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OBJECTIVE To provide a reference for improving the relevant standard operating procedures （SOP） and biological sample management in drug clinical trials. METHODS According to Good Clinical Practice， Data On-site Verification Points of Drugs Clinical Trials， Human Genetic Resources Management Regulations Implementation Rules， Qualification Examination Rules of Drug Clinical Trials Institution， based on the experience of managing clinical trials programs， the irregularities in biological samples management were analyzed by using statistical quality control tables and protocol deviation （PD） reported by sponsors， in the context of the quality control of drug clinical trials projects managed by the author from July 2016 to May 2023. The precautions in various aspects of sample management were put forward. RESULTS & CONCLUSIONS A total of 101 biospecimen- related irregularities were found in the 60 drug clinical trials projects. Biological sample collection， preservation， and handling were the aspects with the highest incidence of irregular operations in biological sample management， accounting for 37.62%， 25.74%， and 21.78%， respectively. Regulating the management of biospecimens requires multiple efforts. The institutional office and the ethics committee carefully reviewed the consistency of the protocols， informed consent， and genetic office application involving biospecimen collection and handling when the project was initiated. Institutional office quality controllers should pay attention to the attendance and training of authorized personnel at project initiation. The principal investigator， research nurse， collector， handler， transporter， relevant personnel of the central laboratory， and institutional office quality controller have their roles during the project implementation phase. On this basis， all parties involved in the management of biological samples should do a good job of effective communication， find problems and report them in time， and conduct special studies on key aspects.
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Plastic products are widely used in various fields, and the discarded plastics in the environment can be degraded into microplastics (MPs) or even nanoplastics (NPs), which significantly increases the risk of organism exposure. MPs/NPs have been found in aquatic organisms, birds of prey, and even humans. The detection of plastic particles in biological samples is more complicated than that in environmental samples. Biological samples are mainly composed of various organic substances such as proteins and lipids, which makes the pretreatment process particularly critical. Effective detection and accurate quantification of MPs/NPs are crucial to health risk assessment. In this paper, the exposure levels and composition of MPs/NPs in different tissues and organs of the human body, aquatic organisms, and birds of prey were reviewed. The digestion of biological samples (acids, bases, enzymes, and hydrogen peroxide digestion protocols) and MPs/NPs identification methods (spectroscopy and chromatography) were compared and their advantages and disadvantages were assessed, providing a methodological basis for plastic exposure risk assessment and pollution control.
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With the rapid development of clinical trials, the relevant medical research and molecular detection based on biological samples are closely related to the progress of clinical trials, making the role of biological samples in clinical trials increasingly obvious. The standardized supervision mode of biological samples is an important prerequisite for carrying out high-quality clinical trials. Although the laws and regulations related to clinical trials are becoming more and more perfect, there are still a large number of adverse events related to biological samples, which seriously affects the progress and results of clinical trials, and is one of the important challenges currently facing. Therefore, it is urgent to enhance the supervision of biological samples and improve the management methods of biological samples in clinical trials at this stage. Through in-depth discussion of the current status of biological sample management in clinical trials at home and abroad, this paper analyzed the issues existed during the supervision of biological samples, and supplemented the biological sample management methods by further combing the existing relevant laws and regulations and the Guidelines for the Ethical Management of Biological Samples in Clinical Trials, with a view to providing suggestions and ideas for optimizing the management mode of biological samples in clinical trials.
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At the end of February 2023, the new Notice on the Issuance of Ethical Review Measures for Life Science and Medical Research Involving Humans was issued by the National Health Commission, the Ministry of Education, the Ministry of Science and Technology, and the State Administration of Traditional Chinese Medicine. It adheres to the basic principles and institutional framework of the Ethical Review Measures for Biomedical Research Involving Humans , and combines with the actual situation of domestic ethical work to optimize and improve the details and procedures of the review. Based on the Ethical Review Measures for Biomedical Research Involving Humans, the Ethical Review Measures for Life Science and Medical Research Involving Humans have expanded the scope of application of ethical review. Different experts in the field have discussed in detail the changes in the scope of review, and proposed review procedures that may need to be corresponding adjustments based on the changes for the readers’ reference.
