Recommended Minimum Criteria For The Validation Of Various -Books Download

Recommended Minimum Criteria for the Validation of Various
26 Mar 2020 | 5 views | 0 downloads | 11 Pages | 654.59 KB

Share Pdf : Recommended Minimum Criteria For The Validation Of Various

Download and Preview : Recommended Minimum Criteria For The Validation Of Various


Report CopyRight/DMCA Form For : Recommended Minimum Criteria For The Validation Of Various



Transcription

All results could be statistically evaluated, Environmental conditions can be taken into consideration. The validation of any new method should examine inter operator variation. Proficiency tests samples should be part of the validation experiments GEDNAP other. For the validation of a specific parameter repeatability at least 5 samples have to be analysed. not including the negative control, After running 5 10 replicate samples for a particular experiment there are diminishing returns to. obtaining additional results The number five is already in use throughout the forensic DNA. community1, When calibration or general performance of equipment is altered due to. maintenance repairs relocation verification of this equipment is necessary. When conducting an internal validation the SWGDAM Revised Validation Guidelines recommend running a. total of at least 50 samples not 50 samples per experiment Debunking Some Urban Legends Surrounding Validation. Within the Forensic DNA Community by John Butler National Institute of Standards and Technology Gaithersburg. Maryland USA Promega Profiles in DNA September 2006. Ref code ENFSI DNA WORKING GROUP Issue No 001 Page 2 11. Definitions cfr SWGDAM revised validation guidelines. Internal validation is conducted by each forensic DNA testing laboratory and is the in. house demonstration of the reliability and limitations of the procedure Prior to using a. procedure for forensic applications a laboratory must conduct internal validation studies. Developmental validation is the demonstration of the accuracy precision and. reproducibility of a procedure by the manufacturer technical organization academic. institution government laboratory or other party Developmental validation must. precede the use of a novel methodology for forensic DNA analysis. Sensitivity The range of DNA quantities able to produce reliable typing results must. cover the range of DNA concentration encountered in the samples to be analysed using. the technique, Specificity indicates to what extend the test is likely to give positive results in the case. that the tested substance is present and negative results in case of absence of the tested. Repeatability is the variation in measurements obtained when one person measures the. same unit with the same measuring equipment, Reproducibility is the variation in average mean measurements obtained when two or.
more people measure the same parts or items using the same measuring technique. Linearity indicates the range over which the output signal strength varies in direct. proportion to the input signal,Profile quality assessment. locus peak balance check the peak balance of heterozygote alleles within a locus. Acceptable inter locus peak balance ratios are 60 for good quality samples. between loci peak balance check the peak balance of alleles between all loci. Acceptable inter loci peak balance ratios are 60 for good quality samples. peak height area equivalent amounts of DNA should at least give equivalent peak. height area using the new regime as the previously used regime. Ref code ENFSI DNA WORKING GROUP Issue No 001 Page 3 11. presumptive test is a test used to determine the biological origin of the trace sample. blood saliva semen, Ref code ENFSI DNA WORKING GROUP Issue No 001 Page 4 11. Presumptive tests, Due to the great variety of presumptive tests available no specific indications are given in this. document Remember that the use of these tests in your laboratory should be validated or verified as. appropriate,Extractions, A new extraction method should be compared with the method already in use in the laboratory for. all the parameters listed below, The validation should include the sample types normally analysed in the laboratory or any new.
sample types intended to be processed with the new method. As the DNA extraction is one of the most important steps for any downstream analysis consideration. should be given to increasing the number of tested samples to reflect the degree of modification of. the current method, It should be verified that comparable quantities of DNA are extracted using both systems and that. DNA profiles of the same or better quality are obtained using the new system. Minimum parameters to be validated,Repeatability 5 replicates of the same sample. Reproducibility 5 replicates of the same sample as in the repeatability test extracted at. another time by another person, Sensitivity limit of detection a series of 5 dilutions tested in three replicates. Yield of DNA use the sensitivity study to compare between replicates and with the previous. technique in use, In addition the following parameters should be considered. Matrix dependence check the influence of the matrix in which the sample is present. Samples of known genotype are examined after contact with a variety of substrates. commonly encountered in forensic cases, Different cell types blood semen epithelial can be tested depending on the.
laboratory s common encountered samples, Ref code ENFSI DNA WORKING GROUP Issue No 001 Page 5 11. DNA Quantification, The aim of the validation of a new DNA quantification system is to establish the optimum DNA. concentration range using the new system to produce good quality DNA profiles. Any commercially available and quantified human control DNA can be used to adjust a system. although any quantification results obtained can only be calculated referring to standard DNA xxx. When changing quantification systems the new system should be compared with the previous. system in order to see if amplification protocols should be modified. Minimum parameters to be validated,Repeatability 5 replicates of the standard DNA. Reproducibility 5 replicates of the standard as in the repeatability test quantified by. another person, Sensitivity limit of detection a series of 5 dilutions tested in three replicates. Determination of the link between quantification results and the genetic profile no. quantification DNA no profile due to a different sensitivity between quantification. and PCR multiplexes or possible inhibition,Other possible parameters.
