A patologia clínica/medicina laboratorial é uma especialidade direcionada à realização de exames complementares no auxílio ao diagnóstico, com impacto nos diferentes estágios da cadeia de saúde: prevenção, diagnóstico, prognóstico e acompanhamento terapêutico. Diversos elementos apontam para maior utilização da medicina diagnóstica no futuro. Para discutirmos as principais tendências na medicina laboratorial, descrevemos os fatores que colaboram e são fundamentais para o crescimento desse mercado denominados, neste estudo, drivers de crescimento. As principais tendências que terão forte impacto na medicina laboratorial, e que serão descritas neste artigo, são: ferramentas de gestão, inserção de novos testes no mercado e rol de procedimentos, qualidade dos serviços em medicina diagnóstica, modelos de operação, automação, consolidação e integração, tecnologia da informação, medicina personalizada e genética. Sabemos que a medicina diagnóstica demonstra sua importância ao participar de 70% das decisões clínicas, absorvendo uma pequena parte dos custos em saúde (cerca de 10%). Todas as tendências analisadas neste trabalho apontam para um crescimento na utilização dos exames laboratoriais e também para sua importância na cadeia de saúde. Esse novo posicionamento, somado às novas expectativas de alta resolubilidade, pressiona o mercado e as companhias que o compõem a buscar mudanças e novas estratégias de atuação.

Clinical pathology/laboratory medicine, a specialty focused on performing complementary tests to aid diagnosis, has impact upon several stages of health care: prevention, diagnosis, prognosis, and therapeutic management. There are several factors that will foster the use of laboratory medicine in the future. In order to discuss the main trends in laboratory medicine, this article describes the major factors that have promoted growth in this market, which herein are referred to as growth drivers. The major trends that will cause substantial impact on laboratory medicine are: management tools, inclusion of new tests and procedures, service quality, operational models, automation, consolidation and integration, information technology, personalized and genetic medicine. Laboratory medicine occupies a pivotal role in 70% of all clinical decisions with minimal healthcare costs of approximately 10%. All trends discussed herein sustain an increase in the use of laboratory tests as well as its importance in health care. Both this new model and the expectation of optimal solutions have led the market to search for changes and new management strategies.

Nas últimas décadas, a introdução da automação na medicina laboratorial foi destacada como a espinha dorsal na busca de eficiência e viabilidade das empresas atuantes nesse setor e expandiu-se em todas as fases dos processos no laboratório clínico: pré-analítica, analítica e pós-analítica. A implementação de um processo de automação laboratorial deve levar em consideração o posicionamento estratégico da empresa e sua forma de atuação. Diferentes modelos de processos automatizados funcionam para diferentes negócios, definidos pelo mix de exames, volume de processamento, atributos estratégicos necessários, capacidade de investimento, entre outros. Este artigo tem como principal objetivo apresentar uma breve revisão dos processos automatizados disponíveis em medicina laboratorial.

In the last decades, the introduction of automation in laboratory medicine has played a major role in the search for efficiency and viability promoted by enterprises from this sector. Additionally, it has been expanded to all phases and processes within clinical laboratories: pre-analytical, analytical and post-analytical. Automation program implementation must take into account the company's strategic planning and business approach. Different automated processes cater for different business platforms, which are defined by test mix, workflow volume, required strategic characteristics, investment capacity, among others. This article aims at briefly reviewing the automation processes available in laboratory medicine.

A medicina diagnóstica é, hoje, um conglomerado de especialidades direcionadas à realização de exames complementares no auxílio ao diagnóstico. A maior competitividade do mercado fez com que os gestores realizassem os denominados trade offs entre diferentes fatores estratégicos de produção - qualidade, confiabilidade, flexibilidade, velocidade e custo -, com o objetivo de definir o posicionamento ante a contribuição da área de produção para a organização. A determinação dos fatores escolhidos, diante das expectativas dos clientes e de um benchmarking com a concorrência, analisados de forma sistemática, define o posicionamento estratégico da organização. Para sedimentar os conceitos defendidos neste artigo, uma simulação de um caso de definição da estratégia da área de produção é apresentada.

