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.

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.

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."