Sensitivity to inhibitors and degraded DNA, Detection of male female components in mixtures when using human human male. DNA quantification kits,Conservation in time of standards and samples. Ref code ENFSI DNA WORKING GROUP Issue No 001 Page 6 11. PCR Instruments, For a new thermal cycler model it is suggested that a number adapted to the format of the machine. of samples previously profiled are repeated using the kits to be used on the machine The quality of. the resulting DNA profiles is to be equivalent or better than the profiles generated using the current. thermal cycler The selected samples will obviously allow examination of parameters such as. reproducible results including from mixtures and low DNA concentration samples. For a new thermal cycler that is of the same model as others already in use a certificate from the. manufacturer detailing a technical performance check done after installation in the laboratory and. an internal sensitivity homogeneity check would be sufficient. Minimum parameters to be validated, Sensitivity limit of detection a series of dilutions tested in three replicates. Repeatability the three replicates of the same sample distributed over the entire heating. block can be used to evaluate the repeatability, Reproducibility 3 repetitions of the amplification reactions used in the sensitivity test.
Homogeneity of heating block temperature control of the heating block or a comparison. of the replicates allows the evaluation of the homogeneity of the heating block. Ref code ENFSI DNA WORKING GROUP Issue No 001 Page 7 11. New Multiplex Kit, If using a commercially manufactured kit there is no requirement for a developmental validation of. the kit if the validation is published or done by a collaborative exercise e g by ENFSI A. sensitivity and concordance study is recommended for samples that have previously given. acceptable profiles especially for samples with low amounts of DNA. Minimum parameters to be validated,Repeatability 5 replicates of the same sample. Reproducibility 5 replicates of the same sample as in the repeatability test amplified at. another time by another person if manually processed. Sensitivity limit of detection a series of 5 dilutions tested in three replicates. Mixture analysis not necessary if only reference samples are processed with this kit a. series of different laboratory defined mixture ratios should be tested in three replicates. Analysis of peak balance check the peak balance of heterozygote alleles within a locus. and of alleles between all loci Acceptable peak balance ratios are 60 for good quality. Check stutter ratios by calculating the ratio of the stutter peak height or area compared to. the corresponding allele peak height or area In general stutter peaks have to be lower. than the of the allele peak height indicated by the manufacturer of the kit to be ignored. as a biological artefact of the sample, Concordance study a concordance study must be have been done using PCR products. that have previously given full balanced profiles,Other possible parameters. Sensitivity to inhibitors and degraded DNA, Detection of male female components in mixtures when using specific human male DNA.
amplification kits, If deviations from the manufacturers protocol are introduced these deviations should be. Ref code ENFSI DNA WORKING GROUP Issue No 001 Page 8 11. Electrophoresis Equipment, The sensitivity of the new instrument should be at least as good as the sensitivity of the old. instrument and cover the PCR kit working range The lowest concentration of DNA allowing the. operator to obtain a full genetic profile on the new instrument under the standard laboratory. procedures should be equal to or less than that obtained using the old instrument. For a new capillary electrophoresis that is of the same model as others already in use a certificate. from the manufacturer about a technical performance check done after installation in the. laboratory and an internal sensitivity check would be sufficient. Minimum parameters to be validated,Repeatability 5 replicates of the same sample. Reproducibility 5 replicates of the same sample as in the repeatability test run at another. Sensitivity limit of detection a series of 5 dilutions tested in three replicates. Mixture analysis a series of lab defined mixture ratios should be tested in three replicates. Analysis of peak balance check the peak balance of heterozygote alleles within a locus and of. alleles between all loci Acceptable peak balance ratios are 60 for good quality samples. Check stutter ratios by calculating the ratio of the stutter peak height or area compared to the. corresponding allele peak height or area In general stutter peaks have to be lower than the of. the allele peak height indicated by the manufacturer of the kit to be ignored as a biological. artefact of the sample, Precision the precision of the instrument should be such that all measured alleles fall within a. 0 5 bp window around the measured size for the corresponding allele in the allelic ladder. Concordance study a concordance study must be done using PCR products that have. previously given full balanced profiles,Other possible parameters.
Maximum number of runs with capillaries,Storage time of polymer. Ref code ENFSI DNA WORKING GROUP Issue No 001 Page 9 11. New Software, Software eg interpretation software sold by a company or commercially available should undergo. a concordance study with the previously used method Validation data of the software should be. available from the manufacturer, Every change in the system should be validated by a manual visual inspection of the tested. functionality and must be documented, Home made software like macros or calculation sheets should be validated. Parameters to be validated can vary according to the nature of the software should consider the. following aspects,Sample tracking,Data storage and alteration traceability.
Calculation method, Ref code ENFSI DNA WORKING GROUP Issue No 001 Page 10 11. Laboratory automation, For a pipetting robot that replaces manual pipetting for a single laboratory step e g PCR or CE. setup the validation should consider the parameters listed above see laboratory step that will be. automated together with the following, The performance of different robots i e extraction robots should meet the requirements defined by. the laboratory and yield enough DNA for their intended use reference samples crime scene. User programmed protocols e g for pipetting channels or robotic arm displacements should be. tested with every change made to the protocol,Minimum parameters to be validated. Reproducibility across the whole plate, Repeatability dispensing volumes of each pipetting channel should be verified.
Plate homogeneity, Cross contamination tests i e droplet formation or spilling during liquid transfer. Traceability of sample tracking e g sample dispatching protocols between source plate. tubes and destination plate tubes, Different cell types blood semen epithelial can be tested depending on the. laboratory s common encountered samples, Ref code ENFSI DNA WORKING GROUP Issue No 001 Page 11 11.


