SPOT/Dx Pilot Reanalysis and College of American Pathologists Proficiency Testing for <i>KRAS</i> and <i>NRAS</i> Demonstrate Excellent Laboratory Performance-Reference-Cited by-同舟云学术

SPOT/Dx Pilot Reanalysis and College of American Pathologists Proficiency Testing for KRAS and NRAS Demonstrate Excellent Laboratory Performance

Published:2023-09-30 Issue:2 Volume:148 Page:139-148
ISSN:1543-2165
Container-title:Archives of Pathology & Laboratory Medicine
language:en
Short-container-title:

Author:

Zehir Ahmet¹,Nardi Valentina²,Konnick Eric Q.³,Lockwood Christina M.³,Long Thomas A.⁴,Sidiropoulos Nikoletta⁵,Souers Rhona J.⁴,Vasalos Patricia⁶,Lindeman Neal I.⁷,Moncur Joel T.⁸

Affiliation:

1. From the Department of Pathology and Laboratory Medicine, Memorial Sloan Kettering Cancer Center, New York, New York (Zehir)

2. the Department of Pathology, Massachusetts General Hospital, Mass General Brigham, Harvard Medical School, Boston (Nardi)

3. the Department of Laboratory Medicine and Pathology, University of Washington, Seattle (Konnick, Lockwood)

4. Biostatistics (Long, Souers) Departments, College of American Pathologists, Northfield, Illinois

5. Pathology and Laboratory Medicine, University of Vermont Medical Center, Larner College of Medicine at the University of Vermont, Burlington (Sidiropoulos)

6. Proficiency Testing (Vasalos) Departments, College of American Pathologists, Northfield, Illinois

7. the Department of Pathology, Weill Cornell Medicine, New York, New York (Lindeman)

8. the Office of the Director, The Joint Pathology Center, Silver Spring, Maryland (Moncur)

Abstract

Context.— The Sustainable Predictive Oncology Therapeutics and Diagnostics quality assurance pilot study (SPOT/Dx pilot) on molecular oncology next-generation sequencing (NGS) reportedly demonstrated performance limitations of NGS laboratory-developed tests, including discrepancies with a US Food and Drug Administration–approved companion diagnostic. The SPOT/Dx pilot methods differ from those used in proficiency testing (PT) programs. Objective.— To reanalyze SPOT/Dx pilot data using PT program methods and compare to PT program data. Also see p. 136. Design.— The College of American Pathologists (CAP) Molecular Oncology Committee reanalyzed SPOT/Dx pilot data applying PT program methods, adjusting for confounding conditions, and compared them to CAP NGS PT program performance (2019–2022). Results.— Overall detection rates of KRAS and NRAS single-nucleotide variants (SNVs) and multinucleotide variants (MNVs) by SPOT/Dx pilot laboratories were 96.8% (716 of 740) and 81.1% (129 of 159), respectively. In CAP PT programs, the overall detection rates for the same SNVs and MNVs were 97.2% (2671 of 2748) and 91.8% (1853 of 2019), respectively. In 2022, the overall detection rate for 5 KRAS and NRAS MNVs in CAP PT programs was 97.3% (1161 of 1193). Conclusions.— CAP PT program data demonstrate that laboratories consistently have high detection rates for KRAS and NRAS variants. The SPOT/Dx pilot has multiple design and analytic differences with established PT programs. Reanalyzed pilot data that adjust for confounding conditions demonstrate that laboratories proficiently detect SNVs and less successfully detect rare to never-observed MNVs. The SPOT/Dx pilot results are not generalizable to all molecular oncology testing and should not be used to market products or change policy affecting all molecular oncology testing.

Publisher

Archives of Pathology and Laboratory Medicine

Subject

Medical Laboratory Technology,General Medicine,Pathology and Forensic Medicine

Link

https://meridian.allenpress.com/aplm/article-pdf/148/2/139/3322732/i1543-2165-148-2-139.pdf

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