Steam quality monitoring as a strategy to reduce wet packs and sterilization failure.

BACKGROUND: Hospital articles processed by steam are widely used in the Central Sterile Supply Department (CSSD), responsible for due sterilization. Steam sterilization is discussed worldwide, aiming to protect patients. If steam is outside the specified requirements, the sterilization process may fail, resulting in the wet packs at the end of the sterilization cycle. METHODS: The present study evaluated the steam quality at Santa Catarina Hospital (São Paulo, SP, Brazil) from 2016 to 2022. Saturated steam containing noncondensable gases, excess condensate, or even superheat was characterized using the methodology indicated in the European Standard EN 285:2015. RESULTS: From 2016 to 2020, qualification tests showed that the saturated steam quality does not achieve standard limit parameters. Infrastructural maintenance actions were taken to adjust the saturated steam quality. In 2021, the steam quality followed technical standards, and its adequacy was confirmed in 2022. CONCLUSIONS: The points developed by the hospital's maintenance department, the adoption of appropriate devices for this purpose, and the correct preventive maintenance in the autoclaves, together with the correct qualification of the equipment and proof of the steam quality, contributed to improve the safety of the hospital sterilization process and reduce the incidence of wet packages.

Opening avenues for treatment of neurodegenerative disease using post-biotics: Breakthroughs and bottlenecks in clinical translation.

Recent studies have indicated the significant involvement of the gut microbiome in both human physiology and pathology. Additionally, therapeutic interventions based on microbiome approaches have been employed to enhance overall health and address various diseases including aging and neurodegenerative disease (ND). Researchers have explored potential links between these areas, investigating the potential pathogenic or therapeutic effects of intestinal microbiota in diseases. This article provides a summary of established interactions between the gut microbiome and ND. Post-biotic is believed to mediate its neuroprotection by elevating the level of dopamine and reducing the level of α-synuclein in substantia nigra, protecting the loss of dopaminergic neurons, reducing the aggregation of NFT, reducing the deposition of amyloid ß peptide plagues and ameliorating motor deficits. Moreover, mediates its neuroprotective activity by inhibiting the inflammatory response (decreasing the expression of TNFα, iNOS expression, free radical formation, overexpression of HIF-1α), apoptosis (i.e. active caspase-3, TNF-α, maintains the level of Bax/Bcl-2 ratio) and promoting BDNF secretion. It is also reported to have good antioxidant activity. This review offers an overview of the latest findings from both preclinical and clinical trials concerning the use of post-biotics in ND.

Endotoxin test by recombinant Factor C for 0.9% sodium chloride injection

Endotoxin contamination is a threat to the safety of pharmaceutical products, especially parenteral drugs. Any sterile and/or pyrogen-free pharmaceutical product requires regulatory specifications to ensure safe patient use. This study covers the performance evaluation study of an endotoxin quantitation commercial kit by recombinant Factor C (rFC), Endozyme II® Go, for 0.9% sodium chloride injection. The samples were spiked with endotoxin solutions between 0.0005 and 10 EU/mL and tested by the rFC kit to evaluate precision, accuracy, detection and quantification limits, linearity, and robustness. Each of the six points was assayed at least five times.The relative standard deviation for precision testing ranged from 1.9 to 8.3%. The recovery accuracy values of endotoxin were between 61% and 125% for the range from 0.005 to 10 EU/mL. The results demonstrated that the rFC method allows endotoxin quantification with accuracy, precision, specificity, and linearity for the range of 0.005 and 10 EU/mL for 0.9% sodium chloride injection. (AU)

A contaminação por endotoxinas é uma ameaça à segurança dos produtos farmacêuticos, especialmente dos medicamentos parenterais. Qualquer produto farmacêutico estéril e/ou livre de pirogênios requer especificações regulatórias para garantir a segurança de uso para o paciente. Este estudo abrange o estudo de avaliação de desempenho empregando o kit comercial Endozyme II® Go para quantificação de endotoxina, por Fator C recombinante (FCr), em amostras de cloreto de sódio 0,9% para uso parenteral. As amostras foram fortificadas com cinco concentrações distintas de soluções de endotoxina na faixa entre 0,0005 e 10 UE/mL. Cada um dos cinco níveis foi testado pelo menos cinco vezes para avaliação dos critérios de precisão, exatidão, limites de detecção e quantificação, linearidade e robustez. O desvio padrão relativo para os testes de precisão variou de 1,9 a 8,3%. Os valores de recuperação de endotoxina para o parâmetro exatidão estiveram compreendidos entre 61% e 125%. Os resultados demonstraram que o método por FCr permite a quantificação de endotoxinas com exatidão, precisão, especificidade e linearidade para a faixa de 0,005 e 10 UE/mL em amostras de cloreto de sódio 0,9% para uso parenteral. (AU)

Analysis of water quality over non-condensable gases concentration on steam used for sterilization.

