The US Food and Drug Administration (FDA) today announced the release of finalized food safety guidance for the producers of sprouts, a food that has been linked to several foodborne illness outbreaks. The document details recommendations on how sprout operations may comply with the Produce Safety Rule, a part of the Food Safety Modernization Act that establishes science-based standards for safe produce production and harvest.
The guidance covers topics including cleaning, sanitization, use of agricultural water, seeds for sprouting, environmental monitoring, and recordkeeping. Also, the FDA released a revised draft of a second guidance document, which includes a section on testing spent sprout irrigation water for pathogens.
Between 1996 and 2020, the FDA reported 52 foodborne illness outbreaks linked to sprouts, which are produced in conditions ideal for pathogen growth. The outbreaks involved various organisms, including Salmonella, Listeria, and Escherichia coli. The events led to at least 2,700 infections, 200 hospitalizations, and 3 deaths.
Investigations often revealed that contaminated seeds were the contamination source, but other factors also played a role, including poor sanitation and unhygienic production practices.
Evolving peak SARS-CoV-2 loads relative to symptom onset may influence home-test timing
In a group of adults in the state of Georgia tested for both COVID-19 and influenza A, most of whom were vaccinated and/or previously infected, median SARS-CoV-2 viral loads peaked on the fourth day of symptoms, while flu loads peaked soon after symptom onset.
The authors of the study, published today in Clinical Infectious Diseases, say the findings have implications for the use of rapid antigen tests for COVID-19 and flu.
The Emory University-led team evaluated SARS-CoV-2 and influenza A viral loads relative to symptom duration in symptomatic patients aged 16 years and older tested for COVID-19 from April 2022 to April 2023, a period of Omicron variant predominance.
Median age among the 348 COVID-positive patients was 39.2 years, 65.5% were women, and 91.1% were vaccinated, previously infected, or both. Among the 74 influenza A-positive patients, the median age was 35.0 years, and 55.4% were women.
The researchers noted that early in the pandemic, viral loads peaked at the same time as symptom onset and then steadily decreased. At that time, the Food and Drug Administration approved rapid antigen test instructions directing symptomatic people to test only once in the first week of symptoms. In November 2022, the FDA amended the instructions, recommending repeat testing within 48 hours of an initial negative result.
Peak viral loads now peak days later
Median SARS-CoV-2 viral loads, as measured by polymerase chain reaction cycle threshold (Ct) and antigen concentrations, rose from symptom onset, peaking on the fourth or fifth day of symptoms. Estimated rapid antigen test sensitivity was 30.0% to 60.0% on the first day, 59.2% to 74.8% on the third, and 80.0% to 93.3% on the fourth.
Our data suggest that the relationship between SARS-CoV-2 Ct value distributions... and the timing of symptom onset in a highly immune population is very different than the relationship between these parameters observed early in the pandemic—a finding with major implications for testing practice going forward.
Median influenza viral loads among the 74 flu-positive patients peaked on the second day of symptoms.
"Our data suggest that the relationship between SARS-CoV-2 Ct value distributions (as a well-established proxy for viral load distributions) and the timing of symptom onset in a highly immune population is very different than the relationship between these parameters observed early in the pandemic—a finding with major implications for testing practice going forward," the researchers wrote.
HHS awards $104 million for project to combat antibiotic resistance
The US Department of Health and Human Services (HHS) yesterday announced an award of up to $104 million for a new project to combat drug-resistant bacteria.
The award from the Advanced Research Projects Agency for Health (ARPA-H) will support the Defeating Antibiotic Resistance through Transformative Solutions (DARTS) project, which will focus on developing a set of diagnostic platforms that can rapidly detect antibiotic-resistant bacteria from a blood sample, identify the right antibiotic for an infection in real time, and provide insight into how resistance develops.
"Antibiotic resistance is an urgent and growing threat, and we do not currently have the tools we need to combat it," HHS Secretary Xavier Becerra said in a news release. "We must combine better stewardship of antibiotics with novel technologies in order to save lives – exactly what this award will do."
Compact and rapid diagnostic tool
ARPA-H officials say the goal of the project is to develop platforms that can aid antibiotic stewardship and be easily employed at any hospital or clinic.
"Quickly identifying the right antibiotic empowers healthcare providers to fight off superbugs and return patients to health," ARPA-H Program Manager Paul Sheehan, PhD, said in a press release. "With DARTS, we aim to develop a compact diagnostic tool for the most problematic bacterial strains."
The DARTS project also aims to develop a platform that can rapidly screen natural samples for new antibiotics and test combinations of antibiotics.
The project will be led by researchers from Harvard Medical School and will include scientists from 25 research groups.
We must combine better stewardship of antibiotics with novel technologies in order to save lives – exactly what this award will do.