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In order to enhance the translation of stem cell based therapies into the clinic, methods that permit the non-invasive characterisation of stem cell cultures prior to their end point are required.
Strengths include the fact that the study was designed from the perspective of hospital administrators responsible for operating budgets interested in the costs and benefits of using a newer reprocessor relative to their existing equipment; as such, actual clinic procedures were recorded by an unbiased, third-party observer and actual clinic methods and costs were incorporated.
At high SAA concentrations the CV of the in-clinic method for inter-assay variation was 12%, which is acceptable for clinical purposes considering the biological behaviour of SAA.
The stability of SAA with the in-clinic method was not evaluated.
Intra- and inter- assay variation of the in-clinic method was determined.
The in-clinic method was previously reported to have an acceptable linearity under dilution [ 17].
The imprecision of the in-clinic method was acceptable at high SAA concentrations but not at low concentrations.
Only 11 samples (18%) had SAA concentrations of 10-270 mg/L with the in-clinic method.
The in-clinic method (EVA1) results were compared to a reference method (Eiken LZ SAA) with 62 patient samples.
We remunerated each group practice, minimum 3 physicians with a focus on obstetrics, participating in the fax or in-clinic method (see following) $250/month.
It is recommended that each laboratory using the in-clinic method evaluate their own imprecision at different concentrations, and also determine reference values and cut off values.
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