Rapid establishment of a frontline field laboratory in response to an imported outbreak of Ebola virus disease in western Uganda, June 2019.

The Democratic Republic of the Congo (DRC) declared an Ebola virus disease (EVD) outbreak in North Kivu in August 2018. By June 2019, the outbreak had spread to 26 health zones in northeastern DRC, causing >2,000 reported cases and >1,000 deaths. On June 10, 2019, three members of a Congolese family with EVD-like symptoms traveled to western Uganda's Kasese District to seek medical care. Shortly thereafter, the Viral Hemorrhagic Fever Surveillance and Laboratory Program (VHF program) at the Uganda Virus Research Institute (UVRI) confirmed that all three patients had EVD. The Ugandan Ministry of Health declared an outbreak of EVD in Uganda's Kasese District, notified the World Health Organization, and initiated a rapid response to contain the outbreak. As part of this response, UVRI and the United States Centers for Disease Control and Prevention, with the support of Uganda's Public Health Emergency Operations Center, the Kasese District Health Team, the Superintendent of Bwera General Hospital, the United States Department of Defense's Makerere University Walter Reed Project, and the United States Mission to Kampala's Global Health Security Technical Working Group, jointly established an Ebola Field Laboratory in Kasese District at Bwera General Hospital, proximal to an Ebola Treatment Unit (ETU). The laboratory consisted of a rapid containment kit for viral inactivation of patient specimens and a GeneXpert Instrument for performing Xpert Ebola assays. Laboratory staff tested 76 specimens from alert and suspect cases of EVD; the majority were admitted to the ETU (89.3%) and reported recent travel to the DRC (58.9%). Although no EVD cases were detected by the field laboratory, it played an important role in patient management and epidemiological surveillance by providing diagnostic results in <3 hours. The integration of the field laboratory into Uganda's National VHF Program also enabled patient specimens to be referred to Entebbe for confirmatory EBOV testing and testing for other hemorrhagic fever viruses that circulate in Uganda.

Improving the quality of malaria diagnosis in southern Africa through the development of a regional malaria slide bank.

BACKGROUND: A malaria slide bank (MSB) is a useful asset for any malaria microscopy testing laboratory to have access to. However, it is not feasible for every country to have its own MSB. If countries are able to pool their resources, a regional MSB is a viable solution. This paper describes the methodology, costing and lessons learnt of establishing and maintaining an MSB over a 3-year period, for a Southern Africa Development Community region. METHODS: A national reference laboratory in South Africa was granted funding for setting up the MSB; it possessed experienced staff and suitable resources. Two additional full-time personnel were employed to carry out the activities of this project. Strict protocols for donor/patient blood sample screening, smear preparation, mass staining, quality control and slide validation were followed. Slides from the MSB were used for training and proficiency testing purposes. The initial and recurrent yearly costs to set up and maintain the MSB were calculated. RESULTS: Over 35 months, 154 batches (26,623 slides) were prepared; the majority were Plasmodium falciparum. Ninety-two percent (141/154) of batches passed internal quality control, and 89% (93/104) passed external validation. From these slides, two training slide sets and six proficiency testing slide sets were sent out. The initial year's cost to establish an MSB was calculated at approximately $165,000, and the recurrent year-on-year cost was $130,000. CONCLUSIONS: The key components for maintaining a high-quality MSB are consistent funding, competent staff and adherence to standardized protocols. Travel to malaria-endemic areas for access to non-falciparum malaria species, and dilution of P. falciparum blood to desired parasite densities, are extremely useful to ensure variety. The MSB created here supported multiple laboratories in eight countries, and has the potential to expand.

Initial Clinical Laboratory Response to COVID-19: A Survey of Medical Laboratory Professionals.

OBJECTIVE: To explore the experiences of medical laboratory professionals (MLPs) and their perceptions of the needs of clinical laboratories in response to COVID-19. METHODS: We surveyed laboratory professionals working in United States clinical laboratories during the initial months of the pandemic. RESULTS: Overall clinical laboratory testing and overtime work for laboratorians decreased during the first months of the pandemic. Laboratory professionals reported better or unchanged job satisfaction, feelings toward their work, and morale in their workplace, which were related to healthcare facility and laboratory leadership response. They reported receiving in-kind gifts, but no hazard pay, for their essential work. Important supply needs included reagents and personal protective equipment (PPE). CONCLUSION: The response by healthcare facilities and laboratory leadership can influence MLPs job satisfaction, feelings toward their work, and laboratory morale during a pandemic. Current COVID-19 laboratory testing management, in the absence of sufficient reagents and supplies, cannot fully address the needs of clinical laboratories.

