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."

Serial COVID-19 testing of 50,000 children in 714 German daycare facilities over 1 year didn't result in increased infections and averted 7 to 20 days of post-exposure quarantine per child, according to a study published today in Pediatrics.

University Hospital Cologne researchers led the study, which linked polymerase chain reaction (PCR) COVID-19 test results with data on reported infections to evaluate the change in infection frequency with serial testing ("test-to-stay" approach) versus quarantine among children aged 2 to 6 years from March 2021 to April 2022.

From weeks 11 to 36 in 2021, daycares quarantined exposed children for up to 14 days, switching to the test-to-stay strategy from week 37 in 2021 to week 14 in 2022. Under test-to-stay, COVID-exposed children were tested with single PCRs for 5 days. 

The study period spanned the Alpha, Beta, and Omicron BA.1 and BA.2 variants. The 7-day incidence of COVID-19 in Cologne ranged from about 9 per 100,000 people in week 25 of 2021 to 2,573 per 100,000 in week 9 of 2022. 

While quarantine reduces COVID spread, it can lead to impaired cognitive development, executive functions, and mental and physical health.

"Furthermore, quarantine was shown to negatively impact parents, increasing negative mood or likelihood of losing temper and punishment," the study authors wrote. "Additionally, high-frequent and unexpected disruption of daycare attendance impacts workforce participation of parents because of the necessity of at-home childcare."

Test-to-stay appears safe, effective

Of the 219,885 pooled PCRs performed, 2.9% were positive for COVID-19, and 17,208 infections were reported. 

This approach offers a promising option to avoid use of quarantine after exposure to respiratory pathogens in daycare settings.

The test-to-stay strategy avoided an estimated 7 to 20 days of quarantine per child, with no significant increase in infections. A regression-discontinuity-in-time analysis suggested a 26% reduction in COVID-19 cases. The results held true regardless of 7-day incidence, season, variant, or socioeconomic status.

"Our analyses provide evidence that suggest safety of the test-to-stay approach compared with quarantine measures," the researchers wrote. "This approach offers a promising option to avoid use of quarantine after exposure to respiratory pathogens in daycare settings."