ISFG: Recommendations on biostatistics in paternity testing

The Paternity Testing Commission (PTC) of the International Society for Forensic Genetics has taken up the task of establishing the biostatistical recommendations in accordance with the ISO 17025 standards and a previous set of ISFG recommendations specific to the genetic investigations in paternity cases. In the initial set, the PTC recommended that biostatistical evaluations of paternity are based on a likelihood ratio principle – yielding the paternity index, PI. Here, we have made five supplementary biostatistical recommendations. The first recommendation clarifies and defines basic concepts of genetic hypotheses and calculation concerns needed to produce valid PIs. The second and third recommendations address issues associated with population genetics (allele probabilities, Y-chromosome markers, mtDNA, and population substructuring) and special circumstances (deficiency/reconstruction and immigration cases), respectively. The fourth recommendation considers strategies regarding genetic evidence against paternity. The fifth recommendation covers necessary documentation, reporting details and assumptions underlying calculations. The PTC strongly suggests that these recommendations should be adopted by all laboratories involved in paternity testing as the basis for their biostatistical analysis.     

ISO Standards Addressing Issues of Bias and Impartiality in Forensic Work

The ISO/IEC 17020 and 17025 standards both include requirements for impartiality and the freedom from bias. Meeting these requirements for implicit cognitive bias is not a simple matter. In this article, we address these international standards, specifically focusing on evaluating and mitigating the risk to impartiality, and quality assurance checks, so as to meet accreditation program requirements. We cover their meaning to management as well as to practitioners, addressing how these issues of impartiality and bias relate to forensic work, and how one can effectively evaluate and mitigate those risks. We then elaborate on specific quality assurance policies and checks and identify when corrective action may be appropriate. These measures will not only serve to meet ISO/IEC 17020 and 17025 requirements, but also enhance forensic work and decision-making.     

The current status of forensic science laboratory accreditation in Europe

Forensic science is gaining some solid ground in the area of effective crime prevention, especially in the areas where more sophisticated use of available technology is prevalent. All it takes is high-level cooperation among nations that can help them deal with criminality that adopts a cross-border nature more and more. It is apparent that cooperation will not be enough on its own and this development will require a network of qualified forensic laboratories spread over Europe. It is argued in this paper that forensic science laboratories play an important role in the fight against crime. Another, complimentary argument is that forensic science laboratories need to be better involved in the fight against crime. For this to be achieved, a good level of cooperation should be established and maintained. It is also noted that harmonization is required for such cooperation and seeking accreditation according to an internationally acceptable standard, such as ISO/IEC 17025, will eventually bring harmonization as an end result. Because, ISO/IEC 17025 as an international standard, has been a tool that helps forensic science laboratories in the current trend towards accreditation that can be observed not only in Europe, but also in the rest of the world of forensic science. In the introduction part, ISO/IEC 17025 states that "the acceptance of testing and calibration results between countries should be facilitated if laboratories comply with this international standard and if they obtain accreditation from bodies which have entered into mutual recognition agreements with equivalent bodies in other countries using this international standard." Furthermore, it is emphasized that the use of this international standard will assist in the harmonization of standards and procedures. The background of forensic science cooperation in Europe will be explained by using an existing European forensic science network, i.e. ENFSI, in order to understand the current status of forensic science in Europe better. The Council of Europe and the European Union approaches to forensic science will also be discussed by looking at the legal instruments and documents published by these two European organizations. Data collected from 52 European forensic science laboratories will be examined and findings will be evaluated from a quality assurance and accreditation point of view. The need for harmonization and accreditation in forensic science will be emphasized. The steps that should be taken at the European level for increasing and strengthening the role of European forensic science laboratories in the fight against crime will be given as recommendations in the conclusion.     

A competence assessment framework for scientific support within policing in England and Wales

The Association of Chief Police Officers commissioned Skills for Justice to develop a competence assessment framework to support police forces' scientific support units evidence the competence of their staff against nationally agreed standards of competence. This will also help forces on their journey towards ISO 17025 and ISO 17020 accreditation. A six point framework has been developed and published and is now being implemented across many forces.     

