Letters, 11/14

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Jeffrey Gilbert, MD
Medical Director, STIs

Frank Buccini, MS
Director of Molecular Diagnostics

BioReference Laboratories
Elmwood Park, NJ

Genomic testing and the LIS

In “Why LIS limitations shouldn’t inhibit genomic testing” (Newsbytes, September 2014), Lynn Bry, MD, PhD, said “outside of the upfront sample handling and getting results out the door and billing for it, you probably aren’t going to be able to handle the intermediate steps with current lab information systems.” This continues to be true for many vendors, but in December 2013 Sunquest Information Systems released a complex testing workflow application, completely integrated with the core laboratory information system, that supports genotyping and is well suited to handle the wet bench work of sequencing applications.

This year, Sunquest made a strategic investment in GeneInsight, an IT platform company that streamlines the analysis, interpretation, and reporting of complex genetic test results. Sunquest and GeneInsight are teaming up to offer clients a complete genetics workflow, with integration enabling the exchange of structured information.

It is the case that “Some companies have developed laboratory information management systems to support complex sequencing in a research setting, ‘but what they often lack is the capacity to operate effectively in a CLIA laboratory.’” Sunquest and GeneInsight have been operating in a clinical setting for years and are both registered class I exempt medical devices. Let Sunquest be the first to say, “Here’s a solution that’s going to help you with your complex genomic testing.”

Megan Schmidt
Director, Product Strategy
Sunquest Information Systems

■ Lynn Bry, MD, PhD, medical director and associate pathologist at Brigham and Women’s Hospital, Harvard Medical School, replies: BWH is a founding institution of Partners Healthcare, a majority shareholder in the GeneInsight application. I was aware of the potential partnership between GeneInsight and Sunquest but unable to discuss it at the Pathology Informatics 2014 conference, and later when interviewed by CAP TODAY, as the agreement was still under negotiation. The features offered by GeneInsight cover variant calling from processed sequences, curation of content for evaluating the variants, generation of reports, and data transmission to other clinical systems. Integrating these and earlier stages of bioinformatic processing with clinical information systems will further support genomic analyses in clinical laboratories.

TRALI

Your article on TRALI (October 2014) reported that the BloodCenter of Wisconsin is one of a few laboratories that do most of the human neutrophil antigen testing through their own laboratory-developed tests. As the manager of one of the laboratories that does this HNA testing, I was surprised you named only the BloodCenter of Wisconsin. Our laboratory at the American Red Cross deserved mention also for the following reasons, among others.

The Neutrophil Laboratory at the American Red Cross was developed by Jeffrey McCullough, MD, in 1985. Dr. McCullough along with Dave Stroncek, MD, also a former laboratory director, have been world leaders in the research of neutrophil testing and TRALI investigations for decades. Dr. McCullough was the primary author of Granulocyte Serology: A Clinical and Laboratory Guide (ASCP Press, 1988), which is still used today as a source for laboratory methods linked with HNA laboratory analysis.

Our laboratory and the lab at the BloodCenter of Wisconsin are the only two neutrophil laboratory members in the U.S. associated with the International Society of Blood Transfusion Working Party on Granulocyte Immunobiology. Both of the labs participate in the quality assurance exercises distributed by the International Granulocyte Immunology Workshops (IGIW). The American Red Cross Neutrophil Laboratory is one of four reference laboratories in the IGIW that organize and distribute these QA samples. (The others are in Bristol, U.K., Hagen, Germany, and Amsterdam, the Netherlands.)

The IGIW has recommended a combination of the granulocyte immunofluorescence test (GIFT) and the granulocyte agglutination test (GAT) when detecting and identifying HNA antibodies (Transfusion. 1997;37:977–983; Transfusion. 2002;42:462–468; Vox Sang. 2013;105:259–269). The American Red Cross is the only neutrophil lab in the U.S. that routinely tests all donors and patients for both GAT and GIFT. All other neutrophil laboratories in the U.S. routinely screen samples for HNA antibody by GIFT.

Your article referred to the four-year prospective study led by Pearl Toy, MD, as the seminal investigation in TRALI (Blood. 2012;119[7]:1757–1767). Dr. Toy named our laboratory the neutrophil laboratory to perform all HNA antibody testing for this National Heart, Lung and Blood Institute SCCOR study.

Randy M. Schuller
Neutrophil and Platelet
Immunology Laboratory Manager
Mid-America Blood Services Division
American Red Cross
Saint Paul, Minn.

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