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ANA IIF Automation: Moving towards Harmonization? Results of a Multicenter Study.

Abstract Background. Our study aimed to investigate whether the introduction of automated anti-nuclear antibody (ANA) indirect immunofluorescence (IIF) analysis decreases the interlaboratory variability of ANA titer results. Method. Three serum samples were sent to 10 laboratories using the QUANTA-Lyser® in combination with the NOVA View®. Each laboratory performed the ANA IIF analysis 10x in 1 run and 1x in 10 different runs and determined the endpoint titer by dilution. One of the three samples had been sent in 2012, before the era of ANA IIF automation, by the Belgian National External Quality Assessment (EQA) Scheme. Harmonization was evaluated in terms of variability in fluorescence intensity (LIU) and ANA IIF titer. Results. The evaluation of the intra- and interrun LIU variability revealed a larger variability for 2 laboratories, due to preanalytical and analytical problems. Reanalysis of the EQA sample resulted in a lower titer variability. Diluted endpoint titers were similar to the estimated single well titer and the overall median titer as reported by the EQA in 2012. Conclusion. The introduction of automated microscopic analysis allows more harmonized ANA IIF reporting, provided that this totally automated process is controlled by a thorough quality assurance program, covering the total ANA IIF process.
PMID
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Authors

Mayor MeshTerms

Automation, Laboratory

Fluorescent Antibody Technique, Indirect

Keywords
Journal Title journal of immunology research
Publication Year Start




PMID- 28321418
OWN - NLM
STAT- MEDLINE
DA  - 20170321
DCOM- 20170407
LR  - 20170407
IS  - 2314-7156 (Electronic)
IS  - 2314-7156 (Linking)
VI  - 2017
DP  - 2017
TI  - ANA IIF Automation: Moving towards Harmonization? Results of a Multicenter Study.
PG  - 6038137
LID - 10.1155/2017/6038137 [doi]
AB  - Background. Our study aimed to investigate whether the introduction of automated 
      anti-nuclear antibody (ANA) indirect immunofluorescence (IIF) analysis decreases 
      the interlaboratory variability of ANA titer results. Method. Three serum samples
      were sent to 10 laboratories using the QUANTA-Lyser(R) in combination with the
      NOVA View(R). Each laboratory performed the ANA IIF analysis 10x in 1 run and 1x 
      in 10 different runs and determined the endpoint titer by dilution. One of the
      three samples had been sent in 2012, before the era of ANA IIF automation, by the
      Belgian National External Quality Assessment (EQA) Scheme. Harmonization was
      evaluated in terms of variability in fluorescence intensity (LIU) and ANA IIF
      titer. Results. The evaluation of the intra- and interrun LIU variability
      revealed a larger variability for 2 laboratories, due to preanalytical and
      analytical problems. Reanalysis of the EQA sample resulted in a lower titer
      variability. Diluted endpoint titers were similar to the estimated single well
      titer and the overall median titer as reported by the EQA in 2012. Conclusion.
      The introduction of automated microscopic analysis allows more harmonized ANA IIF
      reporting, provided that this totally automated process is controlled by a
      thorough quality assurance program, covering the total ANA IIF process.
FAU - Van den Bremt, Stefanie
AU  - Van den Bremt S
AUID- ORCID: 0000-0002-4352-5208
AD  - Department of Laboratory Medicine, OLV Hospital, Aalst, Belgium.
FAU - Schouwers, Sofie
AU  - Schouwers S
AD  - Department of Laboratory Medicine, GZA Hospitals, Antwerp, Belgium.
FAU - Van Blerk, Marjan
AU  - Van Blerk M
AD  - Scientific Institute of Public Health (WIV-ISP), Brussels, Belgium.
FAU - Van Hoovels, Lieve
AU  - Van Hoovels L
AUID- ORCID: 0000-0002-3462-7288
AD  - Department of Laboratory Medicine, OLV Hospital, Aalst, Belgium.
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
DEP - 20170221
PL  - Egypt
TA  - J Immunol Res
JT  - Journal of immunology research
JID - 101627166
RN  - 0 (Antibodies, Antinuclear)
SB  - IM
MH  - Antibodies, Antinuclear/*blood
MH  - *Automation, Laboratory
MH  - Belgium
MH  - Crohn Disease/*diagnosis/epidemiology
MH  - *Fluorescent Antibody Technique, Indirect/instrumentation/methods
MH  - Humans
MH  - Microscopy, Fluorescence
MH  - Observer Variation
MH  - Quality Assurance, Health Care
MH  - Reproducibility of Results
MH  - Sjogren's Syndrome/*diagnosis/epidemiology
MH  - Technology Assessment, Biomedical
PMC - PMC5339452
COI - The authors declare that they have no competing interests.
EDAT- 2017/03/23 06:00
MHDA- 2017/04/08 06:00
CRDT- 2017/03/22 06:00
PHST- 2016/11/01 [received]
PHST- 2017/01/24 [revised]
PHST- 2017/02/01 [accepted]
AID - 10.1155/2017/6038137 [doi]
PST - ppublish
SO  - J Immunol Res. 2017;2017:6038137. doi: 10.1155/2017/6038137. Epub 2017 Feb 21.

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