DEVELOPMENT OF PLASMID-BASED FOR EXTERNAL CONTROL MATERIALS OF CYP2D6*10 (rs1065852) GENE PCR-BASED DETECTION

Main Article Content

Jekmal Malau
Aliya Azkia Zahra
Ahsanal Kasasiah
Ratika Rahmasari
Muhareva Raekiansyah
Siti Rohmah
Nanda Diva Meilani
Annisa Frastica Septi
Aurora Fatimatuz Zahro
Fathina Annajla
Anastasia Aliesa Hermosaningtyas
Indah Laily Hilmi

Abstract

Reliable clinical diagnosis of Single Nucleotide Polymorphisms (SNPs) is necessary for personalizing tamoxifen medication according to CYP2D6*10 genetic variations. Our research aimed to create a recombinant plasmid for external control material with a molecular size of 3812 bp. The recombinant plasmid was achieved by cloning an 838 bp gene insert of CYP2D6*10 rs1065852 into a 2974 bp pJET1.2 plasmid into Escherichia coli DH10B and selection on ampicillin agar medium. Isolated E. coli recombinants provided the plasmid molecules for analysis. Bi-directional sequencing and Real-Time PCR confirmed the presence of wild-type and mutant rs1065852 DNA fragments in the plasmid, namely homozygote CC and TT. The conclusion is that we have successfully introduced a novel recombinant plasmid developed by cloning the SNP rs1065852, which carries the 100C>T mutation, using pJET 1.2/blunt system, which could significantly enhance the accuracy of clinical SNP diagnostics for personalized medicine in breast cancer treatment.

Article Details

How to Cite
Malau, J., Zahra, A. A., Kasasiah, A., Rahmasari, R., Raekiansyah, M., Rohmah, S., Meilani, N. D., Septi, A. F., Zahro, A. F., Annajla, F., Hermosaningtyas, A. A., & Hilmi, I. L. (2023). DEVELOPMENT OF PLASMID-BASED FOR EXTERNAL CONTROL MATERIALS OF CYP2D6*10 (rs1065852) GENE PCR-BASED DETECTION. Jurnal Bioteknologi Dan Biosains Indonesia, 10(2), 220–235. Retrieved from https://ejournal.brin.go.id/JBBI/article/view/2557
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References

Abdel-Salam MS, Ameen HH, Kassab ASM, Mahgoob AEA, Elkelany US (2018) Enhancement of nematicidal potential through cloning and expression of chitinase gene from Bacillus subtilis subsp. subtilis BTN7A strain. J Genet Eng Biotechnol 16:305–310. https://doi.org/10.1016/j.jgeb.2018.05.006

Abderrahman B, Jordan VC (2019) A novel strategy to improve women’s health: selective estrogen receptor modulators. pp 189–213

Abdullah-Koolmees H, van Keulen AM, Nijenhuis M, Deneer VHM (2020) Pharmacogenetics guidelines: overview and comparison of the DPWG, CPIC, CPNDS, and RNPGx guidelines. Front Pharmacol 11:595219. https://doi.org/10.3389/fphar.2020.595219

Adams JU (2008) Pharmacogenomics and personalized medicine. In: Nat. Educ. https://www.nature.com/scitable/topicpage/pharmacogenomics-and-personalized-medicine-643/

Astuti NT, Darsono N, Widyaningrum S, Sawitri WD, Astuti SP, Darmanto W (2019) Expression and purification of recombinant coat protein of sugarcane mosaic virus from Indonesian isolate as an antigen for antibody production. Indones J Biotechnol 24:57. https://doi.org/10.22146/ijbiotech.45551

Bakar NS (2021) Pharmacogenetics of common SNP affecting drug metabolizing enzymes: comparison of allele frequencies between European and Malaysian/Singaporean. Drug Metab Pers Ther 36:173–181. https://doi.org/10.1515/dmpt-2020-0153

Bars-Cortina D, Riera-Escamilla A, Gou G, Piñol-Felis C, Motilva M-J (2019) Design, optimization and validation of genes commonly used in expression studies on DMH/AOM rat colon carcinogenesis model. PeerJ 7:e6372. https://doi.org/10.7717/peerj.6372

