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Results of Colombian exercise interlaboratory quality control 2012
Forensic Science International: Genetics Supplement Series 4 (2013) e158–e159
Contents lists available at ScienceDirect
Forensic Science International: Genetics Supplement Series journal homepage: www.elsevier.com/locate/FSIGSS
Results of Colombian exercise interlaboratory quality control 2012 J.J. Builes a,b,*, J.F. Castro a,b, C.M. Velilla a,c, A. Manrique a,b, D.P. Aguirre a, L. Mendoza a,d, M.L.J. Bravo a, L. Gusma˜o e a
Laboratorio GENES Ltda, Medellı´n, Colombia Instituto de Biologı´a, Universidad de Antioquia, Medellı´n, Colombia c Universidad CES, Medellı´n, Colombia d Universidad Pontificia Bolivariana, Medellı´n, Colombia e IPATIMUP, Institute of Molecular Pathology and Immunology of the University of Porto, Portugal b
A R T I C L E I N F O
A B S T R A C T
Article history: Received 27 August 2013 Accepted 2 October 2013
Participation in interlaboratory quality control exercises is one of the main mechanisms currently used for quality assurance and continuous improvement of the trials. The objective of this study was to design, to manage and to evaluate the Colombian Exercise Interlaboratory Quality Control 2012 (CEIQC-2012). The CEIQC-2012 included both practical and theoretical exercises. For practical exercise three samples were provided, two from blood and one from buccal swab, all on FTA cards, participants were requested to process the samples according to the methods and the markers used routinely in their own laboratories. For theoretical section four exercises were sent, and only one was mandatory, the remain have different degrees of difficulty and were optional. In the mandatory exercise, the participants were asked to calculate the partial and total IP of 15 autosomal STRs markers of an alleged father and a son. This exercise involved 28 laboratories from 6 Latin American and Caribbean countries (Brazil, Ecuador, Peru, Panama, Dominican Republic and Colombia), all reported results for the theoretical mandatory and 27 for the practical. Fifty-four STR markers distributed in autosomal, Y and X chromosomes were under consensus. The Proficiency Test conducted through the Colombian National Reference Laboratory has become a useful tool for quality assurance of all Colombian laboratories and some of Latin America and Caribbean that perform DNA testing to establish biological relationships. This exercise is also an excellent opportunity for constant experts training in the region. ß 2013 Elsevier Ireland Ltd. All rights reserved.
Keywords: Quality control exercise Interlaboratory comparison Colombia Latin America and the Caribbean Genes Ltda
1. Introduction Interlaboratory comparisons are used by large number of purposes, for the users of the laboratory by regulatory authorities and by the laboratories themselves to control the quality of their essays. The use of this interlaboratory comparisons has increased worldwide because many laboratories must be accredited as the Paternity Testing Commission (PTC) of the ISFG recommended according to the standards of ISO 17025, which specifies the general requirements for laboratories to be competent to perform paternity testing [1]. Genes Ltda, acting as the National Reference Laboratory, has coordinated the implementation of Colombian Exercise Interlaboratory Quality Control (CEIQC) between 2008 and 2012 for laboratories carrying out tests for paternity, maternity and forensic
* Corresponding author at: Carrera 48 # 10–45, Cons. 611–612, Medellı´n, Colombia. Tel.: +57 4 268 48 75; fax: +57 4 3185270. E-mail addresses: [email protected], [email protected] (J.J. Builes). 1875-1768/$ – see front matter ß 2013 Elsevier Ireland Ltd. All rights reserved. http://dx.doi.org/10.1016/j.fsigss.2013.10.082
analysis of DNA markers [2,3]. In this paper we report the results for the year 2012 involving 28 laboratories in 6 countries of Latin America and the Caribbean: Brazil, Ecuador, Panama, Peru, Dominican Republic and Colombia. 2. Materials and methods The National Reference Laboratory of Colombia sent an e-mail invitation to participate in the CEIQC-2012 to all laboratories that had participated in previous years and other new laboratories that had expressed interest in participate. This invitation included conditions, costs and record format. Subsequently, the samples, the format for submission of results, a tutorial with instructions on how to report the results, the activities scheduled with dates for sending, reporting results, and conditions of evaluation and assessment of results were sent to all laboratories registered to participate. The CEIQC-2012 consisted of two sections: one practical and one theoretical. For the practical section were sent to all participating laboratories two spots of blood and a stain smear
J.J. Builes et al. / Forensic Science International: Genetics Supplement Series 4 (2013) e158–e159
e159
Table 1 List of genetic markers under consensus. F13A01 F13B FES/FPS LPL CSF1PO TH01
TPOX VWA FGA PENTA D PENTA E ACTBP2(SE33)
D1S1656 D2S1338 D2S441 D3S1358 D5S818 D7S820
D8S1179 D10S1248 D12S391 D13S317 D16S539 D18S51
D19S433 D21S11 D22S1045 DYS19 DYS385 DYS389 I
of buccal cell, all on FTA cards, to be genotyped with DNA markers according to the methods of each laboratory. For theoretical section were sent four cases with different degrees of complexity, three cases were optional and one case was mandatory. In the latter case were sent genetic profiles of an alleged father and son for 15 STRs, was provided a database of allele frequencies for biostatistical calculations of partial and total IP. For the three nonobligatory theoretical cases, were sent 4 STRs typing to calculate the LR or Biological Relationship Index (BRI) in each case. Consensus is established with a minimum of three [5] laboratories that send results for each marker. But, the final result must match in 70% of the laboratories that send results in each marker. For analysis of the results were taken into account the findings from previous years [2,3] and the recommendations of both the ISFG [4] and the GHEP-ISFG [5].
