchased by the central government and that any that did not meet the country's requirements were returned. However, these tests only make up about half of all rapid antibody tests performed in Peru. Millions more were imported by dozens of other brands, many of which are FDA banned.
Suarez said the government's regulator has been conducting sample surveys of non-governmental purchases and issuing warnings to remove many of them. Public warnings have been issued for a dozen or so tests, but not all that have been questioned.
Overall, despite the questions about individual brands, they would have helped Peru identify more cases than it would otherwise have.
"We did our best to identify most of the possible cases," he said. "Whether through molecular or rapid tests."
Ten of the 80 or so types of antibodies of various brands imported are banned in the United States, records show. A number of them were bought by relatively small, new companies that received substantial orders. A company that until recently had a contract with the Peruvian government applied as a cosmetics brand.
Emergency declaration rules have made it easier to get contracts out and there are fewer safeguards to protect against corruption, said several doctors and pharmaceutical workers.
"They brought tests from just every company," said Victor Chu, director of Diagnostica Peruana, one of the country's older pharmaceutical companies. "Anyone can buy the brand they want, the amount they want with little control."
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The FDA - which countries like Peru routinely turn to for advice - was initially unsure which antibody tests were approved on the market.
The agency has been criticized for being too slow in providing molecular tests. When antibody tests came into the picture, it was decided to move quickly. US regulators put the blood tests on the market without first showing that they worked. All they had to do was notify the FDA of their plans and submit disclaimers.
By May, the FDA announced that it would repeal this policy as part of a crackdown on the quality of emergency products.
"We're sadly seeing unscrupulous actors marketing fraudulent kits and using the pandemic as an opportunity to take advantage of Americans," said FDA Deputy Commissioner Anan Shah.
But it wasn't just Americans who were sold with faulty products.
In Spain, England, India and elsewhere, regulators have rejected the purchased rapid antibody test and found it to give too many false positive or negative results, or both.
Less developed countries without a strong system to validate the accuracy of tests have been slower to remove them, and some are still approved for use today.
"This is clearly a mistake the FDA made in the US and which has had a significant negative ripple effect in other countries," said Peter Pitts, former FDA deputy commissioner. "Any country that has relied on the FDA has to admit that it made a mistake - that it was inappropriately convinced that these tests were correct."
He added, “Bad data only helps the virus spread faster. Bad data costs lives. "
Peru isn't the only country that has imported potentially flawed tests. In Ecuador, Chile, Mexico and elsewhere in Latin America, the lists of approved antibody tests still include some on the FDA's prohibited list. Their governments did not respond to requests for comment.
The specific brand of antibody test used is critical, advised the Infectious Diseases Society of America, a professional organization of medical specialists. Lateral flow assays - like the most commonly used blood prick test in Peru - are particularly inconsistent. Even for surveillance purposes, the Society warned that it is important to run tests with a specificity of 99.5% or greater in order to correctly identify negative cases.
Independent studies sponsored by the National Cancer Institute found that some of the tests, now removed from the US market but still used in other countries like Peru, had low rates for correctly identifying a positive or negative case.
"A lot of people who are sick think that they are negative and they are not," Chu said. “The government is putting up food labels and warning about the amount of fat. Why not do the same for rapid tests when it comes to life or death? "
The company also urged health professionals to do antibody tests three or four weeks after symptoms appear to avoid false results. In Peru, on the other hand, tests are often done within days or just a week of symptoms.
"I would not conclude that they are all bad," said Dr. Angela Caliendo, a board member of the company. “I would conclude that some do noticeably better than others. And if you want to use, take a close look at the performance statistics. "
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In Cantagallo, the nearly 250 families who live in small huts got even sicker after the state's first round of COVID-19 testing.
When government officials returned 10 days later, they discovered far more cases; Of 656 people who received an antibody test, 476 were positive, or nearly 73%. People who tested negative, like Canayo, hadn't isolated properly. Longstanding skepticism about hospitals meant that the sick refused to seek help. As people with close relationships, they were also reluctant to leave those who tested positive alone.
Instead, families kept their sick close and tried to help them recover by natural means such as inhaling the fumes of cooked eucalyptus leaves.
"Everyone was sick," said Pineda, the artist. "Everyone had COVID."
Pictures from a day of mass testing in May show technicians were using a test made by the Chinese company Coretests. Relatively little information is available from its website or from published independent studies. The test is not on the FDA's blacklist, but it is also not approved. It is not approved for use by China's own medical regulatory agency.
Canayo was getting worse and worse. He's had all of the classic COVID-19 symptoms, including a loss of his sense of taste. His fiancée said he took Tylenol but likely needed oxygen that the community didn't have.
