Anticipating higher demand for the flu vaccine this season, many pharmacy chains are expanding their services.

Kroger Health is focusing on drive-through influenza vaccines as well as touchless in-store appointments, whereas Meijer is offering patients the option to fill out their vaccination forms online or on their smartphones using its new contactless texting-based pharmacy service.

Grand Rapids, Michigan-based Meijer expects to administer nearly double the number of flu immunizations compared with last year, the retailer said in a news release.

The expected increase is because of higher awareness around the need to be vaccinated, as well as a shift toward patients looking for more convenient options and flexibility, Meijer Vice President of Pharmacy Jason Beauch said.

In fact, 1-third of flu vaccines provided by Meijer pharmacies so far this year have taken place on weekends or before/after traditional business hours, according to Beauch. Senior citizens and customers with chronic health conditions can take advantage of dedicated pharmacy hours from 7:00 a.m. - 8:00 a.m. on Tuesdays and Thursdays.

"While the flu shot will not protect against the coronavirus, getting it as soon as you can helps protect you and your family from unwanted illness and can help reduce the potential for symptoms that could be confused with COVID-19,” Beauch said.

Meanwhile, Kroger Health’s expanded flu vaccine program includes touchless in-store appointments and drive-through vaccinations at community Flu Shot Centers across the country — both of which can be 

 Kroger Health will also provide on-site flu vaccines programs for businesses and organizations.

“With so many health facilities already overburdened due to the COVID-19 pandemic, it is more important than ever for all Americans to get a flu shot,” said Colleen Lindholz, president of Kroger Health, in a news release.

 “At our COVID-19 drive-thru test sites, we were able to assist thousands of people in getting a test in a short amount of time. By using that model to provide flu shots, we hope to provide more customers with a safe, convenient option to get vaccinated.”

Flu vaccines will be administered at all of Kroger Health’s 2200 pharmacies and 223 clinics, called The Little Clinic, across 35 states, in addition to larger venues such as the Ohio State Fairgrounds and Expo Center, the Salem (Virginia) Civic Center, and the Indianapolis Zoo.

Additional drive-through Flu Shot Centers will open in various locations over the next several weeks, the company said.

Companies and other organizations can also work with Kroger Health to set up vaccine clinics for their members. “Flu shot events can be held on site with flu shots administered by Kroger Health pharmacists or nurse practitioners,” the retailer said.

1. Meijer Pharmacy expects to administer 75% more flu shots this year amidst pandemic. Meijer; September 23, 2020. Accessed September 25, 2020. 

http://newsroom.meijer.com/2020-09-23-Meijer-Pharmacy-Expects-to-Administer-75-Percent-More-Flu-Shots-This-Year-Amidst-Pandemic

2. Kroger Health expands flu shot program to help combat the challenges of COVID-19. Kroger Health; September 8, 2020. Accessed September 25, 2020. https://www.krogerhealth.com/news/kroger-health-expands-flu-shot-program-help-combat-challenges-covid-19

Articles

Anticipating higher demand for the flu vaccine this season, many pharmacy chains are expanding their services. 

Kroger, Meijer Expand Flu Vaccine Services

The FDA has approved mepolizumab (Nucala; GlaxoSmithKline) for the treatment of adult and pediatric patients aged 12 and older with hypereosinophilic syndrome (HES) for at least 6 months without an identifiable non-hematologic secondary cause.

HES is a rare and under-diagnosed disorder; therefore, its prevalence in the United States and globally is difficult to estimate. However, Dr. Hal Barron, chief scientific officer and president R&D, estimated that the disease affects approximately 5000 patients in the United States. “Today’s approval gives these patients access to a biologic treatment for the first time and demonstrates our commitment to maximizing Nucala’s impact on eosinophil-driven diseases,” Barron continued.

Individuals with HES experience an overproduction of eosinophils, a type of white blood cell, which can lead to inflammation and organ damage. Maintenance of the levels of eosinophils can improve these results, but if left untreated, HES symptoms can become worse and life-threatening.

