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Monkeypox has recently been described as a public health emergency of international concern by the World Health Organization and a public health emergency by the United States. If the outbreak continues to grow, rapid scalability of laboratory testing will be imperative. During the early days of the coronavirus disease 2019 (COVID-19) pandemic, laboratories improved the scalability of testing by using a direct-to-PCR approach. To improve the scalability of monkeypox testing, a direct real-time PCR protocol for the detection of monkeypox virus was validated. The assay retains the sensitivity and accuracy of the indirect assay while eliminating the need for nucleic acid extraction kits, reducing laboratory technologist time per sample and decreasing exposure to an infectious agent. The direct method will make it easier for laboratories across the world to rapidly develop, validate, and scale testing for monkeypox virus., (Copyright © 2022 Association for Molecular Pathology and American Society for Investigative Pathology. Published by Elsevier Inc. All rights reserved.)

Background: Transgender women in the United States (U.S.) experience a disproportionate burden of HIV infection and challenges to engagement in HIV prevention and care. This excess burden is driven by structural and economic inequities. Microeconomic interventions may be effective strategies for reducing HIV inequities for this population. However, few studies have explored transgender women's preferences for microeconomic interventions to address structural determinants of HIV vulnerability., Methods: We conducted individual interviews with 19 adult transgender women in 2 U.S. cities (Richmond, VA and St. Louis, MO) who reported one or more sexual risk behaviors and recent economic hardship related to employment/income, housing, or food security. Interviews were recorded, transcribed, and analyzed using thematic content analysis., Results: The majority (74%) of transgender women were racial/ethnic minorities with mean age of 26.3 years. 89% were currently economically vulnerable; and 23% were employed full-time. 37% reported living with HIV. Participants expressed strong support for unrestricted vouchers, with many expressing the need for funds to support gender-affirming interventions. Assistance with how to budget and save and support for job acquisition, career planning, and employment sustainment were also preferred, including access to non-stigmatizing employment. Visible transgender leadership, group empowerment, and small (rather than large) numbers of participants were considered important aspects of intervention design for transgender women, including outreach through existing transgender networks to facilitate inclusion. Incorporating HIV counseling and testing to reduce vulnerability to HIV was acceptable. However, transgender women enrolled in the study preferred that HIV not be the focus of an intervention., Conclusions: Flexible microeconomic interventions that support gender affirming interventions, improve financial literacy, and provide living-wage non-stigmatizing employment are desired by economically vulnerable transgender women. While not focused on HIV, such interventions have the potential to reduce the structural drivers of HIV vulnerability among transgender women., (© 2021. The Author(s).)

Context: Monitoring minimal residual disease by quantitative reverse transcription polymerase chain reaction has proven clinically useful, but as yet there are no Food and Drug Administration-approved tests. Guidelines have been published that provide important information on validation of such tests; however, no practical examples have previously been published., Objective: To provide an example of the design and validation of a quantitative reverse transcription polymerase chain reaction test., Design: To describe the approach used by an individual laboratory for development and validation of a laboratory-developed quantitative reverse transcription polymerase chain reaction test for BCR-ABL1 fusion transcripts., Results: Elements of design and analytic validation of a laboratory-developed quantitative molecular test are discussed using quantitative detection of BCR-ABL1 fusion transcripts as an example., Conclusions: Validation of laboratory-developed quantitative molecular tests requires careful planning and execution to adequately address all required analytic performance parameters. How these are addressed depends on the potential for technical errors and confidence required for a given test result. We demonstrate how one laboratory validated and clinically implemented a quantitative BCR-ABL1 assay that can be used for the management of patients with chronic myelogenous leukemia.