Best Practice Recommendations: User Acceptance Testing for Systems Designed to Collect Clinical Outcome Assessment Data Electronically.

Implementing clinical outcome assessments electronically in clinical studies requires the sponsor and electronic clinical outcome assessment (eCOA) provider to work closely together to implement study-specific requirements and ensure consensus-defined best practices are followed. One of the most important steps is for sponsors to conduct user acceptance testing (UAT) using an eCOA system developed by the eCOA provider. UAT provides the clinical study team including sponsor or designee an opportunity to evaluate actual software performance and ensure that the sponsor's intended requirements were communicated clearly and accurately translated into the system design, and that the system conforms to a sponsor-approved requirements document based on the study protocol. The components of an eCOA system, such as the study-specific application, customization features, study portal, and custom data transfers should be tested during UAT. While the provider will perform their own system validation, the sponsor or designee should also perform their due diligence by conducting UAT. A clear UAT plan including the necessary documentation may be requested by regulatory authorities depending on the country. This paper provides the electronic patient-reported outcome (ePRO) Consortium's and patient-reported outcome (PRO) Consortium's best practice recommendations for clinical study sponsors or their designee for conducting UAT with support from eCOA providers to ensure data quality and enhance operational efficiency of the eCOA system. Following these best practice recommendations and completing UAT in its entirety will support a high quality eCOA system and ensure more reliable and complete data are collected, which are essential to the success of the study.

Characteristics and Clinical Implications of the Nasal Microbiota in Extranodal NK/T-Cell Lymphoma, Nasal Type.

Natural killer/T cell lymphoma (NKTCL) most frequently affects the nasal cavity and upper aerodigestive tract (UAT) and is often mistaken for reactive disease processes, such as chronic rhinosinusitis (CRS). Recently, alterations of the nasal resident microbiota have been found in CRS. However, nasal microbial features in NKTCL have never been reported. This case-control study collected 46 NKTCL patients, 25 CRS patients and 24 matched healthy controls (HCs) to analyze nasal microbial profiles via 16S rRNA sequencing technology to improve our understanding of changes in the nasal microbiota in NKTCL. We found that alpha diversity was significantly decreased, while beta diversity was significantly increased in NKTCL compared with those in CRS and HCs. The genus Corynebacterium was significantly depleted in CRS and NKTCL versus that in HCs, while genus Staphylococcus was the most abundant in the NKTCL compared to that in the other two groups. The nasal microbial community was significantly different between UAT-NKTCL and non-UAT NKTCL patients. Importantly, based on a panel of taxa, excellent classification power with an AUC of 0.875 between UAT-NKTCL and CRS was achieved. Furthermore, the alpha diversity of the nasal microbiota was associated with several clinical covariates of NKTCL. Finally, PICRUSt analysis implicated an array of distinct functions in NKTCL that might be involved in the pathogenesis of the disease. In conclusion, the nasal microbial profile was unique in NKTCL. The nose-microbiota-UAT NKTCL axis represents a panel of promising biomarkers for clinical practice and contributes to revealing the potential pathogenesis of this malignancy.

Predictors and usefulness of targeted therapy for pneumococcal community-acquired pneumonia diagnosed by the urinary antigen test: a prospective, observational cohort study.

The aim of the present study was to investigate the predictors of targeted therapy (TT) for pneumococcal community-acquired pneumonia (PCAP) with a positive urinary antigen test (UAT) and compare the outcomes with those of nontargeted therapy. This prospective cohort study enrolled consecutive PCAP patients with a positive UAT who were hospitalized at Kurashiki Central Hospital from October 2010 to November 2019. A total of 286 patients were included. Of them, 56 patients (19.6%) were included in the TT group. On multivariate analysis, identification of Gram-positive diplococci by Gram stain (OR [95% CI]: 2.46 [1.32-4.63]) was a positive predictor, whereas aspiration pneumonia (0.17 [0.03-0.59]) and CURB-65 score (0.59 [0.42-0.81]) were negative predictors of TT. Initial treatment failure and 30-day mortality were not significantly different. The UAT is not used enough for TT, and TT for PCAP did not have worse outcomes.

Comparison of Four Streptococcus pneumoniae Urinary Antigen Tests Using Automated Readers.

