Deutsche Akkreditierungsstelle GmbH German Accreditation Body Annex to the Accreditation Certificate D PL 13372 01 00 according to DIN EN ISO/IEC 17025:2005 Period of validity: 22.05.2014 to 25.03.2017 Holder of certificate: Eurofins Medigenomix GmbH Anzinger Str. 7a, 85560 Ebersberg Tests in the fields: Veterinary Medicine / Pharmaceuticals; Food, Commodities and Animal Feed; Health Care (medical laboratory testing in the context of clinical studies; genetic diagnostics) Testing areas: Genetics (molecular genetics, parentage certificates); food including the necessary raw s, molecular biological testing of pharmaceuticals, human genetic (molecular human genetic) Testing methods: Molecular testing methods (amplification); spectrometry (Mass Spectrometry (MALDI TOF MS)) The laboratory is permitted within the testing area(s) marked with *), without being required to inform and obtain prior approval from DAkkS the modification, development and refinement of test methods. The listed test methods are exemplary. The laboratory maintains a current list of all test methods in a flexible scope of accreditation. This document is a translation. The definitive version is the original German annex to the accreditation certificate. 1/1
Test field: Veterinary Medicine / Pharmaceuticals Testing area: Genetics (molecular genetics, parentage certificates) Sequence specific detection of amplification products, qualitative, by DNA Sequencing SOP_APG_PRPS_5.0 2012 02 Prion protein genotyping in sheep Single plex PCR with PrP gene specific primers. Sequencing of PCR products and sequence comparison Genomic sheep DNA from whole blood or tissue with ovine cell SOP_APG_Species_Qualitativ_ 2.0 2010 07 PCR amplification of species specific gene loci with species specific primers. Sequencing of PCR products and database sequence comparison. Mitochondrial DNA isolated from meat or fish (native or (processed) SOP_APG_Species_Qualitativ_ 2.0 2010 07 SOP_APG_PKD1_5.0 PCR amplification of species specific gene loci with species specific primers. Sequencing of PCR products and database sequence comparison. Detection of Polycystic Kidney Disease in cats PCR amplification of PKD1 gene. Sequencing of PCR products and sequence comparison. Genomic and plastid DNA isolated from animal or plant tissues, fungi or bacteria Genomic cat DNA buccal swabs with feline SOP_APG_SLS_3.0 2010 02 Spider Lamb Syndrome (SLS) genotyping in sheep PCR amplification of FGFR3 gene. Sequencing of PCR products and sequence comparison. Genomic sheep DNA ear tissue with ovine Detection of amplification products by microsatellite analysis (fragment length analysis) SOP_APG_GenoHund_4.0 2012 02, SOP_APG_GenoHund22_2.0 PCR with dog specific micro satellite marker with PCR with 22 In House designed dog specific micro satellite marker. Capillary electrophoresis (CE) of PCR products. Genomic dog DNA buccal scrapes or trace samples with canine Period of validity: 22.05.2014 to 25.03.2017 Translation 2/2
SOP_APG_GenotypKatze_3.0 SOP_APG_GenotypRind_4.0, SOP_APG_MultiQ_3.0 SOP_APG_GenotypPferd_3.0 SOP_APG_GenotypSchaf_2.0 PCR with cat specific micro satellite marker with PCR with cattle specific micro satellite marker with PCR with MultiQ In House designed cattle specific micro satellite marker with subsequent electrophoresis and allelic mapping of PCR products PCR with horse specific micro satellite marker with PCR with sheep specific micro satellite marker with Genomic cat DNA buccal scrapes or trace samples with feline Genomic cattle DNA buccal scrapes or trace samples with bovine Genomic horse DNA hairs or trace samples with equine cell Genomic sheep DNA buccal scrapes or trace samples with ovine Sequence specific detection of amplification products, qualitative, by SNP SOP_APG_ScrapieZiegeLC480_ SNP or Double SNP analysis on Roche Light Cycler 480 3.0 with fluorescence labeled PCR primer and subsequent 2012 07 melting curve analysis Genomic goat DNA isolated from whole blood or ear tissue with ovine cell Test methods: Spectrometry (Mass Spectrometry (MALDI TOF MS)) Matrix Assisted Laser Desorption Ionization Time of Flight Mass Spectrometry (MALDI TOF MS) SOP_P_PRPS_MALDI_V01 2011 03 Genotyping of PRP1 gene in sheep Multiplex PCR with PrP gene specific primer, analysis of five SNP s. Mass spectrometry of PCR products Genomic sheep DNA isolated from whole blood or ear tissue with ovine cell Period of validity: 22.05.2014 to 25.03.2017 Translation 3/3