DYS389 II DYS390 DYS391 DYS392 DYS393 DYS437
DYS438 DYS439 DYS448 DYS456 DYS458 DYS635
GATA H4.1 DXS6809 DXS7423 GATA172D05 DXS6789 DXS9902
DXS7132 GATA31E08 DXS7133 DXS9898 DXS8378 AMELOGENIN
values. For Exercises Optional, sixteen laboratories reported results for the # 1, eighteen for # 2 and twenty-one for the # 3. The National Reference Laboratory in 2012 organized a meeting in San Andres Island – Colombia to discuss the results of this exercise and perform the XVII Conference of the Spanish Portuguese-Speaking Group of the International Society of Forensic Genetics (GHEP-ISFG). 4. Conclusion The Proficiency Test conducted through the Colombian National Reference Laboratory has become a useful tool for quality assurance of all Colombian laboratories and some of Latin America and Caribbean that perform DNA testing to establish biological relationships. This exercise is also an excellent opportunity for constant experts training in the region.
3. Results and discussion Conflict of interest Twenty-eight laboratories have participated in 2012. From the 2089 genotypes reported by 27 participating laboratories in 2012, fifty-four markers were under consensus and distributed in autosomal, Y and X chromosomes STR (Table 1); only two laboratories analyzed mitochondrial DNA. 4.66% was the total error rate found in the practical exercise of 2012, discriminated by 0.74% genotyping errors, by 0.42% in reporting errors, attributed to marker Amelogenin, and 3.51% in the absence of report genotypes required due mainly to two laboratories that reported partial profiles for the sample of buccal cells (M3). The 28 participating laboratories reported results for the obligatory exercise. Twenty-three laboratories reported the correct values of the partial IP for all markers, five laboratories reported wrong the values of all partial IP, and three laboratories reported incorrect partial IP values for at least one marker. With respect to total IP value, 22 laboratories reported it correctly, three laboratories reported it inappropriately and three had incorrect
None. References [1] N. Morling, R.W. Allen, A. Carracedo, H. Geada, F. Guidet, C. Hallenberg, W. Martin, W.R. Mayr, B. Olaisen, V.L. Pascali, P.M. Schneider, Paternity Testing Commission of the International Society of Forensic Genetics: recommendations on genetic investigations in paternity cases, Forensic Science International 129 (2002) 148–157. [2] J.J. Builes, D. Aguirre, A. Manrique, et al., Results of the 2008 Colombian paternity testing quality control exercise, Forensic Science International: Genetics Supplement Series 2 (December) (2009) 93–94. [3] J.J. Builes, D. Aguirre, A. Manrique, et al., Colombian results of the interlaboratory Quality Control Exercise 2009–2010, Forensic Science International: Genetics Supplement Series 3 (2011) e57–e58. [4] D.W. Gjertson, C.H. Brenner, M.P. Baur, et al., ISFG: recommendations on biostatistics in paternity testing, Forensic Science International: Genetics 1 (3) (2007) 223–231. [5] J. Go´mez, J. Garcı´a-Hirschfeld, O. Garcı´a, et al., GEP proficiency testing program in forensic genetics: 10 years of experience, International Congress Series 1261 (2004) 124–126.
