Asian locales reacted swiftly to the threat of COVID-19 by leveraging lessons learned from previous pandemics and making use of serology testing in aggressive contact tracing
America’s healthcare leaders in government, hospitals, clinical pathology, and medical laboratories can learn important lessons from the swift responses to the early outbreaks of COVID-19 in countries like Taiwan and South Korea and in cities like Singapore and Hong Kong.
Strategies such as early intervention, commitment to tracing contacts of infected people within two hours, quarantines, and social distancing all contributed to significantly curtailing the spread of the latest coronavirus pandemic within their borders, The New York Times (NYT) reported.
Another response common to the efforts of these countries and cities was the speedy introduction of clinical laboratory tests for SARS-CoV-2, the novel coronavirus that causes coronavirus disease 2019 (COVID-19), supported by the testing of tens of thousands of people in the earliest stages of the outbreaks in their communities. And that preparation and experience is paying off as those countries and cities continue to address the spread of COVID-19.
‘We Look at SARS as the Dress Rehearsal’
“Maybe it’s because of our Asian context, but our community
is sort of primed for this. We will keep fighting, because isolation and
quarantine work,” Lalitha
Kurupatham, Deputy Director of the Communicable Diseases Division in
Singapore, told the NYT. “During peacetime, we plan for epidemics like
this.”
Clinical laboratory leaders and pathologists may recall that Hong Kong was the site of the 2003 severe acute respiratory syndrome (SARS) epidemic. About 8,096 people worldwide were infected, and 774 died from SARS, according to the World Health Organization (WHO). In Hong Kong, 299 died out of 1,755 cases. However, Singapore had just 238 cases and 33 deaths.
To what does Singapore attribute the country’s lower
COVID-19 infection/death rate today?
“We can look at SARS as the dress rehearsal. The experience was raw, and very, very visceral. And on the back of it, better systems were put in place,” Jeremy Lim, MD, Co-Director of the Leadership Institute for Global Health Transformation at the National University of Singapore, told TIME.
“It’s a mix of carrots and sticks that have so far helped us. The US should learn from Singapore’s response and then adapt what is useful,” Lim added.
Singapore Debuts Serology Testing for COVID-19 Tracking
As microbiologists and infectious diseases doctors know, serology tests work by identifying antibodies that are the sources of infection. In the case of COVID-19, these tests may have aided in the surveillance of people infected with the coronavirus.
This is one lesson the US is learning.
“CDC (Centers for Disease Control and Prevention) has developed two serological tests that we’re evaluating right now, so we can get an idea through surveillance what’s the extent of this outbreak and how many people really are infected,” Robert Redfield, MD, CDC Director, told STAT.
The graphic above, which is based on data from the federal Centers for Disease Control and Prevention, illustrates how contact tracing is accomplished. “We believe this is the first time in the world where these particular tests have been used in this context of contact tracing,” Danielle Anderson, PhD, Scientific Director, Duke-NUS Medical School ABSL3 Laboratory, told Science. (Graphic copyright: CDC/Carl Fredrik Sjöland.)
‘Leaving No Stone Unturned’
As of March 27, Singapore (located about 2,374 miles from
mainland China with a population of 5.7 million) had reported 732 COVID-19
cases and two deaths, while Hong Kong had reported 518 cases and four deaths.
According to Time, in its effort to battle and treat
COVID-19, Singapore took the following steps:
Clinical laboratory testing for COVID-19 of all
people presenting with “influenza-like” and pneumonia symptoms;
Contact tracing of each infected person,
including interviews, review of flight manifests, and police involvement;
Using locally developed test to find antibodies
after COVID-19 clears;
Ran ads on page one of newspapers urging people
with mild symptoms to see a doctor; and
Government paid $100 Singapore dollars per day to
quarantined self-employed people.
