scope:

This document establishes performance guidelines for applying the science of flow cytometry (FCM) to RBC diagnostic testing. It provides guidelines for:

• Specimen collection, handling, and storage

• Procedures for calibrating instruments

• Procedures for QC of blood samples

Specific sections are dedicated to:

• Paroxysmal nocturnal hemoglobinuria (PNH)

• Diseases of RBC shape, including hereditary spherocytosis (HS)

• Detection of fetomaternal hemorrhage (FMH)

• Detection of nucleated RBCs (NRBCs)

This document is intended for use by laboratory practitioners, in vitro diagnostic (IVD) device manufacturers concerned with quality laboratory medicine practice, and regulators responsible for clearance of new diagnostic devices and quality laboratory medicine practice.

While there are many other RBC applications, particularly in the area of blood transfusion science or immunohematology, they will not be addressed in this guideline. In addition, it is beyond the scope of this document to establish general performance criteria and reference intervals. Therefore, it is each laboratory's responsibility to establish instrument performance criteria and staining characteristics for its own specific reagents.