New Depression Screening Guidelines in Adults Do Little to Address Mental Health Care Crisis

 According to the World Health Organization (WHO), approximately 5% of adults (or 280 million people) suffer from depression globally. Although depression is more common in women, it can affect anyone. It is seen in all socioeconomic classes, ages, and races. In response, the WHO developed the Mental Health Gap Action Programme to bring mental health care services to those in need.

Depression can lead to severe consequences, such as loss of employment, relationships difficulties, and suicide. In fact, suicide is the 10th leading cause of death in the United States.

Linda Girgis, MD

The U.S. Preventive Services Task Force (USPSTF), in past years, concluded that there was insufficient evidence to screen adolescents and adults for depression, However, new guidelines were issued this year in which the task force concluded there was a moderate benefit to screening adults for depression but insufficient evidence to screen for suicide risk. The agency now recommends screening for depression in all adults, even in the absence of risk factors, by using brief screening instruments such as the PHQ (Patient Health Questionnaire).

As family doctors, we have witnessed the burden of depression in our practices. The previous recommendations neglected the fact that mental health disorders were often purposely hidden because of stigma. Many patients do not readily come for treatment for mental illness and sometimes do not even accept these diagnoses. It is good that screening is now recommended, but we need to do more to tear down the stigma attached to mental illness.

These new guidelines do not address the effect that the lack of available mental health services has on treatment. It can take months to get an appointment for a patient with a mental health disorder, even if that person is potentially suicidal. Primary care physicians are often left treating these disorders; sometimes we are treating mental illness whether we feel comfortable doing so or not. Patients may not receive the best care but it is better than no care at all.

Although treating anxiety and depression is common for primary care doctors, specialists should be contacted when cases get more complicated. Even a call to crisis intervention can lead to an emergency department visit with discharge back to the family doctor because there is nowhere else to send the patient. The burden falls on us when we are already burdened by many other things, such as the rising rates of obesity with the resultant consequences of diabetes and heart disease. We simply do not have the time or expertise to treat complicated mental illness.

Creating guidelines to diagnose more undetected cases of depression without increasing the infrastructure to handle it is only going to lead to more pressure on family doctors. Many of us are already burnt out and at our limits. Yes, we want to diagnose every case of depression we can and to treat these patients for these disorders, but we need help.

Another problem with the guidelines is the recommendation to screen for depression and not suicide risk. As family doctors, we ask all patients who are depressed if they have thoughts of hurting themselves or others. Also, some people who commit suicide are not clinically depressed. These questions are simple to ask on an intake form.

Screening for depression is a pretty simple process. A patient can complete a screening tool or the clinician can directly ask the questions. It is a quick, noninvasive process. The Diagnostic and Statistical Manual of Mental Disorders criteria for diagnosing depression are pretty rigid and straightforward so misdiagnoses are not likely to be common.

The new guidelines do not make recommendations for treatment. In the real world, we often see patients unable to get the medications we prescribe because their insurance won’t cover it. Having guidelines supporting medication use would be very helpful.

In the area where I practice, it is difficult to refer a patient for counseling despite there being a plethora of counselors, therapists, and psychologists. These mental health providers often take only cash-paying patients, which eliminates access for many patients.

If we truly want to address the ever-increasing rates of depression in our country, we need to do much more than create new screening guidelines (screening that many family doctors were already doing). We must remove stigma, especially in the health care setting, fund mental health services, make them more readily available, and provide care that is affordable and covered by insurance. Until then, we are just going to add to the load of family doctors until we either break or leave our profession. Patients deserve better.

Dr. Linda Girgis practices family medicine in South River, N.J., and is a clinical assistant professor of family medicine at Robert Wood Johnson Medical School, New Brunswick, N.J. She was paid by Pfizer as a consultant on Paxlovid and is the editor in chief of Physician’s Weekly.

https://www.medscape.com/s/viewarticle/994795

Long COVID Disability Court Battles Just 'Tip of Iceberg'

 A growing number of long COVID patients, denied disability benefits despite being unable to work, are turning to the courts for legal relief.

At least 30 lawsuits have been filed seeking legal resolution of disability insurance claims, according to searches of court records. In addition, the Social Security Administration said it has received about 52,000 disability claims tied to SARS-CoV-2 infections, which represents 1% of all applications.

But legal experts say those cases may not reflect the total number of cases that have gone to court. They note many claims are initially dismissed and are not appealed by claimants.

