Developmental validation of the Huaxia™ Platinum PCR amplification kit: A 6-dye multiplex direct amplification assay designed for Chinese reference samples

Zhong, Chang; Gopinath, Siddhita; Norona, Wilma; Ge, Jianye; Lagacé, Robert; Wang, Dennis Y.; Short, Marc L.; Mulero, Julio J.

doi:10.1016/j.fsigen.2019.07.001

Cited by 6 publications

(7 citation statements)

References 17 publications

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“…This could be due to a SNP polymorphism at a primer binding site that affects one kit but not the other. Several examples of allele dropout have been described in the literature [13,23]. The other disagreement between the kits was simply the result of a large, rare Penta E allele that was included in the VeriFiler Plus kit allelic ladder (and therefore able to be correctly genotyped), but not in the PowerPlex 21 kit ladder.…”

Section: Samplementioning

confidence: 99%

“…The VeriFiler Plus kit amplifies all the loci included in the DNA profiles used to build important national and local databases, including the 20 core loci proposed by the Chinese MPS and CODIS, as well as the highly discriminatory Penta D and Penta E markers. The VeriFiler Plus kit amplifies 23 autosomal STR loci: D3S1358, vWA, D16S539, CSF1PO, D6S1043, D8S1179, D21S11, D18S51, D5S818, D2S441, D19S433, FGA, D10S1248, D22S1045, D1S1656, D13S317, D7S820, Penta E, Penta D, TH01, D12S391, D2S1338, and TPOX, two internal quality control markers (IQCS and IQCL), one insertion/deletion polymorphic marker on the Y chromosome (Yindel), and Amelogenin (sex determining marker) [11][12][13]. The VeriFiler Plus kit offers extremely high discrimination power, enabling matching of casework samples with database profiles with the highest level of confidence.…”

Section: Introductionmentioning

confidence: 99%

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Developmental validation of VeriFiler™ Plus PCR Amplification Kit: A 6-dye multiplex assay designed for casework samples

Green

Elliott

Norona

et al. 2021

Forensic Science International: Genetics

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and TPOX), a quality indicator system, and two sex-identification markers. Combined, the markers satisfy the requirements of the Chinese National autosomal DNA database as well as expanded CODIS (Combined DNA Index System). The VeriFiler Plus kit was developed with an improved Master Mix which incorporates the brighter TED™ dye, and accommodates a higher sample loading volume thus allowing for increased sensitivity and enabling maximum information recovery from challenging casework samples including touch, degraded, and inhibited samples. Here, we report the results of the developmental validation study which followed the SWGDAM (Scientific Working Group on DNA Analysis Methods) guidelines and includes data for PCR-based studies, sensitivity, species specificity, stability, precision, reproducibility and repeatability, concordance, stutter, DNA mixtures, and performance on mock casework samples. The results validate the multiplex design as well as demonstrate the kit's robustness, reliability, and suitability as an assay for human identification with casework DNA samples.

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Section: Samplementioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Developmental validation of VeriFiler™ Plus PCR Amplification Kit: A 6-dye multiplex assay designed for casework samples

Green

Elliott

Norona

et al. 2021

Forensic Science International: Genetics

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“…In the genotype concordance study, the HUAXIA™ Platinum kit ( Zhong et al, 2019 ) was employed to type the 500 individuals. As no discordance was observed by checking the profiles of the two systems, the S6 system was proved to be reliable ( Supplementary Table S3 ).…”

Section: Resultsmentioning

confidence: 99%

Validation of a 6-Dye Short Tandem Repeat System: A Dry Kit With Lyophilized Amplification Reagent

Lin

Honglei³

et al. 2021

Front. Genet.

