Labcorp, a lab services company based in North Carolina, today announced that the US Food and Drug Administration (FDA) has granted emergency use authorization (EUA) for its PCR Test Home Collection Kit for mpox, the first at-home sample collection kit of its kind for the virus.

In a statement, the company said the test is available for physicians to order for use in adults who have suspected mpox infections.

Brian Caveney, MD, JD, MPH, Labcorp's chief medical and scientific officer, said the EUA authorization allows the company to play a key role in early detection and management of mpox. "The collection kit reflects our ongoing commitment to providing critical diagnostic tools to physicians and accessible and convenient testing options to patients."

Available via physician order

Doctors order the test through Labcorp's provider interface, and the company sends the testing kit to the patient's home. The kit contains detailed instruction on how to correctly collect a lesion swab, secure the sample in the collection tube, and prepare the package for return to the lab.

Testing is done by Labcorp-authorized labs, with results delivered to the prescribing physician and made available to the patient through the company's patient portal.

The FDA's EUA for the test comes as US mpox cases outpace activity reported last year at this time. So far, 664 cases have been reported this year as of the week ending March 30, more than double the 307 cases reported during the same period last year, according to the latest data from the Centers for Disease Control and Prevention.

An online survey of UK men who have sex with men (MSM) in late 2022 reveals that, among mpox vaccine-eligible respondents, uptake was 69% overall but 92% among those offered the vaccine, and 53% reported behavior modification to avoid mpox. The survey results are published in Emerging Infectious Diseases. 

The United Kingdom was the first epicenter of a global mpox outbreak that began in the spring of 2022 and quickly spread across continents, fueled largely by sexual transmission among MSM. According to the study authors, UK case numbers peaked in July 2022 and topped 3,500 cases by the end of 2022.

Beginning in the summer of 2022, an mpox vaccine was available to UK citizens who were at risk of mpox, which was estimated to be 111,000 people, including 103,000 MSM and 8,000 healthcare workers. 

Bisexual men, unemployed less likely vaccinated 

A survey of 1,333 MSM recruited from websites showed that 875 surveyed were considered vaccine eligible; 655 (75%) were offered a vaccine, and 601 received vaccination. Vaccination uptake was 69% (95% CI, 65% to 72%) for vaccine-eligible respondents but 92% (95% CI, 89% to 94%) for those who were offered a vaccine. But only 42% of those who started the vaccine series reported receipt of a second dose. 

Bisexual men were less likely to report mpox vaccination than gay men (32% vs 54%; adjusted odds ratio [aOR] 0.43; 95% confidence interval [CI], 0.29 to 0.62), as were participants with below college degree–level education qualifications (40% vs 59% in degree-level or higher; aOR 0.50; 95% CI, 0.39 to 0.63), and unemployed participants (37% vs. 55% of employed participants; aOR 0.59; 95% CI, 0.40 to 0.80).

Completion of the vaccination course among those receiving a first dose must be urgently prioritized.

"To reduce the likelihood of future mpox outbreaks, given threats of resurgence, provision of first mpox vaccine doses and completion of the vaccination course among those receiving a first dose must be urgently prioritized," the authors said. 

A systematic review and meta-analysis shows that colonization with multidrug-resistant (MDR) organisms is associated with increased risk of death and infection in solid-organ transplant (SOT) recipients, researchers reported yesterday in Clinical Microbiology and Infection.

The review by researchers at the University of Alberta identified 39 studies that reported on outcomes in adult SOT recipients who were colonized by methicillin-resistant Staphylococcus aureus (MRSA), vancomycin-resistant Enterococci (VRE), extended-spectrum beta lactamase (ESBL)–producing or carbapenem-resistant Enterobacterales (CRE), and MDR Pseudomonas and compared them to outcomes in non-colonized SOT recipients. Outcomes included mortality, infection, and graft-loss.

Increased risk of death, infections

The 39 studies included 15,202 SOT recipients, of whom 4,077 (27%) were colonized with MDR bacteria. Nearly half of the patients received liver transplants. MDR colonization was associated with significantly increased post-transplant 1-year mortality (odds ratio [OR], 2.35; 95% confidence interval [CI], 1.63 to 3.38) and mixed infections (OR, 10.47; 95% CI, 7.56 to 12.26) across transplant types, but there was no detected impact on graft loss (OR, 1.17; 95% CI, 0.81 to 1.69). 

Subgroup analyses found that the highest mortality risk was in SOT recipients colonized by CRE (OR, 3.94; 95% CI, 1.86 to 8.37), followed by VRE (OR, 3.65; 95% CI, 2.17 to 6.11) and MRSA (OR, 2.25; 95% CI, 1.25 to 4.05). The highest risk for infection was in patients colonized by CRE (OR, 19.57; 95% CI, 7.78 to 49.28) and ESBL (OR, 9.09; 95% CI, 5.59 to 14.78).

The study authors acknowledge that SOT recipients with MDR colonization may be more ill, which could explain the increased risk of death. But they say the findings could contribute to development of guidelines for MDR-colonized SOT candidates.

"Our study highlights the burden of MDR colonization in SOT and can aid in stratifying the recipient's risk of infection and mortality according to type of MDR colonization," they wrote. "Whether pre-transplant decolonization strategies may improve the prognosis of SOT patients should be evaluated in prospective studies."

The US Food and Drug Administration (FDA) yesterday approved the antibiotic pradofloxacin for treating respiratory diseases in cattle and swine.

Marketed under the name Pradelex, pradofloxacin is a third-generation fluoroquinolone, which is considered a medically important antibiotic class. It was approved for use in cats and dogs by the European Medicines Agency in 2011.

The approval is for the treatment of bovine respiratory diseases caused by Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis, and for use in swine to treat respiratory diseases caused by Bordetella bronchiseptica, Glaesserella (Haemophilus) parasuis, Pasteurella multocida, Streptococcus suis, and Mycoplasma hyopneumoniae.

Veterinary prescription only

The FDA says that, like other medically important antibiotics used in food-producing animals, pradofloxacin may be prescribed by a licensed veterinarian only. 

"All medically important antimicrobials for animals require the authorization of a licensed veterinarian because the FDA believes that, given their specialized training and experience, veterinarians play a critical role in antimicrobial stewardship and can help reduce the risks of antimicrobial resistance," the agency said in a press release.

The drug's label includes a statement that it should be used only after considering other, non-fluoroquinolone options.