alexa Evaluation of paroxysmal nocturnal hemoglobinuria screening by flow cytometry through multicentric interlaboratory comparison in four countries.
Biomedical Sciences

Biomedical Sciences

Journal of Biomolecular Research & Therapeutics

Author(s): Debliquis A, WagnerBallon O, Le GarffTavernier M, Fossat C, Chatelain B,

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Abstract OBJECTIVES: Paroxysmal nocturnal hemoglobinuria (PNH) is currently diagnosed by flow cytometry; although highly sensitive, its interpretation and reporting appear as critical as its technique. Thus, we developed a quality control scheme for the French-speaking region based on the international recommendations for PNH screening. METHODS: After a topical workshop, we proposed a 1-year, two-step survey program to any volunteering French-speaking clinical laboratory. The first survey consisted of sending raw data files to evaluate gating and the interpretation strategy of each center. The second stipulated sending fresh whole-blood samples to evaluate the whole process and its practice. RESULTS: Forty-nine participants from voluntary centers returned results for each of the two successive surveys. On virtual survey, 27\% reported false-positive PNH created by immature granulocytes, whereas the minor PNH clone was not detected by 9\%. On fresh survey, 63\% of centers used at least the same six-color combination (CD24, CD14, CD33, CD15, CD45, and fluorescent aerolysin), and nearly 70\% of participants were able to perform a sensitivity test less than 0.1\% on neutrophils. All participants detected the major PNH clone, yet 16\% returned false-positive results for the non-PNH clone case. CONCLUSIONS: We succeeded in rallying numerous French-speaking clinical laboratories for both surveys and in harmonizing the technical practice by highlighting common pitfalls. Copyright© by the American Society for Clinical Pathology. This article was published in Am J Clin Pathol and referenced in Journal of Biomolecular Research & Therapeutics

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