- Email: [email protected]
Comments on “Proceedings of the Task Force on Guidelines for Standardizing old and new Technologies used for the Diagnosis and Treatment of allergic Diseases”
Correspondence Comments on “Proceedings of the Task Force on Guidelines for Standardizing old and new Technologies used for the Diagnosis and Treatment of allergic Diseases” To the Editor:
The Health Industry Manufacturers Association (HIMA) and its Allergy In Vitro Diagnostics Task Force (AIVDTF) read with great interest the Proceedings of the Task Force on Guidelines for Standardizing Old and New Technologies Usedfor the Diagnosis and Treatment of Allergic Diseases,
I. L. Bernstein, editor (J ALLERGYCLIN IMMUNOL1988; 82:487-526).
The Task Force of the National Institute of Allergy and Infectious Diseases (NIAID) should be congratulated for undertaking such a herculean task in an area fraught with controversy. We are pleased that the Task Force tried to contrast in vitro with in vivo diagnostic procedures. The open criticism of the skin testing techniques, consideredby many to be the “gold standard’ of allergy testing, was long overdue and is especially welcomed. As manufacturersof health products, we would like to comment on several of the more important issues raised in the Proceedings.We agree with the Task Force that many issues related to allergy testing are critical. In particular, the use of biologically standardizedallergenic extracts, the developmentof uniform standards,reporting of quantitative results, and the need for proficiency testing programswere discussedby the Task Force, and certain new recommendations were made. But we disagreeand are surprisedthat the Task Forcedid not choose to extend the samerecommendationson these very critical issues to the area of skin testing. The Task Force recommendations,which createa double standard,is unfair to the manufacturersof IVD allergy kits and not in the best interests of the patient. The facts speakfor themselves.Under the Foodand Drug Administration (FDA) regulations, manufacturersof in vitro diagnostic products must obtain allergenic extracts from FDA-licensed sources. In vitro diagnostic products use the sameextracts that are used by practicing physicians for in vivo testing. However, the limiting factor for both in vivo and in vitro testing is the restricted number of standardized extracts on the market today. The strongly worded recommendation of the Task Force for the use of standardized extracts for in vitro products should therefore apply equally to their use for in vivo testing. The document makesrepeatedreferencesto the fact that becauseof a lack of uniform standards, it is difficult to obtain comparableresults for various in vitro IgE antibody assays. This is simply not the case. Recent surveys and programs conducted by the College of American Pathologists (CAP) (The Diagnostic Allergy Survey Set SEA SEB, 1988CAP surveys, College of American Pathologists,copyright 1988, Henry Homburger, MD, CAP chairman, Diagnostic Imaging ResourceCommittee) demonstratesthat mostlaboratoriesandmanufacturers’productscomparevery 138
well with each other quarter after quarter. Should the art of skin testing be subjectedto the samescrutiny, it is doubtful it would fare as well. It is the areaof skin testing that lacks uniform standards,both in test performanceand in grading results. The need for quantitative results is far more acute in skin testing in which results are left to individual, subjective interpretation. Most in vitro techniques yield quantitative results through the use of reference standardsand calibrated instrumentation. Most statesrequire laboratories performing in vitro testing to participate in proficiency testing programs. Many individual users voluntarily participate in other programs, such asthe one administeredby the CAP. The manufacturers of in vitro products welcome an even wider participation, by testing laboratories, in such programs and recommend the institution of similar programsfor the physicians using in vivo diagnostic tests. The Task Force was also concerned about the lack of detailed information regarding various reagents and components of in vitro test kits. Although such data may be of assistanceto researchers,it is of very litle value in clinical settings. Such information is reviewed by the FDA as part of an ongoing inspection program of manufacturing sites. Allergy products are also manufacturedand labeled in accordance with detailed requirements known as the Good Manufacturing Practicesregulation. The diagnosis of an allergic disease, either through in vivo or in vitro technology, involves educatedjudgment on the part of the attending physician. It therefore appears that this area is prime for an extensive user education program. The manufacturersstand ready to discuss with medical and professionalorganizationssuch educationprograms to bring about improved patient care that is both cost effective and consistent with the patient’s needsand the physician’s judgment. HIMA believes that the manufacturersof IVDs will have to be an integral part of any future group that will try to addressthe issuesraised in the NIAID report. The industry possessesa vast store of technical knowledge and performance data on their products. These resourcesshould be used in this effort. We thank you for the opportunity to bring to your attention the views of the manufacturers. Amiram Daniel, PhD Health Industry Manufacturers Association 1030 Fifeenth Street, NW Washington, DC 20005-1598 Reply To the Editor:
The general comments regarding “Proceedings of the Task Force on Guidelines for Standardizing old and new Technologies used for the Diagnosis and Treatment of allergic Diseases” appearedto agree with the overall objectives of the Task Force. It was also reassuringto learn that Dr. Daniel endorsedsome of our conclusions and recommendationsregarding skin testing.
