FDA warns of false results from Cue Health COVID tests

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nasal swab
Banc d'Imatges Infermeres, Ariadna Creus i Àngel García / Flickr cc

The Food and Drug Administration (FDA) yesterday urged home test users, caregivers, and health providers not to use Cue Health's COVID-19 tests for home and over-the-counter use and its test for point-of-care settings due to an increased risk of false results. 

The two tests, which detect nucleic acid from SARS-CoV-2, are identical except for their emergency use authorizations (EUAs), according to the company.

The FDA said it issued a warning letter to the company on May 10 after an inspection revealed that Cue Health had made changes to the tests that reduced the reliability of the tests to detect SARS-CoV-2. The point-of-care test had received an EUA on June 10, 2020, and the home test was granted an EUA on March 5, 2021.

Consumers and healthcare providers who have Cue Health tests should dispose of them in the household or general trash, the FDA said. It added that health providers should consider retesting patients using a different test if they suspect an inaccurate result from a Cue Health test.

Panel recommends closure of wild poliovirus outbreak in Mozambique and Malawi

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After a detailed investigation, the independent Polio Outbreak Response Assessment Team (OBRA) today recommended closure of a wild poliovirus type 1 (WPV1) outbreak in Malawi and Mozambique, the World Health Organization (WHO) regional office for Africa said in a statement.

polio vaccination
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The outbreak was declared in February 2022, and nine cases were reported in Mozambique and neighboring Malawi. The last case was reported from Tete province in Mozambique in August 2022. The strain was genetically linked to a WPV1 strain circulating in Pakistan.

As part of the response, more than 50 million children from five nations in southern Africa were vaccinated against the virus.

The WHO said the OBRA team conducted two in-depth field reviews, along with a data review that found no ongoing wild polio transmission.

Successfully stopping the outbreak reflects collaborative efforts from African governments, health workers, communities, and partners, including the Global Polio Eradication Initiative and Rotary International.

Surveillance improvements, more wastewater tracking

Matshidiso Moeti, MD, who directs the WHO's African regional office, said, "I commend the governments of Malawi and Mozambique, as well as all those involved in the response, for their tireless efforts to contain the outbreak. It is now imperative that we continue to strengthen our immunization systems, enhance surveillance, and reach every child with life-saving vaccines."

Along with vaccination efforts in high-risk areas, health officials have established 15 new wastewater surveillance sites in affected countries. Also, groups have strengthened surveillance and data management to include real-time coverage information that includes missing settlements. 

Study highlights inappropriate antibiotic prescribing in US emergency departments

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A review of US emergency department (ED) visits involving antibiotic prescribing found that more than a quarter had inappropriate antibiotic prescriptions, and nearly half of those didn't even have a plausible indication for antibiotics, US researchers reported today in Antimicrobial Stewardship & Healthcare Epidemiology.

Using data from the National Hospital Ambulatory Medical Care Survey, which includes patient characteristics, up to five diagnosis codes, and information on up to 30 medications prescribed, researchers examined ED visits with one or more oral antibiotic prescription from 2016 through 2021. They classified each diagnostic code as "always," "sometimes," or "never" justifying antibiotic use to determine whether antibiotic prescriptions were appropriate, potentially appropriate, or inappropriate.

Of the more than 152 million ED visits with one or more antibiotic prescription, 27.6% resulted in inappropriate prescribing, while 14.9% were inappropriate with a plausible indication (such as bronchitis) and 12.6% had diagnostic codes considered not plausibly antibiotic-related, including high blood pressure, chest pain, and joint pain. Thus, only 54% of the visits with inappropriate prescribing had a plausible indication.

ED visits for adults ages 18 to 64 had the highest prevalence of inappropriate antibiotic prescribing (29.8%) compared with adults 65 and older (24.6%) and children (23.7%), while inappropriate prescribing with a plausible indication was highest for children (16.7%) followed by working-age adults (15%) and older adults (12.6%).

Poor coding quality

The authors suggest the visits with inappropriate prescribing and no plausible coded indication for antibiotics could represent instances in which clinicians prescribed antibiotics correctly but neglected to code the condition, or deliberately avoided coding for an inappropriate prescription to avoid scrutiny.

"Findings suggest that ED antibiotic stewardship initiatives should focus both on reducing antibiotic prescribing for infectious, antibiotic-inappropriate conditions and on improving coding quality for antibiotic prescriptions," the study authors wrote.

TB-COVID co-infections increasingly common, tied to worse outcomes, data show

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Iuliia Mikhalitskaia / iStock

A new meta-analysis of 17 studies reveals that tuberculosis (TB) and COVID-19 co-infection are becoming increasingly prevalent around the world, with death rates gradually declining but remaining higher than COVID-19 infection alone. The study was published yesterday in PLOS Neglected Tropical Diseases. 

The 17 studies were conducted in 38 countries or regions, spanning both high- and low-TB prevalence areas. Sixteen of the studies were single-country studies. The other study included TB-COVID patients from 172 centers in 34 countries as part of the TB/COVID-19 Global Study Group in 2022.

Two studies estimated TB-COVID joint infection prevalence, one conducted in Western Cape Province, South Africa, (prevalence of 0.06%) and one in California (prevalence of 0.02%). In all studies, patients were treated with known TB drugs, including rifampicin, isoniazid, ethambutol, and pyrazinamide. The authors found no studies that could provide specific guidance on the best practices for managing TB-COVID co-infections.

Hospitalized patients face 11% risk of death

Patients with both infections were at an increased risk for hospitalization, intensive care unit admission, and death. The estimated fatality rate among hospitalized patients with TB-COVID co-infection was 11.4% (95% confidence interval [CI], 5.6% to 18.8%). Overall fatality rate for patients co-infected was 7.1% (95% CI, 4.0% to 10.8%).

The pooled relative risk of in-hospital fatality was 0.8 (95% CI, 0.18 to 3.68) for TB-COVID patients versus patients with COVID-19 only, the authors found. 

Individuals with TB-COVID co-infection are at heightened risk of hospitalization, protracted recovery periods, and accelerated mortality compared to those with sole COVID-19 infections

"Our analysis consistently shows that individuals with TB-COVID co-infection are at heightened risk of hospitalization, protracted recovery periods, and accelerated mortality compared to those with sole COVID-19 infections," the study authors wrote. "Remarkably, we found limited information on the post-COVID-19 condition of co-infected patient."

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