Streptococcus pneumoniae urinary antigen tests (UATs) may be interpreted using automatic readers to potentially automate sample incubation and provide standardized results reading. Here, we evaluated four UATs the BinaxNOW S. pneumoniae Antigen Card (Abbott, Chicago, IL, USA), ImmuView S. pneumoniae and Legionella (SSI Diagnostica, Hillerød, Denmark), STANDARD F S. pneumoniae Ag FIA (SD Biosensor, Gyeonggi, South Korea), and Sofia S. pneumoniae FIA (Quidel Corporation, San Diego, CA, USA) with their respective benchtop readers for their ability to detect S. pneumoniae urinary antigen. We found that these assays had a sensitivity of 76.9-86.5%, and specificity of 84.2-89.7%, with no significant difference found among the four UATs. The assays had a high level of agreement with each other, with 84.5% of samples testing consistently across all four assays. The automatically and visually read test results from the two immunochromatographic assays, BinaxNOW and ImmuView, were compared and showed excellent agreement between the two types of reading. Immunofluorescent-based assays, Sofia and STANDARD F, had significantly less time to detect compared to the two immunochromatographic assays due to having less assay setup procedures and shorter sample incubation times. In conclusion, the four UATs performed similarly in the detection of S. pneumoniae urinary antigen, and readers can bring increased flexibility to running UATs in the clinical routine.

Evaluation of Four Lateral Flow Assays for the Detection of Legionella Urinary Antigen.

Urinary antigen tests (UATs) are often used to diagnose Legionnaires' disease as they are rapid and easy to perform on readily obtainable urine samples without the need for specialized skills compared to conventional methods. Recently developed automated readers for UATs may provide objective results interpretation, especially in cases of weak result bands. Using 53 defined patient urine samples, we evaluated the performance of the BinaxNOW Legionella Antigen Card (Abbott), ImmuView S. pneumoniae and Legionella (SSI Diagnostica), STANDARD F Legionella Ag FIA (SD Biosensor), and Sofia Legionella FIA (Quidel) simultaneously with their respective automated readers. Automatic and visual interpretation of result bands were also compared for the immunochromatography-based BinaxNOW and ImmuView UATs. Overall sensitivity and specificity of Legionella UATs were 53.9-61.5% and 90.0-94.9%, respectively. All four UATs successfully detected all samples from L. pneumophila serogroup 1-positive patients, but most failed to detect samples for Legionella spp., or other serogroups. Automatic results interpretation of results was found to be mostly concordant with visual results reading. In conclusion, the performance of the four UATs were similar to each other in the detection of Legionella urinary antigen with no major difference between automated or visual results reading.

Laryngopharyngeal Reflux and Inflammatory Responses in Mucosal Barrier Dysfunction of the Upper Aerodigestive Tract.

The upper aerodigestive tract (UAT) is the first line of defense against environmental stresses such as antigens, microbes, inhalants, foods, etc., and mucins, intracellular junctions, epithelial cells, and immune cells are the major constituents of this defensive mucosal barrier. Laryngopharyngeal reflux (LPR) is recognized as an independent risk factor for UAT mucosal disorders, and in this review, we describe the components and functions of the mucosal barrier and the results of LPR-induced mucosal inflammation in the UAT. We discuss the interactions between the refluxate and the mucosal components and the mechanisms through which these damaging events disrupt and alter the mucosal barriers. In addition, we discuss the dynamic alterations in the mucosal barrier that might be potential therapeutic targets for LPR-induced disorders.

Fatal Case of Nosocomial Legionella pneumophila Pneumonia, Spain, 2018.

A nosocomial case of Legionella pneumophila pneumonia likely caused by a serogroup 3 strain was detected by a urinary antigen test in Spain in 2018. Although Legionella bacteria could not be isolated from respiratory samples, molecular methods implicated the sink faucet of the patient's room as the probable infection source.

Bacillus cereus e Geobacillus stearothermophilus em leite ultra alta temperatura (UAT) / Bacillus cereus and Geobacillus steartothermophilusin ultra high temperature (UHT) milk

O objetivo deste trabalho foi avaliar a presença de B. cereus e G. stearothermophilus em 100 amostras de leite UAT (integral e desnatado). O isolamento dos esporos e das células vegetativas seguiu metodologias oficiais, com pequenas modificações. B. cereus foi isolada de 7% amostras de leite UHT, de 6 diferentes marcas. As contagens máximas de células vegetativas e esporos de B. cer eus foram de 3,54 Log UFC/mL e 3,93 Log esporos/mL, respectivamente. A presença dos genes codificadores de enterotoxina não hemolítica (NHE) foi observada em 33% dos isolados e da hemolisina (HBL ) em 100% dos isolados. O gene hblA foi encontrado em 91,6 % dos isolados, porém nenhum isolado apresentou os 3 genes do complexo HBL. G. stearothermophilus foi identificada em 22,8% (34/149) dos isolados de esporo altamente resistente ao calor (HRRS), representando 18% das amostras de leite UAT e as contagens de esporos variaram de < 1Log a 3,40 Log esporos/mL.