“Patients with HES often suffer from debilitating flares of their disease,” said D. Gerald Gleich, MD, allergist, immunologist, and a HES expert. “Reducing them is an important treatment goal. For the first time, we now have a biologic treatment option to offer appropriate patients with this complex disease.”

Mepolizumab is the first-in-class monoclonal antibody that targets interleukin 5 (IL-5); researchers believe that the drug functions by preventing IL-5 from binding to its receptor on the surface of eosinophils, reducing blood eosinophils to normal levels. It has been studied for numerous eosinophilic indications and has been approved under the Nucala brand in the United States, Europe, and more than 20 other markets.

The approval was based on a 32-week, randomized, double-blind, placebo-controlled, phase 3 study that included 108 patients 12 years and older with uncontrolled HES that aimed to investigate the efficacy and safety of subcutaneous mepolizumab 300 mg. Mepolizumab was administered to patients every 4 weeks and compared with placebo.

The results showed 50% fewer patients experienced a HES flare when treated with mepolizumab, compared with placebo, when added to standard-of-care treatment over the 32-week study period, according to the study.

“HES can take many years to diagnose and most patients go through a long and frustrating journey that continues even after the diagnosis is confirmed as treatment roadmaps are often unclear and limited,” said Mary Jo Strobel, executive director, American Partnership for Eosinophilic Disorders (APFED). “APFED welcomes this approval of Nucala for HES as it gives our community hope.”

FDA approves Nucala as the first and only biologic treatment for Hypereosinophilic Syndrome (HES). News Release. GSK; September 25, 2020. Accessed September 25, 2020. 

https://www.gsk.com/en-gb/media/press-releases/fda-approves-nucala-as-the-first-and-only-biologic-treatment-for-hypereosinophilic-syndrome-hes/

The FDA has approved mepolizumab (Nucala; GSK) as the first biologic treatment of hypereosinophilic syndrome. 

FDA Approves Mepolizumab for Hypereosinophilic Syndrome

Results of a study based in Detroit, Michigan reported that the initial viral load (VL) of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in nasopharyngeal samples has been decreasing throughout the pandemic’s progression.

The study was presented at the ESCMID Conference on Coronavirus Disease, held online September 23-25, 2020.

According to the investigators from Wayne State University/Detroit Medical Center, the VL decline was also associated with a decrease in death rate. The study took place between April 4 and June 5, 2020 among hospitalized patients in Detroit.

"During the April-June 2020 period of the COVID-19 pandemic, the initial SARS-CoV-2 load steadily declined among hospitalized patients with a corresponding decrease in the percent of deaths over time,” the authors concluded. “Though confounding variables have not been evaluated, this suggests an association between initial viral load and mortality."

However, the dynamics of SARS-CoV-2 VL on a population level remain unclear. Study investigators focused on the initial SARS-CoV-2 VL in nasopharyngeal swab samples that returned positive for SARS-CoV-2 and utilized the cycle threshold (Ct) value provided by the test for each sample, in which a higher Ct demonstrates a lower VL.

Study authors labeled high, intermediate, and low VL samples with Ct values of 25 or lower, 26-36, or 37 or higher, respectively. In the first week of the study, 49% of the initial VL samples spanned the intermediate group; 25.5% VL samples were in the low and high VL categories. Following the first week, data demonstrated a progressive decline in the high and intermediate VL categories and a rise in the numbers of samples in the low VL category.

At week 5 of the study, 70% of samples showed an initial low VL and corresponded with a decrease in deaths; 45% of patients with high VL died, compared with 32% of those in the intermediate group, and 14% of patients in the low VL group.

"Exact reasons for a decrease in initial viral load over time are unclear,” study investigator Said El Zein, MD, Wayne State University/Detroit Medical Center, said in the press release. “A downward trend in the initial VL may reflect a reduction in the severity of the pandemic and trends in the viral load values over time may represent a marker to assess the progress of the pandemic. Rapid implementation of social distancing measures, lockdown, and widespread use of facemasks may have contributed to a decrease in the exposure to the virus."