The Singapore government’s WhatsApp account shares updates on the coronavirus, and Singapore citizens acquire wearable stickers after having their temperature checked at building entrances, Wired reported. The article also noted teams of healthcare workers are kept separate in hospitals—just in case some workers have to be quarantined.
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Meanwhile, in Hong Kong, citizens donned face masks and
pressured the government to respond to the COVID-19 outbreak. Officials subsequently
tightened borders with mainland China and took other action, the NYT reported.
Once the COVID-19 genetic sequence became available, national medical laboratory networks in Singapore, Hong Kong, and Japan developed their own diagnostic tests, reported The Lancet, which noted that the countries also expanded capacity for testing and changed financing systems, so people would not have to pay for the tests. In Singapore, the government pays for hospitalization as well, noted The Lancet.
Lessons Learned
The US has far less experience with pandemics, as compared to the Asian locales that were affected by the H1N1 influenza (Spanish Flu) of 1918-1920 and the H5N1 influenza (Avian Flu) of 1957-1958.
And, controversially, National Security Council (NSC) officials in 2018 discontinued the federal US Pandemic Response Unit, moving the NSC employees into other government departments, Associated Press reported.
According to the March 26 US Coronavirus Task Force’s televised
news conference, 550,000 COVID-19 tests have been completed nationwide and
results suggest 86% of those tested are negative for the disease.
The fast-moving virus and rapidly developing story are placing
medical laboratory testing in the global spotlight. Pathologists and clinical laboratory
leaders have a unique opportunity to advance the profession, as well as improving
the diagnosis of COVID-19 and the health of patients.
AccuWeather interviewed experts, including pathologists who have analyzed the virus, who say SARS-CoV-2 is susceptible to heat, light, and humidity, while others study weather patterns for their predictions
AccuWeather, as it watched the outbreak of SARS-CoV-2, the novel coronavirus that causes COVID-19, wanted to know what effect that warmer spring temperatures might have on curbing the spread of the virus. There is a good reason to ask this question. As microbiologists, infectious disease doctors, and primary care physicians know, the typical start and end to every flu season is well-documented and closely watched.
As SARS-CoV-2 ravages countries around the world, clinical pathologists and microbiologists debate whether it will subside as temperatures rise in Spring and Summer. Recent analyses suggest it may indeed be a seasonal phenomenon. However, some infectious disease specialists have expressed skepticism.
CNN reported that Nicholls was part of a research team which reproduced the virus in January to study its behavior and evaluate diagnostic tests. Nicholls was also involved in an early effort to analyze the coronavirus associated with the 2003 SARS outbreak involving SARS-CoV, another coronavirus that originated in Asia.
“Sunlight will cut the virus’ ability to grow in half, so the half-life will be 2.5 minutes and in the dark it’s about 13 to 20,” Nicholls told AccuWeather. “Sunlight is really good at killing viruses.” And that, “In cold environments, there is longer virus survival than warm ones.” He added, “I think it will burn itself out in about six months.”
The graphic above, created by John Nicholls, MBBS Adel, FRCPA, FHKCPath, FHKAM (Pathology), Clinical Professor of Pathology at the University of Hong Kong, shows “the temperate zone where the major SARS-CoV-2 hotspots have appeared so far. The variation from year to year, in this case, is minimal; however, meteorologists would typically use the 30-year normal data for this type of analysis.” (Caption and graphic copyright: AccuWeather/John Nicholls.)
Can Weather Predict the Spread of COVID-19?
Other researchers have analyzed regional weather data to see if there’s a correlation with incidence of COVID-19. A team at the Massachusetts Institute of Technology (MIT) found that the number of cases has been relatively low in areas with warm, humid conditions and higher in more northerly regions. They published their findings in SSRN (formerly Social Science Research Network), an open-access journal and repository for early-stage research, titled “Will Coronavirus Pandemic Diminish by Summer?”