Desenvolvimento de um modelo preditivo para identificação de perda de estabilidade e ocorrência de proteólise em leite UAT / Development of a predicative model for identification of loss of stability and proteolysis occurrence in UHT milk

Este trabalho se propôs a desenvolver um modelo preditivo para identificação de perda de estabilidade e de sedimentação em leite UAT por determinação da atividade enzimática de aminopeptidase no leite por espectrofotometria. Foram analisadas amostras de leite cru, pasteurizado e UAT após envase durante seis meses, na região Sul do Brasil. Acidez, crioscopia, gordura, extrato seco total, extrato seco desengordurado e densidade foram analisados nos leites cru e pasteurizado. Amostras de leite cru foram ainda submetidas à análise de contagem de psicrotróficos e à atividade de aminopeptidase, e amostras de leite UAT estocadas foram analisadas quanto ao grau de proteólise mediante análises sensoriais e atividade de aminopeptidase. Alterações sensoriais foram observadas em tempos de estocagem menores para amostras originadas de leite cru com contagem de psicrotróficos acima de 107 UFC mL-1. Não houve correlação entre a atividade de aminopeptidase e proteólise e também não foi observada correlação significativa entre os parâmetros físico-químicos e a ocorrência de proteólise no leite estocado. O modelo estudado não foi apto para predizer perda de estabilidade e ocorrência de proteólise no leite UAT.(AU)

The aim of this work was to develop a predictive model for identifying loss of stability and sedimentation in UHT milk by determining the enzymatic activity of aminopeptidasis in milk by spectrophotometry. Samples of raw milk, pasteurized and UHT after filling for 6 months in Southern Brazil were analyzed. Acidity, freezing point, fat, total solids, nonfat solids and density were analyzed in raw and pasteurized milk. Raw milk samples were also subjected to psychrotrophic count analysis and aminopeptidasis activity and UAT samples of stored milk were analyzed for degree of proteolysis through sensory analysis and aminopeptidasis activity. Sensory changes were observed in smaller storage time for samples of raw milk originated with psychrotrophic count above 107 CFU ml-1. There was no correlation between aminopeptidasis activity and proteolysis and there was also no significant correlation between physicochemical parameters and the occurrence of proteolysis in stored milk. The model was unable to predict loss of stability and occurrence of proteolysis in UHT milk.(AU)

Caracterización de la microbiota de leche ultra alta temperatura (UAT, UHT) analizada en Bogotá / Characterization of the microbiota of ultra-high temperatura (UHT) milk scrutinized in Bogotá / Caracterização da microbiota no leite ultra-alta temperatura (UAT) analisada em Bogotá

En los últimos años, las leches ultra alta temperatura (UAT, o UHT por sus siglas en inglés) ­definidas en el Decreto 616 de 2006­ analizadas en el Laboratorio de Salud Pública de Bogotá han venido presentando resultados no satisfactorios respecto a la prueba de esterilidad comercial, debido a que se han detectado microorganismos productores de esporas altamente resistentes a los tratamientos de ultrapasteurización (HHRS). A escala mundial, se informa como principal causa de esta clase de contaminación al Bacillus sporothermodurans. Con este estudio se determinó si las leches UAT de distribución en Bogotá presentan la misma contaminación detectada por bacterias HHRS del género Bacillus, y principalmente B. sporothermodurans. Las muestras de leches UAT que ingresaron al Laboratorio de Salud Pública de Bogotá se utilizaron para análisis microbiológico, como parte de la vigilancia rutinaria realizada por el Hospital de Fontibón durante 2010 y 2011. Como resultado de la prueba de esterilidad comercial aplicada a las leches UAT se recuperaron 36 cepas de muestras analizadas durante 2010-2011, a las que se les realizó la identificación bioquímica con el test BCL de Biomerieux, en el equipo Vitek ®2 Systems. Los microorganismos recuperados morfológicamente correspondieron a bacilos grampositivos, pertenecientes al género Bacillus, así: Bacillus smitii, 66,67 %; Bacillus sphaericus/fusiformis, 8,33 %; Bacillus choshinensis y Geobacillus stearothermophilus, 8,33 %. Esto permite concluir que no toda la contaminación de las leches UAT (UHT) analizadas en Bogotá se debe a una sola especie de Bacillus; por tanto, no se debe enfocar únicamente en B. sporothermodurans como contaminante único de leches higienizadas a escala nacional