Broeders S, Huber I, Grohmann L, Berben G, Taverniers I, Mazzara M, Roosens N, Morisset D (2014) Guidelines for validation of qualitative Real-Time PCR methods. Trends Food Sci Technol 37:115–126. https://doi.org/10.1016/j.tifs.2014.03.008

Byeon J-Y, Kim Y-H, Lee C-M, Kim S-H, Chae W-K, Jung E-H, Choi C-I, Jang C-G, Lee S-Y, Bae J-W, Lee YJ (2018) CYP2D6 allele frequencies in Korean population, comparison with East Asian, Caucasian and African populations, and the comparison of metabolic activity of CYP2D6 genotypes. Arch Pharm Res 41:921–930. https://doi.org/10.1007/s12272-018-1075-6

Cengiz M, Battal A, Aydin G, Eroglu A (2013) Vector construction strategies for transformation of wheat plant. J Anim Plant Sci 23(3):906–912

Chan W, Li MS, Sundaram SK, Tomlinson B, Cheung PY, Tzang CH (2019) CYP2D6 allele frequencies, copy number variants, and tandems in the population of Hong Kong. J Clin Lab Anal 33. https://doi.org/10.1002/jcla.22634

Dean L (2014) Tamoxifen Therapy and CYP2D6 Genotype. In: Medical Genetics Summaries. National Center for Biotechnology Information (US)

Gaedigk A, Turner A, Everts RE, Scott SA, Aggarwal P, Broeckel U, McMillin GA, Melis R, Boone EC, Pratt VM, Kalman L V (2019) Characterization of reference materials for genetic testing of CYP2D6 alleles: a GeT-RM collaborative project. J Mol Diagn 21:1034–1052. https://doi.org/10.1016/j.jmoldx.2019.06.007

Goetz MP, Kamal A, Ames MM (2008) Tamoxifen pharmacogenomics: The role of CYP2D6 as a predictor of Drug Response. Clin Pharmacol Ther 83:160–166. https://doi.org/10.1038/sj.clpt.6100367

Gokduman K, Dilek Avsaroglu M, Cakiris A, Ustek D, Candan Gurakan G (2016) Recombinant plasmid-based quantitative Real-Time PCR analysis of Salmonella enterica serotypes and its application to milk samples. J Microbiol Methods 122:50–58. https://doi.org/10.1016/j.mimet.2016.01.008

Han N, Oh JM, Kim I-W (2021) Combination of genome-wide polymorphisms and copy number variations of pharmacogenes in Koreans. J Pers Med 11:33. https://doi.org/10.3390/jpm11010033

Hernandez RN, Isakeit T, Al Rwahnih M, Villegas C, Alabi OJ (2021) First report of watermelon crinkle Leaf-Associated Virus 1 (WCLaV-1) and WCLaV-2 infecting watermelon (Citrullus lanatus) in the United States. Plant Dis 105:2025. https://doi.org/10.1094/PDIS-02-21-0249-PDN

Holden MJ, Madej RM, Minor P, Kalman L V (2011) Molecular diagnostics: harmonization through reference materials, documentary standards and proficiency testing. Expert Rev Mol Diagn 11:741–755. https://doi.org/10.1586/erm.11.50

Hoseini S, Sauer MG (2015) Molecular cloning using polymerase chain reaction, an educational guide for cellular engineering. J Biol Eng 9:2. https://doi.org/10.1186/1754-1611-9-2

Hoskins JM, Carey LA, McLeod HL (2009) CYP2D6 and tamoxifen: DNA matters in breast cancer. Nat Rev Cancer 9:576–586. https://doi.org/10.1038/nrc2683

Jordan VC (2015) The new biology of estrogen-induced apoptosis applied to treat and prevent breast cancer. Endocr Relat Cancer 22:R1–R31. https://doi.org/10.1530/ERC-14-0448

Kalman L V., Datta V, Williams M, Zook JM, Salit ML, Han J-Y (2016) Development and characterization of reference materials for genetic testing: focus on public partnerships. Ann Lab Med 36:513–520. https://doi.org/10.3343/alm.2016.36.6.513

Kirby LT (1990) DNA Fingerprinting. Palgrave Macmillan UK, London

Kisoi M, Imai M, Yamamura M, Sakaguchi Y, Murata S, Ichikawa A, Kinoshita K (2020) Unique genotyping protocol of CYP2D6 allele frequency using Real-Time Quantitative PCR from Japanese healthy women. Biol Pharm Bull 43:904–907. https://doi.org/10.1248/bpb.b19-00512

