PMID- 30809983
OWN - NLM
STAT- MEDLINE
DCOM- 20190603
LR  - 20200225
IS  - 2234-3814 (Electronic)
IS  - 2234-3806 (Print)
IS  - 2234-3806 (Linking)
VI  - 39
IP  - 4
DP  - 2019 Jul
TI  - Development and Evaluation of an Immunoglobulin Y-Based ELISA for Measuring 
      Prostate Specific Antigen in Human Serum.
PG  - 373-380
LID - 10.3343/alm.2019.39.4.373 [doi]
AB  - BACKGROUND: Measurement of serum prostate specific antigen (PSA) concentrations 
      remains one of the leading methods for diagnosing prostate cancer. We developed 
      and evaluated an immunoglobulin Y (IgY)-based ELISA to measure total PSA (tPSA) 
      concentrations in human serum that could be used as an alternative to 
      commercially available in vitro diagnostic assays that rely on mouse monoclonal 
      IgG. METHODS: A sandwich ELISA based on an anti-PSA IgY antibody was developed. 
      We evaluated the ability of the anti-PSA IgY antibody to detect free and 
      complexed PSA at the same molar ratio. The assay was optimized, and its 
      analytical performance was verified by calculating limit of background (LoB), 
      limit of detection (LoD), and limit of quantification (LoQ). We performed 
      correlation and regression analyses between tPSA concentrations measured by our 
      ELISA and those from commercial assays: Cobas 6000 (Roche Diagnostics, Warszawa, 
      Poland) and PSA total ELISA (IBL International, Hamburg, Germany). RESULTS: LoB, 
      LoD, and LoQ, were 0.061, 0.083, and 0.100 ng/mL, respectively, and linearity 
      range was 0.100-3.375 ng/mL. tPSA concentrations from our IgY-based ELISA 
      strongly correlated with those from the commercial assays. CONCLUSIONS: Our 
      IgY-based ELISA is an efficient equivalent to the above commercial assays. The 
      use of IgY as the detecting agent could reduce the risk of false positive 
      results, as well as decrease the overall cost of analysis.
CI  - (c) The Korean Society for Laboratory Medicine.
FAU - Lupicka-Slowik, Agnieszka
AU  - Lupicka-Slowik A
AUID- ORCID: 0000-0002-5593-5167
AD  - Faculty of Chemistry, Division of Medicinal Chemistry and Microbiology, Wroclaw 
      University of Science and Technology, Wroclaw, Poland.
FAU - Grzywa, Renata
AU  - Grzywa R
AUID- ORCID: 0000-0002-4064-2409
AD  - Faculty of Chemistry, Division of Medicinal Chemistry and Microbiology, Wroclaw 
      University of Science and Technology, Wroclaw, Poland.
FAU - Leporowska, Ewa
AU  - Leporowska E
AUID- ORCID: 0000-0001-5193-8697
AD  - Greater Poland Cancer Centre, Department of Laboratory Diagnostics, Poznan, 
      Poland.
FAU - Procyk, Danuta
AU  - Procyk D
AUID- ORCID: 0000-0002-7577-5340
AD  - Greater Poland Cancer Centre, Department of Laboratory Diagnostics, Poznan, 
      Poland.
FAU - Oleksyszyn, Jozef
AU  - Oleksyszyn J
AUID- ORCID: 0000-0002-6696-6129
AD  - Faculty of Chemistry, Division of Medicinal Chemistry and Microbiology, Wroclaw 
      University of Science and Technology, Wroclaw, Poland.
FAU - Sienczyk, Marcin
AU  - Sienczyk M
AUID- ORCID: 0000-0002-5528-5264
AD  - Faculty of Chemistry, Division of Medicinal Chemistry and Microbiology, Wroclaw 
      University of Science and Technology, Wroclaw, Poland. 
      marcin.sienczyk@pwr.edu.pl.
LA  - eng
GR  - LIDER/08/90/l-1/09/NCBiR/2010/National Center for Research and Development/Poland
GR  - 0401/0145/18/PWr/Politechnika Wroclawska/Poland
GR  - 399/2016/KNOW/KNOW/Krajowy Naukowy Osrodek Wiodacy/Poland
PT  - Journal Article
PL  - Korea (South)
TA  - Ann Lab Med
JT  - Annals of laboratory medicine
JID - 101571172
RN  - 0 (Antibodies)
RN  - 0 (IgY)
RN  - 0 (Immunoglobulins)
RN  - EC 3.4.21.77 (Prostate-Specific Antigen)
SB  - IM
MH  - Aged
MH  - Antibodies/immunology
MH  - Enzyme-Linked Immunosorbent Assay/*methods
MH  - Humans
MH  - Immunoglobulins/*immunology
MH  - Limit of Detection
MH  - Male
MH  - Middle Aged
MH  - Prostate-Specific Antigen/*blood/immunology
MH  - Prostatic Neoplasms/diagnosis
MH  - Regression Analysis
PMC - PMC6400723
OTO - NOTNLM
OT  - Immunoglobulin Y
OT  - In vitro diagnostics
OT  - Performance
OT  - Prostate cancer
OT  - Prostate specific antigen
OT  - Sandwich ELISA
COIS- No potential conflicts of interest relevant to this article were reported. The 
      authors have no other relevant affiliations or financial involvement with any 
      organization or entity with a financial interest in or financial conflict with 
      the subject matter or materials discussed in the manuscript apart from those 
      disclosed. No writing assistance was utilized in the production of this 
      manuscript.
EDAT- 2019/02/28 06:00
MHDA- 2019/06/04 06:00
PMCR- 2019/07/01
CRDT- 2019/02/28 06:00
PHST- 2018/09/12 00:00 [received]
PHST- 2018/11/20 00:00 [revised]
PHST- 2019/02/05 00:00 [accepted]
PHST- 2019/02/28 06:00 [entrez]
PHST- 2019/02/28 06:00 [pubmed]
PHST- 2019/06/04 06:00 [medline]
PHST- 2019/07/01 00:00 [pmc-release]
AID - 39.373 [pii]
AID - 10.3343/alm.2019.39.4.373 [doi]
PST - ppublish
SO  - Ann Lab Med. 2019 Jul;39(4):373-380. doi: 10.3343/alm.2019.39.4.373.