US study shows decline in viral load of patients with COVID-19 as pandemic progressed. News Release. EurekAlert; September 23, 2020. Accessed September 24, 2020. 

https://www.eurekalert.org/pub_releases/2020-09/esoc-uss092320.php

Investigators also reported a potential association between initial viral load and mortality in patients with COVID-19. 

Study: Initial SARS-CoV-2 Viral Loads Decreased As Pandemic Progressed

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes coronavirus disease 2019 (COVID-19), has infected an estimated 32,345,456 individuals worldwide, and approximately 6.9 million Americans. The latest COVID-19 related news includes promising phase 3 clinical trials, as well as the FDA’s authorization of the first serology point-of-care (POC) COVID-19 test.

Here’s a roundup of the latest coronavirus-related news:

Phase 3 EMPACTA Study: Tocilizumab Shows Efficacy in COVID-19 Associated Pneumonia

Treatment with tocilizumab (Actemra; Genentech) reduced the likelihood of needing mechanical ventilation in hospitalized patients with COVID-19 associated pneumonia, according to results from a phase 3 study.

Walmart Pilots Drone Delivery of COVID-19 Tests

Walmart is piloting drone delivery of at-home COVID-19 self-collection kits, which provides a contactless testing option amid the pandemic, the retailer said.

FDA Issues EUA for First Point-of-Care COVID-19 Antibody Test

The FDA has issued an emergency use authorization (EUA) for the first serology (antibody) POC test for COVID-19.

Johnson & Johnson’s COVID-19 Vaccine Candidate Enters Phase 3 Trial

Johnson & Johnson announced the initiation of its phase 3 clinical trial for Janssen’s COVID-19 vaccine candidate, JNJ-78436735, according to a press release.

Study Compares Clinical Features of COVID-19 and Seasonal Influenza

The United States is still in the midst of the COVID-19 pandemic and the 2020-2021 influenza season is on the way.

How much the upcoming season will tax a health care system that has been stretched is unknown. However, a 

 offers a look at the similarities and differences between COVID-19 and seasonal influenza.

Study Evaluates Famotidine Use in Hospitalized COVID-19

Results from a recent study showed that famotidine was associated with a reduced risk of clinical deterioration leading to intubation or death in patients hospitalized with SARS-CoV-2, the virus that causes COVID-19.

Here's this week's roundup of the coronavirus-related news you should know.

Coronavirus News Roundup: Johnson & Johnson’s Vaccine Enters Phase 3 Trial, FDA Authorizes Point-of-Care Antibody Test 

Officials with the FDA have issued a warning about the serious problems associated with high doses of diphenhydramine (Benadryl), according to a drug safety communication.

The warning cites teen misuse of the allergy medicine sparked by the “Benadryl Challenge,” a dangerous social media trend promoted on the popular application TikTok. The agency issued the communication following news reports of teenagers ending up in emergency rooms or dying as a result of participating in the challenge.

According to the FDA, the agency is investigating these reports and conducting a review to determine if additional cases have been reported.

The Benadryl Challenge went viral on TikTok, challenging users to take excessive doses of the allergy medication to elicit hallucinatory effects. Taking higher than the recommended doses of diphenhydramine can lead to serious heart problems, seizures, coma, or even death. The FDA said it has contacted the platform and “strongly urged” it to remove videos of the Benadryl Challenge and monitor for any new posts.

Johnson & Johnson also issued its own warning.

“We understand that consumers may have heard about an online ‘challenge’ involving the misuse or abuse of diphenhydramine. The challenge, which involves ingestion of excessive quantities of diphenhydramine, is a dangerous trend and should be stopped immediately. Benadryl products and other diphenhydramine products should only be used as directed by the label,” the company said in the statement.

Additionally, Johnson & Johnson said it is working with TikTok and other social media platforms to remove content that showcases this behavior.