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The MIT researchers found that as of March 22, 90% of the
transmissions of SARS-CoV-2 occurred within a temperature range of three to 17
degrees Celsius (37.4 to 62.6 degrees Fahrenheit) and an absolute humidity
range of four to nine grams per cubic meter. Fewer than 6% of the transmissions
have been in warmer climates further south, they wrote.
“Based on the current data on the spread of [SARS-CoV-2], we
hypothesize that the lower number of cases in tropical countries might be due
to warm humid conditions, under which the spread of the virus might be slower
as has been observed for other viruses,” they wrote.
In the US, “the outbreak also shows a north-south divide,”
with higher incidence in northern states, they wrote. The outliers are Oregon,
with fewer than 200 cases, and Louisiana, where, as of March 22, approximately
1,000 had been reported.
There’s been a recent spike in reported cases from warmer
regions in Asia, South America, and Africa, but the MIT researchers attribute
this largely to increased testing.
Still, “there may be several caveats to our work,” they
wrote in their published study. For example, South Korea has been engaged in
widespread testing that includes asymptomatic individuals, whereas other
countries, including the US, have limited testing to a narrower range of
people, which could mean that more cases are going undetected. “Further, the
rate of outdoor transmission versus indoor and direct versus indirect
transmission are also not well understood and environmental related impacts are
mostly applicable to outdoor transmissions,” the MIT researchers wrote.
Even in warmer, more humid regions, they advocate “proper
quarantine measures” to limit the spread of the virus.
The New York Times (NYT) reported that other recent studies have shown a correlation between weather conditions and the incidence of COVID-19 outbreaks as well, though none of this research has been peer reviewed.
Why the Correlation? It’s Unclear, MIT Says
Though the MIT researchers found a strong relation between
the number of cases and weather conditions, “the underlying reasoning behind
this relationship is still not clear,” they wrote. “Similarly, we do not know
which environmental factor is more important. It could be that either
temperature or absolute humidity is more important, or both may be equally or
not important at all in the transmission of [SARS-CoV-2].”
Some experts have looked at older coronaviruses for clues. “The coronavirus is surrounded by a lipid layer, in other words, a layer of fat,” said molecular virologist Thomas Pietschmann, PhD, Director of the Department for Experimental Virology at the Helmholtz Center for Infection Research in Hanover, Germany, in a story from German news service Deutsche Welle. This makes it susceptible to temperature increases, he suggested.
However, Pietschmann cautioned that because it’s a new
virus, scientists cannot say if it will behave like older viruses. “Honestly
speaking, we do not know the virus yet,” he concluded.
Epidemiologist and virologist Joseph Fair, PhD, MPH (above), Special Advisor for Ebola, USAID, and Research Professor at Texas A&M University, said that sunlight might be a bigger factor than temperature or humidity. “It really doesn’t have anything to do with the warmth, but it has to do with the length of the day and the exposure to sunlight which inactivates the virus through UV light,” he told NBC News. “The science is still out,” he said. “We can assume this will follow typical other coronavirus cases,” but “everyone in the scientific and public health community expect it to be back in the fall and we expect to be in this for quite some time.” (Photo copyright: Texas A&M University.)
Marc Lipsitch, DPhil, Professor of Epidemiology and Director of the Center for Communicable Disease Dynamics at the Harvard T.H. Chan School of Public Health, is skeptical that warmer weather will put the brakes on COVID-19. “While we may expect modest declines in the contagiousness of SARS-CoV-2 in warmer, wetter weather, and perhaps with the closing of schools in temperate regions of the Northern Hemisphere, it is not reasonable to expect these declines alone to slow transmission enough to make a big dent,” he wrote in a commentary for the center.
How should pathologists and clinical laboratories in this country prepare for COVID-19? Lipsitch wrote that Influenza does tend to be seasonal, in part because cold, dry air is highly conducive to flu transmission. However, “for coronaviruses, the relevance of this factor is unknown.” And “new viruses have a temporary but important advantage—few or no individuals in the population are immune to them,” which means they are not as susceptible to the factors that constrain older viruses in warmer, more humid months.
