The Dogma of the Realities of the Accuracy of SARS-CoV-2 Tests!

SARS-CoV-2, the virus responsible for the COVID-19 pandemic, is a new/novel virus for the human race. One of the pillars of managing this virus and the pandemic is accurate testing. Testing for the SARS-CoV-2 virus remains a challenge with regards to the accuracy of tests on the market. Epidemiologically, any diagnostic or laboratory test is always evaluated on two key metrics: it’s specificity and sensitivity rate.

Specificity

Specificity is the likelihood that the COVID test results are truly positive. That is, could a similar Non-COVID-19 Coronavirus be responsible for the positive result? A COVID test with a high specificity (i.e., reliable) will have a LOW false positive rate. Generally speaking it is desirable to have a test with high specificity. However, high specificity is attained at the expense of sensitivity. It is desirable to have a test with high specificity and sensitivity, but almost impossible to create a perfect test.

SARS-CoV-2 in its worldwide prevalence in the general population is still low. Even with the current pandemic raging, the prevalence and incidence is still low based on identified active cases (Some 5 million active cases identified worldwide out of a population of about 7.7 billion as of May 21, 2020). Aside from the diagnosed positive cases, it is estimated that the prevalence of coronavirus infection is more around 5% in the general population. We commonly associate a low prevalence of disease with increased false positive rates when testing. The current low prevalence of COVID infection affects the accuracy of SARS-CoV-2 tests coming into the market for use, with the risk of false positives becoming a major problem. Test manufacturers and regulators alike will have to be diligent and guard against a high number of false positives when developing and approving tests.

Sensitivity

Sensitivity of a SARS-CoV-2 molecular test or antibody test is the likelihood of how accurately the test will detect the virus or presence of the different types of antibodies. That is if you are infected with the virus, will the test correctly identify that you are infected, or will it not identify the virus in your respiratory system, resulting in a false negative. A highly sensitive test (i.e., accurate) will have a LOW false negative rate.

Most of the tests granted emergency use approval by the FDA during this pandemic have limited data with regards to their reliability and accuracy. Scientists at the Cleveland Clinic found that one popular rapid genetic test (the widely promoted Abbot test) told users they didn’t have the virus when they actually did (false negatives) about 15 percent of the time (1). Meanwhile, researchers at UCSF California studied 14 antibody tests on the market, some that were granted emergency use authorizations by the Food and Drug Administration (FDA), and found that only three of these tests delivered consistent results (1). Given the 5% prevalence rate, if a serological test has about 90% specificity, its positive predictive value (PPV) will be 32.1% – meaning nearly 70% of positive results will most likely be false. At this same disease prevalence, a test with 95% specificity will lead to a 50% chance that a positive result is wrong. Only at 99% specificity does the false positive rate become anywhere near acceptable, and even here the chances are that 16% of positive results would be wrong.

We know that a number of individuals with COVID infection are asymptomatic, sometimes for weeks, increasing the transmissibility of the disease in the population. For such cases it is important to have tests that can look for active infections with a high degree of sensitivity and specificity (low number of false negatives and false positives). If we can quickly identify such cases and isolate them, then we can prevent the rapid spread of this contagion.

The table below summarises test accuracy data, as of May 06, 2020, from selected manufacturers for their serological Covid-19 tests. However, when reviewing this data it has to be stressed that the validation tests these companies have performed have varied widely in size; Abbott’s antibody assay was tested on 1,200 specimens, whereas Epitope’s tests were run on only 54 samples from healthy people, and just 20 and 30 cases of PCR-confirmed Covid-19 cases for the IgM and IgG tests respectively.

Accuracy & Reliability of Selected COVID 19 Tests in the US & EU Markets:

[table id=3 /]

Note: All accuracy claims made by the companies. *Tests with FDA emergency use authorisation. Source: EvaluateMedTech & company websites.

Similar to most processes associated with COVID 19, since the emergence of the infection, tests for active infection and/or for antibodies are evolving daily by different clinical research laboratories, academic health organizations, and biomedical companies worldwide. However, in the US we are still facing a challenge with regards to ready and widespread availability of accurate and reliable COVID tests for both the molecular PCR test and the serological tests for the different antibodies. The situation is both dire and murky to say the least.

At this point, it is well recognized that both the molecular tests for Covid-19 (the nasal PCR that look for active infections) and the serological antibody tests (IgM for more recent and IgG for past infections) have had significant issues with respect to their accuracy. Shortage of good tests in turn means that we will not know how many active cases are out there in the public, or how many have recovered with a degree of short or long term immunity conferred on them to decrease the risk of contraction and/or rate of reinfection.

