PMID- 37296687
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20230612
IS  - 2075-4418 (Print)
IS  - 2075-4418 (Electronic)
IS  - 2075-4418 (Linking)
VI  - 13
IP  - 11
DP  - 2023 May 24
TI  - Lot-to-Lot Variance in Immunoassays-Causes, Consequences, and Solutions.
LID - 10.3390/diagnostics13111835 [doi]
LID - 1835
AB  - Immunoassays, which have gained popularity in clinical practice and modern 
      biomedical research, play an increasingly important role in quantifying various 
      analytes in biological samples. Despite their high sensitivity and specificity, 
      as well as their ability to analyze multiple samples in a single run, 
      immunoassays are plagued by the problem of lot-to-lot variance (LTLV). LTLV 
      negatively affects assay accuracy, precision, and specificity, leading to 
      considerable uncertainty in reported results. Therefore, maintaining consistency 
      in technical performance over time presents a challenge in reproducing 
      immunoassays. In this article, we share our two-decade-long experience and delve 
      into the reasons for and locations of LTLV, as well as explore methods to 
      mitigate its effects. Our investigation identifies potential contributing 
      factors, including quality fluctuation in critical raw materials and deviations 
      in manufacturing processes. These findings offer valuable insights to developers 
      and researchers working with immunoassays, emphasizing the importance of 
      considering lot-to-lot variance in assay development and application.
FAU - Luo, Yunyun
AU  - Luo Y
AUID- ORCID: 0000-0002-4515-5888
AD  - Biomarkers and Research, Nordic Bioscience, 2730 Herlev, Denmark.
FAU - Pehrsson, Martin
AU  - Pehrsson M
AD  - Biomarkers and Research, Nordic Bioscience, 2730 Herlev, Denmark.
FAU - Langholm, Lasse
AU  - Langholm L
AUID- ORCID: 0000-0003-0549-5797
AD  - Biomarkers and Research, Nordic Bioscience, 2730 Herlev, Denmark.
FAU - Karsdal, Morten
AU  - Karsdal M
AD  - Biomarkers and Research, Nordic Bioscience, 2730 Herlev, Denmark.
FAU - Bay-Jensen, Anne-Christine
AU  - Bay-Jensen AC
AUID- ORCID: 0000-0001-7952-9297
AD  - Biomarkers and Research, Nordic Bioscience, 2730 Herlev, Denmark.
FAU - Sun, Shu
AU  - Sun S
AD  - Biomarkers and Research, Nordic Bioscience, 2730 Herlev, Denmark.
LA  - eng
PT  - Journal Article
PT  - Review
DEP - 20230524
PL  - Switzerland
TA  - Diagnostics (Basel)
JT  - Diagnostics (Basel, Switzerland)
JID - 101658402
PMC - PMC10252387
OTO - NOTNLM
OT  - critical quality attributes
OT  - immunoassay
OT  - lot-to-lot variance
OT  - quality control
COIS- Y.L., M.P., L.A., S.S., A.-C.B.-J. and M.K. are full-time employees of Nordic 
      Bioscience. The authors declare no conflict of interest.
EDAT- 2023/06/10 15:13
MHDA- 2023/06/10 15:14
PMCR- 2023/05/24
CRDT- 2023/06/10 01:02
PHST- 2023/03/25 00:00 [received]
PHST- 2023/05/05 00:00 [revised]
PHST- 2023/05/23 00:00 [accepted]
PHST- 2023/06/10 15:14 [medline]
PHST- 2023/06/10 15:13 [pubmed]
PHST- 2023/06/10 01:02 [entrez]
PHST- 2023/05/24 00:00 [pmc-release]
AID - diagnostics13111835 [pii]
AID - diagnostics-13-01835 [pii]
AID - 10.3390/diagnostics13111835 [doi]
PST - epublish
SO  - Diagnostics (Basel). 2023 May 24;13(11):1835. doi: 10.3390/diagnostics13111835.