亲权指数和个体识别似然比计算软件的开发与应用

目的建立计算亲子鉴定亲权指数(PI)和个体识别似然比(LR)的计算软件。方法依据相关行业规范和文献中给出的计算方法,利用计算机语言Visual Basic 6.0编写程序。结果开发出适用于PI和LR的计算软件。结论该计算软件可以帮助工作人员提高计算效率,服务法医物证工作。     

亲权鉴定若干问题综述

对亲权鉴定中遗传标记的研究历史及现状进行了综述，并对国际法医遗传学会亲子鉴定委员会关于DNA生物计算的建议进行了解读。     

从亲子鉴定的问题看标准化规范化管理的重要性

近年来,亲子鉴定技术在我国发展较快,越来越多的人应用这一鉴定手段维护了自己的合法权益.但我们发现,我国目前对鉴定部门的管理却相对滞后,主要表现为实验室缺乏规范化管理、鉴定机构良莠不齐、技术标准不够完备以及缺乏实验室的质量检测体系等.这些问题如不解决,将不适应司法体制改革的趋势,阻碍鉴定技术科学、公正地为司法实践服务.因此,我们呼吁有关部门对这一问题加以重视、加强协作,使科学鉴定早日走上标准化、规范化管理的道路.     

Current status of accreditation for drug testing in hair

At the annual meeting of the Society of Hair Testing in Vadstena, Sweden in 2006, a committee was appointed to address the issue of guidelines for hair testing and to assess the current status of accreditation amongst laboratories offering drug testing in hair. A short questionnaire was circulated amongst the membership and interested parties. Fifty-two responses were received from hair testing laboratories providing details on the amount and type of hair tests they offered and the status of accreditation within their facilities. Although the vast majority of laboratories follow current guidelines (83%), only nine laboratories were accredited to ISO/IEC 17025 for hair testing. A significant number of laboratories reporting that they were in the process of developing quality systems with a view to accrediting their methods within 2-3 years. This study provides an insight into the status of accreditation in hair testing laboratories and supports the need for guidelines to encourage best practice.     

Automated extraction of DNA from reference samples from various types of biological materials on the Qiagen BioRobot EZ1 Workstation

We have validated and implemented a protocol for DNA extraction from various types of biological materials using a Qiagen BioRobot EZ1 Workstation. The sample materials included whole blood, blood from deceased, buccal cells on Omni swabs and FTA Cards, blood on FTA Cards and cotton swabs, and muscle biopsies. The DNA extraction was validated according to EN/ISO 17025 for the STR kits AmpF?STR^® Identifiler^® and AmpF?STR^® Yfiler^® (Applied Biosystems). Of 298 samples extracted, 11 (4%) did not yield acceptable results. In conclusion, we have demonstrated that extraction of DNA from various types of biological material can be performed quickly and without the use of hazardous chemicals, and that the DNA may be successfully STR typed according to the requirements of forensic genetic investigations accredited according to EN/ISO 17025.     

Validation of powder X-ray diffraction following EN ISO/IEC 17025

Powder X-ray diffraction (PXRD) is used widely in forensic science laboratories with the main focus of qualitative phase identification. Little is found in literature referring to the topic of validation of PXRD in the field of forensic sciences. According to EN ISO/IEC 17025, the method has to be tested for several parameters. Trueness, specificity, and selectivity of PXRD were tested using certified reference materials or a combination thereof. All three tested parameters showed the secure performance of the method. Sample preparation errors were simulated to evaluate the robustness of the method. These errors were either easily detected by the operator or nonsignificant for phase identification. In case of the detection limit, a statistical evaluation of the signal-to-noise ratio showed that a peak criterion of three sigma is inadequate and recommendations for a more realistic peak criterion are given. Finally, the results of an international proficiency test showed the secure performance of PXRD.     

The National Ballistics Imaging Comparison (NBIC) project

In response to the guidelines issued by the American Society of Crime Laboratory Directors/Laboratory Accreditation Board (ASCLD/LAB-International) to establish traceability and quality assurance in U.S. crime laboratories, a NIST/ATF joint project entitled National Ballistics Imaging Comparison (NBIC) was initialized in 2008. The NBIC project aims to establish a National Traceability and Quality System for ballistics identifications in crime laboratories within the National Integrated Ballistics Information Network (NIBIN) of the U.S. NIST Standard Reference Material (SRM) 2460 bullets and 2461 cartridge cases are used as reference standards. 19 ballistics examiners from 13 U.S. crime laboratories participated in this project. They each performed 24 periodic image acquisitions and correlations of the SRM bullets and cartridge cases over the course of a year, but one examiner only participated in Phase 1 tests of SRM cartridge case. The correlation scores were collected by NIST for statistical analyses, from which control charts and control limits were developed for the proposed Quality System and for promoting future assessments and accreditations for firearm evidence in U.S. forensic laboratories in accordance with the ISO 17025 Standard.     

