Another Free Contact Tracing Course is Available

Arizona needs a sprawling network of contact tracers to track and halt the spread of covid-19. Some researchers believe that an effective tracking system will require a few hundred contact tracers for a population the size of Arizona. 

Last week I wrote about how the Association of State and Territorial Health Officials had developed a free on-demand training for entry-level COVID-19 contact tracers. The course, called Making Contact: A Training for COVID-19 Contact Tracers supports ongoing public health agency efforts to prepare new contact tracers for their work of helping identify COVID-19 positive cases and those with whom they have been in close contact.

This week the Johns Hopkins Bloomberg School of Public Health unveiled a similar 5 hour online Course that’s designed teach non-public health professionals the fundamentals of contact tracing.

What do Sensitivity and Specificity Mean, Exactly?

When new tests come out, they’re evaluated for how well they work. As tests are evaluated, you’ll often read the words sensitivity, specificy and predictive positive value. Here is a pointer about what those words mean:

Sensitivity refers to the “true positive rate.” It measures how frequently the test is positive when the person being tested actually has the disease. For example, when a test has 80% sensitivity, the test detects 80% of patients with the disease (true positives). However, 20% of patients with the disease are not detected (false negatives) by the test.

Specificity refers to the “true negative rate.” It measures how frequently the test is negative when the person being tested doesn’t have the disease. For example, when a test has 80% specificity, the test correctly reports 80% of patients without the disease as test negative (true negatives). However, 20% of patients without the disease are incorrectly identified as testing positive (false positives) by the test.

Positive Predictive Value is the measure of how likely it is that a positive test is a true positive rather than a false positive. This depends on how many people in the population being tested have had the disease. When there are very few people in the population that have had the disease, then there’s a higher chance that a positive test is a false positive. When there are many people in a population that have had the disease, then there’s a higher chance that a positive test is a true positive.

Antibody Rapid Tests Becoming Less of the Wild-Wild West

The FDA said they’ll be tightening requirements for companies that develop COVID-19 antibody tests to better regulate the frenzy of tests coming to market. The updated policy requires commercial antibody test developers to apply for Emergency Use Authorization (EUA) from the FDA with performance thresholds for specificity and sensitivity.

Previously, manufacturers of the tests could validate their own tests and bring them to market without FDA review. More than 100 antibody tests have entered the market, fueling a congressional investigation into the accuracy of tests.

FDA posted a list of antibody tests removed from the “notification list” of tests offered under the Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency. FDA announced revised guidance recommending that commercial manufacturers of antibody tests submit an Emergency Use Authorization request within 10 business days from the date they notified FDA of their test validation or the date of publication of the revised policy, whichever was later.

Editorial Note: My advice for folks that believe that they may have recovered from a COVID infection and want to find out for sure is to get a blood draw serology test rather than the simple finger stick rapid test. The results are a lot more reliable. That test costs about $100. Turn around time is about 2 days.

How are Antibody Tests Useful for Public Health Purposes?

Antibody tests have several important public health applications. High-quality serologic tests (e.g. the blood draw kind) can be used to estimate the prevalence of past viral infection or estimate the cumulative incidence of infection in a population (progress toward herd immunity).

They can help identify people that can be plasma donors. Plasma from donors with a good IgG titer can provide antibodies for infected persons that helps with their recovery. Antibody status can also help inform persons and employers who is at less risk for infection. 

Last week APHL issued a document outlining potential public health applications for antibody testing.  The statement provides an overview of serologic methods, considerations for selecting assays for seroprevalence surveys and test result interpretation, and outstanding research needs.

University of Arizona’s Antibody Testing Project Underway

The U of A expanded its analysis of blood samples statewide to find out who has antibodies against the SARS CoV2 virus.  The State Legislature appropriated the $3.5M to fund the effort.

Testing sites are opening in all 15 counties tomorrow. Overall, there are 31 antibody testing sites across the state, with additional sites becoming available as needed. The specific testing site for each participant will be selected during the registration process.

Registration for health care workers and 1st responders is now available at covid19antibodytesting.arizona.edu. That site also has the most current information on the antibody testing initiative including qualifications for registering.

Most people who are infected by the virus that causes COVID-19 make antibodies within a few weeks of infection. The presence of COVID-19 antibodies in blood serum means the immune system mounted a response against the virus.

Journal Article of the Week 

High SARS-CoV-2 Attack Rate Following Exposure at a Choir Practice — Skagit County, Washington, March 2020

MMWR / May 15, 2020 / 69(19);606–610 

Faith worship services are in the process of figuring out how to begin operations safely. CDC published an MMWR this week regarding an investigation into a SARS CoV2 choir spreading event that helps to inform the choral aspects of worship.

It underscores the importance of distancing and masks among choirs and if hymns are included in services. While it doesn’t exactly demonstrate that singing is an amplifier of the virus, it suggests that it plays a role. Important to consider as congregations begin their plans to resume services.

Also, the state issued a 1 page guidance document this week outlining some basic tips for faith based organizations.