Koh DW-S, Chan K-F, Wu W, Gan SK-E (2021) Yet Another Quick Assembly, Analysis and Trimming Tool (YAQAAT): A server for the automated assembly and analysis of Sanger sequencing data. J Biomol Tech jbt.2021-3202-003. https://doi.org/10.7171/jbt.2021-3202-003

Lahijani R, Hulley G, Soriano G, Horn NA, Marquet M (1996) High-yield production of pBR322-derived plasmids intended for human gene therapy by employing a temperature-controllable point mutation. Hum Gene Ther 7:1971–1980. https://doi.org/10.1089/hum.1996.7.16-1971

Lin G, Zhang K, Han Y, Li J (2017) Quality control materials for pharmacogenomic testing in the clinic. Clin Chem Lab Med 55:926–933. https://doi.org/10.1515/cclm-2016-0755

Logan G, Freimanis GL, King DJ, Valdazo-González B, Bachanek-Bankowska K, Sanderson ND, Knowles NJ, King DP, Cottam EM (2014) A universal protocol to generate consensus level genome sequences for foot-and-mouth disease virus and other positive-sense polyadenylated RNA viruses using the Illumina MiSeq. BMC Genomics 15:828. https://doi.org/10.1186/1471-2164-15-828

Manna S, Harman A, Accari J, Barth C (2013) Altering the selection capabilities of common cloning vectors via restriction enzyme-mediated gene disruption. BMC Res Notes 6:85. https://doi.org/10.1186/1756-0500-6-85

Mawardi A, Aisoi LE, Lefaan PN (2018) Kloning dan analisis bioinformatika gen MSP1 Plasmodium falciparum isolat kota Jayapura. J Biol Papua 10:1–10. https://doi.org/10.31957/jbp.126

Ministry of Health (2022) Kanker Payudara Paling Banyak di Indonesia, Kemenkes Targetkan Pemerataan Layanan Kesehatan. https://sehatnegeriku.kemkes.go.id/. Accessed 23 Oct 2023

Nawawi O, Abdullah MP, Yusuf CYL (2022) A strategy for in-house production of a positive selection cloning vector from the commercial pJET1.2/blunt cloning vector at minimal cost. 3 Biotech 12:216. https://doi.org/10.1007/s13205-022-03289-x

Nawawi O, Abdullah MP, Yusuf CYL (2023) A streamlined strategy for self-production of a commercial positive selection vector, the pJET1.2/blunt cloning vector, using common laboratory E. coli strains. 3 Biotech 13:224. https://doi.org/10.1007/s13205-023-03647-3

Niraula A, Bataju M (2020) External quality assessment practices in clinical biochemistry laboratory: what is the need? Kathmandu Univ Med J 18:86–92. https://doi.org/10.3126/kumj.v18i1.34660

Nuraeni U, Malau J, Astuti RT, Dewantoro A, Apriori D, Lusiana ED, Prasetya B (2023) Droplet digital PCR versus Real-Time PCR for in-house validation of porcine detection and quantification protocol: an artificial recombinant plasmid approach. PLoS One 18:e0287712. https://doi.org/10.1371/journal.pone.0287712

Oertel W, Wichard T, Weissgerber A (2015) Transformation of Ulva mutabilis (Chlorophyta) by vector plasmids integrating into the genome. J Phycol 51:963–979. https://doi.org/10.1111/jpy.12336

Pratt VM, Everts RE, Aggarwal P, Beyer BN, Broeckel U, Epstein-Baak R, Hujsak P, Kornreich R, Liao J, Lorier R, Scott SA, Smith CH, Toji LH, Turner A, Kalman L V (2016) Characterization of 137 genomic DNA reference materials for 28 pharmacogenetic genes: a

GeT-RM collaborative project. J Mol Diagn 18:109–23. https://doi.org/10.1016/j.jmoldx.2015.08.005

