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.
As standard masks are used they collect exhaled airborne pathogens that remain living in the masks’ fibers, rendering them infectious when handled
Surgical-style facial masks harbor a secret—viruses that could be infectious to the people wearing them. However, masks can become effective virus killers as well. At least that’s what researchers at the University of Alberta (UAlberta) in Edmonton, Canada, have concluded.
If true, such a re-engineered mask could protect clinical laboratory workers from exposure to infectious diseases, such as, SARS (Severe Acute Respiratory Syndrome), MERS (Middle East Respiratory Syndrome), and Swine Influenza.
“Surgical masks were originally designed to protect the wearer from infectious droplets in clinical settings, but it doesn’t help much to prevent the spread of respiratory diseases such as SARS or MERS or influenza,” Hyo-Jick Choi, PhD, Assistant Professor in UAlberta’s Department of Chemical and Materials Engineering, noted in a press release.
So, Choi developed a mask that effectively traps and kills airborne viruses.
Clinical Laboratory Technicians at Risk from Deadly Infectious Diseases
The global outbreak of SARS in 2003 is a jarring reminder of how infectious diseases impact clinical laboratories, healthcare workers, and patients. To prevent spreading the disease, Canadian-based physicians visited with patients in hotel rooms to keep the virus from reaching their medical offices, medical laboratory couriers were turned away from many doctors’ offices, and hospitals in Toronto ceased elective surgery and non-urgent services, reported The Dark Report—Dark Daily’s sister publication. (See The Dark Report, “SARS Challenges Met with New Technology,” April 14, 2003.)
UAlberta materials engineering professor Hyo-Jick Choi, PhD, (right) and graduate student Ilaria Rubino (left) examine filters treated with a salt solution that kills viruses. Choi and his research team have devised a way to improve the filters in surgical masks, so they can trap and kill airborne pathogens. Clinical laboratory workers will especially benefit from this protection. (Photo and caption copyright: University of Alberta.)
How Current Masks Spread Disease
How do current masks spread infectious disease? According to UAlberta researchers:
A cough or a sneeze transmits airborne pathogens such as influenza in aerosolized droplets;
Virus-laden droplets can be trapped by the mask;
The virus remains infectious and trapped in the mask; and,
Risk of spreading the infection persists as the mask is worn and handled.
“Aerosolized pathogens are a leading cause of respiratory infection and transmission. Currently used protective measures pose potential risk of primary and secondary infection and transmission,” the researchers noted in their paper, published in Scientific Reports.
That’s because today’s loose-fitting masks were designed primarily to protect healthcare workers against large respiratory particles and droplets. They were not designed to protect against infectious aerosolized particles, according to the Centers for Disease Control and Prevention (CDC).
In fact, the CDC informed the public that masks they wore during 2009’s H1N1 influenza virus outbreak provided no assurance of infection protection.
“Face masks help stop droplets from being spread by the person wearing them. They also keep splashes or sprays from reaching the mouth and nose of the person wearing the face mask. They are not designed to protect against breathing in very small particle aerosols that may contain viruses,” a CDC statement noted.
Pass the Salt: A New Mask to Kill Viruses
Choi and his team took on the challenge of transforming the filters found on many common protective masks. They applied a coating of salt that, upon exposure to virus aerosols, recrystallizes and destroys pathogens, Engineering360 reported.
“Here we report the development of a universal, reusable virus deactivation system by functionalization of the main fibrous filtration unit of surgical mask with sodium chloride salt,” the researchers penned in Scientific Reports.
The researchers exposed their altered mask to the influenza virus. It proved effective at higher filtration compared to conventional masks, explained Contagion Live. In addition, viruses that came into contact with the salt-coated fibers had more rapid infectivity loss than untreated masks.
How Does it Work?
Here’s how the masks work, according to the researchers:
Aerosol droplets carrying the influenza virus contact the treated filter;
The droplet absorbs salt on the filter;
The virus is exposed to increasing concentration of salt; and,
The virus is damaged when salt crystallizes.
“Salt-coated filters proved highly effective in deactivating influenza viruses regardless of [influenza] subtypes,” the researchers wrote in Scientific Reports. “We believe that [a] salt-recrystallization-based virus deactivation system can contribute to global health by providing a more reliable means of preventing transmission and infection of pandemic or epidemic diseases and bioterrorism.”
Other Reports on Dangerous Exposure for Clinical Laboratory Workers
This is not the first time Dark Daily has reported on dangers to clinical laboratory technicians and ways to keep them safe.
In “Health of Pathology Laboratory Technicians at Risk from Common Solvents like Xylene and Toluene,” we reported on a 2011 study that determined medical laboratory technicians who handle common solvents were at greater risk of developing auto-immune connective tissue diseases.
The UAlberta team may have come up with an inexpensive, simple, and effective way to protect healthcare workers and clinical laboratory technicians. Phlebotomists, laboratory couriers, and medical technologists also could wear the masks as protection from accidental infection and contact with specimens. It will be interesting to follow the progress of this special mask with its salty filter.
Called ‘ViroCap,’ this new diagnostic technology is able to discover more viruses in patient samples, as compared to PCR genome sequencing tests
It could be the ultimate multi-analysis medical laboratory test ever. Researchers at Washington University School of Medicine in St. Louis have developed a diagnostic test that they claim tests for any virus infecting people and animals.
The HHMI research resulted in VirScan, an alternative to medical laboratory tests that test for specific viruses one at a time, and which can detect all diseases a patient has had over his or her lifetime, according to an HHMI news statement about the new technology. (more…)
It took UCSF physicians just 48 hours to identify the bacteria in cerebrospinal fluid that was causing fourteen-year-old Joshua Osborn’s hydrocephalus and status epilepticus
There’s rich irony in the FDA’s recent announcement that it would move forward with plans to regulate “laboratory-developed tests ” (LDTs) just weeks after the national media published stories about how innovative use of an LDT helped physicians make an accurate diagnosis that saved the life of seriously-ill 14-year old boy.
Pathologists and clinical laboratory managers may be aware of the case of Joshua Osborn. It was a laboratory-developed test that used next-generation gene sequencing in a unique approach that gave his care team the diagnostic information they needed to select the right therapies for his condition. (more…)
The study was conducted over two and one-half years and involved hospital rooms used by thousands of patients. The goal of this study was to verify the effectiveness of a new robot-like device, known as Bioquell Q-10. This system disperses a hydrogen peroxide vapor to disinfect hospital rooms and was described in a news release issued by Baltimore-based Johns Hopkins University Hospital. (more…)