According to the FDA, health care professionals should be aware that the Benadryl Challenge is occurring among teens, and alert caregivers about it. Encourage teens and caregivers to read and follow the Drug Facts label.

The FDA reminds consumers, patients, and caregivers to store diphenhydramine and all other medications out of children’s reach and sight. The agency also recommends locking up medicines to prevent accidental poisoning by children and misuses by teens.

FDA warns about serious problems with high doses of the allergy medicine diphenhydramine (Benadryl). Drug safety communication. FDA; September 24, 2020. Accessed September 25, 2020. 

https://www.fda.gov/drugs/drug-safety-and-availability/fda-warns-about-serious-problems-high-doses-allergy-medicine-diphenhydramine-benadryl

Benadryl. Safety. Johnson & Johnson; Accessed September 25, 2020. 

Dangerous social media challenges prompt the FDA to warn about the serious risks associated with taking excessive doses of diphenhydramine (Benadryl). 

FDA Issues Warning Over Dangerous TikTok ‘Benadryl Challenge’ 

Although some jobs are down, traffic for pharmacy technician jobs has increased. The increased need for pharmacy technicians was apparent before coronavirus disease 2019 (COVID-19)-related events affected our health care system. And the need for skilled and knowledgeable pharmacy technicians in our workforce remains steady throughout current times. It’s true that many pharmacies are remodeling how staffing looks in a forced need to meet COVID-related financial constraints. But, these adjusted staffing models keep pharmacy technicians in the essential need category.

Pharmacy technicians are essential, because they serve as frontline individuals in the pharmacy. In most cases, it is the pharmacy technician who first meets with the patient to gather information and determine patient needs. Based on acuity, the pharmacy technician triages tasks and workflow within the medication dispensing process. 

The great thing about a career as a pharmacy technician is the variety of job descriptions. A community pharmacy setting offers the pharmacy technician a wide array of responsibilities that focus on face to face patient interaction. Accepting prescriptions, taking blood pressure readings and helping to improve patient mobility by fitting the patient with a walker are a just a few examples of the importance a pharmacy technician in the community pharmacy has on the patient experience. 

Working in a home infusion pharmacy, the technician compounds or prepares products in an area of the pharmacy called a clean room. These preparations will be administered intravenously to patients who receive therapy while at home. Technicians who work in a long term care pharmacy repackage oral medication for residents living in nursing homes and other assisted living facilities. Job descriptions also include work in veterinary pharmacies supplying medication for animal-use, hospital pharmacies preparing oral and IV medication for inpatients and pharmacy benefits management (PBM) companies where instead of working with the medication product, their work is within the insurance-side of pharmacy by assisting with prior authorization approval and claim processing. From insurance adjudication to IV medication compounding and advanced practices such as COVID testing, pharmacy technicians assist pharmacists in many exciting ways. 

Tony Beraldi, RPh in Council Bluffs, Iowa, and president of the Southwest Iowa Pharmacists Association shares, “Pharmacies simply would not function without technicians. This goes for community pharmacies, hospital pharmacies, long term care pharmacies, and every other pharmacy setting.”

In this time of employment uncertainty, rest assured that the outlook for a pharmacy technician career is favorable. To be a successful technician, it's a good idea to look at qualifications 

and job expectations that employers value. One hundred sixty local pharmacy technicians responded to a survey question that asked the expectations they feel their employer has of them. Common survey question replies centered around the professional attributes of honesty, accountability, work ethic and competency. 

Work while I'm at work. Be flexible and ready to work where needed.

Be honest, kind, and friendly answering phones.

Be accountable and knowledgeable of my duties. Be competent.

Be respectful, responsible, attentive to patient/customer needs.

As for help when I need it. Try new ways of doing a task. 

Work efficiently. Ask questions instead of making assumptions. 

Be punctual. Have regular attendance. Be reliable and dependable. 

Have accuracy in data entry and all dispensing tasks. 

Focus on the job to complete the work assigned to me.