MiniFiler及Yfiler试剂盒无创产前亲子鉴定的可能性探究

目的采用Mini Filer~(TM)及YFiler~(TM)试剂盒对孕妇血浆进行STR分型,评估上述试剂盒进行无创产前亲子鉴定的可行性。方法采用Mini Filer~(TM)及YFiler~(TM)试剂盒,对2例成人男性的全血及血浆进行STR分型,评估血浆检材的分型准确率及适用性;对8组已知亲子关系的孕妇家系(4组非父,4组亲父,均为男胎样本)采用Mini Filer~(TM)及YFiler~(TM)试剂盒进行STR分型,对STR分型图谱直接观察,总结归纳孕妇血浆STR图谱的特征,探讨进行无创产前亲子鉴定的可行性。结果血浆检材的STR分型结果与全血STR分型结果 100%一致,且等位基因峰高接近,表明血浆是一类可以进行STR分型的检材;观察8组孕妇血浆检材的STR分型图谱,可获得2~5个可用(含胎儿STR信息)Mini-STR位点,1~8个可用Y-STR位点,且在位点充足的情况下(6个),肯定父权家系可计算累计父权指数达192 653,否定父权家系中有3~7个位点支持否定父权。结论采用Mini Filer~(TM)及Yfiler~(TM)试剂盒对孕妇血浆进行STR分型,存在进行无创产前亲子鉴定的可能性。     

单亲亲子鉴定及其法律问题思考--附275例单亲鉴定分析

目的探讨单亲鉴定及其有关的法律及社会问题. 方法对1998年1月至2002年12月275例单亲鉴定进行回顾分析,对案例的数量、来源、鉴定事由、鉴定结论等作统计分析. 结果单亲鉴定近3年明显增多,占亲子鉴定总数的三成.案例来源以自诉为主,占95.27%.鉴定事由中,怀疑妻子有婚外性关系为主 ,占88.36%.275例单亲鉴定中,排除亲生关系39例,占14.18%.结果表明,非婚生子女只占少数. 结论自诉单亲鉴定存在法律盲区,但在维护家庭稳定具有一定作用.受理单亲鉴定宜取慎重态度,有关的社会及法律问题需要解决.     

The 1998-1999 collaborative exercises and proficiency testing program on DNA typing of the Spanish and Portuguese Working Group of the International Society for Forensic Genetics (GEP-ISFG)

A total of 28 laboratories (labs) submitted results for the 1998 collaborative exercise and the proficiency testing program of the Spanish and Portuguese Working Group of the International Society for Forensic Genetics (GEP-ISFG) group. This number increased to 46 labs in 1999. Six bloodstains were submitted, each one with 200 microl soaked in cotton except the sample no. 6 submitted for DNA quantification which had 2 microl. One of the samples was a mixed stain. A paternity testing case and a criminal case in the 1998 trial (GEP'98) and two paternity testing cases in 1999 (GEP'99) were included and the statistical evaluation of the evidence was requested in both cases. In the GEP'99 trial, a theoretical paternity testing case was included. A total of 52 DNA genetic markers were used by the participants in the GEP'98 trial, which increased to 101 in GEP'99. Despite this increasing number of participating labs, results remained quite satisfactory. All the labs used PCR-based DNA polymorphisms with an increasing number of markers, obtaining good results. SLPs were used by a decreasing number of labs but the results indicated a good level of expertise despite the different protocols used.Good results were also obtained for mtDNA despite the difficulties presented by the samples due to the presence of length heteroplasmy in some samples in both trials. The detection of heteroplasmy should, however, be improved.Similar conclusions were reached for both, the paternity and the criminal case by all the labs. Common methodologies for the statistical evaluation of the paternity case were used and the paternity index and the probability of paternity (with an a priori value of 0.5) reported by most of the labs. Also, a great uniformity was found in the evaluation of the criminal case despite the lack of a specific hypothesis in the design of the exercise. Some errors in statistical programs or in calculations were detected in a theoretical paternity case included in the GEP'99 trial for statistical analysis.     

