No abstract

Introduction: One of the major risks associated with drugs and immunobiologicals production is microbial contamination. Therefore, an environmental monitoring program is essential to ensure that aseptic production areas are maintained under appropriate control levels. To be efficient, it must contain an adequate identification level of isolated microorganisms, because the information provided may be extremely relevant in investigating sources of contamination of products or processes. Sporulated Gram-positive rods (SGPR) are among the main contaminant groups of productive clean areas from Bio-Manguinhos in 2016 and 2017. Due to spore resistance, SGPR's are not easily eliminated. SGPR identification by classical methods is particularly difficult because of similarities between closely related species that share the same morphological and biochemical patterns. The pharmaceutical industry has adopted automated identification systems, due to greater rigidity in regulatory requirements, regarding microbial identification. However, many identification systems have databases directed to medical microorganisms, being more limited considering pharmaceutical and industrial environmental microorganisms, which makes it difficult to obtain results at species level. Objective: The aim of this study was to compare three automated methodologies: VITEK® 2 Compact (bioMérieux), VITEK® MS RUO (bioMérieux) and MicroSEQ® Full Gene 16S rDNA (Thermo Fisher Scientific) in SGPR isolated from Bio-Manguinhos productive áreas identification. Methodology: 98 strains of SGPR were isolated from Bio-Manguinhos clean rooms from 2016 to 2017. These strains were analyzed by three different methodologies: biochemical identification by VITEK® 2 Compact; molecular identification through proteome profile analysis generated by VITEK® MS RUO; and molecular identification by sequencing the 16S rDNA gene, through MicroSEQ® Full Gene 16S rDNA kit. Results: For 98 isolates, 45.9% were identified at the species level; 19.4% at the genus level; 21.4% of the results were inconclusive and 13.3% were not identified by VITEK 2. Identification by VITEK® MS RUO showed 26.5% of isolates identified at the species level; 38.8% at the genus level and 34.7% were not identified. Identification by sequencing of the 16S rDNA gene provided 44.6% of the results at the species level; 54.1% at the genus level and 1.3% of the results were inconclusive. Identification by sequencing has not yet been completed. Conclusion: The highest percentage of identified microorganisms was obtained by sequencing the 16S rDNA gene. However, other housekeeping genes should be tested to enhance methodological performance for species-level identification. On the other hand, VITEK MS provides lower time and cost results as long as a robust database based on proteomic spectra is built. By combining the two methodologies, housekeeping genes sequencing enables the identification of SGPR species, whose spectra can be inserted in the database, configuring an effective identification tool in a reduced t...

Psychomotor intervention has been used to promote development by the enhancement of psychomotor and socio-emotional competence. However, studies with high-quality evidence, describing psychomotor-intervention processes and outcomes are scarce. Therefore, we aimed to generate expert consensus regarding psychomotor-intervention guidelines to support psychomotor therapists through the design and implementation of interventions for preschool (3–6 years old) children with autism spectrum disorder (ASD). A formal consensus process was carried out, using modified nominal group (phase I) and Delphi survey (phase II) techniques. We recruited 39 Portuguese experts in psychomotor intervention with preschool children with ASD in phase I. Experts participated in at least one of the five online meetings, discussing themes (e.g., objectives, methods, strategies) concerning psychomotor intervention with preschool children with ASD. A deductive thematic analysis from phase I resulted in 111 statements composing round 1 of the Delphi survey. Thirty-five experts completed round 1, and 23 round 2. The experts reached a consensus (agreement > 75%) on 88 statements, grouped under 16 sections, (e.g., intervention source, general setting, intended facilitation-style), reflecting generic psychomotor-intervention guidelines. Consensus guidelines may be used to support transparent and standard psychomotor interventions, although further studies should be undertaken to determine their efficacy.