Diagnostic Medicine is currently a pool of medical specialties oriented to conduct complementary tests for clinical diagnostics. The higher market competitiveness has led management teams to make trade offs among strategic factors such as quality, reliability, flexibility, velocity and costs with the aim to define the contribution of the production area to the company. The determination of these factors based on clients' expectations, benchmarking and subject to systematical analysis define the company strategy. The simulation of a production area strategy planning is presented to demonstrate the concepts discussed in this article.

A tuberculose é uma doença de importância mundial e há alguns anos, em muitos países, foi quase erradicada, mas, com o advento da Aids, novos casos da doença começaram a ocorrer, com o agravante do surgimento de cepas resistentes a diversos antimicrobianos. Concomitantemente a este aumento na incidência de tuberculose, as metodologias diagnósticas apresentaram avanços consideráveis, e atualmente existem diversas metodologias manuais ou automatizadas para um diagnóstico mais rápido das infecções por micobactérias. Um dos sistemas semi-automatizados, o Bactec 460 (Becton Dickinson Diagnostic Systems, Sparks, MD), é utilizado para detectar a presença de micobactérias em espécimes clínicos, realizar testes de sensibilidade aos antimicrobianos e fazer a diferenciação entre micobactérias do complexo tuberculosis e as não-pertencentes a este complexo, diminuindo o tempo do processo em vários dias. O intuito deste trabalho foi verificar o impacto ocasionado com a introdução de um sistema semi-automatizado na rotina do laboratório. No período de janeiro a junho de 1995, foram processadas, pelo método tradicional de cultura em meio de Lowenstein-Jensen (LJ), 326 amostras, das quais 39 (12%) foram positivas, sendo 77% destas identificadas como Mycobacterium tuberculosis. Do total de amostras positivas para M. tuberculosis, 29 (74,3%) apresentaram um prazo de detecção superior a 30 dias. No mesmo período, no ano de 1997, com a introdução do sistema semi-automatizado, foram processadas 340 amostras, das quais 50 (14,7%) foram positivas, sendo 46% destas identificadas como Mycobacterium tuberculosis. O tempo médio para detecção do crescimento das amostras positivas para M. tuberculosis foi de 12 dias. A implantação do sistema automatizado para culturas de micobactérias proporcionou um aumento no número de isolamento de diferentes espécies, em diversos materiais clínicos, com diminuição no tempo de detecção, além de oferecer maior segurança para os técnicos durante a realização destes procedimentos.

Tuberculosis is a disease of worldwide importance and several years ago in many countries the disease was almost eradicated. With the advent of Aids infection, new cases of the disease started to emerge with the appearance of multiple drug resistant strains. Together with the increase in tuberculosis cases, diagnostic methodologies showed an advance and nowadays there are several manual and automated methodologies for the diagnosis of these infections. The Bactec 460 (Becton Dickinson Diagnostic Systems, Sparks, MD) system is used for the direct detection of mycobacteria in clinical specimens, for susceptibility testing against tuberculostatic drugs and differentiation of Mycobacterium tuberculosis complex from other species not of the complex, shortening the process in several days. In this study we evaluated the impact of the introduction of an automated system. In the period of January to June 1995, 326 specimens were processed using the traditional methodology of culture in Lowenstein-Jensen (LJ). Thirty-nine (12%) were positive being 77% of these identified as M. tuberculosis. Of the total of 39 positive cultures for M. tuberculosis, 29 (74.3%) showed a time for detection greater than 30 days. In the same period in the year of 1997 with the introduction of the semiautomated system, 340 specimens were processed of which 50 (14.7%) were positive being 46% of these M. tuberculosis. The mean time for detection of positive cultures for M. tuberculosis was 12 days. The use of the automated system for culture of mycobacteria showed an increase in the number of different species isolated from different specimens, decreasing the time for detection and allowing a better and safe condition for technicians while executing theses procedures.