"With this system, they deny two thirds of initial applications, then people who appeal get denied almost 90% of the time, and then they can appeal before a judge," said Kevin LaPorte, a Social Security disability attorney at LaPorte Law Firm in Oakland, California. "What happens next doesn't have a lot of precedent because long COVID is a mass disabling event, and we haven't seen that many of these cases get all the way through the legal system yet."

As a result, the exact number of long COVID disability claims and the number of these cases going to court isn't clear, he said.

"It can take a year or more for cases to get to court, and even longer to reach resolution," LaPorte added. "I suspect the few cases we've heard about at this point are going to be the tip of the iceberg."

The process is convoluted and can drag on for months with multiple denials and appeals along the way. Many disabled workers find their only recourse is to take insurers to court.

Long COVID patients typically apply for disability benefits through private insurance or Social Security. But the process can drag on for months, so many find their only recourse is to take insurers to court, according to legal experts.

But even in the courts, many encounter delays and hurdles to resolution.

In one of the first federal lawsuits involving long COVID disability benefits, William Abrams, a trial and appellate attorney and active marathon runner, sued Unum Life Insurance seeking long-term disability income. Symptoms included extreme fatigue, brain fog, decreased attention and concentration, and nearly daily fevers, causing him to stop working in April 2020.

His diagnosis wasn't definitive. Three doctors said he had long COVID, and four said he had chronic fatigue syndrome. Unum cited this inconsistency as a rationale for rejecting his claim. But the court sided with Abrams, granting him disability income. The court concluded the following:

"Unum may be correct that [the plaintiff] has not been correctly diagnosed. But that does not mean he is not sick. If [the plaintiff's] complaints, and [the doctor's] assessments, are to be believed, [the plaintiff] cannot focus for more than a few minutes at a time, making it impossible for [the plaintiff] to perform the varied and complex tasks his job requires."

Unum said in an emailed statement to WebMD that the company doesn't comment on specific claims as a matter of policy, adding that its total payouts for disability claims from March 2020 to February 2022 were 35% higher than prepandemic levels. "In general, disability and leave claims connected to COVID-19 have been primarily short-term events with the majority of claimants recovering prior to completing the normal qualification period for long-term disability insurance," Unum said.

Abrams prevailed in part because he had detailed documentation of the numerous impairments that eventually required him to stop work, said Michelle Roberts of Roberts Disability Law in Oakland, California.

He submitted videos of himself taking his temperature to prove he had almost daily fevers, according to court records. He underwent neuropsychological testing, which found learning deficiencies and memory deficits.

Abrams also submitted statements from a colleague who worked with him on a complex technology patent case involving radio frequency identification. Before he got COVID, Abrams "had the analytical ability, legal acumen, and mental energy to attack that learning curve and get up to speed very rapidly," according to court records.

"The court focused on credulity." Roberts said. "There was all this work to be done to show this person was high functioning and ran marathons and worked in an intense, high-pressure occupation but then couldn't do anything after long COVID."

Documentation was also crucial in another early federal long COVID disability lawsuit that was filed last year on behalf of Wendy Haut, an educational software sales representative in California who turned to the courts seeking disability income through her company's employee benefits plan.

Several of Haut's doctors documented a detailed list of long COVID symptoms, including "profound fatigue and extreme cognitive difficulties" that they said prevented her from working as a sales representative or doing any other type of job. A settlement agreement in June 2022 required Reliance Standard Life Insurance to pay Haut long-term disability benefits, including previously unpaid benefits, according to a report by the advocacy group Pandemic Patients.

Representatives of Reliance Standard didn't respond to a request for comment.

The growing number of workers being sidelined by long COVID makes more claims and more court cases likely. Right now, an estimated 16 million working-age Americans aged 18 to 65 years have long COVID, and as many as four million of them can't work, according to a July 2023 Census Bureau report.

Uncertainty about the volume of claims in the pipeline is part of what's driving some insurers to fight long COVID claims, Roberts said. Another factor is the lack of clarity around how many years people with long COVID may be out of work, particularly if they're in their 30s or 40s and might be seeking disability income until they reach retirement age.

"Doctors are not always saying that this person will be permanently disabled," Roberts said. "If this person doesn't get better and they're disabled until retirement age, this could be a payout in the high six or seven figures if a person is very young and was a very high earner."

Insurance companies routinely deny claims that can't be backed up with objective measures, such as specific lab test results or clear findings from a physical exam. But there are steps that can increase the odds of a successful claim for long COVID disability benefits, according to New York–based law firm Hiller, PC.