An Australian diagnostic microbiology surge response to the COVID-19 pandemic.

Diagnostic microbiology services form a critical component of the response to infectious disease outbreaks. Like previous respiratory virus pandemics, the COVID-19 pandemic has placed significant strains on the standing capacity of laboratories around the world. In this case study, we describe the surge response required by our laboratory to meet the fluctuating demand for SARS-CoV-2 in our regional pathology service in Western Sydney, Australia between March and May 2020. While the overall number of SARS-CoV-2 PCR positive cases was relatively low compared to other Australian local health districts, testing numbers were highly unpredictable and changed on a weekly basis as local outbreaks were detected. As with other laboratories, numerous other challenges were also faced during this period, including the requirement to introduce a new and unaccredited diagnostic PCR assay for SARS-CoV-2, local and global shortages of reagents for sampling and sample processing, and a significant institutional SARS-CoV-2 outbreak in our laboratory catchment area. A successful service delivery during this period could only be maintained by a dynamic whole-of-laboratory and organizational response including (1) operational changes to the hours of service and the expansion of diagnostic testing at our laboratory site and other sites within our organization (2) careful management of specialist staff and re-training and recruitment of additional staff (3) changes to laboratory workflows to improve SARS-CoV-2 PCR test turnaround time and to accommodate limits to precious laboratory reagents; (4) clear communication within our laboratory and the NSW Health Pathology organization; and (5) collaborative co-ordination and support by NSW Health Pathology.

Utility of repeat testing for COVID-19: Laboratory stewardship when the stakes are high.

As the coronavirus disease 2019 (COVID-19) continues to circulate, testing strategies are of the utmost importance. Given national shortages of testing supplies, personal protective equipment, and other hospital resources, diagnostic stewardship is necessary to aid in resource management. We report the low utility of serial testing in a low-prevalence setting.

Comparability of laboratory-developed and commercial PD-L1 assays in non-small cell lung carcinoma.

PD-L1 expression in non-small cell lung cancer (NSCLC) is predictive of response to treatment with PD-1 and PD-L1 inhibitors. Different inhibitors have been developed with different PD-L1 assays, which use different PD-1 antibody clones on different immunohistochemistry platforms. Depending on instrument and reagent availability, laboratory-developed tests with cross-platform use of PD-L1 antibodies may have practical benefits over commercial assays. The 22C3 pharmDx Assay (referred to as 22C3 DAKO), the VENTANA PD-L1 SP263 Assay (referred to as SP263 VENTANA) and a lab-developed test using the 22C3 antibody on the VENTANA BenchMark ULTRA IHC/ISH system (referred to as 22C3 VENTANA) were performed on whole sections of 85 NSCLC surgical resections. All sections were independently scored by three pathologists using tumor proportion scores. Correlation coefficients for continuous scores in pairwise comparisons between assays ranged from 0.976 to 0.978. When using a 1% positivity threshold (dichotomous scores), the 22C3 DAKO assay and 22C3 VENTANA assays showed the greatest agreement (93% agreement, κ = 0.86, 95% CI 0.75-0.97), and the 22C3 DAKO and SP263 VENTANA assays tended to show slightly less agreement (84% agreement, κ = 0.66, 95% CI 0.50-0.82). When using a 50% positivity threshold (dichotomous scores), all pairwise comparisons showed similar agreement (96-99% agreement, κ = 0.89-0.97). Overall, there was no significant difference between assays at 1% or 50% thresholds (P = .77). These data are consistent with potential interchangeability of these assays, which may widen the scope of PD-L1 assays available to laboratories and reduce logistical barriers to testing.

Increasing molecular diagnostic capacity and COVID-19 incidence in Brazil.

Different countries have adopted strategies for the early detection of SARS-CoV-2 since the declaration of community transmission by the World Health Organization (WHO) and timely diagnosis has been considered one of the major obstacles for surveillance and healthcare. Here, we report the increase of the number of laboratories to COVID-19 diagnosis in Brazil. Our results demonstrate an increase and decentralisation of certified laboratories, which does not match the much higher increase in the number of COVID-19 cases. Also, it becomes clear that laboratories are irregularly distributed over the country, with a concentration in the most developed state, São Paulo.