So, we may not yet know enough to adequately prepare for
what’s coming. Nevertheless, monitoring the rapidly changing data on COVID-19
should be part of every lab’s daily agenda.
‘Aerosol and Surface Stability’ study shows that the virus can remain infectious in aerosol form for hours and on surfaces for days
By now, clinical laboratory workers, microbiologists, and phlebotomists should be fully aware of the potential for transmission on surfaces of the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), the novel coronavirus that causes Coronavirus disease 2019 (COVID-19). The CDC’s latest Morbidity and Mortality Weekly Report revealed that the coronavirus “was identified on a variety of surfaces in cabins of both symptomatic and asymptomatic infected passengers up to 17 days after cabins were vacated on the Diamond Princess, but before disinfection procedures had been conducted,” the New York Post reported. That means the virus can survive on surfaces significantly longer than CDC previously believed.
But did you know a recent study published in the New England Journal of Medicine (NEJM) found that SARS-CoV-2 can also survive in the air for many hours, potentially allowing aerosolized transmission of the virus as well?
The NEJM study also showed that the stability of SARS-CoV-2 to survive on surfaces and in aerosolized form mirrors the stability of the SARS coronavirus (SARS-CoV) that caused the severe acute respiratory syndrome (SARS) outbreak of 2003.
This is critically important information for clinical laboratory professionals in open-space laboratories, phlebotomists collecting medical laboratory specimens, and frontline healthcare workers who come in direct contact with potentially infected patients. They should be aware of every potential COVID-19 transmission pathway.
Hospital infection control teams will be particularly
interested in the possibility of airborne transmission, as they often visit
infected patients and are tasked with tracking both the source of the infection
as well as individuals who may be exposed to sick patients.
The NEJM study, titled “Aerosol and Surface Stability of SARS-CoV-2 as Compared with SARS-CoV-1” was conducted by scientists at the National Institute of Allergy and Infectious Diseases (NIAID), an agency of the US Department of Health and Human Services (HHS), the Centers for Disease Control and Prevention (CDC), Princeton University, and University of California, Los Angeles. The researchers concluded that SARS-CoV-2 remains in the air “up to three hours post aerosolization.”
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They also found the virus was detectable for up to four
hours on copper and up to 24 hours on cardboard. The scientists concluded SARS-CoV-2
can remain on plastic and stainless-steel surfaces for two to three days,
though the amount of the virus on surfaces decreases over time.
“Our results indicate that aerosol and fomite transmission of SARS-CoV-2 is plausible, since the virus can remain viable and infectious in aerosols for hours and on surfaces up to days,” the study states. “These findings echo those with SARS-CoV-1, in which these forms of transmission were associated with nosocomial spread and super-spreading events, and they provide information for pandemic mitigation efforts.”
But Can COVID-19 Be Caught Through Air?
However, as noted in Wired, the researchers did not clearly state that infected persons can spread COVID-19 to others in the same airspace. Some experts have pointed out that there is a difference between a virus that can exist as an aerosol—defined as a liquid or solid suspended in gas under only limited conditions—and the measles virus, for example, which the CDC estimates “can live for up two hours in an airspace where the infected person has coughed or sneezed.”
“While the researchers tested how long the virus can survive
in aerosols suspended in the air, they didn’t actually sample the air around
infected people,” Wired noted. “Instead, they put the virus into a
nebulizer and puffed it into a rotating drum to keep it airborne. Then, they
tested how long the virus could survive in the air inside the drum.”
Neeltje van Doremalen, PhD, a research fellow at National Institutes of Health (NIH) and researcher at the NIAID’s Rocky Mountain Laboratories in Hamilton, Montana, who coauthored the NEJM study, cautioned against an overreaction to this latest research. On Twitter she wrote, “Important: we experimentally generated [COVID-19] aerosols and kept them afloat in a drum. This is not evidence of aerosol transmission.”
