PMID- 35622670
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20240214
IS  - 2305-6304 (Electronic)
IS  - 2305-6304 (Linking)
VI  - 10
IP  - 5
DP  - 2022 May 17
TI  - Development of a 96-Well Electrophilic Allergen Screening Assay for Skin 
      Sensitization Using a Measurement Science Approach.
LID - 10.3390/toxics10050257 [doi]
LID - 257
AB  - The Electrophilic Allergen Screening Assay (EASA) has emerged as a promising in 
      chemico method to detect the first key event in the adverse outcome pathway (AOP) 
      for skin sensitization. This assay functions by assessing the depletion of one of 
      two probe molecules (4-nitrobenzenethiol (NBT) and pyridoxylamine (PDA)) in the 
      presence of a test compound (TC). The initial development of EASA utilized a 
      cuvette format resulting in multiple measurement challenges such as low 
      throughput and the inability to include adequate control measurements. In this 
      study, we describe the redesign of EASA into a 96-well plate format that 
      incorporates in-process control measurements to quantify key sources of 
      variability each time the assay is run. The data from the analysis of 67 TCs 
      using the 96-well format had 77% concordance with animal data from the local 
      lymph node assay (LLNA), a result consistent with that for the direct peptide 
      reactivity assay (DPRA), an OECD test guideline (442C) protein binding assay. 
      Overall, the measurement science approach described here provides steps during 
      assay development that can be taken to increase confidence of in chemico assays 
      by attempting to fully characterize the sources of variability and potential 
      biases and incorporate in-process control measurements into the assay.
FAU - Petersen, Elijah J
AU  - Petersen EJ
AUID- ORCID: 0000-0001-8215-9127
AD  - Biosystems and Biomaterials Division, Material Measurement Laboratory, National 
      Institute of Standards and Technology (NIST), 100 Bureau Drive, Gaithersburg, MD 
      20899, USA.
FAU - Uhl, Richard
AU  - Uhl R
AD  - Division of Laboratory Sciences, Chemistry, US Consumer Product Safety Commission 
      (CPSC), 5 Research Place, Rockville, MD 20850, USA.
FAU - Toman, Blaza
AU  - Toman B
AD  - Statistical Engineering Division, Information Technology Laboratory, National 
      Institute of Standards and Technology (NIST), 100 Bureau Drive, Gaithersburg, MD 
      20899, USA.
FAU - Elliott, John T
AU  - Elliott JT
AD  - Biosystems and Biomaterials Division, Material Measurement Laboratory, National 
      Institute of Standards and Technology (NIST), 100 Bureau Drive, Gaithersburg, MD 
      20899, USA.
FAU - Strickland, Judy
AU  - Strickland J
AUID- ORCID: 0000-0002-4112-7484
AD  - Inotiv-RTP., 601 Keystone Park Drive, Suite 800, Morrisville, NC 27560, USA.
FAU - Truax, James
AU  - Truax J
AD  - Inotiv-RTP., 601 Keystone Park Drive, Suite 800, Morrisville, NC 27560, USA.
FAU - Gordon, John
AU  - Gordon J
AD  - Division of Toxicology and Risk Assessment, US Consumer Product Safety Commission 
      (CPSC), 5 Research Place, Rockville, MD 20850, USA.
LA  - eng
GR  - HHSN273201500010C/ES/NIEHS NIH HHS/United States
PT  - Journal Article
DEP - 20220517
PL  - Switzerland
TA  - Toxics
JT  - Toxics
JID - 101639637
PMC - PMC9147637
OTO - NOTNLM
OT  - adverse outcome pathway
OT  - direct peptide reactivity assay
OT  - in vitro method
OT  - measurement science
OT  - metrology
OT  - new approach methodology
OT  - skin sensitization
COIS- The authors declare no conflict of interest.
EDAT- 2022/05/28 06:00
MHDA- 2022/05/28 06:01
PMCR- 2022/05/17
CRDT- 2022/05/27 13:03
PHST- 2022/03/31 00:00 [received]
PHST- 2022/04/26 00:00 [revised]
PHST- 2022/05/05 00:00 [accepted]
PHST- 2022/05/27 13:03 [entrez]
PHST- 2022/05/28 06:00 [pubmed]
PHST- 2022/05/28 06:01 [medline]
PHST- 2022/05/17 00:00 [pmc-release]
AID - toxics10050257 [pii]
AID - toxics-10-00257 [pii]
AID - 10.3390/toxics10050257 [doi]
PST - epublish
SO  - Toxics. 2022 May 17;10(5):257. doi: 10.3390/toxics10050257.