Application of traditional clinical pathology quality control techniques to molecular pathology

Shu Ling Liang, Ming-Tseh Lin, Michael J. Hafez, Christopher Gocke, Kathleen M. Murphy, Lori J Sokoll, James Eshleman

Research output: Contribution to journalArticle

Abstract

Many molecular diagnostic laboratories have evolved from research laboratories, initially performing low numbers of homebrew assays, but many laboratories now perform more kit-based assays, with ever increasing test volumes. One such assay is assessment of bone marrow transplantation engraftment. Allogeneic bone marrow transplantation is performed primarily in the treatment of hematological malignancies. Monitoring of engraftment was traditionally evaluated using minisatellites (variable number tandem repeats) and Southern blotting, but most laboratories now use Food and Drug Administration-cleared microsatellite (short tandem repeats) kits to assess the extent of engraftment. With the increase in equipment reliability, the use of kit-based assays, and the desire to provide the highest quality clinical data, we began applying traditional clinical pathology quality control tools to the molecular diagnostics laboratory. In this study, we demonstrate this approach using a microsatellite-based bone marrow engraftment assay. We analyzed control samples (pure and mixed) for two different microsatellites to establish quality control parameters and constructed Levey-Jennings charts to monitor both the precision and accuracy of this assay. By incorporating these tools into an overall quality assurance program, a laboratory can identify systematic errors and perform corrective actions before actual assay failure, thereby improving the quality of patient care.

Original languageEnglish (US)
Pages (from-to)142-146
Number of pages5
JournalJournal of Molecular Diagnostics
Volume10
Issue number2
DOIs
StatePublished - Mar 2008

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Clinical Pathology
Molecular Pathology
Quality Control
Microsatellite Repeats
Minisatellite Repeats
Bone Marrow Transplantation
Quality of Health Care
Homologous Transplantation
Hematologic Neoplasms
United States Food and Drug Administration
Southern Blotting
Patient Care
Bone Marrow
Equipment and Supplies
Research

ASJC Scopus subject areas

  • Molecular Biology

Cite this

Application of traditional clinical pathology quality control techniques to molecular pathology. / Liang, Shu Ling; Lin, Ming-Tseh; Hafez, Michael J.; Gocke, Christopher; Murphy, Kathleen M.; Sokoll, Lori J; Eshleman, James.

In: Journal of Molecular Diagnostics, Vol. 10, No. 2, 03.2008, p. 142-146.

Research output: Contribution to journalArticle

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