Building a network of TP53 and IGHV testing reference centers across Spain: the Red53 initiative.

Among the different biomarkers predicting response in chronic lymphocytic leukemia (CLL), the most influential parameters are the mutational status of the IGHV genes and the presence of TP53 gene disruptions. Nevertheless, these important assessments are not readily available in most centers dealing with CLL patients. To provide this molecular testing across the country, the Spanish Cooperative Group on CLL (GELLC) established a network of four analytical reference centers. A total of 2153 samples from 256 centers were analyzed over a period of 30 months. In 9% of the patients, we found pathological mutations in the TP53 gene, whereas 48.96% were classified as IGHV unmutated. Results of the satisfaction survey of the program showed a Net Promoter Score of 85.15. Building a national network for molecular testing in CLL allowed the CLL population a broad access to complex biomarkers analysis that should translate into a more accurate and informed therapeutic decision-making.

Simple Questionnaires to Improve Pooling Strategies for SARS-CoV-2 Laboratory Testing.

Background: Liberal PCR testing for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is key to contain the coronavirus disease 2019 (COVID-19) pandemic. Combined multi-sample testing in pools instead of single tests might enhance laboratory capacity and reduce costs, especially in low- and middle-income countries. Objective: The purpose of our study was to assess the value of a simple questionnaire to guide and further improve pooling strategies for SARS-CoV-2 laboratory testing. Methods: Pharyngeal swabs for SARS-CoV-2 testing were obtained from healthcare and police staff, hospital inpatients, and nursing home residents in the southwestern part of Germany. We designed a simple questionnaire, which included questions pertaining to a suggestive clinical symptomatology, recent travel history, and contact with confirmed cases to stratify an individual's pre-test probability of having contracted COVID-19. The questionnaire was adapted repeatedly in face of the unfolding pandemic in response to the evolving epidemiology and observed clinical symptomatology. Based on the response patterns, samples were either tested individually or in multi-sample pools. We compared the pool positivity rate and the number of total PCR tests required to obtain individual results between this questionnaire-based pooling strategy and randomly assembled pools. Findings: Between March 11 and July 5, 2020, we processed 25,978 samples using random pooling (n = 6,012; 23.1%) or questionnaire-based pooling (n = 19,966; 76.9%). The overall prevalence of SARS-CoV-2 was 0.9% (n = 238). Pool positivity (14.6% vs. 1.2%) and individual SARS-CoV-2 prevalence (3.4% vs. 0.1%) were higher in the random pooling group than in the questionnaire group. The average number of PCR tests needed to obtain the individual result for one participant was 0.27 tests in the random pooling group, as compared to 0.09 in the questionnaire-based pooling group, leading to a laboratory capacity increase of 73% and 91%, respectively, as compared to single PCR testing. Conclusions: Strategies that combine pool testing with a questionnaire-based risk stratification can increase laboratory testing capacities for COVID-19 and might be important tools, particularly in resource-constrained settings.

Pandemic planning: plotting a course through the coronawars.

The biological motor behind the current coronavirus pandemic has placed microbiology on a global stage, and given its practitioners a role among the architects of recovery. Planning for a return to normality or the new normal is a complex, multi-agency task for which healthcare scientists may not be prepared. This paper introduces a widely used military planning framework known as the Joint Military Appreciation Process, and outlines how it can be applied to deal with the next phase of the COVID-19 pandemic. Recognition of SARS-CoV-2's critical attributes, targetable vulnerabilities, and its most likely and most dangerous effects is a necessary precursor to scoping, framing and mission analysis. From this flows course of action development, analysis, concept of operations development, and an eventual decision to act on the plan. The same planning technique is applicable to the larger scale task of setting a microbiology-centric plan in the broader context of social and economic recovery.

Plano municipal de contingenciamento para o enfrentamento da crise do Coronavirus (covid-19) 2020 [Aliança do Tocantins] / Municipal contingency plan to face the Coronavirus crisis (covid-19) 2020 [Aliança do Tocantins]

Descreve ações de Vigilância e Atenção em Saúde do Município de Aliança do Tocantins, a serem executadas na rotina das Unidades de Saúde e fluxograma de atendimento frente a casos suspeitos de Infecção Humana pelo Novo CoronaVírus (COVID-2019). Busca minimizar riscos à população frente a casos suspeitos de COVID-2019. Divulga informações em Saúde e estabelece estratégia de Comunicação de Risco além de orientar a adoção de medidas preventivas e indicação de uso de Equipamento de proteção individual ­ EPI.

Describes Health Surveillance and Attention actions in the municipality of Aliança do Tocantins, to be carried out in the routine of the Health Units and flowchart of care in the face of suspected cases of Human Infection by the New CoronaVirus (COVID-2019). It seeks to minimize risks to the population in the face of suspected cases of COVID-2019. Discloses information on Health and establishes a Risk Communication strategy in addition to guiding the adoption of preventive measures and the indication of the use of Personal Protective Equipment - PPE.

