Biochemical Tumor Markers: Are New Testing Guidelines Fit for Purpose?

CLSI guidance achieves technical excellence but has some questionable omissions, says Mustafa Barbhuiya

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The CLSI guideline C65 standardizes protein-based oncology diagnostics, focusing on the total testing process for soluble tumor markers.
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CLSI C65 covers ten biochemical tumor markers but omits serum free light chains, crucial for managing plasma cell dyscrasias.
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The guideline emphasizes pre-examination factors, estimating that 70% of lab errors occur during this phase due to specimen quality.
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CLSI C65 does not address molecular techniques, maintaining a divide between biochemical and nucleic acid-based markers.
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Future editions of CLSI C65 should integrate molecular guidelines and address the nuances of radiation therapy monitoring.

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