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Liquid-phase microextraction is a novel pretreatment technique for biological samples developed on the basis of liquid-phase extraction technology, which is simple, rapid, economical, and environmentally friendly, and has been widely used in the analysis of biological matrix samples such as blood, urine, and saliva. In this paper, we review the basic principles of the main modes of liquid-phase microextraction techniques, i.e., single-drop microextraction, dispersive liquid-liquid microextraction, and hollow-fiber liquid-phase microextraction, and the progress of their applications in biological sample pretreatment by reviewing the literature in the past five years, with a view to providing technical support and reference for sample pretreatment in the fields of in vivo drug analysis, pharmacokinetic studies and new drug development.
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Resumen Los biobancos son infraestructuras multidisciplinares y esta investigación integradora pretende exponer su concepto a las diferentes ciencias que lo construyen e interpretan, para entender sus elementos esenciales de forma holística. La revisión integradora se realizó siguiendo la guía PRISMA y la evaluación de la calidad según CASPe dando como resultado un total de 30 trabajos. El análisis de los datos se realizó a través de las categorías aristotélicas y los resultados se interpretaron según el paradigma de la complejidad de Edgar Morin. El concepto de Biobanco fue aclarado al considerarlo como la representación de un fenómeno bio-socio-cultural en el que los campos científicos desarrollan relaciones de tipo: complementarias, antagónicas y ambiguas de conocimientos y prácticas. Esta red de significación, desde la filosofía, impacta en la construcción de la subjetividad y en las formas de socialización.
Abstract Biobanks are multidisciplinary infrastructures and, accordingly, this integrative research seeks to bring out the concept of biobank in the various sciences that construct and interpret it, so as to arrive at a holistic understanding of its essential components. This integrative review - guided by PRISMA and with quality assessment following CASPe - resulted in a selection of 30 articles. Data were analysed by Aristotelian categories and the results were interpreted on the complexity paradigm of Edgar Morin. The biobank concept was clarified by considering it to be the representation of a biological, social and cultural phenomenon in which knowledge and practices from diverse scientific fields enter into complementary, antagonistic and ambiguous types of relationship. This network of signification, analysed here using categories from Aristotelian philosophy, has impacts on the construction of subjectivity and forms of socialisation.
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Humans , Philosophy , Biological Specimen BanksABSTRACT
El procedimiento pre-analítico en el laboratorio clínico es un conjunto de pasos que inician a partir de la orden de examen realizada por el médico, verificación de la identificación del paciente, criterios de aceptación y rechazo de la muestra, recolección de la muestra, identificación de la muestra, transporte seguro, en temperatura y tiempo apropiado. Luego ingresan para su preparación, y termina en el momento que se inicie con el análisis de las pruebas. Objetivos: Determinar el cumplimiento del procedimiento pre-analítico que contribuye a la seguridad del paciente en el laboratorio clínico. Método: El presente, es un estudio observacional, de tipo cuantitativo, de alcance descriptivo no experimental, de corte transversal. Resultados: de acuerdo a los resultados obtenidos de 112 muestras, con base a la ficha de observación, se logró evidenciar que ha habido muestras con calidad inadecuada como son las hemolizadas, coagulas y contaminadas. Y por estar en esas condiciones, son rechazadas por el laboratorio clínico, lo que conlleva a que se realice otra toma en el paciente, causando malestar, demora en la entrega de sus resultados e insatisfacción. También se evidencia que las muestras hemolizadas son mayores a las coaguladas y contaminadas. Conclusión: Este estudio ha ayudado a conocer que en los puestos de toma de muestra no se está implementando las normas de calidad para evitar errores que han estado causando malestar en los pacientes. Así como también, los puestos de toma de muestra no disponen de equipos para ayudar a conservar las muestras y trazabilidad de sus análisis(AU)