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The SureID®S6 system used a lyophilized pellet as the amplification reagent to enable multiplexing of sex-determining marker Amelogenin, 21 autosomal short tandem repeats (STRs), and one Y-STR. To assess the performance, reliability, and limitation of the dry amplification system, the validation studies including PCR condition, reproducibility, sizing and precision, analytical threshold calculation, sensitivity and stochastic threshold calculation, species specificity, stability, mixture, case sample, and population and concordance were conducted according to the Scientific Working Group on DNA Analysis Methods (SWGDAM) Validation Guidelines. Experimental data suggested that the optimal range of total input DNA was from 125 to 500 pg; the appropriate analytical threshold was 80 relative fluorescence units (RFUs) while the stochastic threshold was 260 RFUs; for the stability studies, SureID®S6 system could resist against less than 500 μmol/L of hematin, 100 ng/μl of humic acid, 4 mM of indigotin, 800 mM of tannic acid, and 800 mM of calcium ion. Population and concordance studies using 500 unrelated individuals showed that the combined probability of discrimination (CPD) and cumulative probability of exclusion (CPE) values were 0.999999999999 and 0.999999998416, respectively. The genotypes for the same sample were concordant with the previously validated HUAXIA™ Platinum kit. The validation results demonstrated that the SureID®S6 system could be used for forensic applifications.

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“…Although other genetic markers can also be used for forensic applications, STR typing has remained the main tool for decades now [1–3]. It is worth noting that the Chinese National Database has expanded to include over 50 million samples with the rapid growth of DNA databases worldwide and the continuous increase of international cooperation [4]. Furthermore, as different regions usually choose different loci that are suitable for their own population, there is a need to develop efficient multiplex systems to facilitate international data sharing and minimize adventitious matches for Chinese population.…”

Section: Introductionmentioning

confidence: 99%

“…Although several companies have developed six‐dye multiplex assays, such as GlobalFiler kit and Huaxia Platinum kit of Applied Biosystems (Foster City, CA), PowerPlex Fusion 6C kit of Promega, and Investigator 24plex GO! kit of QIAGEN (Hilden, Germany), the number of loci they select is still limited [4–6]. In order to maximize the advantages of the six‐dye chemistry format, we conceived the idea of developing a six‐dye fluorescent multiplex that includes more STR loci, to be as comprehensive as possible.…”

Section: Introductionmentioning

confidence: 99%

Development and validation of a forensic six‐dye multiplex assay with 29 STR loci

Tao

et al. 2021

Electrophoresis

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This paper describes the development and validation of a novel 31‐locus, six‐dye STR multiplex system, which is designed to meet the needs of the rapidly growing Chinese forensic database. This new assay combines 20 extended‐CODIS core loci (D3S1358, D5S818, TPOX, CSF1PO, TH01, vWA, D7S820, D21S11, D8S1179, D18S51, D16S539, D13S317, FGA, D1S1656, D2S441, D2S1338, D10S1248, D12S391, D19S433, and D22S1045), nine highly polymorphic loci in Chinese Han population (D3S3045, D6S1043, D6S477, D8S1132, D10S1435, D15S659, D19S253, Penta D, and Penta E), and two gender determining markers, amelogenin and Y‐Indel, which could amplify DNA from extracts, as well as direct amplification from substrates. To demonstrate the suitability for forensic applications, this system was validated by precision and accuracy evaluation, concordance tests, case sample tests, sensitivity, species specificity, stability, stutter calculation, and DNA mixtures, according to the guidelines described by the Scientific Working Group on DNA Analysis Methods (SWGDAM) and regulations published by the China Ministry of Public Security. The validation results indicate the robustness and reliability of this new system, and it could be a potentially helpful tool for human identification and paternity testing in the Chinese population, as well as facilitating global forensic DNA data sharing.

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Developmental validation of the Huaxia™ Platinum PCR amplification kit: A 6-dye multiplex direct amplification assay designed for Chinese reference samples

Abstract: The Huaxia™ Platinum Kit for short tandem repeat (STR) amplification was designed to meet the needs of the rapidly growing Chinese forensic database. This PCR multiplex allows simultaneous amplification of the following autosomal loci: D3S1358,

Cited by 6 publications

References 17 publications

Developmental validation of VeriFiler™ Plus PCR Amplification Kit: A 6-dye multiplex assay designed for casework samples

Developmental validation of VeriFiler™ Plus PCR Amplification Kit: A 6-dye multiplex assay designed for casework samples

Validation of a 6-Dye Short Tandem Repeat System: A Dry Kit With Lyophilized Amplification Reagent

Development and validation of a forensic six‐dye multiplex assay with 29 STR loci

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