Coronavírus: como será a distribuição dos testes aos laboratórios?

Saiba mais em www.saopaulo.sp.gov.br/coronavirus/planosp

Coronavírus: como está a fila de testes?

Saiba mais em www.saopaulo.sp.gov.br/coronavirus/planosp

Lineamientos para la toma, envío y manejo de muestras provenientes de casos sospechosos inusitados, así como lineamientos de Bioseguridad en el manejo del COVID-19 / Guidelines for the collection, shipment and handling of samples from unusual suspected cases, as well as Biosafety guidelines in the management of COVID-19

Fecha de actualización: 22 de mayo 2020. Brindar los lineamientos generales para la toma de muestra, conservación y transporte para el diagnóstico de virus respiratorios, con su posterior envío al Centro Nacional de Influenza (NIC) del Laboratorio Nacional de Salud; aplicable a establecidos del nivel nacional en atención a pacientes que cumplen con la definición de caso y se tipifica como "sospechoso inusitado". Y lineamientos de bioseguridad para la toma de muestras de casos tipificados como "sospechosos inusitados" que presuntivamente contengan el virus influenza A(H5N1), A(H7N9) A(H9N2) y 2019-nCoV o cualquier otro virus proveniente de un paciente tipificado como caso Inusitado. Con aplicación a nivel nacional, en las dependencias dentro y fuera del Ministerio de Salud Pública y Asistencia Social, encargadas de la toma de muestra para el diagnóstico de Virus Respiratorios.

GOFlow: Smartwatch app to deliver laboratory results in emergency departments - A feasibility study.

PURPOSE: Information Technology (IT) plays a critical role in supporting emergency physicians' (EPs) routines. Pagers, personal computers, and smartphones offer fast access to patient data, such as laboratory results. However, due to the inherent features of specimen processing and laboratory instruments, the turnaround time from test ordering to availability of results can be long. Lack of follow-up of abnormal results can lead to missed information that could impact patient care and safety. Despite the increasing use of ubiquitous technologies, a third of physicians remains devoid of reliable methods for ensuring that results have been received. In this feasibility study, we report the potential of using a smartwatch to deliver laboratory results to EPs at the point-of-care and to support efficiency in emergency care. Unlike mobile devices that are increasingly used by EPs, smartwatches are always accessible, even during hands-on procedures. METHOD: Two EPs and four experts in human-computer interaction designed the smartwatch application following the Design Science Research Methodology (DSRM). The application was then evaluated in a pediatric emergency department through semi-simulated scenarios by eleven EPs. The primary outcome was to measure both the app perceived usability and satisfaction scores by the aim of the System Usability Scale (SUS), and the perceived usefulness and intention of its use by the aim of the Unified Theory of Acceptance and Use of Technology (UTAUT) scale. Secondary outcomes were to assess the application's efficiency by measuring the delay between the reception of the notification and 1) the access to its details and 2) the visit to the patient. Finally, open questions about the positive and negative aspects of the prototype as well as potential improvements were asked and evaluated qualitatively. RESULTS: The prototype obtained a score of 81.4 out of 100 (good) on the SUS and a score of 5.96 out of 7 on the UTAUT scale. EPs using the smartwatch visited patients within 30 seconds receiving the laboratory results. CONCLUSIONS: This study demonstrates the capacity of smartwatches to speed up the point-of-care delivery of laboratory results in the ED.

The Strengthening of Laboratory Systems in the Meningitis Belt to Improve Meningitis Surveillance, 2008-2018: A Partners' Perspective.

Laboratories play critical roles in bacterial meningitis disease surveillance in the African meningitis belt, where the highest global burden of meningitis exists. Reinforcement of laboratory capacity ensures rapid detection of meningitis cases and outbreaks and a public health response that is timely, specific, and appropriate. Since 2008, joint efforts to strengthen laboratory capacity by multiple partners, including MenAfriNet, beginning in 2014, have been made in countries within and beyond the meningitis belt. Over the course of 10 years, national reference laboratories were supported in 5 strategically targeted areas: specimen transport systems, laboratory procurement systems, laboratory diagnosis, quality management, and laboratory workforce with substantial gains made in each of these areas. To support the initiative to eliminate meningitis by 2030, continued efforts are needed to strengthen laboratory systems.

