PMID- 36961441
OWN - NLM
STAT- MEDLINE
DCOM- 20231206
LR  - 20231217
IS  - 1536-4798 (Electronic)
IS  - 0277-3740 (Print)
IS  - 0277-3740 (Linking)
VI  - 43
IP  - 1
DP  - 2024 Jan 1
TI  - Novel Application of Immunochromatographic Assay for Measurement of Total Tear 
      Immunoglobulin E.
PG  - 13-17
LID - 10.1097/ICO.0000000000003267 [doi]
AB  - PURPOSE: The aim of this study was to evaluate the efficacy of a new 
      immunochromatographic assay (Aifeice) in the diagnosis of allergic conjunctivitis 
      diseases (ACDs) and to explore the relationship between Aifeice testing results 
      and the severity of ACDs. METHODS: A multicenter prospective cross-sectional 
      study (390 patients diagnosed with ACDs and 619 healthy controls) was conducted. 
      Patients with ACDs were scored based on clinical symptoms. All participants 
      received the Aifeice test. The positive testing results were further divided into 
      3 immunoglobulin E (IgE) grades. Statistical analysis was performed to evaluate 
      the indexes associated with the testing results. RESULTS: The sensitivity, 
      specificity, positive predictive value, negative predictive value, and total 
      coincidence rate of the Aifeice test were 96.15%, 98.87%, 98.17%, 97.61%, and 
      97.82%, respectively. The total clinical score was significantly correlated with 
      the IgE grade. The factors that affected the IgE score were conjunctival 
      hyperemia, conjunctival swelling, conjunctival papillae, and Horner-Trantas dots. 
      CONCLUSIONS: The high sensitivity and specificity of Aifeice in the diagnosis of 
      ACD was confirmed. This new immunochromatographic assay could be used to assess 
      the severity of ACD.
CI  - Copyright (c) 2023 The Author(s). Published by Wolters Kluwer Health, Inc.
FAU - Liu, Xuhui
AU  - Liu X
AD  - Department of Ophthalmology, Beijing Chaoyang Hospital, Capital Medical 
      University, Beijing, China.
FAU - Wang, Gaixin
AU  - Wang G
AD  - Department of Ophthalmology, Shijiazhuang No. 2 Hospital, Hebei, China.
FAU - He, Jiwu
AU  - He J
AD  - Department of Ophthalmology, Xiangyang No. 1 People's Hospital, Hubei, China.
FAU - Xu, Yunqiang
AU  - Xu Y
AD  - Department of Clinical Laboratories, Shijiazhuang No. 2 Hospital, Hebei, China.
FAU - Yang, Jinbo
AU  - Yang J
AD  - Department of Clinical Laboratories, Xiangyang No. 1 People's Hospital, Hubei, 
      China.
FAU - Qian, Zhuyun
AU  - Qian Z
AD  - Department of Ophthalmology, Beijing Chaoyang Hospital, Capital Medical 
      University, Beijing, China.
AD  - Key Laboratory Jointly Built by the National Institute for Viral Disease Control 
      and Prevention of China Center for Disease Control and Prevention and Beijing 
      GIANTMED Medical Diagnostics Lab, Beijing, China; and.
AD  - Beijing GIANTMED Medical Diagnostics Lab, Beijing, China.
FAU - Tao, Yong
AU  - Tao Y
AD  - Department of Ophthalmology, Beijing Chaoyang Hospital, Capital Medical 
      University, Beijing, China.
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
DEP - 20230324
PL  - United States
TA  - Cornea
JT  - Cornea
JID - 8216186
RN  - 37341-29-0 (Immunoglobulin E)
SB  - IM
MH  - Humans
MH  - Immunoglobulin E
MH  - Cross-Sectional Studies
MH  - Prospective Studies
MH  - Immunoassay
MH  - *Conjunctivitis, Allergic/diagnosis
MH  - *Lacerations
MH  - Tears
PMC - PMC10686273
COIS- Conflict of interest: Y.T. has 2 domestic patents (ZL 2016 1 0403954.6 and ZL 
      2016 1 0404661.X, method and apparatus for using LAMP in examination of pathogens 
      in the intraocular fluids) assigned to the Beijing Chaoyang Hospital which have 
      been licensed to Beijing GiantMed Diagnostic Corp (Beijing, China). Y.T. is stock 
      equity holder of Beijing GiantMed Diagnostic Corp. Zhide Mingchuang Biotechnology 
      Corp is wholly owned subsidiary of Beijing GiantMed Diagnostic Corp. Z.Q. is 
      employed by Beijing GiantMed Diagnostic Corp. Both Z.Q. and Y.T. stand to gain 
      financially from the publication of these results. This does not alter our 
      adherence to the policies of Cornea on sharing data and materials.
EDAT- 2023/03/25 06:00
MHDA- 2023/12/06 06:42
PMCR- 2023/11/29
CRDT- 2023/03/24 11:13
PHST- 2022/09/28 00:00 [received]
PHST- 2023/01/22 00:00 [accepted]
PHST- 2023/12/06 06:42 [medline]
PHST- 2023/03/25 06:00 [pubmed]
PHST- 2023/03/24 11:13 [entrez]
PHST- 2023/11/29 00:00 [pmc-release]
AID - 00003226-202401000-00003 [pii]
AID - CORNEA-D-22-00797 [pii]
AID - 10.1097/ICO.0000000000003267 [doi]
PST - ppublish
SO  - Cornea. 2024 Jan 1;43(1):13-17. doi: 10.1097/ICO.0000000000003267. Epub 2023 Mar 
      24.