Coordinating at-home testing for monkeypox may provide opportunities for clinical laboratories to add value for their physician clients
Microbiologists and clinical laboratory managers who oversee medical laboratory tests for monkeypox (aka, mpox) will be interested to learn that, according to the US Centers of Disease Control (CDC), cases per day have dropped into the single digits.
The United States led the world in cases during the 2022-2023 outbreak, according to the most recent CDC statistics. As of February 15, the US has reported 30,193 cases of monkeypox with 32 deaths.
Nevertheless, January 31 was the day that the US public health emergency involving monkeypox officially expired. Data from the World Health Organization shows the number of daily monkeypox cases in most countries around the world is declining, although numbers of cases are still increasing in some South American countries.
The global monkeypox outbreak appears to have slowed considerably, but are we out of the woods?
“There were concerns that there would be ongoing transmission and that ongoing transmission would become endemic in the United States like other STIs: gonorrhea, chlamydia, syphilis. We have not seen that occur,” Jonathan Mermin, MD (above), Director of the National Center for HIV, Viral Hepatitis, STD, and TB Prevention at the CDC, told CNN.”We are now seeing three to four cases a day in the United States, and it continues to decline. And we see the possibility of getting to zero as real.” This decline in monkeypox test corresponds with a similar decline in COVID-19 clinical laboratory testing as well. (Photo Copyright: CDC.)
Untried Vaccine and At-home Testing for Monkeypox
When the monkeypox outbreak began in May of 2022, there were concerns about the US’ level of preparedness for dealing with a second pandemic while also battling COVID-19. But monkeypox was not entirely unknown to the scientific and medical communities.
Monkeypox first appeared in 1958 amongst a colony of monkeys being kept for research. The origin of the disease is not known. According to the CDC, the first reported human case of monkeypox was in 1970. Prior to the 2022 outbreak, most cases were found in central and western African countries. Cases outside of those areas could be traced back to travel from those specific countries.
When cases of monkeypox first appeared in the US, public health officials were concerned about the availability of testing, vaccines, and treatments. As CNN reported, though there was a new vaccine available, its effectiveness against monkeypox had never been tested on humans.
That treatment, known as TPOXX (Tecovirimat), was an antiviral drug approved by the FDA in 2018 to treat smallpox in adults and children, according to an FDA factsheet. The drug was difficult to obtain, and it took until August of 2022 for the federal government to declare monkeypox a public health emergency. That allowed it to deploy emergency funds towards fighting the outbreak.
The demographic found to be at the highest risk of monkeypox infection were men who have sex with other men. According to MedPage Today, “Daskalakis had both pandemic experience as former senior lead on equity in COVID-19 data and engagement for the New York City Department of Health and Mental Hygiene and an ‘in’ with the LGBTQ+ community from his work in HIV prevention and his transparency about being a gay man.”
When comparing monkeypox to HIV, Daskalakis said, “This one [monkeypox], you don’t have to change behaviors for generations; it’s for a few months. Once you build your force field of immunity with vaccines, people can make their own informed decisions about their risk.”
Opportunities for Clinical Laboratories
So, how should clinical laboratories respond if there’s another monkeypox flare up?
Daskalakis advocates for home testing. “People that are going to order home tests are going to be motivated to action in other ways. And so, thinking about HIV home testing, which was the grandparent of COVID-19 home testing, this really shows us how you reach people you’re not going to reach when you have lab-based, provider-only testing … When you look at the HIV home testing data from the CDC, 26% of the people that ordered a home test had never been tested before. That is way higher than what you would expect,” he told MedPage Today.
We are not out of the woods in regard to monkeypox, vigilance is still required. But with existing harm reduction measures in the most vulnerable community, at-home testing and advancements in vaccines could help us keep our numbers as low as possible.
Though clinical laboratory RT-PCR tests remain the ‘gold standard’ when diagnosing COVID-19, at-home antigen tests offer convenience and quick test results. But are they accurate?
Clinical laboratory and pathologists generally acknowledge that RT-Polymerase Chain Reaction (RT-PCR) tests remain the preferred method for detecting COVID-19 disease. However, according to Popular Science, rapid at-home antigen tests that accurately identify people carrying larger loads of the virus are becoming important tools in the fight against spread of the coronavirus.