Setting Up an Undergraduate Immunology Lab: Resources and Examples.

Laboratory courses in immunology require a different skill set for their development than lecture courses. They vary widely in their form based on factors like institutional budget and class size, and also in the prioritization of learning goals centered around reinforcing lecture concepts and/or building fundamental skills in the field of immunology. Lab activities can come from a variety of sources including published research protocols, commercial kits, computer-based tools or simulations, and case studies. Each has their own strengths, which will be explored here. There are also important decisions to make about how students will report their data, and what level of guidance in interpreting data is best to enhance student learning and growth. Finally, methods like use of rubrics can help ensure fair and efficient grading, especially with skills-based learning goals. Periodic assessment is important to ensure that activities contribute effectively to student learning and to guide improvements to the lab course over time.

Careers in Core Facility Management.

The need for centralized shared core facilities and highly qualified core facility staff is becoming increasingly important in universities, research institutes, and commercial laboratories. With the continued advancement and sophistication of scientific equipment typically comes a larger price tag than can be handled by individual research laboratories. Moreover, the ever-increasing need for researchers to think and act in cross-disciplinary environments, coupled with the increasing sophistication of both the instrumentation and associated technologies, prevents most researchers from becoming "experts" in all areas.At all levels, core facility positions involve a love of technology, working with people, working on many diverse scientific questions, and days full of multitasking. Entry-level positions include basic and advanced technicians that require a BSc or MSc degree and some experience in the field. Midlevel management positions require experience in the field and an MSc or PhD degree. Management experience is a plus but not always required. Scientific directorship positions require a PhD and a keen interest in the technologies that are typically applied in the director's research program. Associate deans of core resources are often former core managers or scientific directors with a vision for the core and who are strong administrators.A career as a core facility staff member can be very rewarding. Successful managers and directors must be able to multitask, reassess priorities, and be adept at using logical reasoning to identify and solve issues as they arise. These positions will continue to be available over the long term with the increasing complexity and continued fast pace of technology development.

Performance of health laboratories in provision of HIV diagnostic and supportive services in selected districts of Tanzania.

BACKGROUND: Roll-out and implementation of antiretroviral therapy (ART) necessitated many countries in Sub-Saharan Africa to strengthen their national health laboratory systems (NHLSs) to provide high quality HIV diagnostic and supportive services. This study was conducted to assess the performance of health laboratories in provision of HIV diagnostic and supportive services in eight districts (from four regions of Iringa, Mtwara, Tabora and Tanga), after nine years of implementation of HIV/AIDS care and treatment plan in Tanzania. METHODS: In this cross-sectional study, checklists and observations were utilized to collect information from health facilities (HFs) with care and treatment centres (CTCs) for HIV/AIDS patients; on availability of laboratories, CTCs, laboratory personnel, equipment and reagents. A checklist was also used to collect information on implementation of quality assurance (QA) systems at all levels of the NHLS in the study areas. RESULTS: The four regions had 354 HFs (13 hospitals, 41 Health Centres (HCs) and 300 dispensaries); whereby all hospitals had laboratories and 11 had CTCs while 97.5 and 61.0% of HCs had both laboratories and CTCs, respectively. Of the dispensaries, 36.0 and 15.0% had laboratories and CTCs (mainly in urban areas). Thirty nine HFs (12 hospitals, 21 HCs and six dispensaries) were assessed and 56.4% were located in urban areas. The assessed HFs had 199 laboratory staff of different cadres (laboratory assistants = 35.7%; technicians =32.7%; attendants = 22.6%; and others = 9.1%); with >61% of the staff and 72.3% of the technicians working in urban areas. All laboratories were using rapid diagnostic tests for HIV testing. Over 74% of the laboratories were performing internal quality control and 51.4% were participating in external QA programmes. Regional and district laboratories had all key equipment and harmonization was maintained for Fluorescence-Activated Cell Sorting (FACS) machines. Most of the biochemical (58.0%) and haematological analysers (74.1%) were available in urban areas. Although >81% of the equipment were functional with no mechanical faulty, 62.6% had not been serviced in the past three years. CONCLUSION: Diagnostic and supportive services for HIV were available in most of the HCs and hospitals while few dispensaries were providing the services. Due to limitations such as shortage of staff, serving of equipment and participation in QA programmes, the NHLS should be strengthened to ensure adequate human resource, implementation of QA and sustainable preventive maintenance services of equipment.