The pre-analytical procedure in the clinical laboratory is a set of steps that start from the order of examination carried out by the doctor, verification of the patient's identification, criteria for acceptance and rejection of the sample, collection of the sample, identification of the sample, safe transport, at appropriate temperature and time. Then they enter for their preparation, and it ends when the analysis of the tests begins. Objectives: To determine compliance with the pre-analytical procedure that contributes to patient safety in the clinical laboratory. Method: This is an observational, quantitative, descriptive, non-experimental, cross-sectional study. Results: according to the results obtained from 112 samples, based on the observation file, it was possible to show that there have been samples with inadequate quality such as hemolizada, coagulated and contaminated ones. In addition, because they are in these conditions, the clinical laboratory the clinical laboratory rejected them, which leads to another taking in the patient, causing discomfort, delay in the delivery of results and dissatisfaction. It is also evident that hemolizada samples are greater than those that are coagulated and contaminated. Conclusion: This study has helped to know that in the sampling stations not implemented quality standards to avoid errors that have been causing discomfort in patients. As well as, the sampling stations do not have equipment to help conserve the samples their traceability and analyzes(AU)
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Unified Health System , Patient Safety , Patient Care , Methods , Clinical Laboratory Techniques , Equipment and Supplies , LaboratoriesABSTRACT
Objective To analyze the 2496 biological samples collected from 1574 larceny cases and improve the application of DNA in the larceny cases. Methods Make a summary of the biological samples collection methods and DNA test results in different type of larceny cases. Results Touch samples have already become the most common type of biological samples in larceny cases, but their DNA test success rate are still low, more work should be done for the DNA mixed type to improve DNA hit. The DNA positive result rate had statistical difference in biological samples with different collection methods. For the Touch samples, flocked swab and original are the best collection methods. Conclusion More Valuable biological samples collected by the crime scene investigators are the Key factor in improvement of DNA detection capability, awareness of trace biological evidence and the touch sample collection technique are very important for the crime scene investigators.
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Objective To develop a simple and fast UPLC-MS/MS method for determination of aconitine in biological human sample. Methods The biological human sample was treated by acetonitrile precipitation, and then analyzed on a UPLC C18(2.1mm×50mm, 1.7μm)column. The mobile phase consisted of acetonitrile-0.1% formic acid with gradient elution, at a flow rate of 0.4 mL/min, at 40℃. UPLC-MS/MS was performed in ESI source with MRM mode for quantification. Results The linear range of the concentration were 0.5~500ng/mL in blood and 1~1000ng/mL for aconitine in blood for aconitine (r>0.995). The relative recoveries of aconitine were in the range of 91.3%~110.2%, and the extraction recoveries were in the range of 72.8%~83.5%. The RSDs of intra-days and inter-day were both less than 14%. Conclusion The method is a simple, fast and could be used for determination of aconitine in biological human sample.
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OBJECTIVE: To establish a method for detecting the contents of 12 toxic elements such as beryllium,vanadium and thallium in human whole blood,urine and hair by inductively coupled plasma-mass spectrometry( ICP-MS).METHODS: Whole blood( 0.25 mL) and urine( 10.00 mL) were diluted 20 times into suspension by 0.1% TritonX-100 + 0.5% nitric acid,and analyzed by ICP-MS.The hair( 0.20 g) was mixed with nitric acid and digested by microwave,then made up to 10.00 mL with purified water.The analysis was performed by ICP-MS.RESULTS: The linear correlation coefficients of all the 12 elements,such as beryllium,vanadium,chromium,manganese,cobalt,nickel,arsenic,cadmium,tin,antimony,tellurium and lead were≥0.999 5.The detection limit for whole blood and urine was 0.097-1.995 μg/L,and the detection limit for hair was 0.001-0.012 μg/g.The recovery rates for whole blood,urine and hair were 92.3%-105.0%,93.7%-115.5% and 92.5%-111.0%,respectively.The within-run relative standard deviation( RSD) were 0.7%-5.8%,0.8%-4.6% and 2.2%-8.4%,respectively; the between-run RSD were 1.6%-7.1%,3.5%-7.5% and 2.8%-8.8%,respectively.CONCLUSION: This method has good accuracy,high sensitivity and good precision,which is suitable for rapid screening for various elements in human biological samples.