In recent years, ultra-high temperature milk categories (enforced by Decree 616 of 2006 and scrutinized by Public Health Laboratory of Bogota) have reported unsatisfactory results regarding a commercial sterility test because of highly heat-resistant spores ­HHRS­ produced by microorganisms. Globally, Bacillus sporothermodurans has reported as the main cause of this kind of pollution. This study established whether these delivery milks in Bogota have the same pollution detected by HHRS bacteria of the genus Bacillus and mainly B. sporothermodurans. For this purpose, we used microbiological samples as a portion of the repetitive surveillance performed by the Hospital de Fontibon during 2010 and 2011, division of Environment and Consumer Surveillance. Because of the commercial sterility test, 36 sample strains were recovered and biochemically identified using Biomerieux BCL test, supported by Vitek ®2 Systems. The morphologically recovered microorganisms were Gram-positive bacilli belonging to Bacillus type, as follows: Bacillus smitii 66,67 %, Bacillus sphaericus/ fusiformis 8,33 %, Bacillus choshinensis and Geobacillus sterarothermophilus 8,33 %. This lets us to conclude that not all of the pollution is due to single species of Bacillus and should not focus only on B. sporothermodurans as a single contaminant of domestic sanitized milks

Nos últimos anos, as categorias de leite ultra-alta temperatura (UAT) ­ definidas no Decreto 616 de 2006 e analisados no Laboratório de Saúde Pública de Bogotá ­ têm vindo apresentando resultados não satisfatórios respeito à prova de esterilidade comercial, isso devido a que se têm afetado microrganismos produtores de esporas altamente resistentes aos tratamentos de ultra- pasteurização (HHRS). Mundialmente reporta-se como principal causa deste tipo de contaminação ao Bacillus sporothermodurans. Com este estudo determinou-se se esses leites de distribuição em Bogotá apresentam a mesma contaminação detectada por bactérias HHRS do gênero Bacillus e principalmente o B. sporothermodurans. Para tal fim, utilizaram-se amostras de análise microbiológico como parte da vigilância costumeira realizada pelo Hospital de Fontibón durante 2010 y 2011 na área de Vigilância do Ambiente e Consumo. Resultados da prova de esterilidade comercial foram recuperadas 36 cepas de amostras nas quais, a seguir, foram realizada a identificação bioquímica com o teste BCL de Biomerieux na equipe Vitek ®2 Systems. Os microrganismos recuperados morfologicamente corresponderam a bacilos Gram positivos, pertencentes ao gênero Bacillus, deste jeito: Bacillus smitii 66.67 %, Bacillus sphaericus/ fusiformis 8.33 %, Bacillus choshinencis e Geobacillus sterarothermophilus 8.33 %. O anterior permite concluir que não toda a contaminação é devida a uma só espécie de bacilos e não deve se enfocar unicamente em B. sporothermodurans como contaminante único nacional dos leites higienizados

ATP-Bioluminescence as a method to evaluated microbiological quality of UHT milk / ATP-Bioluminescência como método para avaliação da qualidade microbiológica de leite UAT

New approaches are needed to quickly indicate possible contamination of UHT milk, among them the technique of ATP-Bioluminescence. Therefore, the aim of this study was to compare the results of culture methods with the results of ATP-Bioluminescence technique of 102 UHT whole milk samples incubated at 48, 72, and 168 hours. UHT milk samples were analyzed for the presence of mesophilic and psychrotrophic aerobic microorganisms using Plate Count Agar (PCA), Brain-Heart Infusion (BHI) media and PetrifilmTM Aerobic Count (AC) plates. The ATP-Bioluminescence technique was applied through the Microbial Luminescent Screening (MLS) system. Significant correlations were found between counts of aerobic mesophilic microorganisms on PCA, PetrifilmTM AC, BHI and results of ATP bioluminescence technique (P≤0.05). The ATP-Bioluminescence technique had higher correlation with counting method in PCA than BHI media. At lower pass/fail limits of Relative Light Units (60, 50, 45 and 40 RLU), the number of samples identified as positive increased and statistically agreed with aerobic mesophilic microorganism counts (P>0.05). For the dairy industry, the ATP-Bioluminescence technique may become an important tool that assists the official methods to quickly monitor the microbiological quality of UHT milk though this will likely require a threshold below 150 RLU...