For starters, patients can document COVID test results, and if testing wasn't conducted, patients can detail the specific symptoms that led to this diagnosis, Hiller advises. Then patients can keep a daily symptom log at home that run lists all of the specific symptoms that occur at different times during the day and night to help establish a pattern of disability. These logs should provide specific details about every job duty patients have and exactly how specific symptoms of long COVID interfere with these duties.

Even though objective testing is hard to come by for long COVID, people should undergo all the tests they can that may help document the frequency or severity of specific symptoms that make it impossible to carry on with business as usual at work, Hiller advises. This may include neuropsychological testing to document brain fog, a cardiopulmonary exercise test to demonstrate chronic fatigue and the inability to exercise, or a tilt table test to measure dizziness.

Seeking a doctor's diagnosis can be key to collecting disability payments, in or out of court.

All of this puts a lot of pressure on doctors and patients to build strong cases, said Jonathan Whiteson, MD, co-director of the NYU Langone Health Post COVID Care Program.

"Many physicians are not familiar with the disability benefit paperwork, and so this is a challenge for the doctors to know how to complete and to build the time into their highly scheduled days to take the time needed to complete," Whiteson said.

It's also challenging because most of the disability benefit forms are 'generic' and do not ask specific questions about COVID disability," Whiteson added. "It can be like trying to drive a square peg into a round hole."

Still, when it comes to long COVID, completing disability paperwork is increasingly becoming part of standard care, along with managing medication, rehabilitation therapies, and lifestyle changes to navigate daily life with this illness, Whiteson noted.

Monica Verduzco-Gutierrez, MD, chair of rehabilitation medicine and director of the Post-COVID-19 Recovery Clinic at the University of Texas Health Science Center at San Antonio, agreed with this assessment.

"I have done letter upon letter of appeal to disability insurance companies," she said.

Some doctors, however, are reluctant to step up in such cases, in part because no standard diagnostic guidelines exist for long COVID and because it can be frustrating.

"This is the work that is not paid and causes burnout in physicians," Verduzco-Gutierrez said. "The paperwork, the fighting with insurance companies, the resubmission of forms for disability all to get what your patient needs ― and then it gets denied.

"We will keep doing this because our patients need this disability income in order to live their lives and to afford what they need for recovery," said Verduzco-Gutierrez. "But at some point something has to change because this isn't sustainable."

Sources

Lexis: "Covid-19 Workplace Litigation Trends."

Social Security Administration (emailed statement to WebMD)

Kevin LaPorte, JD, Social Security disability attorney, LaPorte Law Firm.

Casetext: "William F. Abrams, Plaintiff, v. Unum Life Insurance Company of America, Defendant."

Michelle Roberts, JD, founder, Roberts Disability Law.

Pandemic Patients: "Wendy Haut, Plaintiff, v. Reliance Standard Life Insurance Company; and Cengage Learning Inc. Group Long Term Disability Plan, Defendants."

U.S. Centers for Disease Control and Prevention: "Long COVID Household Pulse Survey."

Hiller: "COVID Long Haulers and Disability Insurance Claims."

Jonathan Whiteson, MD, co-director, NYU Langone Health Post COVID Care Program.

Monica Verduzco-Gutierrez, MD, director, Post-COVID-19 Recovery Clinic at the University of Texas Health Science Center.

https://www.medscape.com/viewarticle/995101

After FTC scrutiny, CooperSurgical calls off $875M deal for Cook Medical's reproductive health portfolio

 After more than a year, it’s been called off. CooperSurgical has ended plans to acquire Cook Medical’s reproductive health portfolio—a $875 million deal that would have included medical hardware for obstetrics, gynecology and in vitro fertilization.

In a brief announcement from the Federal Trade Commission, the agency said it “has learned” of the termination and described the move as “a win for patients,” adding that it came after cooperation with international antitrust regulators in Australia and the U.K.

“Following a full-phase investigation by FTC staff, CooperCompanies’ decision to abandon this proposed acquisition ensures that critical reproductive health markets remain competitive,” Holly Vedova, director of the FTC’s Bureau of Competition, said in a statement.

Cook Medical did not respond to inquiries by press time. CooperCompanies, CooperSurgical’s corporate parent, refused to comment.  

The deal, first announced in February 2022, put forward a plan for a long gestation period: a step-by-step transition spanning two years, where Cook subsidiaries would continue to manufacture products for CooperSurgical. 

