Letters to the editorClarification from HemoCueWe were very pleased and grateful to see mention of our HemoCue Plasma/Low Hb System in the Product Roundup section of the August 2002 issue of MLO. I would, however, like to clarify a statement made concerning the appropriate types of samples that can be analyzed.While it is true that specimens containing intact red blood cells can be utilized, the designed measuring range of the analyzer (0.03-3.0 g/dL) prevents it from being very useful in the typical hematology laboratory. The intended use of the Plasma/Low Hb System is to measure free (plasma) hemoglobin in serum, plasma, and aqueous solutions, not whole blood as stated in the article.Examples of potential use are:To detect moderate to severe in vivo
hemolysis;To quantify free hemoglobin caused by in vitro hemolysis in specimens to be used for the measurement of other analytes (potential interfering substance);As a quality control check on the efficiency of cell washers used in blood salvage procedures;As a quality control check on stored, banked blood products;As a means to calculate blood loss in surgery (used in conjunction with the B-hemoglobin system).In the near future, the measuring range will be expanded to 0-3.0 g/dL and the units will be changed from g/dL to
mg/dL. Carla Matyasz, MT(ASCP)
Training and Education Manager
HemoCue Inc.
South St. Paul, MNHave we lost sight of the critical issues?[The letter below is a response to Anne Pontius October interview with Al DeStefano, president of SIA (Sysmex Infosystems America Inc.)]I really enjoyed your interview with Mr. DeStefano. There were great questions and very interesting answers. I must confess to more than a bit of angst over what the future holds for laboratory medicine and medical technology. As one who learned the profession by memorizing the Folin-Wu technique, and who was in awe of the technology that could produce the counting chamber in a hemocytometer, I find the notion of (easing) the personnel pressures by providing more integrated functionality across the laboratory to provide information in a way that allows the laboratory to focus on the critical issues to be somewhat disconcerting. I learned that the critical issue was performing the test carefully and accurately with strict attention to detail and scrupulous adherence to method and technique. I was taught the importance of walking from the hematology bench to the chemistry workstations to ask my fellow laboratorians if the results I was seeing meshed with the clinical picture revealed by their findings. And, most importantly, I came to understand that all laboratory personnel were vital and critical players in the clinical diagnosis of disease and the implementation of appropriate treatment protocol. We viewed our patients as ill people who needed our help. I am certain that LIS and LAS and HIPAA and HIS are all good things. But dont you think that an important component of the discipline is tragically lost as hands are freed to tend to more critical issues? Sometimes I think more truly is less. Harry L. Grandinett, MT
Supervisor, Marketing and Customer Relations
Medical Laboratory Evaluation Program
Hagerstown, MDMore to the story on Pap smearsIn reference to the cover story that ran in the August 2002 issue of MLO (The Pap smear: A victim of its own success?), I am contacting you on behalf of TriPath Imaging Inc., a company that provides a comprehensive product line for cervical cytology. This cervical cytology solution applies technologies for sample collection, preservation, cell enrichment, slide processing, staining, screening, and image and data management. The Pap smear article provided excellent insights on the litigious aspects of Pap screening and the related impact on the cytology and pathology professions; however, there are a couple of misstatements and omissions in the article. The article states that computer-assisted, automatic scanning devices are used primarily for rescreening Pap smears for quality control and are not yet FDA-approved for primary screening. TriPath does offer an FDA-approved primary screening device called the FocalPoint slide profiler. The FocalPoint is intended for the initial screening of both SurePath liquid-based and conventional Pap smear slides. The FocalPoint system identifies up to 25 percent of processed slides as requiring no further review. In addition, it identifies at least 15 percent of all processed slides for a second (quality control) manual review. (Clinical studies describing performance on SurePath and conventional slides screened by the FocalPoint slide profiler are available in the product inserts which are available online at
www.TriPathImaging.com.)It further states that currently, laboratories are increasingly using thin-layer technology (ThinPrep Pap Test by Cytyc Corp.). While Cytec does offer a thin-layer collection and preparation option, TriPath also offers an FDA-approved thin-layer collection and preparation. TriPath provides an integrated solution that offers a liquid-based, thin-layer collection, preparation and staining system and an automated screening system capable of screening both conventional and SurePath liquid-based slides. The SurePath test pack is the collection kit, the PrepStain slide-processing system prepares and stains the thin-layer, homogenous slides, and the FocalPoint slide profiler system is used for primary screening.TriPath is very pleased to see a published article that brings attention to the mounting legal concerns of Pap smear screening and provides information to its readers on available solutions. Dan Robertson
Senior Product Manager
TriPath Imaging Inc.