Nonetheless, the World House Organization (WHO) took note of the study’s findings and on March 16, 2020, announced it was considering “airborne precautions” for healthcare workers, CNBC reported in its coverage of a virtual press conference on March 16, 2020, led by Maria Van Kerkhove, MS, PhD, Technical Lead for WHO’s Middle East Respiratory Syndrome Coronavirus (MERS-CoV) Task Force.
Van Kerkhove emphasized that health officials were
monitoring results from other studies investigating how environmental
conditions such as humidity, temperature, and ultraviolet light affect
the disease and its ability to live on different surfaces.
“When you do an aerosol-generating procedure like in a medical care facility, you have the possibility to what we call aerosolize these particles, which means they can stay in the air a little bit longer,” said Maria Van Kerkhove, MS, PhD (above), Technical Lead for WHO’s Middle East Respiratory Syndrome Coronavirus (MERS-CoV) Task Force during a virtual press conference, CNBC reported. “It’s very important that healthcare workers take additional precautions when they’re working on patients and doing these procedures,” she added. [Photo copyright: World Health Organization/YouTube.)
To Be or Not to Be an Airborne Pathogen
Stanley Perlman, MD, PhD, Professor of Microbiology and Immunology at the University of Iowa, believes aerosol transmission ultimately will be found not to play a large role in COVID-19 transmission.
“I think the answer will be, aerosolization occurs rarely, but not never,” Perlman told STAT. “You have to distinguish between what’s possible and what’s actually happening.”
In an NEJM editorial, Perlman expanded on those thoughts. “Although specific anti-coronaviral therapies are still in development, we now know much more about how to control such infections in the community and hospitals, which should alleviate some of this fear,” he wrote. “Transmission of [SARS-CoV-2] probably occurs by means of large droplets and contact and less so by means of aerosols and fomites, on the basis of our experience with SARS-CoV and MERS-CoV. Public health measures, including quarantining in the community as well as timely diagnosis and strict adherence to universal precautions in healthcare settings, were critical in controlling SARS and MERS. Institution of similar measures will be important and, it is hoped, successful in reducing the transmission of [SARS-CoV-2].”
An NIH news release announcing the SARS-CoV-2 stability study highlighted two additional observations:
“If the viability of the two coronaviruses is
similar, why is SARS-CoV-2 resulting in more cases? Emerging evidence suggest
that people infected with SARS-CoV-2 might be spreading virus without
recognizing, or prior to recognizing, symptoms. That would make disease control
measures that were effective against SARS-CoV-1 less effective against its
successor.
In contrast to SARS-CoV-1, most secondary cases
of virus transmission of SARS-CoV-2 appear to be occurring in community
settings rather than healthcare settings. However, healthcare settings are also
vulnerable to the introduction and spread of SARS-CoV-2, and the stability of
SARS-CoV-2 in aerosols and on surfaces likely contributes to transmission of
the virus in healthcare settings.”
Clearly, the scientific community has not agreed on
aerosolization as a definite source of infection. Nevertheless, clinical
laboratory workers in settings where potential exposure to SARS-CoV-2 exists
should take precautions against airborne transmission until scientists can
definitively determine whether this latest coronavirus can be acquired through
the airborne transmission.
By taking early measures to combat the spread, the country had a medical laboratory test for COVID-19 available as early as Jan. 24, and was able to focus medical laboratory testing on the most at-risk individuals
With the Coronavirus disease 2019 (COVID-19) outbreak dominating headlines and medical laboratories under growing pressure to increase testing capacity, Taiwan’s rapid response to the pandemic could provide a critical model for other countries to follow.
Given its proximity to mainland China—just 81 miles—and the large number of individuals who frequently travel back and forth between the countries, Taiwan was at risk of having the second-highest number of imported COVID-19 cases, according to a model developed by researchers at Johns Hopkins University and the University of New South Wales Sydney. News reports indicate that, each year, about 60,000 flights carry 10 million passengers between Taiwan and China.