DxTerity SARS-CoV-2: This saliva-based collection kit is available on Amazon and at Walmart for $110. Specimens must be sent via FedEx on the same day as collection. Results are available within 24 to 72 hours of the sample being received by the PCR testing lab.
Lucira Check It COVID-19 Test Kit: Billed as offering “PCR quality molecular accuracy,” this nasal swab test costs $55 and provides results in 30 minutes or less.
Abbott BinaxNOW Antigen Self-Test. Results within 15 minutes and available for $23.99 at major pharmacies. Each box includes two nasal swab tests, with the second test taken within 36 hours of the first.
Pixel COVID-19 At-Home Collection Kit: This nasal-swab-based mail-in collection kit is available online for $119. Results delivered within 24 to 48 hours of the sample being received by Labcorp.
Many of the newest at-home tests not only have users collect their own swab or saliva samples, but some also provide results in less than an hour, which can be sent to the user’s smartphone. Conversely, home-based collection kits that are returned to clinical laboratories for testing can take 48 hours or longer for shipping and processing.
Among the issues cited were the potential for inadequate samples and improper handling to cause inaccurate results, as well as uncertainty whether at-home antigen tests will pick up on COVID-19 variants.
At-home tests also are less likely to be covered by insurance, MedPage Today reported.
How Do the Tests’ Accuracy Compare?
The Quest Direct and LabCorp Pixel tests—both of which are sent to company labs for PCR testing—scored highest on the two main statistical measures of performance sensitivity (positive percent agreement) and specificity (negative percent agreement). According to Popular Science, each of these tests’ sensitivities and specificities are close to 100%.
According to the websites of the other tests reviewed by Popular Science:
DxTerity test, which uses a saliva sample—97.2% sensitivity and a 92.5% specificity.
BinaxNOW test—84.6% sensitivity and 98.5% specificity.
Cue COVID-19 test—98.7% sensitivity and 97.6% specificity.
Lucira Check Its test—98% accuracy.
Ellume test—95% sensitivity and 97% specificity.
Rapid Antigen Tests Accurate and Easy to Use, says Popular Science
Popular Science found the tests generally easy to use and concluded they are a beneficial—if imperfect—tool in the fight against COVID-19.
“If you’re unvaccinated and symptomatic, they’re a great way to confirm a COVID-19 infection without risking a trip out of the house,” Popular Science stated in its article. “If you’re unvaccinated and have no symptoms, and just want to know whether you can safely attend a family dinner or soccer game, an at-home test remains an imperfect way of self-screening. Remember: If the test comes back negative, there’s still the chance the result is false, and you could accidentally expose others by being within six feet of them without a mask on.”
As the popularity of at-home COVID-19 tests increases, clinical laboratories that perform RT-PCR tests may want to keep a watchful eye on the demand for at-home rapid antigen testing, especially now that some tests are available without prescription.
CAP president maintains medical laboratory staff are ‘indispensable’ in pandemic fight and should be in ‘top tier’ for vaccination
As COVID-19 vaccinations continue to roll out, the College of American Pathologists (CAP) is lobbying for clinical pathologists and medical laboratory staff to be moved up the priority list for vaccinations, stating they are “indispensable” in the pandemic fight.
In a news release, CAP’s President Patrick Godbey, MD, FCAP argued for the early vaccination of laboratory workers, “It is essential that early access to the vaccine be provided to all pathologists and laboratory personnel,” he said. “Pathologists have led throughout this pandemic by bringing tests for the coronavirus online in communities across the country and we must ensure that patient access to testing continues. We must also serve as a resource to discuss the facts about the vaccine and answer questions patients, family members, and friends have about why they should get the vaccine when it is available to them.”
Who Does CDC Think Should Be First to Be Vaccinated?
According toThe New York Times (NYT), there are an estimated 21 million healthcare workers in the United States, making it basically “impossible,” the NYT wrote, for them all to get vaccinated in the first wave of COVID-19 vaccinations.
A December 11, 2020, CDC Morbidity and Mortality Weekly Report, titled, “ACIP Interim Recommendation for Allocating Initial Supplies of COVID-19 Vaccine—United States, 2020,” notes that “The [federal] Advisory Committee on Immunization Practices (ACIP) recommended, as interim guidance, that both 1) healthcare personnel and 2) residents of long-term care facilities be offered COVID-19 vaccine in the initial phase of the vaccination program.”