Contents lists available at ScienceDirect
Forensic Science International: Genetics Supplement Series journal homepage: www.elsevier.com/locate/FSIGSS
Results of Colombian exercise interlaboratory quality control 2012 J.J. Builes a,b,*, J.F. Castro a,b, C.M. Velilla a,c, A. Manrique a,b, D.P. Aguirre a, L. Mendoza a,d, M.L.J. Bravo a, L. Gusma˜o e a
Laboratorio GENES Ltda, Medellı´n, Colombia Instituto de Biologı´a, Universidad de Antioquia, Medellı´n, Colombia c Universidad CES, Medellı´n, Colombia d Universidad Pontificia Bolivariana, Medellı´n, Colombia e IPATIMUP, Institute of Molecular Pathology and Immunology of the University of Porto, Portugal b
A R T I C L E I N F O
A B S T R A C T
Article history: Received 27 August 2013 Accepted 2 October 2013
Participation in interlaboratory quality control exercises is one of the main mechanisms currently used for quality assurance and continuous improvement of the trials. The objective of this study was to design, to manage and to evaluate the Colombian Exercise Interlaboratory Quality Control 2012 (CEIQC-2012). The CEIQC-2012 included both practical and theoretical exercises. For practical exercise three samples were provided, two from blood and one from buccal swab, all on FTA cards, participants were requested to process the samples according to the methods and the markers used routinely in their own laboratories. For theoretical section four exercises were sent, and only one was mandatory, the remain have different degrees of difficulty and were optional. In the mandatory exercise, the participants were asked to calculate the partial and total IP of 15 autosomal STRs markers of an alleged father and a son. This exercise involved 28 laboratories from 6 Latin American and Caribbean countries (Brazil, Ecuador, Peru, Panama, Dominican Republic and Colombia), all reported results for the theoretical mandatory and 27 for the practical. Fifty-four STR markers distributed in autosomal, Y and X chromosomes were under consensus. The Proficiency Test conducted through the Colombian National Reference Laboratory has become a useful tool for quality assurance of all Colombian laboratories and some of Latin America and Caribbean that perform DNA testing to establish biological relationships. This exercise is also an excellent opportunity for constant experts training in the region. ß 2013 Elsevier Ireland Ltd. All rights reserved.
Keywords: Quality control exercise Interlaboratory comparison Colombia Latin America and the Caribbean Genes Ltda
1. Introduction Interlaboratory comparisons are used by large number of purposes, for the users of the laboratory by regulatory authorities and by the laboratories themselves to control the quality of their essays. The use of this interlaboratory comparisons has increased worldwide because many laboratories must be accredited as the Paternity Testing Commission (PTC) of the ISFG recommended according to the standards of ISO 17025, which specifies the general requirements for laboratories to be competent to perform paternity testing [1]. Genes Ltda, acting as the National Reference Laboratory, has coordinated the implementation of Colombian Exercise Interlaboratory Quality Control (CEIQC) between 2008 and 2012 for laboratories carrying out tests for paternity, maternity and forensic
* Corresponding author at: Carrera 48 # 10–45, Cons. 611–612, Medellı´n, Colombia. Tel.: +57 4 268 48 75; fax: +57 4 3185270. E-mail addresses: [email protected], [email protected] (J.J. Builes). 1875-1768/$ – see front matter ß 2013 Elsevier Ireland Ltd. All rights reserved. http://dx.doi.org/10.1016/j.fsigss.2013.10.082
analysis of DNA markers [2,3]. In this paper we report the results for the year 2012 involving 28 laboratories in 6 countries of Latin America and the Caribbean: Brazil, Ecuador, Panama, Peru, Dominican Republic and Colombia. 2. Materials and methods The National Reference Laboratory of Colombia sent an e-mail invitation to participate in the CEIQC-2012 to all laboratories that had participated in previous years and other new laboratories that had expressed interest in participate. This invitation included conditions, costs and record format. Subsequently, the samples, the format for submission of results, a tutorial with instructions on how to report the results, the activities scheduled with dates for sending, reporting results, and conditions of evaluation and assessment of results were sent to all laboratories registered to participate. The CEIQC-2012 consisted of two sections: one practical and one theoretical. For the practical section were sent to all participating laboratories two spots of blood and a stain smear
J.J. Builes et al. / Forensic Science International: Genetics Supplement Series 4 (2013) e158–e159
e159
Table 1 List of genetic markers under consensus. F13A01 F13B FES/FPS LPL CSF1PO TH01
TPOX VWA FGA PENTA D PENTA E ACTBP2(SE33)
D1S1656 D2S1338 D2S441 D3S1358 D5S818 D7S820
D8S1179 D10S1248 D12S391 D13S317 D16S539 D18S51
D19S433 D21S11 D22S1045 DYS19 DYS385 DYS389 I
of buccal cell, all on FTA cards, to be genotyped with DNA markers according to the methods of each laboratory. For theoretical section were sent four cases with different degrees of complexity, three cases were optional and one case was mandatory. In the latter case were sent genetic profiles of an alleged father and son for 15 STRs, was provided a database of allele frequencies for biostatistical calculations of partial and total IP. For the three nonobligatory theoretical cases, were sent 4 STRs typing to calculate the LR or Biological Relationship Index (BRI) in each case. Consensus is established with a minimum of three [5] laboratories that send results for each marker. But, the final result must match in 70% of the laboratories that send results in each marker. For analysis of the results were taken into account the findings from previous years [2,3] and the recommendations of both the ISFG [4] and the GHEP-ISFG [5].