That included the U.S.-based Cook Spencer and Cook Vandergrift divisions, plus William Cook Australia, with promises to increase their production capacity to keep up with demand during that period. Over time, Cook Medical’s employees would transition to other Cook Medical products.

The financial side of the deal followed a similar timeline, with $675 million to be paid upfront and the remaining $200 million delivered in annual installments of $50 million over the following four years.

The pitch was to be the latest in a string of reproductive health-focused deals for CooperSurgical, which put down $1.6 billion to acquire Generate Life Sciences in late 2021 for its fertility cryopreservation services of donor egg and sperm, as well as newborn stem cell storage from umbilical cord blood and tissue.

Prior to that, 2021 also saw CooperSurgical absorb OBP Medical and its vaginal speculums, anoscopes and laryngoscopes; Safe Obstetric Systems’ tools for C-section delivery; and Aegea Medical’s in-office endometrial ablation treatment.

https://www.fiercebiotech.com/medtech/after-ftc-scrutiny-coopersurgical-calls-875m-deal-cook-medicals-reproductive-health

Intellia fills gene editing trial outside US after FDA request for preclinical fetal data

 Intellia Therapeutics has patients lined up in the U.S. for a phase 2 trial of a CRISPR-based treatment in hereditary angioedema, but the FDA has thrown down a roadblock over a request for a new preclinical test of the therapy’s impact on a developing fetus.

The FDA has asked the gene editing biotech for additional preclinical data on the inclusion of female patients of child-bearing potential. An investigative new drug application was approved for NTLA-2002 by the agency in March, but the request for an additional animal test means Intellia is revising plans for the 55-person trial.

The good news, according to CEO John Leonard, is that sites outside the U.S. were happy to fill the enrollment gap. On a second-quarter earnings call this morning, the executive said the trial is proceeding “extremely quickly” without U.S. patients, so it will go on mostly as planned.

Intellia will conduct the requested preclinical study and hopes to get the FDA’s blessing to use U.S. patients in a phase 3 trial, which Leonard said could begin as early as the third quarter of 2024.Intellia could have proceeded with the U.S. portion of the study by filing a protocol amendment to exclude women of child-bearing potential but decided not to, a company spokesperson told Fierce Biotech. “While we do have the option to enroll U.S. patients with the exclusion of women of child-bearing potential through a protocol amendment, the global interest in NTLA-2002 enables us to proceed more quickly to a Phase 3 study by fully enrolling Phase 2 in other countries,” the company said in a statement. 

While leaders tried to couch the FDA setback with the news that enrollment had gone ahead anyway, analysts peppered Leonard and his fellow executives with questions on the earnings call.

The situation immediately brought to mind the clinical hold placed in November 2022 on Verve Therapeutics over concerns that gene edits from its high cholesterol gene editing therapy could pass on to children. This is known as germline editing and has been a key concern as gene editing overtakes the clinic. As of a May earnings update, Verve was still working toward resolving the hold for VERVE-101.

Leonard did not say the words “clinical hold” and was careful to note that Intellia already submitted preclinical breeding studies for the IND request that he believes allay concerns about germline editing with the company’s products.

“That is not what this is. That question has been addressed with information that was supplied with the already-cleared IND,” Leonard said. “So as far as we can tell in our dealings with the FDA and every other regulatory agency, that particular germline question has been put to rest with the data that we've supplied.”

Instead, the FDA wants to know whether the embryological development of the fetus in mice is affected in any way by chemicals that are in the lipid nanoparticle systems used to deliver NTLA-2002. The only thing different with the FDA’s request, according to Leonard, is that this specific test is being requested earlier in the development timeline than expected.

“We've looked at germline cells specifically, we know that they're unaffected,” Leonard said. He also noted that there was no specific safety data that spurred the FDA’s request. “Our view is that this is the FDA taking a very considered view of the space and looking for us to fill out what is a typical set of data that usually is supplied a little later in a program.”

The FDA and Intellia have already come to an agreement on what’s needed, which will be an “abbreviated study” that the company is already “well on our way to completing," according to Leonard.

Meanwhile, enrollment has filled up at the ex-U.S. sites, and that includes women of child-bearing potential. Leonard said there was plenty of enthusiasm from U.S. clinicians and patients to participate, but working through these issues for the phase 2 would have “delayed the study substantially.” The goal of the trial is to establish the phase 3 dose.