Describe las acciones de Vigilancia y Atención en Salud en el municipio de Aliança do Tocantins, a realizarse en la rutina de las Unidades de Salud y diagrama de flujo de atención ante casos sospechosos de Infección Humana por el Nuevo CoronaVirus (COVID-2019). Busca minimizar riesgos a la población ante casos sospechosos de COVID-2019. Divulga información sobre Salud y establece una estrategia de Comunicación de Riesgos además de orientar la adopción de medidas preventivas y la indicación del uso de Equipos de Protección Individual - EPI.

Il décrit les actions de surveillance et de soins de santé dans la municipalité d'Aliança do Tocantins, à réaliser dans la routine des unités de santé et le diagramme de flux de soins pour les cas suspects d'infection humaine par le nouveau coronavirus (COVID-2019). Il cherche à minimiser les risques pour la population face aux cas suspects de COVID-2019. Diffuse des informations sur la santé et établit une stratégie de communication des risques en plus de guider l'adoption de mesures préventives et l'indication de l'utilisation des équipements de protection individuelle - EPI.

Optimizing the diagnostic capacity for COVID-19 PCR testing for low resource and high demand settings: The development of information-dependent pooling protocol.

AIM: To compare different pooling methods in an attempt to improve the COVID-19 PCR diagnostic capacities. METHOD: We developed a novel information-dependent pooling protocol (indept), based on transmission of less informative sequential pools on to the next pooling cycle to maximize savings. We then compared it to the halving, generalized halving, splitting and hypercube protocols in a simulation study, across variety of scenarios. RESULTS: All five methods yielded various amount of test savings, which mostly depended on the virus prevalence in the population. In situations of low prevalence (up to 5%), indept had the best performance, requiring on average 20% of tests needed for singular testing across scenarios that were analyzed. Nevertheless, this comes at the expense of speed, with the worst-case scenario of indept protocol requiring up to twice the time needed to test the same number of samples in comparison to the hypercube protocol. In order to offset this, we developed a faster version of the protocol (indeptSp), which minimizes the number of terminal pools and manages to retain savings compared to other protocols, despite marginally longer processing times. CONCLUSION: The increasing demand for more testing globally can benefit from application of pooling, especially in resource-restrained situations of the low- and middle-income countries or situations of high testing demand. Singular testing in situations of low prevalence should be systematically discouraged.

Atypical presentation of Clostridioides difficile pseudomembranous colitis with laboratory rejection of stool specimen.

Clostridioides (formerly Clostridium) difficile is a major cause of nocosomial infection in the USA and worldwide. It has a wide spectrum of presentation, ranging from an asymptomatic carrier state to fulminant colitis. Pseudomembranous colitis is a manifestation of severe C. difficile infection (CDI), typically with progressive symptoms including watery diarrhoea, abdominal cramping and fevers and elevated white cell count and/or creatinine. It is diagnosed on three levels, including clinical assessment, stool assays and visualisation of the colonic mucosa. Laboratories will reject stools that do not meet criteria for testing. In the era of molecular testing for the presence of toxigenic C. difficile DNA, which only indicates the potential for infection, it is vital to use clinical evaluation in the diagnosis of CDI. We present an atypical case of pseudomembranous colitis affecting the right colon in a patient whose stools were rejected multiple times for C. difficile testing.

Respiratory viral testing in laboratories serving acute care hospitals in Rhode Island.

BACKGROUND: The rapid detection of respiratory viral infections is associated with several positive health outcomes. However, little is known about the availability of rapid respiratory viral testing in acute care hospital laboratories. METHODS: A survey was sent to 13 hospital laboratories assessing results' turnaround time, the number of ordered tests and positive results. RESULTS: Rapid viral panel (RVP), respiratory syncytial virus (RSV), and rapid influenza testing was available in 9 of 13, 13 of 13, and 13 of 13 hospitals, respectively. Results were available within 24 hours of specimen collection in 1 of 9 hospitals for RVP; RSV and rapid influenza results were available within 12 hours in 8 of 13 and 13 of 13 hospitals, respectively. CONCLUSIONS: Rapid diagnosis of respiratory viral infections in RI acute care hospitals can be made for influenza and RSV. However, rapid results for other respiratory viruses are unavailable in most of RI hospitals. [Full article available at http://rimed.org/rimedicaljournal-2017-09.asp].

U.S. community pharmacies as CLIA-waived facilities: Prevalence, dispersion, and impact on patient access to testing.