BACKGROUND: Non-condensable gases (NCGs) are all gases that do not undergo liquefaction during the saturated steam sterilization process. During a sterilization cycle, the NCGs presence inside the chamber is one of the biggest threats to the sterilization process compromising process validation and product quality. METHODS: In this work, 170 testing of NCGs concentrations performed between September 2016 and August 2021 were carried out by Orionce Serviços de Metrologia Ltda (Barueri, SP, Brazil), according to EN285:2015 procedure. For steam generation, the types of water used were softened water (SW), one-step reverse osmosis (RO), purified water (PW), and water for injection (WFI). The data obtained were analyzed using Minitab® software, version 18.1, to identify a relationship between the water quality used for steam generation and the concentration of non-condensable gases determined into equipment qualification. FINDINGS: From total tests performed, 109 tests passed, and 61 tests failed, representing 64.2% and 35.8%, respectively. A higher failure rate was observed in terms of concentration of non-condensable gases in systems that used purified water for steam generation (64.7%), followed by softened water (55.6%), one-step reverse osmosis (42.9%), and water for injection (7.6%). CONCLUSION: System processes using WFI for steam generation showed better results for steam quality approvement, in terms of NCGs concentration, compared to softened, purified, or reverse osmosis water treatments in the concentration of non-condensable gases in steam used for sterilization processes of industrial utilities.

Biomedical Applications of polymeric micelles in the treatment of diabetes mellitus: Current success and future approaches.

INTRODUCTION: Diabetes mellitus (DM) is the most common metabolic disease and multifactorial, harming patients worldwide. Extensive research has been carried out in the search for novel drug delivery systems offering reliable control of glucose levels for diabetics, aiming at efficient management of DM. AREAS COVERED: Polymeric micelles (PMs) as smart drug delivery nanocarriers are discussed, focusing on oral drug delivery applications for the management of hyperglycemia. The most recent approaches used for the preparation of smart PMs employ molecular features of amphiphilic block copolymers (ABCs), such as stimulus sensitivity, ligand conjugation, and as a more specific example the ability to inhibit islet amyloidosis. EXPERT OPINION: PMs provide a unique platform for self-regulated or spatiotemporal drug delivery, mimicking the working mode of pancreatic islets to maintain glucose homeostasis for prolonged periods. This unique characteristic is achieved by tailoring the functional chemistry of ABCs considering the physicochemical traits of PMs, including sensing capabilities, hydrophobicity, etc. In addition, the application of ABCs for the inhibition of conformational changes in islet amyloid polypeptide garnered attention as one of the root causes of DM. However, research in this field is limited and further studies at the clinical level are required.

Reflection about the hemodialysis water microbiological quality in Brazil

Abstract Dialysis has been widely used in the treatment of patients with chronic kidney diseases and is considered a global public health issue. This treatment, which has changed the prognosis and quality of life in patients with chronic renal failure, can lead to complications that are often fatal. For this reason, there is a need for validation of alternative tests that favor the monitoring of treated water for dialysis in real-time to promote and prevent injuries to patients submitted to this procedure.

Validation and applicability of an alternative method for dialysis water and dialysate quality analysis.