“We will have an abundance of U.S. patients that I think will be well prepared to begin the phase 3 program potentially as early as the third quarter of next year and that's what we're working towards,” Leonard said.

Coincidentally, Chief Medical Officer David Lebwohl, M.D., noted that many patients with hereditary angioedema are scrambling to get into the trial in the hope that their conditions can be improved so they can go on to have successful pregnancies.

“Of course, we look forward to bringing that great result forward in the future if we can,” Lebwohl said. He does not expect any differences between males and females, older or younger women when data collection begins. Intellia will be monitoring any future pregnancies as part of long-term follow-up.

Analysts wondered whether there was any read-through to the rest of Intellia’s pipeline. Leonard assured them that there should not be any impact on the company’s other programs, including star ATTR amyloidosis therapy NTLA-2001. That disease typically impacts older patients, particularly men, anyway, according to Leonard.

Intellia’s shares were mostly steady in the opening hours of trading at $38.98, down just under 2% from $40.96 at yesterday's close.

https://www.fiercebiotech.com/biotech/intellia-germline-fda-request-gene-editing-verve-clinical-hold-pregnancy

Regeneron rethinks CD28 bispecific R&D plan after 2 patients die

 Regeneron is rethinking development of its prostate cancer bispecific after two patients died in a clinical trial. The deaths prompted the Big Biotech to stop enrolling patients to receive REGN5678 and a full dose of its checkpoint inhibitor, but a reshaped bispecific development program is continuing. 

REGN5678 is designed to bind to CD28 on cytotoxic T-lymphocytes (CTLs) and PSMA on tumor cells. By binding to the costimulatory T-cell-specific surface glycoprotein and tumor-associated antigen, the drug candidate could activate CTLs and direct them to attack cancer cells. Regeneron identified the targeting of CD28 on previously activated T cells as a way to reduce toxicity compared to CD3 bispecifics. 

The candidate, which may synergize with anti-PD-1/L1 checkpoint inhibitors, came through the release of preliminary phase 1/2 data unscathed. But safety concerns have since come to light and prompted a shift in the R&D strategy.

In its second-quarter results statement, Regeneron reported two immune-mediated deaths in a cohort of patients who received REGN5678 in combination with Libtayo, the company’s checkpoint inhibitor. The deaths drove Regeneron to stop enrolling patients to receive REGN5678 and a full dose of Libtayo.

Regeneron is sticking with the candidate, though. The revised R&D road map includes the study of the bispecific as a monotherapy and in combination with lower doses of Libtayo and other immunotherapy modalities. Regeneron’s other costimulatory bispecific development programs, which include candidates against EGFR, MUC16 and CD22, are unaffected and are still making their way through dose escalation. 

Even so, the removal of the option to pair REGN5678 with a full dose of Libtayo is a blow. Regeneron took the bispecific into the clinic in the belief the combination may be able to overcome the resistance of metastatic castration-resistant prostate cancer to PD-1 inhibition. Overcoming resistance could bring the benefits of checkpoint inhibitors to prostate cancer, a setting in which the drugs have had little impact.

CD28 has a troubled history as a cancer target. The CD28 superagonist TGN1412 caused critical illnesses linked to cytokine storms in a phase 1 clinical trial in 2006. In recent years, companies including Johnson & Johnson and Sanofi have invested in candidates against the target, but fresh concerns emerged last year, when two deaths stopped trials of Alpine Immune Sciences’ conditional costimulator of CD28.

https://www.fiercebiotech.com/biotech/regeneron-rethinks-cd28-bispecific-rd-plan-after-2-patients-die

Chiggers infected with typhus bacteria found in NC

 Chiggers carrying bacteria that can cause a deadly kind of typhus never before found in the U.S. have been located in North Carolina. Researchers from N.C. State University and UNC-Greensboro published a paper earlier this month in the journal Emerging Infectious Diseases saying they found chiggers carrying a type of Orientia bacterium that can cause scrub typhus through sampling in 2022. In the paper, the writers say scrub typhus was only thought only to occur within a triangle anchored by Pakistan, Russia and Australia, but recently has been reported in the Middle East, southern Chile and Africa. The illness has not been reported in the U.S

. WHAT IS SCRUB TYPHUS? WHAT ARE THE SYMPTOMS? 

Scrub typhus often is compared to the tick-borne Rocky Mountain Spotted Fever and other illnesses. 