Biotech Company Says they had Encouraging Phase I Vaccine Safety Results (n=45)

Biotech company Moderna put out a press release today saying that the initial Phase I results for a small study of 45 volunteers found that their experimental vaccine had minor side effects and elicited an immune response in participants. On the efficacy side of the table, they found that:

“…Dose dependent increases in immunogenicity were seen across the three dose levels, and between prime and boost within the 25 µg and 100 µg dose levels. All participants ages 18-55 (n=15 per cohort) across all three dose levels seroconverted by day 15 after a single dose. At day 43, two weeks following the second dose, at the 25 µg dose level (n=15), levels of binding antibodies were at the levels seen in convalescent sera (blood samples from people who have recovered from COVID-19) tested in the same assay. At day 43, at the 100 µg dose level (n=10), levels of binding antibodies significantly exceeded the levels seen in convalescent sera. Samples are not yet available for remaining participants.”

“At this time, neutralizing antibody data are available only for the first four participants in each of the 25 µg and 100 µg dose level cohorts. Consistent with the binding antibody data, mRNA-1273 vaccination elicited neutralizing antibodies in all eight of these participants, as measured by plaque reduction neutralization (PRNT) assays against live SARS-CoV-2. The levels of neutralizing antibodies at day 43 were at or above levels generally seen in convalescent sera.”

In other words… among the small number of participants (n=12) for which data are available, there was an immune response that may be immunogenic (works).

So, the DOW stock market index went up 700 points in early trading because of this news (traders say). Seems like a pretty tenuous reason for such a rally (on an n of 12!).

ASU Biodesign Modeling Team Publishes New Model Run

COVID-19 Healthcare Demand Projections: Arizona

Esma Gel, Megan Jehn, Timothy Lant, Anna Muldoon, Trisalyn Nelson, Heather M Ross

The ASU Biodesign Institute team has published their most recent Arizona-specific model using a framework that ties disease surveillance with the future burden on Arizona’s healthcare system. Their framework accounts for multiple COVID-19 patient outcomes and the observed time delay in epidemiological findings following public policy decisions.

Lots to unpack here. Pay particular attention to Section 3.2 on pages 11 and 12, which runs through scenarios that simulate the policy decisions made last week. It’s challenging to put such a sophisticated analysis in to a succinct summary – but basically- the best modeling fit for the existing data trends, along with modifying transmission as a result of the expiration of the stay at home order (and without including seasonal effects- if any) puts us on a track for a big increase in cases and new hospitalizations in early June.

Not good. Let’s cross our fingers that people will for the most part behave responsibly and the chance in transmission will be less than in the model. Also, lets cross our fingers that there will be some kind of modifying seasonal effect.

Governor Declares Phase I: Stay At Home Order Expires

How Good Will Social Distancing Compliance be with Little or No Enforcement?

As you know, the governor declared that we are in Phase I and let his “stay at home” executive order (EO 2020-33) expire Friday night. He created a new one that took effect Saturday morning.  It encourages businesses and people to do the right thing to mitigate COVID spread, but has no compliance or enforcement criteria. Here’s the new Executive Order: EO 36.

While other governors are making modifications to the federal guidance withmore specific and measurable criteria like the number of contact tracers and persons tested per 100,000 people along with more specific hospital measurements to make decisions, our governor is using theraw federal guidance. The basic federal guidance uses the following simple criteria to determine when to move to Phase I:

  • A 14-day downward trend of influenza-like illnesses and COVID-like illnesses;

  • A 14-day downward trend of positive COVID-19 tests, assuming a flat or increasing volume of tests;

  • Robust testing, including antibody testing, for at-risk health care workers; and 

  • Hospital capacity that would allow medical professionals to treat all patients without crisis care.

The first and last of the bullets have been met. The middle two bullets are in a gray area. One could argue that they’ve been met, but one could also argue that they haven’t. Regardless, the Governor believes Arizona meets Federal Phase I and has pressed ahead by letting the former Stay at Home Order expire.

As of yesterday, all businesses can be open but they’re encouraged to implement a series of mitigation measures and have good plans in place. Cities and counties are prohibited from requiring anything more than what’s inEO 36.

There’s no specific enforcement provision in the new executive order. However it does include this language: “All law enforcement and regulatory agencies that have enforcement authority under existing state law should first focus on educating and working to promote best practices to accomplish this goal…”.

I don’t know what existing laws might be out there that would apply to businesses not doing the right thing. Maybe there are some, but I don’t know what they might be. We’ll see in the coming days whether bars, restaurants etc. (and their customers) behave responsibly. If they don’t, we’ll be back to square one probably.

Perhaps you saw the news stories about bars along Mill Avenue in Tempe that were disregarding social distancing and infection control best practices. If behavior like that proliferates, then we’re all in trouble. I sincerely hope this kind of behavior doesn’t metastasize.

Editorial note: There has been a lot of public debate and discussion about what the proper timing is to relax some of the Stay at Home interventions. Basically- lots of talk about WHEN to allow things to open. Far less discussion has been about HOW they open.

To me, thehowquestion is more important than thewhenquestion. It’ll be super important that retail stores, salons, and restaurants have good, effective and evidence-based mitigation measures in place when they open. So, basically, I’d like to see more thought and debate put into providing specific guidance and compliance criteria for how these businesses can open responsibly.

Executive Order Enhances Skilled Nursing & Assisted Living COVID Reporting Requirements

Last week the governor issued an executive order requiring skilled nursing and assisted living facilities to: 1) notify family members if a resident of the facility tests positive for the virus; 2) notify applicants of the number and presence of COVID-19 cases in the facility; and 3) notifying residents and families about the presence of the disease when facility transfers are being considered.

PS: CMS released a new toolkit of best practices in preventing the spread of COVID-19 in nursing homes.