INTRODUCTION: In hemodialysis, patients are exposed to a large volume of water, which may lead to fatal risks if not meeting quality standards. This study aimed to validate an alternative method for monitoring microbiological quality of treated water and assess its applicability in dialysis and dialysate analysis, to allow corrective actions in real-time. METHODS: Validation and applicability were analyzed by conventional and alternative methods. For validation, E. coli standard endotoxin was diluted with apyrogenic water in five concentrations. For the applicability analysis, treated water for dialysis was collected from different points in the treatment system (reverse osmosis, drainage canalization at the storage tank bottom, reuse, and loop), and dialysate was collected from four machines located in different rooms in the hemodialysis sector. RESULTS: The validation results were in accordance with the Brazilian Pharmacopoeia acceptance criteria, except for the last two concentrations analyzed. In addition, the ruggedness criterion performed under the US Pharmacopoeia was in agreement with the results. DISCUSSION: A limiting factor in the applicability analysis was the absence of the endotoxin maximum permitted level in dialysate by the Brazilian legislation. When comparing the analysis time, the alternative method was more time-consuming than the conventional one. This suggests that the alternative method is effective in the case of few analyses, that is, real-time analyses, favoring corrective actions promptly. On the other hand, it does not support the implementation of the alternative method in a laboratory routine due to the high demand for analyses.

Cálculo da estimativa da incerteza de medição associada ao ensaio de contagem de bactérias heterotróficas em matriz água purificada através da técnica de detecção por fluorescência / Measurement uncertainty calculation associated with heterotrophic bacterial count in purified water matrix using the fluorescence detection technique

A incerteza de medição representa o nível de confiança no resultado. Para a estimativa da incerteza de medição foi empregado o cálculo do desvio padrão da reprodutibilidade intralaboratorial de 48 ensaios de contagem de bactérias heterotróficas pela técnica da membrana filtrante com detecção por fluorescência pelo uso de substrato fluorogênico em amostras de água purificada contaminadas artificialmente entre 10 e 100 UFC/mL. O valor obtido, 1,3 x 10-3 (log10), indica que a técnica utilizada pode ser uma alternativa para a estimativa da incerteza de medição em ensaios microbiológicos quantitativos de contagem de bactérias heterotróficas em amostras de água purificada. (AU)

Measurement uncertainty represents the confidence level in the result. To estimate the expanded measurement uncertainty, the standard deviation of intra-laboratory reproducibility of 48 heterotrophic bacterial count assays by fluorescence detection by the use of fluorogenic substrate on artificially contaminated purified water samples between 10 and 100 CFU/mL was used. The value obtained, 1.3 x 10-3 (log10), indicates that the technique used can be an alternative to estimate measurement uncertainty in quantitative microbiological heterotrophic bacterial count assays in purified water samples using fluorogenic substrate. (AU)

Cálculo da estimativa da incerteza de medição associada ao ensaio de contagem de bactérias heterotróficas em matriz água purificada através da técnica de detecção por fluorescência / Measurement uncertainty calculation associated with heterotrophic bacterial count in purified water matrix using the fluorescence detection technique

A incerteza de medição representa o nível de confiança no resultado. Para a estimativa da incerteza de medição foi empregado o cálculo do desvio padrão da reprodutibilidade intralaboratorial de 48 ensaios de contagem de bactérias heterotróficas pela técnica da membrana filtrante com detecção por fluorescência pelo uso de substrato fluorogênico em amostras de água purificada contaminadas artificialmente entre 10 e 100 UFC/mL. O valor obtido, 1,3 x 10-3 (log10), indica que a técnica utilizada pode ser uma alternativa para a estimativa da incerteza de medição em ensaios microbiológicos quantitativos de contagem de bactérias heterotróficas em amostras de água purificada.

Measurement uncertainty represents the confidence level in the result. To estimate the expanded measurement uncertainty, the standard deviation of intra-laboratory reproducibility of 48 heterotrophic bacterial count assays by fluorescence detection by the use of fluorogenic substrate on artificially contaminated purified water samples between 10 and 100 CFU/mL was used. The value obtained, 1.3 x 10-3 (log10), indicates that the technique used can be an alternative to estimate measurement uncertainty in quantitative microbiological heterotrophic bacterial count assays in purified water samples using fluorogenic substrate.

Is dialysis water a safe component for hemodialysis treatment in São Paulo State, Brazil?

Failure on the water treatment poses hemodialysis patients at risk of injury and death. Identifying if the patients are exposed to water quality related microbiological risks is an important objective to reduce the mortality for chronic renal patients and is the main issue of this study. We evaluated the microbiological water quality used by 205 dialysis services in São Paulo State, Brazil between 2010 to 2016. The study included heterotrophic bacteria count, total coliforms research, and bacterial endotoxin determination in 1366 dialysis water samples. The number of unsatisfactory clinics for at least one microbiological parameter decreased 16.0% between 2010 to 2015 but increased 57.2% in 2016. In 2010, the most frequent unsatisfactory parameter was related to heterotrophic bacteria count (54.8%) followed by endotoxin determination (45.2%). However, in 2013 an opposite situation was observed: endotoxin determination as the parameter of the higher incidence of nonconformities. Total coliform was verified at a lower frequency. We highlighted the importance of regular monitoring of dialysis water quality to prevent infections caused by dialytic procedures and to ensure that the water is a safe component of the treatment.