Novos métodos são necessários para detectar de forma rápida a contaminação do leite UAT, entre eles, a técnica de ATP-Bioluminescência. Portanto, objetivou-se comparar os resultados de métodos de cultura tradicionais com os resultados de ATP-Bioluminescência de 102 amostras de leite UAT integral incubadas por 48, 72 e 168 horas. Os leites UAT foram analisados quanto à presença de micro-organismos aeróbicos mesófilos e psicrotróficos usando os ágares PCA, BHI e placas PetrifilmTM AC. A técnica de ATP-Bioluminescência foi aplicada por meio do sistema Microbial Luminescent Screening (MLS). Significantes correlações foram obtidas entre as contagens de micro-organismos mesófilos aeróbios em PCA, PetrifilmTM AC, BHI e os resultados da técnica de ATP-Bioluminescência (p<0,05). A técnica de ATP-Bioluminescência tem maior correlação com o método de contagem em meio PCA que BHI. Quando valores limites de Unidades Relativas de Luz (60, 50, 45 e 40 RLU) foram menores, o número de amostras identificadas como positivas aumentou e concordou estatisticamente com a contagem de micro-organismos mesófilos aeróbios (P>0,05). Para as indústrias de laticínios, a técnica de ATP-Bioluminescência pode se tornar uma ferramenta auxiliar aos métodos oficiais para o monitoramento rápido da qualidade microbiológica do leite UAT, desde que sejam utilizados limites abaixo de 150 RLU...

Caseinomacropeptide index in UHT whole milk stored under different conditions of temperature and time / Efeito das condições de armazenamento no índice de caseinomacropeptídeo de amostras de leite integral ultra alta temperatura (UAT)

Caseinomacropeptide (CMP) index is a method used to detect adulteration of milk by addition of cheese whey, since CMP is a glycopeptide characteristic produced during cheesemaking, and soluble in the whey phase. The objective of this work was to evaluate the caseinomacropeptide index of UHT milk stored under different temperatures. Six batches of recently processed UHT milk were collected and stored under three temperatures (21ºC, 6ºC, and -12ºC) and analyzed by HPLC in the day of the milk collection (day 0) and at 30, 60, 90, and 120 days of storage. The experiment was run as a randomized block design with a 3x5 factorial arrangement, and the Student-Newman-Keuls (SNK) method was used as the post-hoc test (p = 0.05). There was a progressive increase of the CMP index during the storage period of 120 days, and this indicates the possibility of false positive results if the CMP index is used as an adulteration test for long term stored UHT milk. The validity of the CMP index as an adulteration indicator is only possible soon after packaging, and sample freezing is the only alternative when immediate analysis is not possible. The method was found to be precise, with robust CV of 1.9% even with high CMP levels.

O objetivo deste trabalho foi avaliar a influência da temperatura e do tempo de armazenamento de amostras de leite UAT, em relação ao índice de caseinomacropeptídeo, por cromatografia líquida de alta eficiência, e a precisão do método de detecção. Seis lotes foram coletados e armazenados em três temperaturas (21ºC, 6ºC e -12ºC ± 1ºC) e analisadas durante o armazenamento nos dias 0, 30, 60, 90 e 120 dias. Utilizou-se o delineamento em blocos casualizados com os tratamentos em arranjo fatorial 3x5 e os resultados foram comparados por meio do teste Student-Newman-Keuls (SNK) a 5% de significância. Houve aumento progressivo do índice de CMP por CLAE durante os 120 dias; portanto, um produto conforme pode se tornar não conforme sem que ocorra adulteração. A detecção de fraude por adição de soro lácteo em leite UAT pode ser detectada somente após o envase. Caso não seja possível a análise imediata, recomenda-se que as amostras sejam congeladas. O método é muito preciso (CV=1,9%) e indiferente aos níveis de CMP encontrados nas amostras.