Data from Taiwan’s Centers for Disease Control (CDC) and Central Epidemic Command Center (CECC) indicate that the country has managed to contain the outbreak thanks to these aggressive actions.
As of March 19, Taiwan’s CECC reported a total of 108 laboratory-confirmed COVID-19 infections. That compares with 81,155 in China, 41,035 in Italy, and 10,755 in the US, according to data compiled by the Center for Systems Science and Engineering at Johns Hopkins University. When the World Health Organization (WHO) reports on the number of COVID-19 cases by country, it includes the number of COVID-19 cases from Taiwan under the totals for the People’s Republic of China. WHO made this decision several years ago, under pressure by China to not recognize Taiwan as an independent nation.
The World
Population Review website says Taiwan’s population is about 23.8 million.
But its infection rate is low even on a per capita basis: Approximately 45
infections per million population, compared with 6,784 in Italy, 564 in China,
and 326 per million in the US.
The JAMA authors noted that Taiwan was prepared for
an outbreak after its experience with the severe
acute respiratory syndrome (SARS) pandemic in 2003, which also originated
in China.
Timeline of COVID-19 Outbreak at the Earliest Stages
Taiwan apparently learned a lesson about preparedness from
the SARS outbreak the rest of the world did not and that enabled the tiny
nation to respond immediately to the novel Coronavirus threat.
The country’s efforts began on Dec. 31 with inspections of
flight arrivals from Wuhan. “When there were only a very few cases [of
COVID-19] reported in China, [Taiwanese health authorities] already went onto
every airplane that came from Wuhan,” C. Jason Wang,
MD, PhD, an Associate Professor of Pediatrics and Director of the Center for Policy, Outcomes, and
Prevention at Stanford University and lead author of the JAMA
report, told Vox.
“Health officials came on the airplane and checked people for symptoms,” he
added.
Travelers who had recently visited Wuhan and displayed
symptoms of pneumonia were quarantined at home for 14 days. Taiwan’s
CDC reported that quarantined individuals were being tested for the
2019-nCoV coronavirus (later renamed to SARS-CoV-2)
soon after it was identified. The CECC, activated in January to coordinate the
government’s response, reported the first confirmed imported case on Jan. 21.
On Jan. 24, their
CDC announced that testing for the virus was being performed at the CDC and
eight designated hospitals. Testing included samples from physicians around the
country. As of Feb. 17, daily testing capacity was about 1,300 samples, the JAMA
authors reported.
Wang told Vox that aggressive measures to identify
and isolate at-risk individuals at the earliest stages reduced the volume of clinical
laboratory tests that had to be performed. “Here in the US and elsewhere, we’re
now seeing community spread,” he said. “It’s probably been here for a while.
And so now we’re trying to see, ‘Oh, how many people should we test?’ Then, you
really need to have a very large capacity in the beginning.”
“I think the US has enormous capacity that’s currently not being used,” C. Jason Wang, MD, PhD (above), Associate Professor of Pediatrics and Director of the Center for Policy, Outcomes, and Prevention at Stanford University and lead author of the JAMA report, told Vox. “We have big tech companies that really could do a lot, right? We ought to get the big companies together. Get the governors together, get the federal government agencies to work with each other, and try to find innovative ways to think about how to best do this. We’ve got the smartest people here in the US because they come from everywhere. But right now, those are untapped resources. They’re not working together. And the federal government, the agencies, they need to collaborate a little more closely.” (Photo copyright: Stanford University.)
More Actions by Authorities
The JAMA report supplementary materials notes a total of 124 actions taken by Taiwanese authorities between Jan. 20 and Feb. 24 to contain the outbreak. In addition to the border inspections, quarantines and testing, they included integration of data between the country’s National Health Insurance Administration and National Immigration Agency, so authorities, and later hospitals, could identify any patient who had recently traveled to China, Hong Kong, or Macau.