Is dialysis water a safe component for hemodialysis treatment in São Paulo State, Brazil?

Failure on the water treatment poses hemodialysis patients at risk of injury and death. Identifying if the patients are exposed to water quality related microbiological risks is an important objective to reduce the mortality for chronic renal patients and is the main issue of this study. We evaluated the microbiological water quality used by 205 dialysis services in São Paulo State, Brazil between 2010 to 2016. The study included heterotrophic bacteria count, total coliforms research, and bacterial endotoxin determination in 1366 dialysis water samples. The number of unsatisfactory clinics for at least one microbiological parameter decreased 16.0% between 2010 to 2015 but increased 57.2% in 2016. In 2010, the most frequent unsatisfactory parameter was related to heterotrophic bacteria count (54.8%) followed by endotoxin determination (45.2%). However, in 2013 an opposite situation was observed: endotoxin determination as the parameter of the higher incidence of nonconformities. Total coliform was verified at a lower frequency. We highlighted the importance of regular monitoring of dialysis water quality to prevent infections caused by dialytic procedures and to ensure that the water is a safe component of the treatment.

Evaluation of an Amplified ATP Bioluminescence Method for Rapid Sterility Testing of Large Volume Parenteral

The sterility test described in pharmacopoeial compendia requires a 14-day incubation period to obtain a valid analytical result. Therefore, the use of alternative methods to evaluate the sterility of pharmaceuticals, such as the BacT/Alert® 3D system, is particularly interesting, because it allows a reduced incubation period and lower associated costs. Considering that the BacT/Alert® 3D system offers several culture media formulations developed for this microbial detection system, the present study was aimed to evaluate and compare the performance of BacT/Alert® 3D with the pharmacopoeial sterility test. There was no significant difference between the ability of the culture media to allow detection of microbial contamination. However, the rapid sterility testing method allowed a more rapid detection of the challenge microorganisms, which indicates that the system is a viable alternative for assessing the sterility of injectable products.

Role of the Tristetraprolin (Zinc Finger Protein 36 Homolog) Gene in Cancer.

Cancer is a complicated transformational progression that fiercely changes the appearance of cell physiology as well as cells' relations with adjacent tissues. Developing an oncogenic characteristic requires a wide range of modifications in a gene expression at a cellular level. This can be achieved by activation or suppression of the gene regulation pathway in a cell. Tristetraprolin (TTP or ZFP36) associated with the initiation and development of tumors are regulated at the level of mRNA decay, frequently through the activity of AU-rich mRNA-destabilizing elements (AREs) located in their 3'-untranslated regions. TTP is an attractive target for therapeutic use and diagnostic tools due to its characteristic appearance in cancer tissue alone. Thus, the illumination of TTP in diverse types of cancer might deliver additional effective remedies in the coming era for cancer patients. The objective of this review is to familiarize the reader with the TTP proteins, focus on efficient properties that endow them with their effective oncogenic potential, describe their physiological role in cancer cells, and review the unique properties of TT, and of TTP-driven cancer.

Multi-drug resistant Mycobacterium tuberculosis & oxidative stress complexity: Emerging need for novel drug delivery approaches.

Tuberculosis (caused by Mycobacterium tuberculosis, Mtb) treatment involves multiple drug regimens for a prolonged period. However, the therapeutic benefit is often limited by poor patient compliance, subsequently leading to treatment failure and development of antibiotic resistance. Notably, oxidative stress is a crucial underlying factor that adversely influences the various treatment regimens in tuberculosis. Little information is available with advanced drug delivery systems that could be effectively utilized, in particular, for targeting the oxidative stress in tuberculosis. Thus, this presents an opportunity to review the utility of various available, controlled-release drug delivery systems (e.g., microspheres, liposomes, niosomes, solid lipid nanoparticles, dendrimers) that could be beneficial in tuberculosis treatments. This will help the biological and formulation scientists to pave a new path in formulating a treatment regimen for multi-drug resistant Mtb.