Avaliação da qualidade microbiológica de bebida láctea e creme de leite UAT por ATP-Bioluminescência / Evaluation of microbiological quality of UHT milk drink and UHT milk cream by ATP-Bioluminescence

Embora métodos tradicionais sejam utilizados na avaliação microbiológica de produtos UAT, metodologias rápidas, baseadas em ATP-Bioluminescência, têm sido desenvolvidas. Os resultados da aplicação dessa técnica em 54 amostras de bebida láctea UAT achocolatada e 12 de creme de leite UAT foram comparados com os resultados de métodos microbiológicos, utilizando-se diferentes meios de cultura e tempos de incubação das referidas amostras. A técnica de ATP-Bioluminescência foi aplicada por meio do sistema MLS, e os resultados foram expressos em unidades relativas de luz (RLU). Em todos os tempos de incubação - 48, 72 e 168 horas - , as amostras apresentaram contagens baixas de microrganismos mesófilos e psicrotróficos aeróbios quando analisadas em meio PCA, BHI, PetrifilmTM AC e por ATP-Bioluminescência (<150 RLU), demonstrando alta especificidade da técnica. Apenas uma amostra de creme de leite UAT apresentou contagem de mesófilos aeróbios acima do padrão estabelecido pela legislação brasileira (<100 UFC/mL) quando analisada em meio PCA (260 UFC/mL) e PetrifilmTM AC (108 UFC/mL), no tempo de 168 horas. Essa alta contagem de microrganismos mesófilos aeróbios também foi detectada pela técnica de ATP-Bioluminescência (416 RLU). Os resultados da técnica de ATP-Bioluminescência foram iguais aos resultados em meio PCA, BHI e PetrifilmTM AC.

Although traditional methods are used for the microbiological evaluation of UHT products, rapid methodologies based on ATP-Bioluminescence have been developed. The results of applying this technique in 54 samples of chocolate UHT milk drink and 12 of UHT milk cream were compared with the results of microbiological methods, using different culture media and incubation times for the referred samples. The ATP-Bioluminescence technique was applied through the MLS system and the results were expressed as relative light units (RLU). In all incubation times - 48, 72, and 168 hours - , the samples showed lower counts of mesophilic and psychrotrophic aerobic microorganisms when analyzed using PCA, BHI, PetrifilmTM AC and ATP-Bioluminescence (<150RLU), demonstrating the technique's high specificity. Only one sample of UHT milk cream showed a mesophilic aerobic count above the standard established by Brazilian legislation (<100CFU/mL) when analyzed in PCA (260 CFU/mL) and PetrifilmTM AC (108CFU/mL) at 168 hours. This high count of aerobic mesophilic microorganisms was also detected by the ATP-Bioluminescence (416 RLU) technique. The results of the ATP-Bioluminescence technique were equal to the results in PCA, BHI and PetrifilmTM AC.

Características microbiológicas de leite integral e bebida láctea processados por UAT (Ultra Alta Temperatura) ao longo do período de validade / Microbiological characteristics of whole milk and dairy drink processed by UHT (Ultra-High Temperature) during its shelf life

O leite integral e a bebida láctea UAT são submetidos ao mesmo tratamento térmico, mas são produtos diferentes, já que na bebida láctea é permitida a adição de até 50% de soro lácteo. Neste estudo, objetivou-se avaliar as características microbiológicas destes produtos com relação à legislação vigente do Ministério da Agricultura, Pecuária e Abastecimento (MAPA) e, ainda, da população psicrotrófica, ao longo do período de validade. Foram analisadas 150 amostras, 75 de cada produto, a partir de cinco diferentes marcas comerciais nacionais. As 15 amostras de cada marca foram subdivididas em três lotes: início, meio e final do período de validade, cada qual com cinco amostras do mesmo lote. Verificou-se para o leite que todas as amostras de leite UAT estavam de acordo com a legislação vigente. A população de psicrotróficos aumentou em 26,6% das amostras depois que foram abertas e mantidas sob refrigeração por 48 horas. Os resultados para a bebida láctea evidenciaram que 12% das amostras estavam em desacordo com o estabelecido pela legislação vigente. A população de psicrotróficos aumentou em 36% das amostras depois que foram abertas e mantidas sob refrigeração por 48 horas. Tais resultados devem servir de alerta para a necessidade de fiscalização mais rigorosa da bebida láctea UAT, pois parte das amostras não atenderam aos padrões microbiológicos estabelecidos pela legislação.