Continue to learn new ideas and strategies to better the pharmacy culture in the pursuit of zero harm. 

Regarding qualifications needed to work as a pharmacy technician, individuals must meet credentialing as required by the state of their employment. For example, pharmacy technician credentialing in Nebraska includes both licensure/registration and pharmacy technician certification. Certification involves a component of education to qualify for the credentialing status. 

The need for skilled and knowledgeable pharmacy technicians in our workforce remains steady throughout current times.  

Pharmacy Technicians on the Front Line of Health Care

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Treatment with tocilizumab (Actemra; Genentech) reduced the likelihood of needing mechanical ventilation in hospitalized patients with coronavirus disease 2019 (COVID-19 associated pneumonia, according to results from a phase 3 study.

Tocilizumab is a humanized interleukin-6 receptor antagonist approved for the treatment of adult patients with moderately to severely active rheumatoid arthritis, with additional indications in giant cell arteritis, active polyarticular juvenile idiopathic arthritis, and active systemic juvenile idiopathic arthritis.

The phase 3 EMPACTA study, the first trial to primarily enroll patient populations underrepresented in clinical studies and disproportionately affected by COVID-19, assessed the efficacy and safety of tocilizumab in the treatment of hospitalized COVID-19 associated pneumonia.

EMPACTA enrolled hospitalized patients aged 18 years and older with confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV2) infection with SpO2 <94% while on ambient air who did not require noninvasive or invasive mechanical ventilation. Approximately 85% of the 389 patients in the study were Hispanic, with significant representation of Native American and Black populations as well.

According to the results, patients with COVID-19 associated pneumonia who received tocilizumab plus standard of care were 44% less likely to progress to mechanical ventilation or death, compared with patients who received placebo plus standard of care. The cumulative proportion of patients who progressed to mechanical ventilation or death by day 28 was 12.2% in the tocilizumab arm versus 19.3% in the placebo arm.

The findings also showed no statistically significant difference in mortality, time to hospital discharge, or time to clinical failure between patients who received tocilizumab or placebo. 

At day 28, incidence of infections was 10% and 11% in the tocilizumab and placebo arms, respectively. The incidence of serious infections 5% and 6.3%, respectively. The most common adverse effects reported for tocilizumab in the study were constipation, anxiety, and headache. No new safety signals were identified.

“The EMPACTA trial demonstrated that Actemra can reduce the need for mechanical ventilation in patients with COVID-19 pneumonia, an important outcome in this serious disease,” Levi Garraway, MD, PhD, chief medical officer and head of Global Product Development, said in a statement. “We plan to share this important data with the FDA and other health authorities around the world.”

Genentech’s Phase III EMPACTA Study Showed Actemra Reduced the Likelihood of Needing Mechanical Ventilation in Hospitalized Patients With COVID-19 Associated Pneumonia. News release. Genentech; September 17, 2020. Accessed September 24, 2020. 

https://www.gene.com/media/press-releases/14881/2020-09-17/genentechs-phase-iii-empacta-study-showe

Tocilizumab (Actemra; Genentech) reduced the likelihood of needing mechanical ventilation in hospitalized patients with COVID-19 associated pneumonia. 

 Hi, I'm Gabrielle Ientile with Drug Topics®. Today I'll be interviewing Anna Dover with First Databank. First, here's the latest news from drugtopics.com.

President Trump recently signed for executive orders on drug pricing, directing the Secretary of HHS to take action to lower costs for patients on prescription drugs. The Executive Order focused on pharmacy benefit managers (PBMS) and the process by which PBMs negotiate discounts, sometimes up to 50%, on the list price of drugs that work in their favor and allow them to collect large rebate checks. Medicare patients, on the other hand continue to overpay for their medications.

Though the administration's executive order would conceivably save many patients covered under the Medicare Part D program hundreds or thousands of dollars per year, it fails to implement stipulations addressing the impact that DIR fees are having on the viability of American pharmacies.

