RESUMO
The first step to complete in a method validation of a biological analysis is the study of precision intra-assay. In the absence or insufficient quantity of control material, this study may be difficult to perform. This article proposes a methodology for preparing its own control samples for the radioimmunological assay of the amino-terminal peptide of procollagene type III (PIIIP). This methodology is easy to carry out, cost-effective and can be applied to analyses other than PIIIP. Furthermore, it allows the execution of control samples which have similar concentrations of analytes to those described in the precision studies of the datasheets provided by the manufacturers.
Assuntos
Fragmentos de Peptídeos , Pró-Colágeno , Humanos , RadioimunoensaioRESUMO
The study of the crystalluria is the search and the identification for crystals in urines. This multi-parametric study brings a precious help in the diagnosis and/or the follow-up of acquired or congenital lithiasis. The lack of the internal urinary quality control (IQC) makes the accreditation of this analysis, according to the NF EN ISO 15189 standard, particularly delicate. After a presentation of the three steps (pre-analytical, analytical and post-analytical) performed in the laboratory, the authors present some insights in order to mitigate the lack of the urinary IQC. These insights, particularly concern by the "misappropriation" of IQC, the elaboration of an "in house" IQC as well as by the evaluation of the external evaluation of the quality. Thanks to the implementation of these tools, it becomes easier to prove that the laboratory of medical biology masters the qualification, the authorization and the continuous preservation of the skills of the operators performing the study of the crystalluria.
Assuntos
Laboratórios/normas , Controle de Qualidade , Urinálise/normas , Urolitíase/diagnóstico , Acreditação , Cristalização , França , Humanos , Período Pós-Prandial , Guias de Prática Clínica como Assunto/normas , Fase Pré-Analítica/métodos , Fase Pré-Analítica/normas , Urinálise/métodos , Urolitíase/urinaRESUMO
We are reporting a rare case of foetal trisomy 13 due to a robertsnonian translocation. Further to the study of both parents karyotypes, genetic councelling is advisable in order to assess the potential risk of trisomy that may occur during a future pregnancy.
Assuntos
Cromossomos Humanos Par 13 , Translocação Genética , Síndrome da Trissomia do Cromossomo 13/diagnóstico , Aborto Eugênico , Adulto , Feminino , Humanos , Gravidez , Diagnóstico Pré-Natal , Síndrome da Trissomia do Cromossomo 13/genética , Síndrome da Trissomia do Cromossomo 13/terapiaRESUMO
In the perspective of a future request of accreditation according to the NF EN 15189 standard of the sector of prenatal diagnosis of the trisomy 21 foetal, we compared the results obtained for AFP, hCG, free hCG, PAPP-A and for the risks, according to 2 types of blood collection tubes: sterile tube and sterile tube with inert gel barrier. For 107 patients, the study of the Passing-Bablok regressions between the results from the 2 kinds of tubes, showed perfect correlations for measured biochemical markers (AFP, hCG, free hCG and PAPP-A) as well as for the estimated risks. A patient who presented a higher risk of foetal trisomy 21 (risk at 1/244) for the serum from the sterile tube was not in the high-risk area for the serum from the sterile tube with inert gel barrier (risk at 1/295). The fact that these 2 values of risk are very close to the threshold fixed to 1/250 can probably explain the observed conflict. Working on sterile tube, this study confirms that the requests of prenatal diagnosis of the trisomy 21 foetal taken from tube with inert gel barrier which we receive of outer laboratories.
Assuntos
Síndrome de Down/sangue , Síndrome de Down/diagnóstico , Testes Hematológicos/instrumentação , Diagnóstico Pré-Natal/métodos , Adolescente , Adulto , Feminino , Humanos , Gravidez , Adulto JovemRESUMO
In addition to NF EN ISO 15189, the second version of "GBEA AMP", published in the official journal of the French Republic, had set for "AMP" exams, the actions to be implemented in order to achieve an efficient quality management system. As part of continuous improvement of quality, and besides our external and internal quality systems, we have been developping indicators that will allow an early detection of potential drifts within operators performing sperm morphology testing. We have extracted nearly 1900 sperm morphology tests from our database. These tests were performed by three operators. The analysis of the data collected has shown a cross correlation between the percentages of typical forms, malformative acrosomes and "MAI". We have been using these correlations as quality indicators in our laboratory in order to highlight any potential drift in reading sperm morphology tests.
Assuntos
Acrossomo/patologia , Indicadores Básicos de Saúde , Infertilidade Masculina/diagnóstico , Análise do Sêmen/métodos , Contagem de Espermatozoides/estatística & dados numéricos , Espermatozoides/anormalidades , Espermatozoides/patologia , Forma Celular , Interpretação Estatística de Dados , Feminino , Humanos , Infertilidade Masculina/etiologia , Infertilidade Masculina/patologia , Infertilidade Masculina/terapia , Masculino , Variações Dependentes do Observador , Gravidez , Controle de Qualidade , Técnicas de Reprodução Assistida/estatística & dados numéricos , Análise do Sêmen/estatística & dados numéricos , Contagem de Espermatozoides/métodos , Espermatozoides/citologiaRESUMO
BACKGROUND: The objective of this study was to establish for the first time reference levels of sperm malondialdehyde, a stable lipid peroxidation product, in a cohort of fertile men. METHODS: Sperm malondialdehyde, a thiobarbituric acid-reactive substance, was assayed using the 2-thiobarbituric acid method. RESULTS: Sperm malondialdehyde levels, expressed in nM/10(8) spermatozoa, were normally distributed in our cohort of fertile men and averaged 0.0287 +/- 0.0162 (mean +/- S.D.). CONCLUSIONS: Given the impact of lipid peroxidation on spermatozoa and thereby on male fertility, the assay of sperm membrane thiobarbituric acid-reactive substance is clearly of interest. Malondialdehyde levels found in our study form a basis for normal values of sperm thiobarbituric acid-reactive substance observed in the semen of fertile men.