The steps also included:
An escalating series of travel restrictions,
eventually including suspension of most passenger flights from Taiwan to China,
as well as a suspension of tours to Hong Kong or Macau.
Use of government-issued cell phones to monitor
quarantined individuals.
Fines for individuals breaking the 14-day home
quarantine.
Fines for incoming travelers who failed to
provide accurate health information.
Fines for disseminating false information or
rumors about the epidemic.
Fines and jail sentences for profiteering on disease-prevention
products.
Designation of military camps and other
government facilities for quarantine.
Nationwide disinfection of universities,
colleges, and public spaces around schools.
The government also took aggressive action to ensure
adequate supplies of surgical masks, including stepped-up manufacturing, export
bans, price limits, and a limit of one to three masks per purchase.
The JAMA authors noted that government officials issued daily press briefings to educate the public about the outbreak. Communication efforts also included public service announcements by Taiwan Vice President Chen Chien-jen, a trained epidemiologist.
A poll taken in Taiwan on Feb. 17 and 18 indicated high approval ratings for officials’ response to the crisis.
The JAMA authors also noted some “challenges” in the
government’s response. For example, most real-time public communication was in
Mandarin Chinese and sign language, leaving out non-Taiwanese citizens in the
country. And the cruise ship Diamond Princess, later found to have infections
on board, was allowed to dock near Taipei and disembark passengers. There are
also questions about whether similar policies can be sustained through the end
of a pandemic.
Still, “well-trained and experienced teams of officials were
quick to recognize the crisis and activated emergency management structures to
address the emerging outbreak,” the JAMA authors wrote. “Taiwan is an
example of how a society can respond quickly to a crisis and protect the
interests of its citizens.”
One noteworthy difference in the speedy response to
recognition of a novel coronavirus in Taiwan, compared to recognition of the
same novel coronavirus in the United States, was the fast availability of
clinical laboratory tests for COVID-19 in Taiwan.
Pathologists and clinical laboratory professionals here in
the US are frustrated that their skills and talents at developing and
validating new assays on an accelerated timeline were not acknowledged and
leveraged by government officials as they decided how to respond to the
emergence of the novel coronavirus now called SARS-CoV-2.
At present, medical laboratories are collecting blood specimens for testing by authorized public health labs. However, clinical laboratories should prepare for the likelihood they will be called on to perform the testing using the CDC test or other tests under development.
“We need to be vigilant and understand everything related to the testing and the virus,” said Bodhraj Acharya, PhD, Manager of Chemistry and Referral Testing at the Laboratory Alliance of Central New York, in an exclusive interview with Dark Daily. “If the situation comes that you have to do the testing, you have to be ready for it.”
The current criteria for determining PUIs include clinical features, such as fever or signs of lower respiratory illness, combined with epidemiological risks, such as recent travel to China or close contact with a laboratory-confirmed COVID-19 patient. The CDC notes that “criteria are subject to change as additional information becomes available” and advises healthcare providers to consult with state or local health departments if they believe a patient meets the criteria.
Bodhraj Acharya, PhD (above), is Manager of Chemistry and Referral Testing at the Laboratory Alliance of Central New York. In an exclusive interview with Dark Daily, he stressed the importance that medical laboratories be prepared. “We need to be vigilant and be active and understand everything related to this virus and the testing. That’s the role of clinical laboratory scientists, to be ready because this can become a pandemic anytime. It can spread and tomorrow the CDC could announce it is disseminating the test to designated laboratories.” (Photo copyright: Laboratory Alliance of Central New York.)