Pratt VM, Zehnbauer B, Wilson JA, Baak R, Babic N, Bettinotti M, Buller A, Butz K, Campbell M, Civalier C, El-Badry A, Farkas DH, Lyon E, Mandal S, McKinney J, Muralidharan K, Noll L, Sander T, Shabbeer J, Smith C, Telatar M, Toji L, Vairavan A, Vance C, Weck KE, Wu AHB, Yeo K-TJ, Zeller M, Kalman L (2010) Characterization of 107 genomic DNA reference materials for CYP2D6, CYP2C19, CYP2C9, VKORC1, and UGT1A1: a GeT-RM and association for molecular pathology collaborative project. J Mol Diagn 12:835–46. https://doi.org/10.2353/jmoldx.2010.100090

Puaprasert K, Chu C, Saralamba N, Day NPJ, Nosten F, White NJ, Dondorp AM, Imwong M (2018) Real-Time PCR detection of common CYP2D6 genetic variants and its application in a Karen population study. Malar J 17:427. https://doi.org/10.1186/s12936-018-2579-8

Sambrook J, Fritsch ER, Maniatis T (1989) Molecular Cloning: A Laboratory Manual (2nd ed.), 2nd ed. Cold Spring Harbor Laboratory Press, New York

Shah RR, Smith RL (2015) Addressing phenoconversion: the Achilles’ heel of personalized medicine. Br J Clin Pharmacol 79:222–240. https://doi.org/10.1111/bcp.12441

Soga K, Nakamura K, Egi T, Narushima J, Yoshiba S, Kishine M, Mano J, Kitta K, Takabatake R, Shibata N, Kondo K (2022) Development and validation of a new robust detection method for low-content DNA using ΔΔCq-based Real-Time PCR with optimized standard plasmids as a control sample. Anal Chem 94:14475–14483. https://doi.org/10.1021/acs.analchem.2c03680

Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F (2021) Global Cancer Statistics 2020: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin 71:209–249. https://doi.org/10.3322/caac.21660

Sutiman N, Lim JSL, Muerdter TE, Singh O, Cheung YB, Ng RCH, Yap YS, Wong NS, Ang PCS, Dent R, Schroth W, Schwab M, Khor CC, Chowbay B (2016) Pharmacogenetics of UGT1A4, UGT2B7 and UGT2B15 and their influence on tamoxifen disposition in Asian breast cancer patients. Clin Pharmacokinet 55:1239–1250. https://doi.org/10.1007/s40262-016-0402-7

ThermoFisher (2009) Patent Application Publication: Vectors For Cloning. US2009/0042249 A1

ThermoFisher (2023) CloneJET PCR Cloning KIT #K1231, #K1232

van der Straaten T, Swen J, Baak-Pablo R, Guchelaar H-J (2008) Use of plasmid-derived external quality control samples in pharmacogenetic testing. Pharmacogenomics 9:1261–1266. https://doi.org/10.2217/14622416.9.9.1261

Yenny, Panigoro SS, Purwanto DJ, Hidayat A, Louisa M, Andalusia R, Setiabudy R (2019) Association of CYP2D6*10 (c. 100 C>T) genotype with Z-END concentration in patients with breast cancer receiving tamoxifen therapy in Indonesian population. Endocrine, Metab Immune Disord - Drug Targets 19:1198–1206. https://doi.org/10.2174/1871530319666190306094617

Zablocki ODJ, Rybicki EP, Cowan DA (2014) First Report of a Potyvirus Infecting Albuca rautanenii in the Namib Desert. Plant Dis 98:1749–1749. https://doi.org/10.1094/PDIS-07-14-0737-PDN

Abdel-Salam MS, Ameen HH, Kassab ASM, Mahgoob AEA, Elkelany US (2018) Enhancement of nematicidal potential through cloning and expression of chitinase gene from Bacillus subtilis subsp. subtilis BTN7A strain. J Genet Eng Biotechnol 16:305–310. https://doi.org/10.1016/j.jgeb.2018.05.006

Abderrahman B, Jordan VC (2019) A novel strategy to improve women’s health: selective estrogen receptor modulators. pp 189–213

Abdullah-Koolmees H, van Keulen AM, Nijenhuis M, Deneer VHM (2020) Pharmacogenetics guidelines: overview and comparison of the DPWG, CPIC, CPNDS, and RNPGx guidelines. Front Pharmacol 11:595219. https://doi.org/10.3389/fphar.2020.595219

Adams JU (2008) Pharmacogenomics and personalized medicine. In: Nat. Educ. https://www.nature.com/scitable/topicpage/pharmacogenomics-and-personalized-medicine-643/