The ACIP report defines healthcare personnel as “paid and unpaid persons serving in healthcare settings who have the potential for direct or indirect exposure to patients or infectious materials.”
However, a CDC terminology guidance document listed at the bottom of the ACIP report states, “For this update, HCP [Healthcare Personnel] does not include dental healthcare personnel, autopsy personnel, and laboratory personnel, as recommendations to address occupational infection prevention and control (IPC) services for these personnel are posted elsewhere.”
In part, the letter stated, “We are convinced that ACIP did not intend to exclude any healthcare workers from its recommendation to offer vaccinations to healthcare personnel in the initial phase of the COVID-19 vaccination program (Phase 1a). However, we would hate for jurisdictions to overlook dental, autopsy, and laboratory personnel because of a minor footnote in [CDC] guidance that was developed for an entirely different purpose (i.e., infection control).
“We respectfully ask CDC to clarify,” the letter continues, “… that all healthcare workers—including dental, autopsy, and laboratory personnel—are among those who should be given priority access to vaccine during the initial phase of the COVID-19 vaccination program.”
“In the laboratory, they are encountering and handling thousands of samples that have active live virus in them,” said Karger, who called clinical laboratory staff and phlebotomists the “forgotten” frontline healthcare workers. “We’re getting 10,000 samples a day. That’s a lot of handling of infectious specimens, and we do want [staff] to be prioritized for vaccination.”
Karger continued to stress the vital role clinical laboratories play not only in COVID-19 testing but also in the functioning of the overall health system. She added that staff burnout is a concern since laboratory staff have been working “full throttle” since March.
“From an operational standpoint, we do need to keep our lab up and running,” she said. “We don’t want to have staff out such that we would have to decrease our testing capacity, which would have widespread impacts for our health system and state.”
Testing for Post-Vaccine Immunity
The CAP panelists also highlighted the need to prepare for the aftermath of widespread COVID-19 vaccinations—the need to test for post-vaccine immunity.
“It’s not routine practice to check antibody levels after getting a vaccine but given the heightened interest in COVID testing, we are anticipating there is going to be some increased in demand for post-vaccine antibody testing,” Karger said. “We’re at least preparing for that and preparing to educate our providers.”
Karger pointed out that clinical pathologists will play an important role in educating providers about the type of antibody tests necessary to test for COVID-19 immunity, because, she says, only the SARS-CoV-2 spike protein antibody test will check for an immune response.
With the pandemic expected to stretch far into 2021, clinical laboratories will continue to play a crucial role in the nation’s healthcare response to COVID-19. As essential workers in the fight against infectious disease, clinical pathologists, clinical chemists, and all medical laboratory staff should be prioritized as frontline healthcare workers.
Medical laboratories and anatomic pathology groups could face payment delays if physicians fail to code lab test claims properly using ICD-10 codes
Just weeks remain before the implementation to ICD-10 begins. This will be a delicate time for clinical laboratories and anatomic pathology groups, since labs must rely on physicians to provide accurate ICD codes that labs must submit on test claims in order to be reimbursed by payers.
The much-delayed shift from ICD-9 to ICD-10 diagnosis codes will take place on Thursday, Oct. 1. When clocks strike midnight, years of debate over whether the conversion will create a financial hardship on physicians—and in turn disrupt payments to clinical laboratories and anatomic pathology groups—will begin to be answered.
The Medicare program requires appropriate ICD codes on medical laboratory test claims for Medicare patients. That is one reason why clinical laboratories and anatomic pathology are financially vested in a smooth conversion process. All Medicare Part B claims for medical laboratory tests must be submitted with an appropriate International Classification of Diseases (ICD) code provided by the physician who ordered the lab tests. The Medicare program will not reimburse lab test claims without an appropriate ICD code. (more…)
Noted pathologist encourages pathology profession to step up and assert leadership in clinical diagnostics as it enters the era of genomics-based medicine
Lundberg is well known to pathologists in America. A board-certified pathologist himself, Lundberg served 17 years as Editor in Chief of the Journal of the American Medical Association (JAMA). He continues to write and blog for a variety of healthcare publications and Web sites.
That means Lundberg has watched the evolution of medicine from a unique perspective for an extended period of time. The fact that he recently issued a clear and unambiguous call to action for the pathology profession means that pathologists and clinical laboratory managers should take heed. (more…)