The Centers for Disease Control says symptoms of scrub typhus generally appear within 10 day of being bitten by an infected chigger, which is the larval stage of a mite. The illness most often includes: fever headache body aches sometimes a rash People with severe illness can develop organ failure and bleeding that can be fatal if not treated, according to the CDC.

HOW IS SCRUB TYPHUS TREATED? 

You can effectively treat the illness with the antibiotic doxycycline, the CDC says. Adult and larval chiggers on the head of a pin. U.S. Centers for Disease Control

 HOW (AND WHERE) WAS SCRUB TYPHUS FOUND IN NORTH CAROLINA?

 In their paper, the research team said scrub typhus causes more than a million cases of illness each year, but that its presence in the U.S. had never been investigated. In 2022, the team went into several North Carolina state parks, a national wildlife refuge and a national forest to look for chiggers and see if they were carrying the bacteria. They put tiles on the ground at 10 sites in eight counties and checked the tiles after about a minute for the presence of chiggers. They collected the chiggers they found and tested them. Researchers found chiggers carrying the bacteria in Morrow Mountain State Park, Lumber River State Park, Merchant Millpond State Park, Kerr Lake State Recreation Area and Falls Lake State Recreation Area. 

The team said the findings were significant because they show the spread of the bacteria to the continental United States and suggest that the bacteria are passed from mother mites to their offspring. The team said more study is needed to determine how widely distributed infected chiggers are across the country and whether wild animals that serve as hosts for the chiggers become infected with scrub typhus and whether they can transmit it. The team, which included Loganathan Ponnusamy, Michael Roe, Kaiying Chen and Mick Kulikowski of NCSU, also said clinicians here should be alert for possible cases of the illness. There is no vaccine to prevent scrub typhus, and the CDC says the best way to avoid is to not come in contact with chiggers, which live in brush and vegetation.

 HERE IS THE CDC’S ADVICE FOR AVOIDING CHIGGERS

If you’ll be outdoors in places where chiggers live:

 ▪ Use insect repellent containing DEET or other active ingredients registered for use against chiggers on exposed skin and clothing. Follow label instructions.

 ▪ Reapply insect repellent as directed.

 ▪ Don’t spray repellent on the skin under your clothes.

 ▪ If you’re also using sunscreen, apply that first, then the repellent.

 ▪ To protect infants and children, dress them in clothes that cover the arms and legs. If they’ll be in a stroller or baby carrier, cover with mosquito netting. 

▪ Don’t apply insect repellent onto a child’s hands, eyes, mouth or on cuts or irritated skins. Spray the repellent onto your hands and then apply to the child’s face.

https://www.newsobserver.com/news/local/article277761603.html

Rapid Direct Detection of SARS-CoV-2 Aerosols in Exhaled Breath at the Point of Care

• Dishit P. Ghumra
• , 
• Nishit Shetty
• , 
• Kevin R. McBrearty
• , 
• Joseph V. Puthussery
• , 
• Benjamin J. Sumlin
• , 
• Woodrow D. Gardiner
• , 
• Brookelyn M. Doherty
• , 
• Jordan P. Magrecki
• , 
• David L. Brody
• , 
• Thomas J. Esparza
• , 
• Jane A. O’Halloran
• , 
• Rachel M. Presti
• , 
• Traci L. Bricker
• , 
• Adrianus C. M. Boon
• , 
• Carla M. Yuede*
• , 
• John R. Cirrito*
• , and 
• Rajan K. Chakrabarty*

Abstract

Airborne transmission via virus-laden aerosols is a dominant route for the transmission of respiratory diseases, including severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Direct, non-invasive screening of respiratory virus aerosols in patients has been a long-standing technical challenge. Here, we introduce a point-of-care testing platform that directly detects SARS-CoV-2 aerosols in as little as two exhaled breaths of patients and provides results in under 60 s. It integrates a hand-held breath aerosol collector and a llama-derived, SARS-CoV-2 spike-protein specific nanobody bound to an ultrasensitive micro-immunoelectrode biosensor, which detects the oxidation of tyrosine amino acids present in SARS-CoV-2 viral particles. Laboratory and clinical trial results were within 20% of those obtained using standard testing methods. Importantly, the electrochemical biosensor directly detects the virus itself, as opposed to a surrogate or signature of the virus, and is sensitive to as little as 10 viral particles in a sample. Our platform holds the potential to be adapted for multiplexed detection of different respiratory viruses. It provides a rapid and non-invasive alternative to conventional viral diagnostics.

https://pubs.acs.org/doi/10.1021/acssensors.3c00512