Several pharmacy organizations are urging the Trump administration to do away with DIR fees in the executive order. Unless Congress acts, the order in its current form would take effect on August 24 2020. And that's the latest news from drugtopics.com.

 Before we get into our topic, can you give a little bit of your background in pharmacy and your work with first databank?

 Sure, I actually have been practicing pharmacy since 2000. And I spent most of my time in direct patient care in the hospital setting. I had some management roles, worked primarily in critical care and step down units (SDU). And after about 11 years, I had the opportunity to move over to the IT department at the hospital I was at. We were going through a large EHR implementation, and I moved into more of an analyst role: I became the CDS lead, was the instructional designer, and worked a lot on medication warning optimization, as well as general CDS projects.

I was a customer of FDB while I was doing that. After 6 years, I decided it was time for a new challenge and joined FDB actually to work on a new product suite, working on improving medication decision support. And it's really been great I've enjoyed FDB as a customer and I really enjoy working for the company.

 Can you touch upon how FDB has implemented and researched this patient first approach and the results from that research?

 So FDB has been interested in making the decision support more patient specific. It predates me for many, many years. There are several folks in the organization that have really made this a desire and a dream, it's kind of the vision we want to do.

And the traditional content, this would require not just FDB revising the content, but also for that vendor system or that software system to program to the new data elements. What we're doing to help get this idea out there in advance is using web service-enabled technology so that we can use an available integration into that software system and provide the new content in advance.

And we've done this based on not just scholarly articles and research, but also based on feedback from our customers and others in the healthcare IT space. And even more exciting is that we can look at some of the alerting statistics from our customers. We have another product, alert space analytics, that customers can provide us with their alerting patterns. So we can actually look and find the things that are likely fatiguing, and our clinicians can look at it to decide, “How can we make this alert work better?”

So the hyperkalemia or high potassium level is one; another area of concern is Qt prolongation, which can lead to a lethal arrhythmia potentially in a patient. So it’s a very important alert, but it's hard to get the required specificity for it.

Our clinicians have actually evaluated not just what would be required clinically to identify those at higher risk based on research, but also evaluated what data is likely available in the software so that they can have a safe path to allow customers and clinicians to use relevant information about the patient and highlight only those patients at the greatest risk.

 This technology would require that an Electronic Health Record (EHR) system is in place - is that correct?

 Not necessarily. That's the space we started in. Because I think it's funny. As a pharmacist, I think we were so used to alert fatigue that we were less likely to complain compared to physicians who were newer to that type of phenomenon.

And we can provide this outside of EHR, any software system that would be interested in using it. And even more exciting, we're looking at a data version of this that we could provide as well. It's another newer product that we're working on. Because it's been so exciting in the provider space, we're looking at other ways that we can deploy this content, not just the web service model, but other more traditional methods that FDB has provided content.

 How do you envision the future of medication decision support and pharmacy practice fitting in within that system?

 A great question. I think this is where I could wax philosophical for a while, because it's very exciting to me.

I think where we're heading is moving away from interruptive alerts for things that could be potential problems. And now deploying a way to surveil so that pharmacists who have always managed these things could more easily identify potential risks, and then only use interruptive alerting at the point that it's a concern.

Expert Interviews

Anna Dover, PharmD, discusses how modernizations in medication decision support are advancing pharmacy practice.

Expert Interview: Medication Decision Support

Walmart is piloting drone delivery of at-home coronavirus disease 2019 (COVID-19) self-collection kits, which provides a contactless testing option amid the pandemic, the retailer said.

Partnering with Quest Diagnostics and DroneUp, Walmart is launching trial deliveries of collection kits in Las Vegas, Nevada this week, and then Cheektowaga, New York, in early October, the retailer said in a blog post on its web site.

Walmart also partnered with Zipline to test on-demand deliveries of select health and wellness products in mid-September.

“There’s a lot we can learn from our drone delivery pilots to help determine what roles drones can play in pandemic response, health care delivery and retail,” wrote Tom Ward, senior vice president of customer product at Walmart.