Study on the standard components of digital forensics laboratory

Recently, digital forensics has become increasingly important as it is used by investigation agencies, corporate, and private sector. To supplement the limitations of evidence capacity and be recognized in court, it is essential to establish an environment that ensures the integrity of the entire process ranging from collecting and analyzing to submitting digital evidence to court. In this study, common elements were extracted by comparing and analyzing ISO/IEC 17025, 27001 standards and Interpol and Council of Europe (CoE) guidelines to derive the necessary components for building a digital forensic laboratory. Subsequently, based on 21 digital forensic experts in the field, Delphi survey and verifications were conducted in three rounds. As a result, 40 components from seven areas were derived. The research results are based on the establishment, operation, management, and authentication of a digital forensics laboratory suitable for the domestic environment, with added credibility through collection of the opinions of 21 experts in the field of digital forensics in Korea. This study can be referred to in establishing digital forensic laboratories in national, public, and private digital forensic organizations as well as for employing as competency measurement criteria in courts to evaluate the reliability of the analysis results.     

Medical devices; patient examination and surgeons' gloves; test procedures and acceptance criteria. Final rule

The Food and Drug Administration (FDA) is issuing a final rule to improve the barrier quality of medical gloves marketed in the United States. The rule will accomplish this by reducing the current acceptable quality levels (AQLs) for leaks and visual defects observed during FDA testing of medical gloves. By reducing the AQLs for medical gloves, FDA will also harmonize its AQLs with consensus standards developed by the International Organization for Standardization (ISO) and ASTM International (ASTM).     

Automated washing of FTA Card punches and PCR setup for reference samples using a LIMS-controlled Sias Xantus automated liquid handler

We have implemented and validated automated methods for washing FTA Card punches containing buccal samples and subsequent PCR setup using a Sias Xantus automated liquid handler. The automated methods were controlled by worklists generated by our LabWare Laboratory Information Management System (LIMS). The protocols were validated according to EN/ISO 17025 for use with STR amplifications kits AmpF?STR^® Identifiler^® and Y-filer^® (Applied Biosystems).     

双亲皆疑亲子鉴定STR分型亲权指数计算方法探讨

计算标准三联体亲子鉴定的PI值及探讨双亲皆疑亲子鉴定PI值计算的可靠方法 ,对常规STR分型鉴定结果 ,根据Eseen M ller计算理论 ,总结出标准三联体亲子鉴定计算PI值的 4个公式 :1/ p ,1/ ( 2 p) ,1/ (p +q) ,1/ ( 2p +2 q)。提出适用于双亲皆疑亲子鉴定的一种新的PI值计算方法 ,并与其他方法进行比较。认为该方法取值Y时 ,既考虑随机男女生孩子的可能性 ,也考虑假设父 (或假设母 )与随机个体生孩子的可能性 ,更符合随机原则。     

Autosomal and Y-STR mutations in Lithuanian population

The new approach is given in this work combines autosomal and Y-chromosomal short tandem repeats (STRs) data in paternity testing with father/son pairs taking into account mutation events. Our results show that Y-STRs can identify nonpaternity cases with high accuracy but need to be validated with autosomal STR to establish paternity. Autosomal and Y-STR mutations give disputing questions in paternity testing as well.     

Identifiler^TM系统在亲子鉴定中的应用评估

目的评估Identifiler^TM系统15个短串联重复序列（STR）基因座在亲子鉴定中的检验能力。方法用Identifiler^TM系统检测3277例亲子鉴定案例,观测和分析该系统在亲子鉴定中的排除能力及基因突变率。结果累积非父排除率为0．999998827,累积个体识别能力为0．99999999999999998。3277例亲子鉴定中有2863例认定亲权关系,347例排除亲权关系;观察到65例中有1个STR基因座发生突变,2例中有2个STR基因座发生突变。结论Identifiler^TM体系应用于亲子鉴定是高效、可靠的。