Flow Cytometry Validation Protocol

The first document that should be established, when setting up a flow cytometry laboratory is a Validation Protocol.  This will be the master document to follow when preparing to test samples using a flow cytometer.

Components of Flow Cytometry QC should include:

1.  Instrument Control

a: Optical alignment (Daily)

b. Standardized optimal detector voltages (Daily)

c. Sensitivity and linearity (Initially and monthly, thereafter)

d. Compensation (Daily but can be validated and shown to be stable over a one week period)

e. Correlation studies, if applicable.

2.  Antibody Control

a.  Must monitor and verify that fluorescence is consistent, in a normal sample and on a day to day basis

3.  Reagent Control

a.  Must also monitor and parallel all reagents used in testing.

4.  Procedural control – Monitors the sample preparation methods.

5. Specimen integrity verifications – This is a requirement that all samples be evaluated for suitability for analysis.  If the viability is low it is necessary to comment on it’s suitability for analysis.

6.  Patient QC  – Prior to reporting, the identity of the results needs to be able to be verified and tracked.

There are many details of all of the reagents and QC materials used in all of these areas of testing for quality, but suffice it to say that in order to validate flow cytometric analysis in your lab you must:

 

Say what you will do:  Validation Protocol,

 

and more importantly:

Do What You Say

 

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