PMID- 27910018
OWN - NLM
STAT- MEDLINE
DCOM- 20180112
LR  - 20180423
IS  - 1940-6029 (Electronic)
IS  - 1064-3745 (Linking)
VI  - 1541
DP  - 2017
TI  - Fluorescence In Situ Hybridization Probe Validation for Clinical Use.
PG  - 101-118
AB  - In this chapter, we provide a systematic overview of the published guidelines and 
      validation procedures for fluorescence in situ hybridization (FISH) probes for 
      clinical diagnostic use. FISH probes-which are classified as molecular probes or 
      analyte-specific reagents (ASRs)-have been extensively used in vitro for both 
      clinical diagnosis and research. Most commercially available FISH probes in the 
      United States are strictly regulated by the U.S. Food and Drug Administration 
      (FDA), the Centers for Disease Control and Prevention (CDC), the Centers for 
      Medicare & Medicaid Services (CMS) the Clinical Laboratory Improvement Amendments 
      (CLIA), and the College of American Pathologists (CAP). Although home-brewed FISH 
      probes-defined as probes made in-house or acquired from a source that does not 
      supply them to other laboratories-are not regulated by these agencies, they too 
      must undergo the same individual validation process prior to clinical use as 
      their commercial counterparts. Validation of a FISH probe involves initial 
      validation and ongoing verification of the test system. Initial validation 
      includes assessment of a probe's technical specifications, establishment of its 
      standard operational procedure (SOP), determination of its clinical sensitivity 
      and specificity, development of its cutoff, baseline, and normal reference 
      ranges, gathering of analytics, confirmation of its applicability to a specific 
      research or clinical setting, testing of samples with or without the 
      abnormalities that the probe is meant to detect, staff training, and report 
      building. Ongoing verification of the test system involves testing additional 
      normal and abnormal samples using the same method employed during the initial 
      validation of the probe.
FAU - Gu, Jun
AU  - Gu J
AD  - Cytogenetic Technology Program, School of Health Professions, UT MD Anderson 
      Cancer Center, 1515 Holcombe Blvd., Unit 2, Houston, TX, 77030, USA. 
      jungu@mdanderson.org.
FAU - Smith, Janice L
AU  - Smith JL
AD  - Cytogenetics/FISH Division, Baylor Genetics Laboratories, Department of Molecular 
      and Human Genetics, Baylor College of Medicine, Houston, TX, 77030, USA.
FAU - Dowling, Patricia K
AU  - Dowling PK
AD  - Cytogenetics, Pathline-Emerge Pathology Services, 535 East Crescent Avenue, 
      Ramsey, NJ, 07446, USA.
LA  - eng
PT  - Journal Article
PT  - Review
PL  - United States
TA  - Methods Mol Biol
JT  - Methods in molecular biology (Clifton, N.J.)
JID - 9214969
RN  - 0 (DNA Probes)
SB  - IM
MH  - *DNA Probes/standards
MH  - Guidelines as Topic
MH  - Humans
MH  - In Situ Hybridization, Fluorescence/*methods
MH  - Reproducibility of Results
MH  - Sensitivity and Specificity
OTO - NOTNLM
OT  - BETAINV function
OT  - Cutoff value
OT  - FISH
OT  - Fluorescence in situ hybridization
OT  - Normal range
OT  - Probe
OT  - Sensitivity
OT  - Specificity
OT  - Validation
EDAT- 2016/12/03 06:00
MHDA- 2018/01/13 06:00
CRDT- 2016/12/03 06:00
PHST- 2016/12/03 06:00 [entrez]
PHST- 2016/12/03 06:00 [pubmed]
PHST- 2018/01/13 06:00 [medline]
AID - 10.1007/978-1-4939-6703-2_10 [doi]
PST - ppublish
SO  - Methods Mol Biol. 2017;1541:101-118. doi: 10.1007/978-1-4939-6703-2_10.