Burlington, NC
December 2002: Vol. 34, No. 12©
2002 Nelson Publishing, Inc. All rights reserved.
hemolysis;To quantify free hemoglobin caused by in vitro hemolysis in specimens to be used for the measurement of other analytes (potential interfering substance);As a quality control check on the efficiency of cell washers used in blood salvage procedures;As a quality control check on stored, banked blood products;As a means to calculate blood loss in surgery (used in conjunction with the B-hemoglobin system).In the near future, the measuring range will be expanded to 0-3.0 g/dL and the units will be changed from g/dL to
mg/dL. Carla Matyasz, MT(ASCP)
Training and Education Manager
HemoCue Inc.
South St. Paul, MNHave we lost sight of the critical issues?[The letter below is a response to Anne Pontius October interview with Al DeStefano, president of SIA (Sysmex Infosystems America Inc.)]I really enjoyed your interview with Mr. DeStefano. There were great questions and very interesting answers. I must confess to more than a bit of angst over what the future holds for laboratory medicine and medical technology. As one who learned the profession by memorizing the Folin-Wu technique, and who was in awe of the technology that could produce the counting chamber in a hemocytometer, I find the notion of (easing) the personnel pressures by providing more integrated functionality across the laboratory to provide information in a way that allows the laboratory to focus on the critical issues to be somewhat disconcerting. I learned that the critical issue was performing the test carefully and accurately with strict attention to detail and scrupulous adherence to method and technique. I was taught the importance of walking from the hematology bench to the chemistry workstations to ask my fellow laboratorians if the results I was seeing meshed with the clinical picture revealed by their findings. And, most importantly, I came to understand that all laboratory personnel were vital and critical players in the clinical diagnosis of disease and the implementation of appropriate treatment protocol. We viewed our patients as ill people who needed our help. I am certain that LIS and LAS and HIPAA and HIS are all good things. But dont you think that an important component of the discipline is tragically lost as hands are freed to tend to more critical issues? Sometimes I think more truly is less. Harry L. Grandinett, MT
Supervisor, Marketing and Customer Relations
Medical Laboratory Evaluation Program
Hagerstown, MDMore to the story on Pap smearsIn reference to the cover story that ran in the August 2002 issue of MLO (The Pap smear: A victim of its own success?), I am contacting you on behalf of TriPath Imaging Inc., a company that provides a comprehensive product line for cervical cytology. This cervical cytology solution applies technologies for sample collection, preservation, cell enrichment, slide processing, staining, screening, and image and data management. The Pap smear article provided excellent insights on the litigious aspects of Pap screening and the related impact on the cytology and pathology professions; however, there are a couple of misstatements and omissions in the article. The article states that computer-assisted, automatic scanning devices are used primarily for rescreening Pap smears for quality control and are not yet FDA-approved for primary screening. TriPath does offer an FDA-approved primary screening device called the FocalPoint slide profiler. The FocalPoint is intended for the initial screening of both SurePath liquid-based and conventional Pap smear slides. The FocalPoint system identifies up to 25 percent of processed slides as requiring no further review. In addition, it identifies at least 15 percent of all processed slides for a second (quality control) manual review. (Clinical studies describing performance on SurePath and conventional slides screened by the FocalPoint slide profiler are available in the product inserts which are available online at
www.TriPathImaging.com.)It further states that currently, laboratories are increasingly using thin-layer technology (ThinPrep Pap Test by Cytyc Corp.). While Cytec does offer a thin-layer collection and preparation option, TriPath also offers an FDA-approved thin-layer collection and preparation. TriPath provides an integrated solution that offers a liquid-based, thin-layer collection, preparation and staining system and an automated screening system capable of screening both conventional and SurePath liquid-based slides. The SurePath test pack is the collection kit, the PrepStain slide-processing system prepares and stains the thin-layer, homogenous slides, and the FocalPoint slide profiler system is used for primary screening.TriPath is very pleased to see a published article that brings attention to the mounting legal concerns of Pap smear screening and provides information to its readers on available solutions. Dan Robertson
Senior Product Manager
TriPath Imaging Inc.
Burlington, NC
December 2002: Vol. 34, No. 12©
2002 Nelson Publishing, Inc. All rights reserved.