Embarking Effect of ACE2-Angiotensin 1-7/Mas Receptor Axis in Benign Prostate Hyperplasia.

The proliferative cell process that causes prostate enlargement, obstruction of the bladder outlet, and lower urinary tract symptoms (LUTS) is known as benign prostatic hyperplasia (BPH). The prevalence of BPH worldwide is approximately 10%, 20%, 50%, and 80% for men in their 30s, 40s, 60s, and 70s, respectively. Recent data have revealed that overactivation of the renin angiotensin aldosterone system increases the level of bioactive peptide hormone angiotensin II, which downregulates the ACE2-angiotensin 1-7/Mas receptor axis path and upregulates angiotensin receptor type 1-mediated signaling, which finally leads to a proliferation of cellular elements in the prostate. We have hypothesized the mechanism that reverses the downregulation of the ACE2-angiotensin 1-7/Mas receptor axis path and the upregulation of angiotensin receptor type 1-mediated signaling. Thus, we posit that ACE2, Ang-(1-7), and the Mas receptor could be novel therapeutic targets for treating BPH/LUTS.

Formulation and characterization of oral rapid disintegrating tablets of levocetirizine.

BACKGROUND: Levocetirizine, active R (-) enantiomer of cetirizine, is an orally active and selective H1 receptor antagonist used medically as an anti-allergic. Allergic rhinitis is a symptomatic disorder of the nose induced by inflammation mediated by immunoglobulin E (IgE) in the membrane lining the nose after allergen exposure. OBJECTIVES: The purpose of the present study was to prepare rapidly disintegrating tablets of levocetirizine after its complexation with ß-cyclodextrin (ß-CD). MATERIAL AND METHODS: Levocetirizine-ß-CD complex tablets were prepared by direct compression technique using 3 synthetic superdisintegrants in different proportions. Development of the formulation in the present study was mainly based on the concentration of superdisintegrants and the properties of the drug. Nine batches of tablets were formulated and evaluated for various parameters: drug content, weight variation, water absorption ratio, wetting time, in vitro disintegration, hardness, friability, thickness uniformity, and in vitro dissolution. RESULTS: A Fourier-transform infrared spectroscopy (FTIR) study showed that there were no significant interactions between the drug and the excipients. The prepared tablets were good in appearance and showed acceptable results for hardness and friability. The in vitro disintegrating time of the formulated tablet batches was found to be 15-35 s percentage and the drug content of tablets in all formulations was found to be between 90-102%, which complied with the limits established in the United States Pharmacopeia. CONCLUSIONS: Complexation of levocetirizine with ß-CD significantly improves the solubility of the drug. The disintegration time of the tablets was decreased with an increase in superdisintegrant amount. The tablets (batch CPX5) had a minimum disintegration time of 20 s and 99.99% of the drug was released within 10 min.

Performance Survey and Comparison Between Rapid Sterility Testing Method and Pharmacopoeia Sterility Test

The sterility test described in pharmacopoeial compendia requires a 14-day incubation period to obtain a valid analytical result. Therefore, the use of alternative methods to evaluate the sterility of pharmaceuticals, such as the BacT/Alert® 3D system, is particularly interesting, because it allows a reduced incubation period and lower associated costs. Considering that the BacT/Alert® 3D system offers several culture media formulations developed for this microbial detection system, the present study was aimed to evaluate and compare the performance of BacT/Alert® 3D with the pharmacopoeial sterility test. There was no significant difference between the ability of the culture media to allow detection of microbial contamination. However, the rapid sterility testing method allowed a more rapid detection of the challenge microorganisms, which indicates that the system is a viable alternative for assessing the sterility of injectable products.