Astuti NT, Darsono N, Widyaningrum S, Sawitri WD, Astuti SP, Darmanto W (2019) Expression and purification of recombinant coat protein of sugarcane mosaic virus from Indonesian isolate as an antigen for antibody production. Indones J Biotechnol 24:57. https://doi.org/10.22146/ijbiotech.45551

Bakar NS (2021) Pharmacogenetics of common SNP affecting drug metabolizing enzymes: comparison of allele frequencies between European and Malaysian/Singaporean. Drug Metab Pers Ther 36:173–181. https://doi.org/10.1515/dmpt-2020-0153

Bars-Cortina D, Riera-Escamilla A, Gou G, Piñol-Felis C, Motilva M-J (2019) Design, optimization and validation of genes commonly used in expression studies on DMH/AOM rat colon carcinogenesis model. PeerJ 7:e6372. https://doi.org/10.7717/peerj.6372

Broeders S, Huber I, Grohmann L, Berben G, Taverniers I, Mazzara M, Roosens N, Morisset D (2014) Guidelines for validation of qualitative Real-Time PCR methods. Trends Food Sci Technol 37:115–126. https://doi.org/10.1016/j.tifs.2014.03.008

Byeon J-Y, Kim Y-H, Lee C-M, Kim S-H, Chae W-K, Jung E-H, Choi C-I, Jang C-G, Lee S-Y, Bae J-W, Lee YJ (2018) CYP2D6 allele frequencies in Korean population, comparison with East Asian, Caucasian and African populations, and the comparison of metabolic activity of CYP2D6 genotypes. Arch Pharm Res 41:921–930. https://doi.org/10.1007/s12272-018-1075-6

Cengiz M, Battal A, Aydin G, Eroglu A (2013) Vector construction strategies for transformation of wheat plant. J Anim Plant Sci 23(3):906–912

Chan W, Li MS, Sundaram SK, Tomlinson B, Cheung PY, Tzang CH (2019) CYP2D6 allele frequencies, copy number variants, and tandems in the population of Hong Kong. J Clin Lab Anal 33. https://doi.org/10.1002/jcla.22634

Dean L (2014) Tamoxifen Therapy and CYP2D6 Genotype. In: Medical Genetics Summaries. National Center for Biotechnology Information (US)

Gaedigk A, Turner A, Everts RE, Scott SA, Aggarwal P, Broeckel U, McMillin GA, Melis R, Boone EC, Pratt VM, Kalman L V (2019) Characterization of reference materials for genetic testing of CYP2D6 alleles: a GeT-RM collaborative project. J Mol Diagn 21:1034–1052. https://doi.org/10.1016/j.jmoldx.2019.06.007

Goetz MP, Kamal A, Ames MM (2008) Tamoxifen pharmacogenomics: The role of CYP2D6 as a predictor of Drug Response. Clin Pharmacol Ther 83:160–166. https://doi.org/10.1038/sj.clpt.6100367

Gokduman K, Dilek Avsaroglu M, Cakiris A, Ustek D, Candan Gurakan G (2016) Recombinant plasmid-based quantitative Real-Time PCR analysis of Salmonella enterica serotypes and its application to milk samples. J Microbiol Methods 122:50–58. https://doi.org/10.1016/j.mimet.2016.01.008

Han N, Oh JM, Kim I-W (2021) Combination of genome-wide polymorphisms and copy number variations of pharmacogenes in Koreans. J Pers Med 11:33. https://doi.org/10.3390/jpm11010033

Hernandez RN, Isakeit T, Al Rwahnih M, Villegas C, Alabi OJ (2021) First report of watermelon crinkle Leaf-Associated Virus 1 (WCLaV-1) and WCLaV-2 infecting watermelon (Citrullus lanatus) in the United States. Plant Dis 105:2025. https://doi.org/10.1094/PDIS-02-21-0249-PDN

Holden MJ, Madej RM, Minor P, Kalman L V (2011) Molecular diagnostics: harmonization through reference materials, documentary standards and proficiency testing. Expert Rev Mol Diagn 11:741–755. https://doi.org/10.1586/erm.11.50

Hoseini S, Sauer MG (2015) Molecular cloning using polymerase chain reaction, an educational guide for cellular engineering. J Biol Eng 9:2. https://doi.org/10.1186/1754-1611-9-2