Related Books

DEPARTMENT OF DEFENSE STANDARD PRACTICE DEPARTMENT OF ...

DEPARTMENT OF DEFENSE STANDARD PRACTICE DEPARTMENT OF

MIL-STD-2401 11 JA.WJARY 1394 Note -The cover page of Ehis standard has been changed for administrativereasons. There are no other changesto this document. DEPARTMENT OF DEFENSE STANDARD PRACTICE DEPARTMENT OF DEFENSE WORLD GEODETIC SYSTEM (W=) AMSC N/A AREA MCGT i3STiWUTWN STATEMENT A. Approved for public release; distribution is unlimited.

Organic Farming Information System - European Commission

Organic Farming Information System European Commission

Regulation (EC) No 834/2007 or produced and certified within the scope of a third country recognised in accordance with Article 33(2) of that Regulation or produced and certified in the Union in accordance with that Regulation (*2). (*1) Commission Regulation (EC) No 1235/2008 of 8 December 2008 laying down detailed rules for implementation of

The Self and Perception 1 Interpersonal Communication: The ...

The Self and Perception 1 Interpersonal Communication The

The Self and Perception 2 Abstract The Self and Perception are key components of the foundation of interpersonal communication. Students new to the communication discipline often have a difficult time understanding these concepts and the value of understanding and practicing them. The following teaching unit is designed to introduce the basics

ANALISIS BANGKITAN DAN TARIKAN PERJALANAN (Studi Kasus ...

ANALISIS BANGKITAN DAN TARIKAN PERJALANAN Studi Kasus

dikeluarkan dan tidak digunakan dalam permodelan. Tarikan Perjalanan di Hari Minggu Tabel 2 di bawah ini merupakan hasil olah data dengan SPSS yang memperlihatkan bahwa terdapat dua variabel bebas yang layak dimasukkan dalam permodelan, berturut-turut dari variabel bebas yang memiliki korelasi lebih kuat terhadap variabel terikat

III PEMODELAN MATEMATIS SISTEM FISIK

III PEMODELAN MATEMATIS SISTEM FISIK

34 III PEMODELAN MATEMATIS SISTEM FISIK Deskripsi : Bab ini memberikan gambaran tentang pemodelan matematis, fungsi alih, diagram blok, grafik aliran sinyal yang berguna dalam pemodelan sistem kendali. Objektif : Memahami bab ini akan mempermudah pembaca untuk memahami prinsip- prinsip pemodelan matematis sistem fisik dari sistem kendali.

VERIFICATION IN CMMI USING PEER REVIEWS

VERIFICATION IN CMMI USING PEER REVIEWS

If you have never participated in a peer review, you may be wondering exactly what a peer review is. Actually, it is likely that you have already participated in many peer reviews without even knowing it. Walking down the hall and asking a co-worker to look at something you have produced is essentially a peer review, boiled down to its simplest ...

www.wellsfargopreforeclosureclassaction.com

www wellsfargopreforeclosureclassaction com

upon by Wells Fargo unenforceable as contrary to Washington State Jaw. Exhibit D. 2 Jordan erodes any purported legal justification for Wells Fargo or its agents' presence on 3 borrowers' properties for the perfonnance of such preservation activities. 4 1.8 However, setting aside the unenforceability of the form deed of trust s provisions, the provisions as written do not pennit Wells Fargo or ...

Blood Vessels of the Skull - Personal Homepage Server

Blood Vessels of the Skull Personal Homepage Server

2 The Meninges The meninges are layers of tissue that separate the skull and the brain. Skull Dura mater Arachnoid Layer Pia Mater Brain Brain Evolution

DIPLOMA IN CIVIL ENGINEERING, CIVIL ENGINEERING ...

DIPLOMA IN CIVIL ENGINEERING CIVIL ENGINEERING

8. Competencies in estimating and costing and contracting of civil works including measurement and billing 9. Knowledge of planning, scheduling, controlling and skill of supervising civil works 10. Skill in managing construction materials, equipment, manpower and cash flow 11. Competencies in maintenance, repairs and upkeep of building 12 ...

Product Installation Manual - HYDRONIC HEATING

Product Installation Manual HYDRONIC HEATING

and Radiant Heating hand tools, a portable table saw, and a pneumatic staple or nail gun. Additional specialized tools may be required for more complex jobs with intricate layouts. Procedure B. Layout each room with equivalent tubing lengths (no more than 250 linear feet max). Be sure not to exceed 250 feet per circuit including runs to and ...