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How to Design and Validate a Clinical Flow Cytometry Assay.

Publication ,  Journal Article
Lagoo, AS
Published in: Clin Lab Med
September 2023

Multiparametric flow cytometry assays are long recognized as an essential diagnostic test for leukemias and lymphomas. Lacking Food and Drug Administration-approved standardized tests, these assays remain laboratory developed tests. The recently published guidelines, CLSI H62, are the most detailed and up-to-date instructions for designing and validating clinical flow cytometry assays. This review provides a historical background for the current situation, summarizes key points from the CLSI guidelines, and lists practical points for assay development gained from personal experience.

Duke Scholars

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Published In

Clin Lab Med

DOI

EISSN

1557-9832

Publication Date

September 2023

Volume

43

Issue

3

Start / End Page

333 / 349

Location

United States

Related Subject Headings

  • United States Food and Drug Administration
  • United States
  • Pathology
  • Flow Cytometry
  • 3202 Clinical sciences
  • 1103 Clinical Sciences
 

Citation

APA
Chicago
ICMJE
MLA
NLM
Lagoo, A. S. (2023). How to Design and Validate a Clinical Flow Cytometry Assay. Clin Lab Med, 43(3), 333–349. https://doi.org/10.1016/j.cll.2023.04.004
Lagoo, Anand Shreeram. “How to Design and Validate a Clinical Flow Cytometry Assay.Clin Lab Med 43, no. 3 (September 2023): 333–49. https://doi.org/10.1016/j.cll.2023.04.004.
Lagoo AS. How to Design and Validate a Clinical Flow Cytometry Assay. Clin Lab Med. 2023 Sep;43(3):333–49.
Lagoo, Anand Shreeram. “How to Design and Validate a Clinical Flow Cytometry Assay.Clin Lab Med, vol. 43, no. 3, Sept. 2023, pp. 333–49. Pubmed, doi:10.1016/j.cll.2023.04.004.
Lagoo AS. How to Design and Validate a Clinical Flow Cytometry Assay. Clin Lab Med. 2023 Sep;43(3):333–349.
Journal cover image

Published In

Clin Lab Med

DOI

EISSN

1557-9832

Publication Date

September 2023

Volume

43

Issue

3

Start / End Page

333 / 349

Location

United States

Related Subject Headings

  • United States Food and Drug Administration
  • United States
  • Pathology
  • Flow Cytometry
  • 3202 Clinical sciences
  • 1103 Clinical Sciences