PMID- 31922364
OWN - NLM
STAT- MEDLINE
DCOM- 20210517
LR  - 20210517
IS  - 1934-8258 (Electronic)
IS  - 1934-8258 (Linking)
VI  - 105
IP  - 1
DP  - 2020 Mar
TI  - Validation of Fluorescence In Situ Hybridization (FISH) for Chromosome 5 Monosomy 
      and Deletion.
PG  - e96
LID - 10.1002/cphg.96 [doi]
AB  - In order to comply with regulations set by established local, state, and federal 
      agencies and other regulatory organizations, such as the College of American 
      Pathologists and the International Organization for Standardization, a clinical 
      laboratory needs to develop procedures for the processes of validating 
      laboratory-developed tests (LDTs) and establishing performance specifications for 
      these assays prior to use in clinical testing. This is applicable to all 
      fluorescence in situ hybridization (FISH) assays. Even Food and Drug 
      Administration-approved FISH assays must undergo some form of verification before 
      implementation in the clinical laboratory. The process of validating an assay as 
      an LDT must include a plan, a procedure, and a report. The validation studies 
      described here include metaphase and interphase FISH methodology for 
      identification of the LSI EGR1/D5S23, D5S721 dual-color probe, which labels 
      distinct biomarkers consistent with myeloid hematologic disorders, including 
      myelodysplasias and acute myeloid leukemia. (c) 2020 by John Wiley & Sons, Inc. 
      Basic Protocol 1: Validation plan for fluorescence in situ hybridization (FISH) 
      probes for chromosome 5 monosomy and deletion Support Protocol: Normal cut-off 
      calculation Basic Protocol 2: Validation procedure for FISH probes for chromosome 
      5 monosomy and deletion Basic Protocol 3: Validation report for FISH probes for 
      chromosome 5 monosomy and deletion.
CI  - (c) 2020 John Wiley & Sons, Inc.
FAU - Zneimer, Susan M
AU  - Zneimer SM
AD  - Medical Operation Systems Consulting (MOSYS), Camas, Washington.
AD  - Symbiotica, Inc., Vacaville, California.
LA  - eng
PT  - Journal Article
PT  - Validation Study
PL  - United States
TA  - Curr Protoc Hum Genet
JT  - Current protocols in human genetics
JID - 101287858
SB  - IM
MH  - *Chromosome Deletion
MH  - Chromosomes, Human, Pair 5/*genetics
MH  - Humans
MH  - In Situ Hybridization, Fluorescence/*methods/*standards
MH  - Leukemia, Myeloid, Acute/diagnosis/*genetics
MH  - *Monosomy
MH  - Myelodysplastic Syndromes/diagnosis/*genetics
OTO - NOTNLM
OT  - DNA probe validation
OT  - chromosome 5 deletion
OT  - cytogenetics analysis
OT  - fluorescence in situ hybridization
OT  - method validation
OT  - monosomy 5
EDAT- 2020/01/11 06:00
MHDA- 2021/05/18 06:00
CRDT- 2020/01/11 06:00
PHST- 2020/01/11 06:00 [entrez]
PHST- 2020/01/11 06:00 [pubmed]
PHST- 2021/05/18 06:00 [medline]
AID - 10.1002/cphg.96 [doi]
PST - ppublish
SO  - Curr Protoc Hum Genet. 2020 Mar;105(1):e96. doi: 10.1002/cphg.96.