The day before Mother's Day, 40-year-old Rossi Canayo called to check on her brother. Although she couldn't see him, she could tell by the sound of his voice that he was sick and upset.
Neighbors came to check on him, but his fiancée and sister were not around, trapped in cities far away amid the nation's strict lockdown.
"He was alone," she said.
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Across Peru, many families have struggled with similarly confusing results.
Janina Huallpa, a phlebotomist in a children's cancer clinic, had a fever in May. She had been out and about in the early months of the pandemic, visiting bus stops, supermarkets and other crowded areas looking for blood donors who could help save lives.
A quick test carried out at work turned out negative. Doubtful she went to a public hospital, where another antibody test also gave a negative result.
"They told me maybe it was an infection," she said.
Over the next three weeks, she got worse and worse, and found it difficult to walk and breathe. She went to the hospital again and again tested negative and sent home. Doctors told her she didn't have the virus.
Worried and afraid, the mother of two went back to the hospital days later when she did not get better. This time the doctors took a chest x-ray and found pneumonia. A fourth rapid test came back negative, but the doctors still decided to send her to a larger hospital in Lima, where she received a molecular test.
The test was positive and she was on a ventilator for 10 days.
When she woke up, doctors told her that eight other people who were admitted to intensive care that same day had died of COVID-19.
"If any of these tests had been positive, I would have received adequate treatment," Huallpa said. "How many people die from it?"
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To date, Peru has diagnosed over 800,000 people with COVID-19. 77% of these cases were diagnosed by rapid antibody tests. In total, over 8 million blood tests were performed - and only 780,000 molecular nasal swabs.
In the worst affected region of the world, it is the country with the third highest number of cases, which is almost the same as Colombia and has almost 20 million more inhabitants.
More than 32,000 people have died, but health officials admit 23,585 others with COVID-19 symptoms may have died before getting a positive test. Even by the lowest statistic, Peru has roughly the same number of deaths as France, which has twice the population.
Some doctors are reluctant to punish the country's heavy reliance on antibody testing. They claim that if used correctly, the tests can be a helpful tool, especially for countries like Peru that do not have extensive molecular testing facilities. Additionally, multiple doctors should make a diagnosis based on symptoms rather than a test - and that multiple factors, including years of underinvestment in health care, are ultimately to blame.
The nation has made strides in expanding molecular testing; There are now 46 public and private laboratories that can process the exams. In addition, Peru recently started using a molecular test created by doctors in the country that can give results within two hours.
"Rapid tests have their place and their timing," said Pilar Mazzetti, Peru's Minister of Health. "No test can detect the virus 100% of the time."
Although Peru can now perform 12,000 molecular tests a day - still far fewer than many other countries in Latin America - it continues to diagnose primarily through antibody tests. Doctors said that widespread misconceptions about the meaning of a positive or negative result on an antibody test lead to serious errors.
"The use of rapid tests has not changed, which is unacceptable to me," said Dr. Ernesto Gozzer, professor at Cayetano Heredia University in Peru.
A variety of jobs - from photo shoots to grocery stores - require employers to have a negative antibody test in order to return to work. The tests - which can cost $ 30 each - have become popular. However, a positive result is not necessarily a sign of active infection. Rather, it may indicate that someone had the virus before.
Likewise, a negative result does not guarantee that someone does not have the virus.
Molecular tests cost around $ 110 each in Lima, or nearly half the monthly minimum wage, making them unreachable for many Peruvians who cannot pay out of pocket and may only get a serological test at a local clinic.
Construction manager Marco Mayo saw firsthand the random results the tests can generate. He used two different tests that were sold under two different brands - one on the left index finger and one on the middle finger. One finger came back positive, the other negative.
He was not allowed to return to work while the results were unclear.
"I lost a month of my life as a result," he said.
Other bad outcomes were far more momentous.
Katy Retamozo, president of the Peruvian Association of Critical Care Nurses, said she saw patients who tested negative on rapid antibody tests return days later with advanced COVID-19 pneumonia. The delay in properly identifying cases could, in their view, be a factor in the country's particularly high mortality rate.
"That delayed her getting to the hospital," she said.
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Rossi Canayo's cell phone rang at 5 a.m. on Mother's Day. At the other end, a voice relayed the message: Your brother was dead.
The news of Ernesto's death scared Cantagallo. Suddenly the virus, which many had dismissed as a distant threat, was in their midst. And if an otherwise healthy adult who tested negative could die a week later, everyone would be vulnerable.
His death has raised questions and torments for his sister. She wonders what would have happened if a test had quickly diagnosed his disease. And she also wonders why the city he worked for ran an antibody test on a worker who was on the street with symptoms.
"You left him," she said.
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Associate press researcher Chen Si in Shanghai, China contributed to this report.
Contact the AP global investigation team at Investigative@ap.org.

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