2017 Volume 27 Issue 1 Pages 1-6
The detection and quantitation of glycosylphosphatidylinositol (GPI) anchor type membrane protein by flow cytometry (FCM) is defined in the diagnosis of paroxymal nocturnal hemoglobinuria (PNH) and is performed as insurance reimbursed test in Japan. However, the sensitivity of this test is 1% and does not meet the requirements for detecting trace amount of PNH clone inbone marrow failure. Therefore, we have performed preliminary study on highly sensitive method for detecting PNH clone that is in compliance with the International Clinical Cytometry Society (ICCS) guideline.
Preliminary results indicated that the PNH clone ratio (RBC, granulocyte and monocyte) for healthy individual was less than 0.01%. This result is in compliance with the sensitivity specified in ICCS guideline which is 0.01%. Furthermore, the validity of the results were backed by testing PNH series survey samples from Collage of American Pathologists (CAP).However, confirmation by re-testing was recommended for samples around 0.01% due to low reproducibility.
With the results obtained from this preliminary study, this test was modified to standard operational testing format. The utility of this new testing method was shown to be useful using clinical samples.