The Health Industry Manufacturers Association (HIMA) and its Allergy In Vitro Diagnostics Task Force (AIVDTF) read with great interest the Proceedings of the Task Force on Guidelines for Standardizing Old and New Technologies Usedfor the Diagnosis and Treatment of Allergic Diseases,
I. L. Bernstein, editor (J ALLERGYCLIN IMMUNOL1988; 82:487-526).
The Task Force of the National Institute of Allergy and Infectious Diseases (NIAID) should be congratulated for undertaking such a herculean task in an area fraught with controversy. We are pleased that the Task Force tried to contrast in vitro with in vivo diagnostic procedures. The open criticism of the skin testing techniques, consideredby many to be the “gold standard’ of allergy testing, was long overdue and is especially welcomed. As manufacturersof health products, we would like to comment on several of the more important issues raised in the Proceedings.We agree with the Task Force that many issues related to allergy testing are critical. In particular, the use of biologically standardizedallergenic extracts, the developmentof uniform standards,reporting of quantitative results, and the need for proficiency testing programswere discussedby the Task Force, and certain new recommendations were made. But we disagreeand are surprisedthat the Task Forcedid not choose to extend the samerecommendationson these very critical issues to the area of skin testing. The Task Force recommendations,which createa double standard,is unfair to the manufacturersof IVD allergy kits and not in the best interests of the patient. The facts speakfor themselves.Under the Foodand Drug Administration (FDA) regulations, manufacturersof in vitro diagnostic products must obtain allergenic extracts from FDA-licensed sources. In vitro diagnostic products use the sameextracts that are used by practicing physicians for in vivo testing. However, the limiting factor for both in vivo and in vitro testing is the restricted number of standardized extracts on the market today. The strongly worded recommendation of the Task Force for the use of standardized extracts for in vitro products should therefore apply equally to their use for in vivo testing. The document makesrepeatedreferencesto the fact that becauseof a lack of uniform standards, it is difficult to obtain comparableresults for various in vitro IgE antibody assays. This is simply not the case. Recent surveys and programs conducted by the College of American Pathologists (CAP) (The Diagnostic Allergy Survey Set SEA SEB, 1988CAP surveys, College of American Pathologists,copyright 1988, Henry Homburger, MD, CAP chairman, Diagnostic Imaging ResourceCommittee) demonstratesthat mostlaboratoriesandmanufacturers’productscomparevery 138
well with each other quarter after quarter. Should the art of skin testing be subjectedto the samescrutiny, it is doubtful it would fare as well. It is the areaof skin testing that lacks uniform standards,both in test performanceand in grading results. The need for quantitative results is far more acute in skin testing in which results are left to individual, subjective interpretation. Most in vitro techniques yield quantitative results through the use of reference standardsand calibrated instrumentation. Most statesrequire laboratories performing in vitro testing to participate in proficiency testing programs. Many individual users voluntarily participate in other programs, such asthe one administeredby the CAP. The manufacturers of in vitro products welcome an even wider participation, by testing laboratories, in such programs and recommend the institution of similar programsfor the physicians using in vivo diagnostic tests. The Task Force was also concerned about the lack of detailed information regarding various reagents and components of in vitro test kits. Although such data may be of assistanceto researchers,it is of very litle value in clinical settings. Such information is reviewed by the FDA as part of an ongoing inspection program of manufacturing sites. Allergy products are also manufacturedand labeled in accordance with detailed requirements known as the Good Manufacturing Practicesregulation. The diagnosis of an allergic disease, either through in vivo or in vitro technology, involves educatedjudgment on the part of the attending physician. It therefore appears that this area is prime for an extensive user education program. The manufacturersstand ready to discuss with medical and professionalorganizationssuch educationprograms to bring about improved patient care that is both cost effective and consistent with the patient’s needsand the physician’s judgment. HIMA believes that the manufacturersof IVDs will have to be an integral part of any future group that will try to addressthe issuesraised in the NIAID report. The industry possessesa vast store of technical knowledge and performance data on their products. These resourcesshould be used in this effort. We thank you for the opportunity to bring to your attention the views of the manufacturers. Amiram Daniel, PhD Health Industry Manufacturers Association 1030 Fifeenth Street, NW Washington, DC 20005-1598 Reply To the Editor:
The general comments regarding “Proceedings of the Task Force on Guidelines for Standardizing old and new Technologies used for the Diagnosis and Treatment of allergic Diseases” appearedto agree with the overall objectives of the Task Force. It was also reassuringto learn that Dr. Daniel endorsedsome of our conclusions and recommendationsregarding skin testing.