 “We hope drone delivery of self-collection kits will shape contactless testing capabilities on a larger scale and continue to bolster the innovative ways Walmart plans to use drone delivery in the future.”

Notably, Walmart said there is no delivery or kit cost for customers electing to receive an at-home kit delivered via drone.

Patients who qualify for drone delivery of the COVID-19 self-collection kits must live in a single-family residence within a 1-mile radius of designated Walmart Supercenter stores in North Las Vegas and Cheektowaga.

The kits will land on the driveway, front sidewalk, or backyard of the customer’s home, depending on where there are cars and trees. Once the kits are delivered, the person will perform a self-administered nasal swab at home and send their sample back to Quest Diagnostics for testing using the included prepaid shipping label.

Meanwhile, trial drone deliveries of health and wellness products will take place near Walmart’s headquarters in Northwest Arkansas using Zipline’s proprietary technology, Ward wrote. Zipline will operate from a Walmart store and can service a 50-mile radius. According to Ward, this operation will likely begin early next year, and, if successful, will expand.

1. Walmart now piloting drone delivery of COVID-19 at-home self-collection kits. Walmart; September 22, 2020. Accessed September 24, 2020. 

https://corporate.walmart.com/newsroom/2020/09/22/walmart-now-piloting-drone-delivery-of-covid-19-at-home-self-collection-kits

2. Walmart and Zipline team up to bring first-of-Its-kind drone delivery service to the United States. Walmart; September 14, 2020. Accessed September 24, 2020. https://corporate.walmart.com/newsroom/2020/09/14/walmart-and-zipline-team-up-to-bring-first-of-its-kind-drone-delivery-service-to-the-united-states

Walmart is piloting drone delivery of at-home coronavirus disease 2019 (COVID-19) self-collection kits.

Walmart Pilots Drone Delivery of COVID-19 Tests 

The FDA has issued an emergency use authorization (EUA) for the first serology (antibody) point-of-care (POC) test for the novel coronavirus disease 2019 (COVID-19).

The Assure COVID-19 IgG/IgM Rapid Test Device joins the nearly 50 serology tests that have been granted EUA status in response to the pandemic. The POC test was initially authorized for emergency use by some labs in July to aid in identifying those with antibodies for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), which demonstrates a recent or prior infection with COVID-19.

The Assure test is a lateral flow assay, authorized for use with venous whole blood, serum, plasma, and fingerstick whole blood, uses a blood sample from a patient’s fingertip to run the test. It is currently the only COVID-19 POC serology test authorized by the FDA.

Although diagnostic research has quickly progressed amid the pandemic, the FDA emphasized the fact that there are still many unknowns about the nature of SARS-CoV-2 and immune responses in infected individuals, including how long antibodies persist, and whether the presence of antibodies leads to immunity. Individuals should therefore not use this most recent, or any, serology test to decide to stop taking precautions against the virus.

Moreover, antibody tests should not be used to indicate an active COVID-19 infection, according to the FDA; these POC tests detect the development of antibodies in response to the virus, not the virus itself.

“Authorizing point-of-care serology tests will enable more timely and convenient results for individuals who want to understand if they have previously been infected with the virus that causes COVID-19,” said FDA Commissioner Stephen M. Hahn, MD. “Until today, serology test samples were generally only able to be evaluated in a central lab, which can be time consuming and use additional resources to transport samples and run the test. As more and more point-of-care serology tests are authorized, they will help conserve those resources and may help reduce processing time for other types of COVID-19 tests, as less time is spent on serology tests.”

As of the FDA’s announcement of the EUA, the Assure test is available by prescription only. The agency expressed their commitment to expanding access to COVID-19 testing.

Coronavirus (COVID-19) Update: FDA Authorizes First Point-of-Care Antibody Test for COVID-19. News Release. FDA; September 23, 2020. Accessed September 24, 2020. 

https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-first-point-care-antibody-test-covid-19

The Assure test is the only FDA authorized COVID-19 point-of-care serology test. 