REFERENCES
1. https://www.vox.com/2020/5/1/21240123/coronavirus-quest-diagnostics-antibody-test-covid
2. Data compiled by EvaluateMedTech.
3. Loeffelholz MJ, Tang YW. Laboratory diagnosis of emerging human coronavirus infections – the state of the art. Emerg Microbes Infect. 2020;9(1):747–756. doi:10.1080/22221751.2020.1745095
4. Sheridan C. Fast, portable tests come online to curb coronavirus pandemic. Nat Biotechnol2020. [Epub ahead of print] doi:10.1038/d41587-020-00010-2 pmid:32203294

A Look at Concierge Medicine in Atlanta

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The Choice for Primary Care

[/fusion_text][fusion_text]The field of medicine is undergoing many changes. The primary care doctor of days past is now overextended. Physicians are being forced to practice “more efficient,” assembly line medicine. It is now clear that patients are in need of a solution to the current state of outpatient medical care.

Although, one size does not fit all, concierge medicine, a.k.a. personalized medical care, is standing tall as an option for overcrowded offices and underserved patients. Concierge medicine is one of the fastest growing medical trends in Atlanta and the country.[/fusion_text][fusion_text]Concierge medicine is a revolutionary form of health care that provides patients with personalized, attentive, quality medical care in a low patient volume setting, with personal physician access 24 hours a day, 7 days a week. While most medical practices carry about 3,000 to 4,000 patients per physician, concierge practices typically maintain about 600 patients per physician.

Concierge members can expect a dedicated internist who will address all concerns, same day or next day urgent appointments, coordination of care while traveling, personalized medical reports, and access to your personal physician via phone, email, and text messaging.

Concierge medicine or personalized medical care is a healthcare system in which the physician understands that you are the client, not just the patient. The physician listens to what you have to say, answers your questions, and is not satisfied until you are satisfied. The physician understands the meaning of combining quality medical care, compassion, and customer service to optimally respond to your healthcare needs.[/fusion_text][fusion_text]Buckhead Medicine is the premier concierge medical practice in Buckhead Atlanta. Our physician is Dr. Edward Espinosa D.O., M.P.H., a board certified internal medicine physician. Our mission is to deliver superior outpatient medical care to the North Atlanta community with an emphasis on quality of care, facilitating access to care, and focusing on the patient as our client.

The annual membership to Buckhead Medicine offers several additional benefits that distinguish the practice not only from traditional internal medicine practices, but more specifically from other concierge practices. A few examples are:[/fusion_text][fusion_text]- Dr. Espinosa sees patients while hospitalized and will assist in coordination of care.

– Dr. Espinosa is on staff at Piedmont, Northside & Emory at St. Joseph’s Hospitals

– Dr. Espinosa provides house calls.

– Our practice maintains a patient to physician ratio of 400:1 compared to other concierge practices’ ratios of 600:1[/fusion_text][fusion_text]We believe the concierge medicine model allows for the development of a strong personal patient-doctor relationship that can lead to an overall improvement in how healthcare is delivered and may ultimately improve clinical outcomes.[/fusion_text][/one_full][button link=”#” color=”default” size=”” stretch=”” type=”” shape=”” target=”_self” title=”” gradient_colors=”|” gradient_hover_colors=”|” accent_color=”” accent_hover_color=”” bevel_color=”” border_width=”” icon=”” icon_position=”left” icon_divider=”no” modal=”” animation_type=”0″ animation_direction=”left” animation_speed=”1″ animation_offset=”” alignment=”center” class=”footer-button modal-trigger-one” id=””]Request Quote[/button]

Atlanta Doctor Switches From Hospital Practice to Concierge Medicine

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Dr. Espinosa’s Journey to Buckhead Medicine

[/fusion_text][fusion_text]Below is a recent interview Dr. Espinosa did on why and how he made the move to concierge medicine.[/fusion_text][fusion_text]For Espinosa, building a concierge medicine practice from the ground up represented a huge challenge. However, he saw it as the best path to long-term financial stability and career satisfaction.

“Concierge medicine seemed like something that I could continue into my retirement years and still enjoy,” he says. “I went into medicine because I like caring for people and I felt like I couldn’t do that well in an environment where it’s all about volume.”

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Starting Out

[/fusion_text][fusion_text]In between his shifts as a hospitalist, Espinosa talked to friends who were running successful concierge practices in California. He also conducted extensive market research and hired a consultant to help him develop a business plan.

Location is the most important initial consideration, he says. He eventually decided on the Buckhead section of Atlanta, a relatively affluent and vibrant neighborhood with the potential to support a membership-based practice.

