COVID-19 Daily: Negative Diagnostic Tests, Whistleblower Complaint

What your doctor is reading on Medscape.com:

MAY 16, 2020 -- Here are the coronavirus stories Medscape's editors around the globe think you need to know about today: 

Negative Diagnostic Test Results 

The diagnostic tests available today for COVID-19 are so new that it's unclear how reliable they are, Medscape Medical News reports, which means clinicians need to use their judgment particularly when interpreting negative results. False negative rates in published studies range from 3% to 66% in different patient cohorts, and early evidence suggests test accuracy varies widely depending on what part of the body is being tested and at what point in the disease course testing occurs, among other factors. 

"How we treat patients is going to depend on understanding this concept," said one expert. "It isn't one number. It's actually much more complicated and very nuanced." If clinicians don't understand that, he added, "We're really going to make mistakes about how to use all these negative tests."

John Ioannidis Responds to His Critics

The influential scientist John Ioannidis, MD, a professor of medicine, epidemiology, and population health at Stanford University, is known for his work exposing research flaws and calls for rigorous evaluation of scientific evidence. But more recently, he's been the subject of criticism for a study he coauthored estimating the prevalence of SARS-CoV-2 infection in Santa Clara County, California. 

In an interview with Undark, Ioannidis responded to some of the criticisms of the initial study and the revision, both of which were posted on a preprint server and have not been peer reviewed. "I'm just a scientist," he said. "I have no political party affiliation and absolutely no interest to turn this into a political debate, or to have a political agenda supported."

The Undark interview is unlikely to settle the issue.

Whistleblower Complaint About Santa Clara Study

New allegations suggest Ioannidis and coauthors disregarded warnings from two colleagues about the accuracy of the tests they used for the study and failed to disclose relevant funding sources, according to a BuzzFeed News report on an anonymous whistleblower complaint submitted to Stanford's research compliance office. 

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In one case, a pathologist who retested samples from the study participants with positive tests using enzyme-linked immunosorbent assay (ELISA) got positive results for a little more than half of them. "The kits did not perform as badly as I had feared they might," the pathologist wrote in an email to the researchers included in the whistleblower complaint, "but I am concerned that they do not perform well enough to report results back to patients if there are better options available." Other study authors had defended the tests in the email thread, but the pathologist and another researcher removed their names from the study because of the disagreement, BuzzFeed News reports. 

The whistleblower's complaint also alleges that JetBlue Airways founder David Neeleman donated funding for the study and raises concerns of a conflict of interest. Both Neeleman and the study authors contacted by BuzzFeed News denied that he influenced the study's conduct, and the study authors said they didn't know Neeleman's donation to Stanford funded the research, though Neeleman disputes that point.

Asthma Patients Advised to Continue Therapy

COVID-19 could be spawning hazardous behavior as patients question whether they should continue using immune-suppressing drugs during the pandemic, cautions an expert in allergy and pediatric pulmonology.

Patients, he said, should be advised to "follow your asthma action plan as outlined by your primary care or specialty clinician and communicate about evolving symptoms, such as fever rather than just congestion, wheezing, and coughing, etc."

FDA Authorizes First Stand-alone At-Home Sample Collection Kit 

The US Food and Drug Administration (FDA) has issued an emergency use authorization for an at-home nasal swab sample collection kit for COVID-19 diagnostic testing from Everlywell, a Texas-based at-home lab testing kit manufacturer. The agency has previously authorized other home specimen collection kits linked to specific tests, but today's announcement is different in that Everlywell's kit is authorized for use with multiple COVID-19 diagnostic tests that have been authorized separately. Individuals must have a prescription to get the kit and testing, but can obtain it by completing an online screening questionnaire that is then reviewed by a healthcare provider. 

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The Week That Wasn't 

This week in COVID-19 news, scientists suggested that mouthwash could help prevent SARS-CoV-2 transmission, the Federal Bureau of Investigation (FBI) warned of Chinese hackers targeting institutions conducting COVID-19 research, and an AI model predicted potential cases. But you didn't see these headlines on Medscape. We explain why in our weekly column "The Week That Wasn't."

In Memoriam

As frontline healthcare workers care for patients with COVID-19, they commit themselves to difficult, draining work and also put themselves at risk of infection. More than 1000 throughout the world have died. 

Medscape has published a memorial list to commemorate them. We will continue updating this list as, sadly, needed. Please help us ensure this list is complete by submitting names with an age, profession or specialty, and location through this form

Ellie Kincaid is Medscape's associate managing editor. She has previously written about healthcare for Forbes, the Wall Street Journal, and Nature Medicine.

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