Test Kit Problems Delay Diagnoses
On Feb. 4, the FDA issued a Novel Coronavirus Emergency Use Authorization (EUA) allowing state and city public health laboratories, as well as Department of Defense (DoD) labs, to perform presumptive qualitative testing using the Real-Time Reverse Transcriptase PCR (RT-PCR) diagnostic panel developed by the CDC. Two days later, the CDC began distributing the test kits, a CDC statement announced. Each kit could test 700 to 800 patients, the CDC said, and could provide results from respiratory specimens in four hours.
However, on Feb. 12, the agency revealed in a telebriefing that manufacturing problems with one of the reagents had caused state laboratories to get “inconclusive laboratory results” when performing the test.
“When the state receives these test kits, their procedure is to do quality control themselves in their own laboratories,” said Nancy Messonnier, MD, Director of the CDC National Center for Immunization and Respiratory Diseases (NCIRD), during the telebriefing. “Again, that is part of the normal procedures, but in doing it, some of the states identified some inconclusive laboratory results. We are working closely with them to correct the issues and as we’ve said all along, speed is important, but equally or more important in this situation is making sure that the laboratory results are correct.”
During a follow-up telebriefing on Feb. 14, Messonnier said
that the CDC “is reformulating those reagents, and we are moving quickly to get
those back out to our labs at the state and local public health labs.”
Above is a picture of CDC’s laboratory test kit for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). CDC is shipping the test kits to laboratories CDC has designated as qualified, including US state and local public health laboratories, Department of Defense (DOD) laboratories, and select international laboratories. The test kits are bolstering global laboratory capacity for detecting SARS-CoV-2. (Photo and caption copyright: Centers for Disease Control and Prevention.)
Serologic Test Under Development
The current test has to be performed after a patient shows
symptoms. The “outer bound” of the virus’ incubation period is 14 days, meaning
“we expect someone who is infected to have symptoms some time during those 14
days,” Messonnier said. Testing too early could “produce a negative result,”
she continued, because “the virus hasn’t established itself sufficiently in the
system to be detected.”
Messonnier added that the agency plans to develop a serologic test that will identify people who were exposed to the virus and developed an immune response without getting sick. This will help determine how widespread it is and whether people are “seroconverting,” she said. To formulate this test, “we need to wait to draw specimens from US patients over a period of time. Once they have all of the appropriate specimens collected, I understand that it’s a matter of several weeks” before the serologic test will be ready, she concluded.
“Based on what we know now, we believe this virus spreads
mainly from person to person among close contacts, which is defined [as] about
six feet,” Messonnier said at the follow-up telebriefing. Transmission is
primarily “through respiratory droplets produced when an infected person coughs
or sneezes. People are thought to be the most contagious when they’re most
symptomatic. That’s when they’re the sickest.” However, “some spread may happen
before people show symptoms,” she said.
The virus can also spread when people touch contaminated surfaces and then touch their eyes, nose, or mouth. But it “does not last long on surfaces,” she said.
Where the Infection Began
SARS-CoV-2 was first identified during an outbreak in Wuhan, China, in December 2019. Soon thereafter, hospitals in the region “were overwhelmed” with cases of pneumonia, Dr. Acharya explained, but authorities could not trace the disease to a known pathogen. “Every time a new pathogen originates, or a current pathogen mutates into a new form, there are no molecular tests available to diagnose it,” he said.
So, genetic laboratories used next-generation sequencing, specifically unbiased nontargeted metagenomic RNA sequencing (UMERS), followed by phylogenetic analysis of nucleic acids derived from the hosts. “This approach does not require a prior knowledge of the expected pathogen,” Dr. Acharya explained. Instead, by understanding the virus’ genetic makeup, pathology laboratories could see how closely it was related to other known pathogens. They were able to identify it as a Betacoronavirus (Beta-CoVs), the family that also includes the viruses that cause SARS and Middle East Respiratory Syndrome (MERS).
This is a fast-moving story and medical laboratory leaders are advised to monitor the CDC website for continuing updates, as well as a website set up by WHO to provide technical guidance for labs.