This study was done to determine the occurrence of mycobacteria in the bloodstreams of patients with fever and advanced AIDS in a Brazilian hospital. We also verified the capability of an automated method for recovering these bacteria. During a period of 19 months, 254 patients with AIDS were evaluated. Blood cultures were generally submitted in pairs and drawn separately. Blood cultures were processed by the BACTEC 460TB System (Becton Dickinson Microbiology Systems, Sparks, MD), using the Bactec 13A media (Becton Dickinson Microbiology Systems, Sparks, MD). Of the 530 vials submitted, 77 (14.5%) from 41 (16%) patients were positive. Mycobacterium avium complex was recovered from 45 (58.4%) of the 77 positive vials, corresponding to 22 (53.6%) patients with positive blood cultures. The average time to detect Mycobacterium avium complex was 15 days. Mycobacterium tuberculosis was recovered from 26 (33.8%) of the 77 positive vials, corresponding to 15 (36.6%) patients with positive blood cultures, with an average detection time of 24 days. Other species of mycobacteria were recovered from 6 (7.8%) of the 77 vials, corresponding to 4 (9.8%) patients. M.avium complex was fairly prevalent (8.7%) in severely ill patients with AIDS in our hospital. M. tuberculosis was also an important (6.0%) agent of systemic bacterial infections in these patients. The rapid diagnosis of mycobacteremia was possible with the implementation of this automated technology.

This study was conducted to evaluate the activity of azithromycin in comparison to 12 other antibacterial agents against recent isolates obtained consecutively from patients with respiratory tract or skin infections, from January to July, 2000. A total of 717 Gram-positive cocci were analyzed in this study and the following species were studied: Staphylococcus aureus (n=576), beta-hemolytic streptococci ( n=115), and Streptococcus pneumoniae (n=26). Susceptibility testing was carried out by the disk diffusion method and interpreted according to NCCLS breakpoints. The activity of azithromycin was compared to erythromycin, clindamycin, chloramphenicol, ciprofloxacin, ofloxacin, oxacillin, penicillin, ceftriaxone, tetracycline, trimethoprim/sulfamethoxazole, teicoplanin, and vancomycin. Of the 26 S. pneumoniae isolates recovered from the respiratory tract, 5 (19.2%) were intermediate resistant to penicillin. All of these strains were susceptible to chloramphenicol, ofloxacin, and vancomycin, and 24 (92%) were also susceptible to azithromycin, clindamycin, and erythromycin. Among the 67 beta-hemolytic streptococci strains isolated from the respiratory tract, 66 (99%) were susceptible to azithromycin, erythromycin, clindamycin, and ofloxacin. All 48 beta-hemolytic streptococci strains isolated from skin were susceptible to azithromycin and clindamycin, 47 (98%) were susceptible to erythromycin, and 46 (96%) were susceptible to ofloxacin. Of the 576 strains of S. aureus, 253 (43.9%) were isolated from the respiratory tract and 323 (56.1%) from skin. Among S. aureus isolates from the respiratory tract and skin, 46 (18%) and 78 (24%), respectively were resistant to oxacillin. Isolates from the respiratory tract and skin showed the same percentage of resistance (36%) to azithromycin. These in vitro results suggest that azithromycin can be a therapeutic option for treatment of infections caused by these bacteria since the newer macrolides have several distinct advantages over erytromycin including improved oral bioavailability, longer half-life allowing once or twice daily administration, higher tissue concentrations and less gastrointestinal adverse effects.

Surveillance programs are essential to detect the increase of antimicrobial resistance, and several different programs are being conducted in many countries. The RESISTNET is a surveillance program for bacterial resistance against several antimicrobial agents initiated in 1998 among Latin American countries. In Brazil, several centers were invited to join this surveillance and a total of 11 centers (6 from São Paulo and 5 from other states) participated in the study. All results were analyzed using the WHONET program. A total of 894 Escherichia coli, 386 Klebsiella pneumoniae, 70 Shigella spp and 57 Salmonella spp strains were analyzed in this study from April, 1998, to April, 1999. Susceptibility testing was performed by the disk diffusion method using NCCLS 1998 guidelines for several different drugs. For all strains, imipenem was the most effective drug (100% of the strains were susceptible). Klebsiella pneumoniae presented a high resistance rate to ampicillin (96.4%). The rate of probable ESBL producers among K. pneumoniae strains was 36.3%, most of them being isolated from catheters (58.8%). Among all Escherichia coli strains analyzed, the highest resistance rate was found for trimethoprim/sulfamethoxazole (46.9%) and the majority of the resistant strains were isolated from urine samples (47.8%). Among Salmonella spp, the resistance rates were low for all antibiotics tested. For Shigella spp strains there was a high resistance to trimethoprim/sulfamethoxazole (80.0%). No resistance to ceftriaxone was observed in these strains. Surveillance of antimicrobial resistance is critical for the successful management of infectious diseases. The results of this survey show significant resistance rates among these bacteria which are responsible for several types of human infections.