BACKGROUND: The Clinical Laboratory Improvement Amendments of 1988 (CLIA) enabled greater access to low-risk tests by allowing their use in facilities with a Certificate of Waiver in the U.S. Community pharmacies are among the most accessible health professionals, and they are increasingly offering CLIA-waived tests. This manuscript aims to determine: 1) the current number of pharmacies in the United States with CLIA-waivers; 2) the uptake of CLIA-waivers by different pharmacy store types; and 3) the state-by-state differences in the percentage of pharmacies with a CLIA-waiver. METHODS: Data were collected from the U.S. Centers for Disease Control and Prevention CLIA Laboratory Search website on May 3rd, 2015. The website allows for exportation of demographic data on all CLIA-waived facilities by state. RESULTS: Pharmacies are currently the fourth highest-ranking facility of CLIA-waived laboratories with 10,838 locations. Supermarkets had the highest percentage of pharmacies with a CLIA-waiver (43.16%). States demonstrated considerable variability in the percentage of pharmacies with a CLIA-waiver, with a median percentage of 19.56% (0%-60.00% range). CONCLUSIONS: Community pharmacies are currently a leading facility for CLIA-waived laboratories. Substantial state-level variation is observed in the percentage of pharmacies with CLIA-waivers, and these differences may be driven by restrictions in state law or regulations.

Grado de implantación de especificaciones de la calidad analítica en España / Level of implementation of analytical quality specifications in Spain

Objetivos: Este trabajo pretende conocer el grado de implantación de las especificaciones de la calidad en los laboratorios clínicos de España y concretamente de las especificaciones mínimas de la calidad analítica consensuadas por el Comité de Expertos Interdisciplinar sobre Especificaciones de la Calidad (CEIEC) en el Laboratorio Clínico, así como la opinión del sector respecto a la necesidad del establecimiento de valores preceptivos de requisitos de la calidad analítica: Material y método: Se diseñó una encuesta que constaba de 22 preguntas, 4 de ellas de tipo descriptivo, 16 retrospectivas y 2 prospectivas. El periodo de recogida de respuestas fue de septiembre a noviembre de 2012. Como requisito de los encuestados solo se consideró que participasen en algún programa de intercomparación de las sociedades científicas españolas representadas en el citado comité. El número de encuestas remitidas fue de 1.738. Resultados: Se recibieron 340 respuestas (19,6% del total). El 59% de los que respondieron tiene implantado un sistema de reconocimiento formal de la calidad. El 83% comprueba si cumplen o no con las especificaciones, el 68% dispone de un compromiso documental de cumplirlas y el 64% ha elaborado el listado con los valores concretos de especificaciones. El 55% conoce la existencia de unas especificaciones mínimas de la calidad consensuadas por el CEIEC. El 49% estaría de acuerdo en que estas especificaciones fueran preceptivas, mientras que el 33% no se define (AU)

Objectives: This work aims to determine the level of implementation of analytical quality specifications in Spanish clinical laboratories and, in particular, the minimum analytical quality specifications obtained by consensus of the Interdisciplinary Expert Committee on Quality Specifications (CEIEC) in the Clinical Laboratory, as well as to determine the opinions of the professionals as regards establishing mandatory analytical quality specifications.. Material and method: A questionnaire was designed including 4 descriptive, 16 retrospective, and 2 prospective questions. The responses were collected during September to November 2012. The requirement for participating was to be involved in an intercomparison program of any of the 4 Spanish scientific societies represented on the abovementioned committee. A total of 1,738 questionnaires were sent. Results: A total of 340 responses (19.6% over the total) were received. The results showed that 59% of respondents have a formally recognized quality system. The attainment of predefined specifications was checked by 83%, with 68% having a commitment for documented quality specifications, and 64% had made a list with specification values. A majority (55%) is aware of the existence of the consensus minimum quality specifications of the CEIEC, and 49% would agree that these specifications should become mandatory, while 33% did not declare a clear position on this subject (AU)

A cross-sectional study for algorithm in diagnosing simple uncomplicated malaria in children in health facilities without laboratory backup in Nigeria.

AIMS AND OBJECTIVES: The objective of this study was to determine an algorithm for malaria diagnosis using presenting signs and symptoms of children (aged 0-13 years) with uncomplicated malaria in Gwagwalada Area Council of Abuja, Nigeria. MATERIALS AND METHODS: A validated questionnaire was used to obtain relevant data from 400 children diagnosed presumptively of simple malaria by clinicians and 400 other children of similar sex and age considered as not having malaria. Giemsa-stained thick blood films were used to determine parasitaemia. Data obtained was analysed using Epi-Info version 3.3.2. RESULTS: Thirty-eight per cent of children with presumptive diagnosis of malaria had parasitaemia. Fever, rigor, vomiting, jaundice, pallor and spleen enlargement had significant statistical relationship with parasitaemia on bivariate analysis, but only fever (p=0.00), rigor (p=0.00), vomiting (p=0.00), and pallor (p=0.00) maintained the relationship when subjected to logistic regression analysis. But these symptoms individually had low sensitivity and/or specificity. Candidate algorithms (combinations of symptoms) were then successively subjected to bivariate, logistic and validity analyses. Fever with vomiting gave the highest sensitivity (56.2%), specificity (76.4%) and PPV (60.0%) and were therefore adopted as the algorithm of choice. CONCLUSION AND RECOMMENDATIONS: Children presenting with fever and vomiting without any other obvious cause in health facilities without laboratory support in the research area should receive antimalarial treatment, to help reduce the malaria scourge. This algorithm should be field-tested and if found reliable should be adopted to ease the problem of malaria diagnosis in peripheral health facilities.