DYS389 II DYS390 DYS391 DYS392 DYS393 DYS437
DYS438 DYS439 DYS448 DYS456 DYS458 DYS635
GATA H4.1 DXS6809 DXS7423 GATA172D05 DXS6789 DXS9902
DXS7132 GATA31E08 DXS7133 DXS9898 DXS8378 AMELOGENIN
values. For Exercises Optional, sixteen laboratories reported results for the # 1, eighteen for # 2 and twenty-one for the # 3. The National Reference Laboratory in 2012 organized a meeting in San Andres Island – Colombia to discuss the results of this exercise and perform the XVII Conference of the Spanish Portuguese-Speaking Group of the International Society of Forensic Genetics (GHEP-ISFG). 4. Conclusion The Proficiency Test conducted through the Colombian National Reference Laboratory has become a useful tool for quality assurance of all Colombian laboratories and some of Latin America and Caribbean that perform DNA testing to establish biological relationships. This exercise is also an excellent opportunity for constant experts training in the region.
3. Results and discussion Conflict of interest Twenty-eight laboratories have participated in 2012. From the 2089 genotypes reported by 27 participating laboratories in 2012, fifty-four markers were under consensus and distributed in autosomal, Y and X chromosomes STR (Table 1); only two laboratories analyzed mitochondrial DNA. 4.66% was the total error rate found in the practical exercise of 2012, discriminated by 0.74% genotyping errors, by 0.42% in reporting errors, attributed to marker Amelogenin, and 3.51% in the absence of report genotypes required due mainly to two laboratories that reported partial profiles for the sample of buccal cells (M3). The 28 participating laboratories reported results for the obligatory exercise. Twenty-three laboratories reported the correct values of the partial IP for all markers, five laboratories reported wrong the values of all partial IP, and three laboratories reported incorrect partial IP values for at least one marker. With respect to total IP value, 22 laboratories reported it correctly, three laboratories reported it inappropriately and three had incorrect
None. References [1] N. Morling, R.W. Allen, A. Carracedo, H. Geada, F. Guidet, C. Hallenberg, W. Martin, W.R. Mayr, B. Olaisen, V.L. Pascali, P.M. Schneider, Paternity Testing Commission of the International Society of Forensic Genetics: recommendations on genetic investigations in paternity cases, Forensic Science International 129 (2002) 148–157. [2] J.J. Builes, D. Aguirre, A. Manrique, et al., Results of the 2008 Colombian paternity testing quality control exercise, Forensic Science International: Genetics Supplement Series 2 (December) (2009) 93–94. [3] J.J. Builes, D. Aguirre, A. Manrique, et al., Colombian results of the interlaboratory Quality Control Exercise 2009–2010, Forensic Science International: Genetics Supplement Series 3 (2011) e57–e58. [4] D.W. Gjertson, C.H. Brenner, M.P. Baur, et al., ISFG: recommendations on biostatistics in paternity testing, Forensic Science International: Genetics 1 (3) (2007) 223–231. [5] J. Go´mez, J. Garcı´a-Hirschfeld, O. Garcı´a, et al., GEP proficiency testing program in forensic genetics: 10 years of experience, International Congress Series 1261 (2004) 124–126.