Hoskins JM, Carey LA, McLeod HL (2009) CYP2D6 and tamoxifen: DNA matters in breast cancer. Nat Rev Cancer 9:576–586. https://doi.org/10.1038/nrc2683

Jordan VC (2015) The new biology of estrogen-induced apoptosis applied to treat and prevent breast cancer. Endocr Relat Cancer 22:R1–R31. https://doi.org/10.1530/ERC-14-0448

Kalman L V., Datta V, Williams M, Zook JM, Salit ML, Han J-Y (2016) Development and characterization of reference materials for genetic testing: focus on public partnerships. Ann Lab Med 36:513–520. https://doi.org/10.3343/alm.2016.36.6.513

Kirby LT (1990) DNA Fingerprinting. Palgrave Macmillan UK, London

Kisoi M, Imai M, Yamamura M, Sakaguchi Y, Murata S, Ichikawa A, Kinoshita K (2020) Unique genotyping protocol of CYP2D6 allele frequency using Real-Time Quantitative PCR from Japanese healthy women. Biol Pharm Bull 43:904–907. https://doi.org/10.1248/bpb.b19-00512

Koh DW-S, Chan K-F, Wu W, Gan SK-E (2021) Yet Another Quick Assembly, Analysis and Trimming Tool (YAQAAT): A server for the automated assembly and analysis of Sanger sequencing data. J Biomol Tech jbt.2021-3202-003. https://doi.org/10.7171/jbt.2021-3202-003

Lahijani R, Hulley G, Soriano G, Horn NA, Marquet M (1996) High-yield production of pBR322-derived plasmids intended for human gene therapy by employing a temperature-controllable point mutation. Hum Gene Ther 7:1971–1980. https://doi.org/10.1089/hum.1996.7.16-1971

Lin G, Zhang K, Han Y, Li J (2017) Quality control materials for pharmacogenomic testing in the clinic. Clin Chem Lab Med 55:926–933. https://doi.org/10.1515/cclm-2016-0755

Logan G, Freimanis GL, King DJ, Valdazo-González B, Bachanek-Bankowska K, Sanderson ND, Knowles NJ, King DP, Cottam EM (2014) A universal protocol to generate consensus level genome sequences for foot-and-mouth disease virus and other positive-sense polyadenylated RNA viruses using the Illumina MiSeq. BMC Genomics 15:828. https://doi.org/10.1186/1471-2164-15-828

Manna S, Harman A, Accari J, Barth C (2013) Altering the selection capabilities of common cloning vectors via restriction enzyme-mediated gene disruption. BMC Res Notes 6:85. https://doi.org/10.1186/1756-0500-6-85

Mawardi A, Aisoi LE, Lefaan PN (2018) Kloning dan analisis bioinformatika gen MSP1 Plasmodium falciparum isolat kota Jayapura. J Biol Papua 10:1–10. https://doi.org/10.31957/jbp.126

Ministry of Health (2022) Kanker Payudara Paling Banyak di Indonesia, Kemenkes Targetkan Pemerataan Layanan Kesehatan. https://sehatnegeriku.kemkes.go.id/. Accessed 23 Oct 2023

Nawawi O, Abdullah MP, Yusuf CYL (2022) A strategy for in-house production of a positive selection cloning vector from the commercial pJET1.2/blunt cloning vector at minimal cost. 3 Biotech 12:216. https://doi.org/10.1007/s13205-022-03289-x

Nawawi O, Abdullah MP, Yusuf CYL (2023) A streamlined strategy for self-production of a commercial positive selection vector, the pJET1.2/blunt cloning vector, using common laboratory E. coli strains. 3 Biotech 13:224. https://doi.org/10.1007/s13205-023-03647-3

Niraula A, Bataju M (2020) External quality assessment practices in clinical biochemistry laboratory: what is the need? Kathmandu Univ Med J 18:86–92. https://doi.org/10.3126/kumj.v18i1.34660

Nuraeni U, Malau J, Astuti RT, Dewantoro A, Apriori D, Lusiana ED, Prasetya B (2023) Droplet digital PCR versus Real-Time PCR for in-house validation of porcine detection and quantification protocol: an artificial recombinant plasmid approach. PLoS One 18:e0287712. https://doi.org/10.1371/journal.pone.0287712