Validação de metodologia analítica para determinação de endotoxina bacteriana em água para diálise por meio de método cromogênico cinético / Analytical methodology validation for determining the bacterial endotoxin in the dialysis water by means of kinetic chromogenic technique

O nível de endotoxina presente na água tratada para hemodiálise é um importante indicador de qualidade, uma vez que altas concentrações de endotoxina atuam como a principal fonte de inflamação crônica em pacientes submetidos à diálise. Este estudo visa validar o método analítico para determinar quantitativamente a endotoxina bacteriana em amostras de água de hemodiálise pelo método cromogênico cinético e de comparar com o método de coagulação em gel. Os ensaios pelo método de coagulação em gel foram realizados de acordo com a Farmacopeia Brasileira em três amostras de água de hemodiálise. A validação do método cromogênico cinético foi realizada utilizando-se as mesmas amostras por meio de sistema de teste portátil. As médias geométricas das concentrações dos pontos finais obtidos nos testes de confirmação de sensibilidade LAL e de interferência por método de coagulação em gel apresentaram resultado de 0,125 UE/mL. Os resultados obtidos pelo método cromogênico para a recuperação do controle positivo do produto variaram de 89 a 186% e o coeficiente de variação de 2,5 a 18,2%, demonstrando que as amostras não apresentaram interferência. Foram obtidos resultados equivalentes em ambos os métodos, o que permite a implementação do método em laboratórios de saúde pública.

The occurrence of endotoxin in the treated water for hemodialysis is an important indicator of quality, since high concentrations of endotoxin constitute the main source for causing chronic inflammation in patients undergoing dialysis. This study aims at validating the analytical method for determining quantitatively the bacterial endotoxin in hemodialysis water samples. The data from the kinetic chromogenic method were compared with the results obtained from the gel coagulation technique. The gel coagulation assays were performed in three samples of hemodialysis water, according to the Brazilian Pharmacopoeia. The validation of the kinetic chromogenic method was performed using the same samples through the portable test system. The geometric means of the concentrations of the endpoints obtained from the tests for confirming the LAL sensitivity and the interference by gel coagulation method showed a result of 0.125 EU/mL. The results obtained by the chromogenic method for recovering the product positive control varied from 89 to 186% and the coefficient of variation from 2.5 to 18.2%, demonstrating that the samples did not show interference. Equivalent results were obtained in both methods, therefore being viable the implementation of this methodology in the public health laboratories.

Validação de metodologia analítica para determinação de endotoxina bacteriana em água para diálise por meio de método cromogênico cinético / Analytical methodology validation for determining the bacterialendotoxin in the dialysis water by means of kinetic chromogenic technique

O nível de endotoxina presente na água tratada para hemodiálise é um importante indicador dequalidade, uma vez que altas concentrações de endotoxina atuam como a principal fonte de inflamaçãocrônica em pacientes submetidos à diálise. Este estudo visa validar o método analítico para determinarquantitativamente a endotoxina bacteriana em amostras de água de hemodiálise pelo métodocromogênico cinético e de comparar com o método de coagulação em gel. Os ensaios pelo métodode coagulação em gel foram realizados de acordo com a Farmacopeia Brasileira em três amostrasde água de hemodiálise. A validação do método cromogênico cinético foi realizada utilizando-se asmesmas amostras por meio de sistema de teste portátil. As médias geométricas das concentrações dospontos finais obtidos nos testes de confirmação de sensibilidade LAL e de interferência por métodode coagulação em gel apresentaram resultado de 0,125 UE/mL. Os resultados obtidos pelo métodocromogênico para a recuperação do controle positivo do produto variaram de 89 a 186% e o coeficientede variação de 2,5 a 18,2%, demonstrando que as amostras não apresentaram interferência. Foramobtidos resultados equivalentes em ambos os métodos, o que permite a implementação do método emlaboratórios de saúde pública.

The occurrence of endotoxin in the treated water for hemodialysis is an important indicator of quality,since high concentrations of endotoxin constitute the main source for causing chronic inflammationin patients undergoing dialysis. This study aims at validating the analytical method for determiningquantitatively the bacterial endotoxin in hemodialysis water samples. The data from the kineticchromogenic method were compared with the results obtained from the gel coagulation technique.The gel coagulation assays were performed in three samples of hemodialysis water, according to theBrazilian Pharmacopoeia. The validation of the kinetic chromogenic method was performed usingthe same samples through the portable test system. The geometric means of the concentrations ofthe endpoints obtained from the tests for confirming the LAL sensitivity and the interference by gelcoagulation method showed a result of 0.125 EU/mL. The results obtained by the chromogenic methodfor recovering the product positive control varied from 89 to 186% and the coefficient of variationfrom 2.5 to 18.2%, demonstrating that the samples did not show interference. Equivalent results wereobtained in both methods, therefore being viable the implementation of this methodology in the publichealth laboratories.