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Objective The magnetic beads direct adsorption method was used to extract the cell-free DNA (cfDNA) from three kinds of human humoral biological samples, including urine, saliva and blood, as to provide a reference for forensic cfDNA research and forensic inspection. Methods The cfDNA was isolated from humoral samples by centrifuging, and the cfDNA was extracted with the method of magnetic beads direct adsorption. Then the samples were sequentially amplified with Identifiler-Plus amplication kit, and the STR genotyping was detected by ABI 3500 Analyzer. Results The cfDNA was detected from all the three kinds of samples. The detection rate of cfDNA from the blood samples was 100%, the saliva was 90%, and the urine was 70%. Conclusion The results suggest that human humoral biological samples contain cfDNA. What's more, the magnetic beads direct adsorption method can be used to extract cfDNA efficiently and conveniently.
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The ablated aerosols of biological matrix sample were studied using 213 nm nanosecond laser ablation system.The stable signal intensity and high sensitivity were obtained when the laser energy was 25%, the spot size was 200 μm, the scan rate was 20 μm/s, the frequency was 20 Hz and the carrier gas was 700 mL He + 700 mL Ar.Relative fractionation index of 56 elements were investigated and 31P as the internal standard element was selected under the optimized laser ablation conditions.The results showed that particle size of the biological sample was 3 μm, which was larger compared with NIST 610 sample.Element fractionation in biological sample was smaller than in glass sample, and relative fractionation index of most elements attained 1.0 ± 0.1.Element fractionation mechanism of biological sample was discussed.The possible reason why the relative fractionation index in biological sample with large particle size did not significantly increase compared to the glass sample is that the 3-μm particles entered into ICP can be atomized.On the other hand, enrichment effect for large ablation particles was relatively small.Further study of the influence factors of fractionation effect indicated that, the fractionation effect had relations with laser ablation energy, laser frequency and scan rate, negatively relation with the oxide boiling point, and positively relation with oxide bond energy and ionization energy.
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Because of the exist of complex matrix, the confirming indicators of qualitative results for toxic substances in biological samples by chromatography-mass spectrometry are different from that in non-biological samples. Even in biological samples, the confirming indicators are different in various application areas. This paper reviews the similarities and differences of confirming indicators for the analyte in biological samples by chromatography-mass spectrometry in the field of forensic toxicological analysis and other application areas. These confirming indicators include retention time （RT）, relative retention time （RRT）, signal to noise （S/N）, characteristic ions, relative abundance of characteristic ions, parent ion-daughter ion pair and abundance ratio of ion pair, etc.
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Chromatography , Forensic Toxicology , Gas Chromatography-Mass Spectrometry , Mass SpectrometryABSTRACT
Biological sample pretreatment is an important step in biological sample analysis. Due to the diversity of biological matrices, the analysis of target substances in these samples presents significant challenges to sample processing. To meet these emerging demands on biopharmaceutical analysis, this paper summarizes several new techniques of on-line biological sample processing: solid phase extraction, solid phase micro-extraction, column switching, limited intake filler, molecularly imprinted solid phase extraction, tubular column, and micro-dialysis. We describe new developments, principles, and characteristics of these techniques, and the application of liquid chromatography-mass spectrometry (LC-MS) in biopharmaceutical analysis with these new techniques in on-line biological sample processing.
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OBJECTIVE:To provide a way to evaluate test capability for biological sample analysis laboratory,so as to im-prove this test quality. METHODS:By analyzing the use of measurement uncertainty in China and detailing the steps of biological sample analysis laboratory measurement uncertainty,the effects of measurement uncertainty on biological sample analysis laborato-ry are illustrated from two aspects of inner and outer quality control. RESULTS & CONCLUSIONS:National laboratories mainly examine the source of uncertainty through establishing mathematical model,and then uncertainty is evaluated. Uncertainty evalua-tion is a continuous process. Uncertainty assessment and assurance is the overall situation in a biological sample analysis laboratory quality control. Thus,biological sample analysis laboratory can find a method of self-testing capabilities by uncertainty evaluation, find the maximum uncertainty and eliminate or reduce it gradually,ultimately improve laboratory testing quality.