Oertel W, Wichard T, Weissgerber A (2015) Transformation of Ulva mutabilis (Chlorophyta) by vector plasmids integrating into the genome. J Phycol 51:963–979. https://doi.org/10.1111/jpy.12336

Pratt VM, Everts RE, Aggarwal P, Beyer BN, Broeckel U, Epstein-Baak R, Hujsak P, Kornreich R, Liao J, Lorier R, Scott SA, Smith CH, Toji LH, Turner A, Kalman L V (2016) Characterization of 137 genomic DNA reference materials for 28 pharmacogenetic genes: a

GeT-RM collaborative project. J Mol Diagn 18:109–23. https://doi.org/10.1016/j.jmoldx.2015.08.005

Pratt VM, Zehnbauer B, Wilson JA, Baak R, Babic N, Bettinotti M, Buller A, Butz K, Campbell M, Civalier C, El-Badry A, Farkas DH, Lyon E, Mandal S, McKinney J, Muralidharan K, Noll L, Sander T, Shabbeer J, Smith C, Telatar M, Toji L, Vairavan A, Vance C, Weck KE, Wu AHB, Yeo K-TJ, Zeller M, Kalman L (2010) Characterization of 107 genomic DNA reference materials for CYP2D6, CYP2C19, CYP2C9, VKORC1, and UGT1A1: a GeT-RM and association for molecular pathology collaborative project. J Mol Diagn 12:835–46. https://doi.org/10.2353/jmoldx.2010.100090

Puaprasert K, Chu C, Saralamba N, Day NPJ, Nosten F, White NJ, Dondorp AM, Imwong M (2018) Real-Time PCR detection of common CYP2D6 genetic variants and its application in a Karen population study. Malar J 17:427. https://doi.org/10.1186/s12936-018-2579-8

Sambrook J, Fritsch ER, Maniatis T (1989) Molecular Cloning: A Laboratory Manual (2nd ed.), 2nd ed. Cold Spring Harbor Laboratory Press, New York

Shah RR, Smith RL (2015) Addressing phenoconversion: the Achilles’ heel of personalized medicine. Br J Clin Pharmacol 79:222–240. https://doi.org/10.1111/bcp.12441

Soga K, Nakamura K, Egi T, Narushima J, Yoshiba S, Kishine M, Mano J, Kitta K, Takabatake R, Shibata N, Kondo K (2022) Development and validation of a new robust detection method for low-content DNA using ΔΔCq-based Real-Time PCR with optimized standard plasmids as a control sample. Anal Chem 94:14475–14483. https://doi.org/10.1021/acs.analchem.2c03680

Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F (2021) Global Cancer Statistics 2020: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin 71:209–249. https://doi.org/10.3322/caac.21660

Sutiman N, Lim JSL, Muerdter TE, Singh O, Cheung YB, Ng RCH, Yap YS, Wong NS, Ang PCS, Dent R, Schroth W, Schwab M, Khor CC, Chowbay B (2016) Pharmacogenetics of UGT1A4, UGT2B7 and UGT2B15 and their influence on tamoxifen disposition in Asian breast cancer patients. Clin Pharmacokinet 55:1239–1250. https://doi.org/10.1007/s40262-016-0402-7

ThermoFisher (2009) Patent Application Publication: Vectors For Cloning. US2009/0042249 A1

ThermoFisher (2023) CloneJET PCR Cloning KIT #K1231, #K1232

van der Straaten T, Swen J, Baak-Pablo R, Guchelaar H-J (2008) Use of plasmid-derived external quality control samples in pharmacogenetic testing. Pharmacogenomics 9:1261–1266. https://doi.org/10.2217/14622416.9.9.1261

Yenny, Panigoro SS, Purwanto DJ, Hidayat A, Louisa M, Andalusia R, Setiabudy R (2019) Association of CYP2D6*10 (c. 100 C>T) genotype with Z-END concentration in patients with breast cancer receiving tamoxifen therapy in Indonesian population. Endocrine, Metab Immune Disord - Drug Targets 19:1198–1206. https://doi.org/10.2174/1871530319666190306094617

Zablocki ODJ, Rybicki EP, Cowan DA (2014) First Report of a Potyvirus Infecting Albuca rautanenii in the Namib Desert. Plant Dis 98:1749–1749. https://doi.org/10.1094/PDIS-07-14-0737-PDN