While encouraged by the success of other concierge practices, he was cognizant of the unique challenges of his situation. Most physicians who transition to concierge already run established traditional practices and are able to immediately convert a percentage of those patients into paying members.

However, Espinosa started from scratch when he opened Buckhead Medicine in 2008.[/fusion_text][fusion_text]Read to learn more about our Concierge Medicine pricing in Atlanta.[/fusion_text][fusion_text]To stay afloat, Espinosa continued to work full-time at the hospital, while maintaining a part-time schedule at his new office. The traditional seven days on/seven days off hospitalist schedule facilitated the arrangement, allowing him to keep regular outpatient office hours during his weeks away from the hospital.

He maintained that schedule for several years as he gradually ramped up to 50 patients over the first two years. Some of his first patients were those he had cared for as a hospitalist or patients referred by hospital colleagues.

The most effective marketing was through word-of-mouth, he says. The concierge concept was relatively new at the time and its message resonated with people who were frustrated with their current providers and looking for alternatives.

“Many people said they had no meaningful relationship with their physician, had to wait a long time for appointments, and often didn’t even get their phone calls returned,” he says. “What we heard over and over was that their current care was impersonal, and those frustrations were a major factor in growing our practice.”

Gradually, Espinosa began reducing his hospitalist shifts and adding office hours as he reached 150 patients in his fourth year — halfway to his goal. He also added staff, including two nurse practitioners, one front-desk administrator, and one floater who helps wherever needed.

Bedside manner is always important but even more so when hiring in a concierge practice, he notes. He looks for extremely customer-focused employees who will reassure patients that they “have a meaningful relationship with our practice.”

It took seven years to grow his patient panel to 300, but the practice now enjoys steady growth. Espinosa has a waiting list for new patients and plans to hire another physician within the next year.[/fusion_text][fusion_text]

Issues and Challenges

[/fusion_text][fusion_text]Patients who join Buckhead Medicine pay a membership fee that can be as low as $100 per month, which covers an expanded menu of services and 24/7 access to providers.

The practice also accepts all major insurance plans and handles billing for services covered under patients’ plans.

At first, the practice asked for the annual fee upfront but many patients were put off by the prospect of making such a large commitment, says Espinosa. He now uses an automated recurring billing service, which has relieved the front desk of the burden of monitoring collections and ensured a steady revenue stream.

“Automated monthly billing changed things drastically for the better,” he says. “It made it easier for patients to join and created a more predictable finan- cial model for our practice.”

The biggest administrative headache now is billing insurers and tracking reimbursements, he says. However, the practice has continued to offer it as an added service for patients.

“We’ve gone back and forth about whether it’s worth it because there’s so much work involved with getting reimbursement from commercial insurers and Medicare,” he says. “But we haven’t dropped it because our patients want things to happen in a streamlined fashion.”

In recent months, handling growth has become the biggest challenges, he says.

“It’s a healthy, busy practice now and we want to continue to provide the level of service people expect,” says Espinosa. “That requires us to sometimes pull back and resist growing so fast that our customer service would suffer.”

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Reaping the Benefits

[/fusion_text][fusion_text]On a typical day, Espinosa sees between seven and 10 patients, traveling between his office, the hospital, and patients’ homes. That leaves enough flexibility in his schedule to handle emergencies without having to cancel scheduled appointments.

For example, one of his patients came in recently with symptoms of dehydration and a urinary tract infection. He was able to see her in the office that afternoon and administer intravenous fluids and antibiotics, potentially preventing a trip to the emergency department.

If a patient is in the hospital, Espinosa connects with the attending physician and helps coordinate care by transferring patient records and following the patient’s progress throughout his stay.

He then schedules a follow-up visit at his office within three days of discharge and keeps close tabs on the patient’s progress. His EHR system is compatible with the systems used at three major Atlanta-area hospitals, allowing him to easily pull up discharge summaries.

“I have a very close follow-up with our patients to prevent unnecessary readmissions,” he says. “We are tracking our readmission rates and seeing much better results than national averages, and that’s because we have the time and flexibility in our schedule to provide that extra service.”[/fusion_text][fusion_text]When general internist Edward Espinosa began his career at Piedmont Hospital in Atlanta nine years ago, he planned to eventually transition from hospital to office-based practice. However, the more he learned about the frustrations of the traditional fee-for-service environment, the less confident he became about taking that path.

“The hospital was willing to set me up in a clinic but then I found out that I would need to see 25 patients a day,” says Espinosa, 43, who now runs Buckhead Medicine in Atlanta. “It defeated the reason I wanted to practice outpatient medicine in the first place, which was to decrease my volume of patients and be less impersonal and rushed.”