SOP_APG_PRPZ_MALDI_2.0 2010 02 SOP_APG_Rind_Merial_3.0 2011 04 Genotyping of PRP1 gene in goat Singleplex PCR with PrP gene specific primer, analysis of two SNP s. Mass spectrometry of PCR products Genotyping of cattle for parental or diagnostic tests Single or multiplex PCR with cattle specific primer. Mass spectrometry of PCR products Genomic goat DNA isolated from whole blood or ear tissue with ovine cell Genomic cattle / bovine DNA isolated from whole blood or ear tissue with bovine Testing area: Molecular biological testing of pharmaceuticals Sequence specific detection of amplification products, quantitative, by Real Time PCR SOP_APG_DNAprozProd_1.0 2011 04 Detection of trace amounts of DNA in highly processed sample. Pharmaceutical intermediate and end products Test field: Food, Commodities and Animal Feed Testing area: Food including the necessary raw s Detection of amplification products by microsatellite analysis (fragment length analysis) SOP_P_GenoReis_V05 2009 10 Genotyping of genomic DNA from rice grains by means of microsatellite analyis for determination of purity of variety. (Multiplex PCR with rice specific DNA markers, capillary electrophoresis of PCR products and quantification of allele proportions.) Rice grains and rice flour Period of validity: 22.05.2014 to 25.03.2017 Translation 4/4
Detection of amplification products by sequence analysis SOP_APG_Species_Qualitativ Qualitative species detection in biological sample _V2.0 by DNA sequencing analysis of genomic, 2010 07 mitochondrial, chromosomal, or plastid DNA strands. Comparison of obtained sequence data with data entries in the BLAST data base of the NCBI PV Spezies_Pilz_V01 PV Spezies_16sRNA_V01 PV Spezies_Ente_V01 Detection of fungi in scrapes, food or cultures by DNA double strand sequencing of the 28s Gene. Comparison of obtained Sequence data with data entries in the BLAST Data base of the NCBI. Detection of vertebrates in tissue samples, blood samples, feathers, hairs of animal origin by DNA double strand sequencing of the ribosomal 16s gene Comparison of obtained Sequence data with data entries in the BLAST Data base of the NCBI. Detection of duck in meet by DNA double strand sequencing of thepre proinsulin gene. Comparison of obtained Sequence data with data entries in the BLAST Data base of the NCBI. processed s of animals, plants, fungi or bacteria processed s processed s processed s Sequence specific detection of amplification products, quantitative by RealTime PCR SOP_APG_Species_Quantitati Quantitative species detection in biological sample v_3.0 by DNA sequencing analysis of genomic, 2010 07 mitochondrial, chromosomal, or plastid DNA strands. (RealTime PCR amplification of species specific Gene loci with species specific primer pairs (literature)). PV QuantiSpecies_Rind Schwein_V01 Detection of bovine and pork in blood or meat samples or processed meat products by RealTime PCR analysis. processed s of animals, plants, fungi or bacteria processed s Test field: Healthcare (Medical laboratory testing in the context of clinical studies) Testing area: Human genetic (molecular human genetic) Genotyping of human DNA by PCR and subsequent DNA Sequencing SOP_PGX_GENOTYP_2.0 2012 08 Analysis of genetic variants in human genes by amplification and sequencing of defined gene loci. PV_Genotyp_CYP2D6_chaba_ 4.0 2012 10 Analysis of genetic variants in the human gene CYP2D6 by amplification and sequencing of gene loci chaba. Period of validity: 22.05.2014 to 25.03.2017 Translation 5/5
PV_Genotyp_FCGR2A_FCGR2 A_E04_1.0 Analysis of genetic variants in the human gene FCGR2A by amplification and sequencing of gene loci FCGR2A E04. Genotyping of human DNA by PCR and subsequent fragment length analysis SOP_APG_HSA CAG Analyis of CAG repeats in exon 1 of the human Repeat_1.0 Androgen Receptor by fragment length analysis 2011 11 SOP_APG_RS4795541_1.0 2011 11 SOP_APG_RS57098334_1.0 2011 11 Analysis of humanen SNP RS4795541 by fragment length analysis. Analysis of human SNP RS57098334 by fragment length analysis. Test field: Healthcare (genetic diagnostics) Testing area: Human genetic (molecular human genetic) Genotyping of human DNA by PCR and subsequent DNA Sequencing SOP_SEQ_VR SALC PW Sequencing of DNA by Sanger Sequencing Pipet_1.0 2012 01, SOP_SEQ_E Sequence_VR_4.0 2012 09, SOP_SEQ_Auswertung_1.0 SOP_SEQ_PCRundRe Seq_2.0 2011 01 SOP_SEQ_Bearbeitung PW&GLP_1.0 2011 10, SOP_SEQ_GLP SEQ_5.0 2012 01 PCR amplification and re sequencing (= exon sequencing) Sequencing by primer walking (PW) Plasmid DNA and related constructs. PCR products, cdna Plasmid DNA and related constructs. PCR products, cdna Plasmid DNA and related constructs. PCR products, cdna Period of validity: 22.05.2014 to 25.03.2017 Translation 6/6
SOP_GEN_SampleReceipt_1.0 SOP_GEN_EQC DNA_1.0 SOP_GEN_EQC RNA_3.0 SOP_GEN_SG Illu_1.0 SOP_GEN_mRNA Illu_1.0 SOP_GEN_Pooling+QC_1.0 SOP_GEN_IlluminaSeq_1.0 SOP_GEN_DataManagement_ 1.0 SOP_GEN_DataGeneration_1. 0 SOP_GEN_DataQC_1.0 SOP_GEN_IlluminaRawData_1.0 SOP_GEN_ProjectReport_1.0 SOP_GEN_DataShipment_1.0 SOP_GEN_DiscPublisher_1.0 SOP_GEN_SampleReceipt_1.0 SOP_GEN_EQC DNA_1.0 SOP_GEN_EQC RNA_3.0 SOP_GEN_SG Tit_1.0 SOP_GEN_SG FLX_1.0 SOP_GEN_Pooling+QC_1.0 SOP_GEN_GS454Seq_1.0 SOP_GEN_DataManagement_ 1.0 SOP_GEN_DataGeneration_1. 0 SOP_GEN_DataQC_1.0 SOP_GEN_FLXRawData_1.0 SOP_GEN_ProjectReport_1.0 SOP_GEN_DataShipment_1.0 SOP_GEN_DiscPublisher_1.0 Sequencing by Next Generation Sequencing (NGS) (Illumina) Sequencing by Next Generation Sequencing (NGS) (Roche 454) DNA, RNA DNA, RNA Period of validity: 22.05.2014 to 25.03.2017 Translation 7/7