PMID- 30213462 OWN - NLM STAT- MEDLINE DCOM- 20190301 LR - 20190301 IS - 1873-3492 (Electronic) IS - 0009-8981 (Linking) VI - 487 DP - 2018 Dec TI - Desirable quality-control materials for the establishment of qualified external quality assessment on prenatal diagnosis of chromosomal aneuploidies. PG - 80-83 LID - S0009-8981(18)30493-5 [pii] LID - 10.1016/j.cca.2018.09.016 [doi] AB - OBJECTIVE: To prepare desirable quality-control materials for the establishement of qualified external quality assessment on fluorescence in situ hybridization (FISH)-detected prenatal diagnosis of chromosomal aneuploidies. METHODS: Four types of amniotic fluid cell suspensions (13-trisomy, 18-trisomy, 21-trisomy and 47,XXY) were mixed together by ratio to produce mosaicism with the percentages of each aneuploidy as 10%, 20%, 30% and 40%, respectively. After being stored in liquid nitrogen of -196  degrees C for six months, randomly selected samples were incubated in 37  degrees C water, followed by cultivation, hypo-osmosis and fixation. Finally, FISH detetion was applied on them before and after external laboratory mailing, in step with detection on conventional case samples. RESULTS: Before mailing, the positive rates of each aneuploidy described above were 12.8%, 23.6%, 33.8%, 44.0%, while 12.6%, 23.8%, 34.0%, 43.5% after mailing. t-test, criteria for stability assessment of quality-control materials in CANS-GL03:2006, showed no significant effect of external mailing on mosaicism since corresponding t values are lower than threshold with significance level alpha as 0.05 and degree of freedom as 10. CONCLUSION: As FISH detection showed, the mosaic cell strains prepared in current study exhibited excellent stabilities after cryopreservation in -196  degrees C, subculture, hypo-osmosis, fixation and external laboratory mailing, demonstrating them as reliable and promising quality-control materials for the establishment of a qualified external quality assessment on prenatal diagnosis of chromosomal aneuploidies. CI - Copyright (c) 2018 Elsevier B.V. All rights reserved. FAU - Mao, Yuchan AU - Mao Y AD - The Key Laboratory of Reproductive Genetics, Ministry of Education(Zhejiang University), Department of Obstetrics and Gynecology, Women's Hospital, School of Medicine, Zhejiang University, Hangzhou 310006, China. FAU - Su, Lan AU - Su L AD - The Key Laboratory of Reproductive Genetics, Ministry of Education(Zhejiang University), Department of Obstetrics and Gynecology, Women's Hospital, School of Medicine, Zhejiang University, Hangzhou 310006, China. FAU - Li, Hongge AU - Li H AD - The Key Laboratory of Reproductive Genetics, Ministry of Education(Zhejiang University), Department of Obstetrics and Gynecology, Women's Hospital, School of Medicine, Zhejiang University, Hangzhou 310006, China. FAU - Yang, Yanmei AU - Yang Y AD - The Key Laboratory of Reproductive Genetics, Ministry of Education(Zhejiang University), Department of Obstetrics and Gynecology, Women's Hospital, School of Medicine, Zhejiang University, Hangzhou 310006, China. FAU - Weng, Binghuan AU - Weng B AD - The Key Laboratory of Reproductive Genetics, Ministry of Education(Zhejiang University), Department of Obstetrics and Gynecology, Women's Hospital, School of Medicine, Zhejiang University, Hangzhou 310006, China. Electronic address: 5503006@zju.edu.cn. LA - eng PT - Journal Article DEP - 20180910 PL - Netherlands TA - Clin Chim Acta JT - Clinica chimica acta; international journal of clinical chemistry JID - 1302422 SB - IM MH - *Aneuploidy MH - Chromosome Disorders/*genetics MH - Chromosomes, Human, Pair 13/*genetics MH - Chromosomes, Human, Pair 18/*genetics MH - Chromosomes, Human, Pair 21/*genetics MH - Humans MH - In Situ Hybridization, Fluorescence MH - Quality Control OTO - NOTNLM OT - Chromosomal aneuploidies OT - External quality assessment OT - Fluorescence in situ hybridization OT - Prenatal diagnosis OT - Quality control materials EDAT- 2018/09/15 06:00 MHDA- 2019/03/02 06:00 CRDT- 2018/09/15 06:00 PHST- 2018/04/01 00:00 [received] PHST- 2018/08/20 00:00 [revised] PHST- 2018/09/07 00:00 [accepted] PHST- 2018/09/15 06:00 [pubmed] PHST- 2019/03/02 06:00 [medline] PHST- 2018/09/15 06:00 [entrez] AID - S0009-8981(18)30493-5 [pii] AID - 10.1016/j.cca.2018.09.016 [doi] PST - ppublish SO - Clin Chim Acta. 2018 Dec;487:80-83. doi: 10.1016/j.cca.2018.09.016. Epub 2018 Sep 10.