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A headspace-solid phase microextraction-gas chromatography-mass spectrometry method（HS-SPME-GC-MS） was adopted for the quantitative study of 4-allylanisole, methyl eugenol, 2,3,5-trimethoxytoluene, 3,4,5-trimethoxytoluene, sarisan, 3,5-dimethoxytoluene and safrole in mice brain, liver tissues and blood after intragastric administration of Asari Radix et Rhizoma. A VF-WAXms (30 m×0.25 mm, 0.25 μm film thickness) capillary column and SPME fiber coated with 65 μm polydimethylsiloxane/divinylbenzene (PDMS/DVB) were used. The calibration curves of seven volatile constituents were established to validate the method's stability (RSD<15%), repeatability (RSD<9.5%), accuracy (RSD<22%), relative recovery (87.0%-108%) and extraction recovery (74.9%-102%). The validated HS-SPME-GC-MS assay was applied to determine the concentrations of seven constituents in liver, brain and blood. The detected contents were 0.22,0.14 μg•g⁻¹,0.25 mg•L⁻¹ (4-allylanisole), 1.1, 0.39 μg•g⁻¹, 0.69 mg•L⁻¹ (methyl eugenol), 0.45, 0.13 μg•g⁻¹, 0.54 mg•L⁻¹ (2,3,5-trimethoxytoluene), 0.51, 0.15 μg•g⁻¹, 0.45 mg•L⁻¹ (3,4,5-trimethoxytoluene), 0.48, 0.039 μg•g⁻¹, 0.69 mg•L ⁻¹ (sarisan), 2.2, 1.2 μg•g⁻¹, 1.5 mg•L⁻¹ (3,5-dimethoxytoluene) and 1.3, 0.67 μg•g⁻¹, 1.1 mg•L⁻¹ (safrole) respectively. This HS-SPME-GC-MS method is rapid and convenient, with a small sample size, and applicable for the analysis and determination of volatile constituents in traditional Chinese medicines, which provides scientific data for further studies on effective substances and toxic substances in Asari Radix et Rhizoma.
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OBJECTIVE: To establish a methodology for determining indium in human whole blood,serum and urine by inductively coupled plasma-mass spectrometry( ICP-MS). METHODS: The whole blood,serum and urine samples were diluted 10 times in 0. 01%( mass fraction) Triton X-100 plus 0. 50%( mass fraction) nitric acid solution,and the indium level was determined by ICP-MS. Rhodium standard solution was used as the internal standard control. RESULTS: The working curve obtained from measurement of whole blood,serum and urine of normal individuals was compared to the standard curve and showed no significant difference in quantitative analysis( P > 0. 05). The linearity range of indium concentration in whole blood,serum and urine was 0. 000-20. 000 μg / L,and all the correlation coefficients were greater than 0. 999 with a detection limit of 0. 144 μg / L. The recovery rates of whole blood,serum and urine were 87. 90%-95. 92%,91. 50%-94. 20% and 90. 40%-96. 57%,respectively. The relative standard deviations( RSDs) of within-run precision were 3. 81%-7. 05%,3. 75%-5. 90% and 4. 31%-6. 62%,respectively. The RSDs of between-run precision were 2. 90%-7. 10%,3. 80%-5. 92% and 4. 16%-5. 94%,respectively. Samples could be stored for at least 14 days under the temperature of- 20 ℃. The indium in whole blood,serum and urine of workers occupationally exposed to indium( exposure group,135 person-time) and control group workers( 120 person-time) were examined. Indium was detected for 17 person-time in whole blood and serum in the exposure group with a detection rate of 1. 26%. Indium was not detected in urine samples in exposure group. It was not detected in all samples in control group. CONCLUSION: This methodology has features of simple operation,high accuracy and good precision,which is suitable for the accurate quantitative analysis of indium in biological samples.
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OBJECTIVE: To review the recent application of ionic liquid in extraction and separation of biological samples.
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Objective: To establish a method for determination of mercury (Hg) and arsenic (As) contents in biological samples. Methods: Biological samples containing Hg were pretreated with digestive agents of HNO3-H2SO4 and that of As with HNO3-HClO4 and HNO3-H2O2 under the pressure of 0.5 MPa,1.0 MPa and 1.5 MPa respectively heated for 2 minutes. And then the concentrations of Hg or As were determined by intermittent flow hydride generation-atomic spectrophotofluorimetry. Results: Recoveries of Hg and As were 97.3 %～99.1 %and 99.4 %～105.7 %respectively. Conclusion: The method is simple, rapid, accurate and sensitivite and with good reproducibility and is suitable for the determination of Hg and As contents in biological samples.