He did some research into alternative practice models and zeroed in on concierge medicine, where patients pay an annual fee or retainer in exchange for enhanced care and expanded access to providers. The model has gained popularity in recent years, according to the 2014 Survey of America’s Physicians conducted by executive search firm Merritt Hawkins, which reports that about 7 percent of all physicians currently practice some form of concierge or direct-pay medicine while 13 percent have plans to do so at some point in their careers.[/fusion_text][/one_full][fullwidth background_color=”#898989″ background_image=”” background_parallax=”none” enable_mobile=”no” parallax_speed=”0.3″ background_repeat=”no-repeat” background_position=”left top” video_url=”” video_aspect_ratio=”16:9″ video_webm=”” video_mp4=”” video_ogv=”” video_preview_image=”” overlay_color=”” overlay_opacity=”0.5″ video_mute=”yes” video_loop=”yes” fade=”no” border_size=”0px” border_color=”” border_style=”solid” padding_top=”20″ padding_bottom=”20″ padding_left=”10″ padding_right=”10″ hundred_percent=”no” equal_height_columns=”no” hide_on_mobile=”no” menu_anchor=”” class=”” id=””][fusion_text]

Lessons Learned

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Physician Edward Espinosa started Atlanta-based Buckhead Concierge Internal Medicine from scratch when he decided to switch from hospital to outpatient practice. He offers the following advice for others looking to make the transition:

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Consider Location

[/fusion_text][fusion_text]Perform an extensive demographic analysis of the zip codes you’re considering before signing a lease, says Espino- sa. Many successful practices are located in affluent, urban neighborhoods that can sup- port growth.[/fusion_text][/one_fourth][one_fourth last=”no” spacing=”yes” center_content=”no” hide_on_mobile=”no” background_color=”” background_image=”” background_repeat=”no-repeat” background_position=”left top” hover_type=”none” link=”” border_position=”all” border_size=”0px” border_color=”” border_style=”solid” padding=”” margin_top=”” margin_bottom=”” animation_type=”0″ animation_direction=”down” animation_speed=”0.1″ animation_offset=”” class=”” id=””][fusion_text]

Seek Help

[/fusion_text][fusion_text]Talking to other physicians with established concierge practices can help you avoid common mistakes, he says.You might also con- sider hiring a consultant to help with initial setup.[/fusion_text][/one_fourth][one_fourth last=”no” spacing=”yes” center_content=”no” hide_on_mobile=”no” background_color=”” background_image=”” background_repeat=”no-repeat” background_position=”left top” hover_type=”none” link=”” border_position=”all” border_size=”0px” border_color=”” border_style=”solid” padding=”” margin_top=”” margin_bottom=”” animation_type=”0″ animation_direction=”down” animation_speed=”0.1″ animation_offset=”” class=”” id=””][fusion_text]

Be Patient

[/fusion_text][fusion_text]It took seven years for Espinosa to reach his goal of signing on 300 patients. To survive financially, he con- tinued to work at the hospital until his new practice took off.[/fusion_text][/one_fourth][one_fourth last=”yes” spacing=”yes” center_content=”no” hide_on_mobile=”no” background_color=”” background_image=”” background_repeat=”no-repeat” background_position=”left top” hover_type=”none” link=”” border_position=”all” border_size=”0px” border_color=”” border_style=”solid” padding=”” margin_top=”” margin_bottom=”” animation_type=”0″ animation_direction=”down” animation_speed=”0.1″ animation_offset=”” class=”” id=””][fusion_text]

Create a Business Plan

[/fusion_text][fusion_text]You should have a clear business plan before you spend a penny on converting. You need to understand the financial model and come up with realistic numbers for your expected growth.[/fusion_text][/one_fourth][/fullwidth][separator style_type=”none” top_margin=”10px” bottom_margin=”10px” sep_color=”#ffffff” border_size=”” icon=”” icon_circle=”” icon_circle_color=”” width=”” alignment=”center” class=”” id=””][button link=”#” color=”default” size=”” stretch=”” type=”” shape=”” target=”_self” title=”” gradient_colors=”|” gradient_hover_colors=”|” accent_color=”” accent_hover_color=”” bevel_color=”” border_width=”” icon=”” icon_position=”left” icon_divider=”no” modal=”” animation_type=”0″ animation_direction=”left” animation_speed=”1″ animation_offset=”” alignment=”center” class=”footer-button modal-trigger-one” id=””]Request Quote[/button]