Serum protein electrophoresis project

Serum protein electrophoresis

• Primary role is to detect monoclonal immunoglobulins associated with plasma cell dyscrasias and lymphoproliferative disorders

SPEP report - What do clinicians want?

• Is there a paraprotein?

• What is the isotype and concentration?

• Cumulative reporting – to calculate the response to the therapy/ to monitor the progression of disease or relapse

• Recognition and reporting of oligoclonal and small bands that occur post BM transplant or novel therapy

• Uniform approach to report paraproteins which migrate with normal serum proteins

• Consistent reporting of paraproteins

Why do we need harmonised approach in testing & reporting?

• Remove unwanted variation in inter-laboratory results

• Electronic medical records

• Facilitate better patient management

Clinical guidelines related to plasma cell dyscrasias • Clinical guidelines make little mention of laboratory issues/ variations

• Strict cut-offs for diagnosis and monitoring – absolute value or % change

eg:

Are there any laboratory guidelines/ recommendations in Aus & NZ?

• Recommendations for - Nomenclature

- Detection systems

- Serum protein and albumin quantification

- Quantitative reporting of SPEP fractions

- Quantification small bands and paraproteins co-migrating with other normal proteins in alpha and beta regions

- Serum and urine paraprotein quantification

- Paraprotein characterization

- Laboratory performance of SPEP, UPEP and IFE

- Laboratory expertise and staffing

- Report formats

Do we report comparable SPEP results between labs?

• Yes

• No

• May be

• Don’t know

Mr A – Known patient with IgA kappa MM. On Rx.

What do you think about this patient’s disease progress?

Lab X 1/01/2018

Total Protein 71 g/L

Albumin 37 g/L

Paraprotein Detected

Type IgA kappa

Concentration 4 g/L

Lab Y 1/02/2018

Total Protein 72 g/L

Albumin 38 g/L

Alpha-1 2.6 g/L

Alpha-2 7 g/L

Beta-1 4.4 g/L

Beta-2 6.1 g/L

Paraprotein Detected

Type IgA kappa

Concentration 12 g/L

Total IgA 5 g/L

Comment

This paraprotein was

detected in the beta

region. The reported

concentration

includes both the

paraprotein and

normal beta proteins

(~7 g/L).

What are the areas with significant inter-laboratory variation?

• Quantification of co-migrating paraproteins in the beta/ alpha region

• Quantification / reporting of small bands

• Report formats / comments?

• Nomenclature and units

• Others???

What are the reasons for inter-lab variation?

• Different analytical methods – eg:Capillary Vs Gel, ISUB Vs IFE

• Different techniques of paraprotein quantification – Perpendicular/ tangent skimming/ corrected perpendicular

• Different report formats - ? due to LIS limitations/ clinician preferences/ ?? historical – don’t want to change

• Others??

2017 AACB/ RCPA QAP Protein workshop in Melbourne

• Overview of current clinical guidelines/ updates on plasma cell dyscrasias

• SPEP and SFLC measurements – current lab practice

• New challenges – eg: therapeutic monoclonal Ab interference

• Need for the update of 2012 Australian and NZ recommendations

- Approach to co-migrating paraproteins

- Reporting of small bands

- ? Others

- Survey questionnaire through RCPAQAP

- Paraprotein sample swap

2018 –SPEP sample swap – Victoria

2018 –SPEP sample swap – Victoria

2018 –SPEP sample swap – QLD

2018 –SPEP sample swap – WA

2018 –SPEP sample swap – NSW

Should we harmonise the laboratory testing of plasma cell dyscrasias?