UHT milk and dairy drinks are submitted to the same heat treatment, but they are different products, since the addition of up to 50% of whey is allowed in dairy drinks. The aim of this study was to evaluate the microbiological characteristics of these products in relation to current legislation, during the course of their shelf life. In the present study, 150 samples, 75 of each type of product, from 5 different national brands were analyzed. The 15 samples of each brand were separated into 3 lots containing 5 samples each, analyzed at the beginning, middle and end of the validity period. Upon microbiological analysis all UHT milk samples were in conformance with current legislation. After the samples were opened and chilled for 48 hours, 26.6% of them presented an increased psychrotrophic population. The dairy drink results showed that 12% of the samples were out of conformance with the current legislation. After the samples were opened and chilled for 48 hours, 36% of them presented an increased psychrotrophic population. These results should be considered as an alert in regard to the need for rigorous inspection of UHT milk and dairy drink products.

Atividade de plasmina e plasminogênio no leite longa vida com alta e baixa contagem de células somáticas durante o armazenamento / Activity of plasmin and plasminogen in ultra high temperature milk with high and low somatic cell counts during storage

O objetivo deste estudo foi avaliar o efeito da contagem de células somáticas (CCS) do leite na atividade de plasmina e plasminogênio durante o período de armazenamento do leite longa vida integral. Os leites crus foram categorizados em grupos de CCS de baixa (342.000-487.000 células mL-1) e alta contagem (603.000-808.000 células mL-1). Dois lotes de leite longa vida em cada categoria de CCS foram analisados para determinação de plasmina e plasminogênio após 10, 30, 60, 90 e 120 dias de armazenamento em temperatura ambiente. Para a fabricação do leite longa vida, o leite cru foi submetido à pasteurização rápida seguida da esterilização industrial do leite por injeção de vapor pelo método direto e embalagem asséptica do produto. A CCS não apresentou efeitos sobre as características físico-químicas do leite cru, e nem sobre a atividade de plasmina e plasminogênio nos leites cru e longa vida, armazenados por 120 dias. Entretanto, independentemente da CCS, a atividade de plasmina e plasminogênio aumentou no leite longa vida ao longo do armazenamento, indicando a possibilidade de aumento da proteólise no produto durante sua vida de prateleira.

This study aimed to evaluate the effect of somatic cell counts (SCC) in milk on plasmin and plasminogen activities of ultra high temperature (UHT) milk during storage. Raw milks were categorized in SCC groups of low (342,000-487,000 cells mL-1) and high cells (603,000-808,000 cells mL-1). Two replicates of UHT milks within each SCC category were analyzed for plasmin and plasminogen activities after 10, 30, 60, 90 and 120 days of storage at room temperature. For manufacture of UHT milk, raw milk was pasteurized and sterilized by direct vapor injection process, followed by aseptic packaging. SCC had no effect on physical-chemical characteristics of raw milk, and on plasmin or plasminogen activities in raw and UHT milks during 120 days of storage. However, independently of the SCC in raw milk, the activity of plasmin and plasminogen increased in UHT milk during storage, hence indicating a possible increase in proteolysis in the product during its shelf-life.

Bacillus cereus enterotoxigênicos em diferentes fases do processamento de leite UAT

Um total de 300 amostras de leite foram submetidas à pesquisa de bactérias do grupo do Bacillus cereus e as cepas isoladasforam analisadas quanto à produção de enterotoxinas através do kit BCET-RPLA. Bactérias do grupo do Bacillus cereus foramverificadas em 36 amostras de leite cru, 55 de pasteurizado e 27 de UAT. Destas, 12 cepas isoladas do leite cru, 24 dopasteurizado e 24 do UAT foram submetidas ao teste de detecção de enterotoxinas. Verificou-se que 50,0% das cepasisoladas de amostras de leite cru, 20,8% das isoladas de pasteurizado e 75,0% das isoladas de UAT submetidas ao testedemonstraram-se positivas para produção de enterotoxinas. Os resultados evidenciaram maior número de cepas de Bacilluscereus enterotoxigênicos em leite UAT, o que serve de alerta para a indústria e autoridades sanitárias pela possibilidade deamostras de leite consideradas isentas de microrganismos estarem veiculando microrganismo potencialmente patogênico.