WARNING: We do not support Internet Explorer. It is not secure and will not work correctly. Please come back using a newer web browser.

Validation of Assays Performed by Flow Cytometry, 1st Edition

View Sample Pages

CLSI H62

Validation of Assays Performed by Flow Cytometry, 1st Edition

This guideline includes validation strategies for cell-based assays performed by flow cytometry. This guideline also includes recommendations for instrument qualification and standardization and assay optimization. It also covers recommended practices for the examination and postexamination phases.

This edition of the document was corrected in December 2021 and April 2022. Read the full correction notices here, and learn more about our corrections process here.

Member price:

List Price:
Log in/sign up to see price and add to cart

Details

Chairholder: Virginia Litwin, PhD

Date of Publication: October 27, 2021

Order Code PDF: CLSI H62Ed1E
ISBN Number: 978-1-68440-129-1

Order Code Print: CLSI H62Ed1
ISBN Number: 978-1-68440-128-4

Edition: First

Pages: 234

CLSI H62 Abstract

Clinical and Laboratory Standards Institute guideline H62–Validation of Assays Performed by Flow Cytometry focuses primarily on analytical method validation. There are currently no official guidance documents for the validation of assays performed by flow cytometry. Existing guidance for the validation of biochemical methods for quantifying soluble analytes found in plasma, serum, and urine is not fully applicable for quantification and characterization of cellular measurands. Validation of flow cytometry is challenging because the data generated are not derived from a calibration curve and true reference standards are lacking. Additional topics covered in this guideline include instrument qualification and standardization and assay optimization. It also covers recommended practices for the examination and postexamination phases. The recommendations presented in H62 are applicable to a wide range of flow cytometry laboratories, including basic research facilities, biopharmaceutical companies, medical laboratories, and manufacturers. This guideline provides specific recommendations for the appropriate analytical method validation approach based on the intended use of the data and regulatory and accreditation requirements, if any, associated with this use. H62 is designed to assist any laboratory using flow cytometry, as well as manufacturers, in developing, validating, verifying, controlling, analyzing, and implementing fluorescence cell-based assays.

Back to Top

CLSI uses cookies to ensure the best website experience. Continuing without changing cookie settings assumes you consent to our use of cookies on this device. You can change these settings at any time, but that may impair functionality on our websites. Review our privacy policy.

Accept