AMERICAN JOURNAL OF CLINICAL PATHOLOGY Editorial
Clarity in Communication
Although guidelines2,3 have been proposed detailing what should and should not appear on a report of an antiHIV test, there is some controversy about what is appropriate. For example, should a quantitative value such as absorbance or sample-to-cutofF ratio be included in addition to the interpretation of an EIA screening test as defined in the manufacturer's package insert? Published guidelines3 indicate that it should not be included. These recognize that lot-to-lot variation and differences among manufacturers make it difficult to compare reactive EIA tests results of samples tested at different times or in different laboratories. On the other hand, a physician obtaining repeated samples from a single patient may find that "quantitative" results from a test that has been designed to provide a "qualitative" answer are useful. Part of the problem relates to the setting in which the report is being used. Information from a laboratory supporting a clinical trial unit may be used quite differently than information provided to a physician who is screening an occasional patient for anti-HIV.
that influence the results and how they might apply to diverse patients, it is best that reports not contain information that could be misleading. Qualitative tests should be reported in qualitative terms just as quantitative tests should include normal ranges for the method based on a defined population. The limited information on the report does not preclude providing additional interpretation in a specific clinical situation or setting. In fact, this provides a unique opportunity for the clinical pathologist to serve as a consultant. Failure to use standard nomenclature for HIV was observed in 25% of the reports. I am surprised that this did not occur more frequently because the accepted terminology has changed several times since the virus now called HIV-1 was first identified as lymphodenopathy-associated virus (LAV)5 or human T-cell leukemia/lymphoma-virus (HTLV-III).6 Developing and using standard terminology is helpful to ensure that all practitioners know what test method was used for each agent. The clinical consequences of a confirmed positive test for the acquired immune deficiency syndrome (AIDS), antibody, antiHTLV-III, and anti-HIV-1 are identical; however, there is continued controversy about the criteria needed to classify a western blot as positive rather than indeterminate.7"9 The clinical importance of standardizing terminology was demonstrated dramatically more than 50 years ago when two widely accepted numeric systems for classifying blood groups were used.10 In one system, group AB blood was designated by " I " and group O was "IV," whereas in the other system AB was "IV" and O was "I". Not only did this make clear communication impossible but it was an invitation to disaster. Other features of the report that were evaluated were whether the name of the testing facility appeared (absent in 4%), if the analytical method was identified (absent in 40%), and the use of highlighting to call attention to abnormal results (present in 14%). The differences observed in the format, length, and information on the reports suggests that quality assurance should include evaluation of the output as well as the sample and the analytical process. One way to avoid some of the pitfalls found in this study is to establish a checklist to review the content of all forms and computer-generated output before they are used routinely." After reading the paper by Hewitt and associates,1 I
An analogous situation is observed in following antiD titers during pregnancy. It has been well demonstrated that the same sample tested in multiple laboratories gives a wide range of results.4 Similarly, the same sample tested in one laboratory by different methods (i.e., enzyme or antiglobulin) may result in different end-point values. Thus a titer of 1:32 obtained in one setting has a different clinical significance than the same titer obtained elsewhere. Because it is impossible to include all the variables
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In this issue of the American Journal of Clinical Pathology, Hewitt and associates1 evaluated the content and design of reports on results of anti-human immunodeficiency virus type 1 (HIV-1) testing on a set of three samples sent to randomly selected public health (PH) and non-public health (NPH) laboratories in California. The primary issue examined was the clarity of the message. It is clear from this study that "static" is common when anti-HIV test results are reported. In the worst-case example, a negative anti-HIV-1 supplemental test, 23% of PH and 73% of NPH laboratories included extraneous information on the report. In the best case examined, an enzyme immunoassay (EIA)-negative sample, none of the PH and 44% of the NPH laboratories included statements related to the quality of the specimen or that affected the interpretation of test results.
AMERICAN JOURNAL OF CLINICAL PATHOLOGY
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Editorial wondered what would be revealed if all the reports issued by laboratories were subjected to similar scrutiny. Is the analytical result provided to the end user clear, concise, and appropriate? Do the format and content of the messages we send reflect the same care and concern we have used in obtaining the correct answer?
4. 5. 6.
HERBERT F. POLESKY, M.D.
Department of Laboratory Medicine and Pathology University of Minnesota School of Medicine Minneapolis, Minnesota
7. 8.
References 9. 10. 11.
Vol. 98 • No. 2
Downloaded from http://ajcp.oxfordjournals.org/ by guest on June 6, 2016
1. Hewitt DJ, Peddecord KM, Francis DP, et al. Content and design of laboratory report forms for human immunodeficiency virus type 1 antibody testing. AJCP 1992;98:199-204. 2. Polesky HF, Hanson M. Practice guidelines for reporting HIV test results. Abstract presented at the Association of State and Territorial Public Health Laboratory Directors Sixth Annual Conference on Human Retrovirus Testing. Kansas City, MO, March 1991. 3. Association of State and Territorial Public Health Laboratory Directors Committee on Human Retrovirus Testing. Report and
Recommendations. Fifth Consensus Conference on Testing for Human Retroviruses. Iowa City, IA: University of Iowa, 1990. Cooper ES, Polesky HF, Schmidt PJ, et al. The 1988 Comprehensive Blood Bank Survey of the College of American Pathologists. Arch Pathol Lab Med 1990;114:1206-1210. Montagnier L, Gruest J, Chamaret S. Adaptation of lymphadenopathy associated virus (LAV) to replication in EBV-transformed B lymphoblastoid cell lines. Science 1984;225:63-66. Popvic M, Sarngadharan MG, Read E, Gallo RC. Detection, isolation and continuous production of cytopathic retrovirus (HTLV-III) from patients with AIDS and pre-AIDS. Science 1984,224:497500. The Consortium for Retrovirus Serology Standardization. Serological diagnosis of human immunodeficiency virus infection by Western blot testing. JAMA 1988;260:674-679. Sandler SG, Dodd RY, Fang CT. Diagnostic tests for HIV infection. In: DeVita VT, Hellman S, Rosenberg SA, eds. AIDS: Etiology, Diagnosis, Treatment, and Prevention. Philadelphia: JB Lippincott, 1988, pp 121-136. Centers for Disease Control. Interpretive criteria used to report western blot results for HIV-1-antibody testing—United States. MMWR 1991;40:692-695. Prokop O, Gohler W. Human Blood Groups. Montreal, Canada: Denis J. Paradis Editions Inc., 1986, pp 23-24. Chou D, Connelly DP, Fine JS. Quality assurance and laboratory informationflow.In: Howanitz PJ, Howanitz JH, eds. Laboratory Quality Assurance. New York, NY: McGraw-Hill, 1987, pp 354370.
Clarity in Communication
Although guidelines2,3 have been proposed detailing what should and should not appear on a report of an antiHIV test, there is some controversy about what is appropriate. For example, should a quantitative value such as absorbance or sample-to-cutofF ratio be included in addition to the interpretation of an EIA screening test as defined in the manufacturer's package insert? Published guidelines3 indicate that it should not be included. These recognize that lot-to-lot variation and differences among manufacturers make it difficult to compare reactive EIA tests results of samples tested at different times or in different laboratories. On the other hand, a physician obtaining repeated samples from a single patient may find that "quantitative" results from a test that has been designed to provide a "qualitative" answer are useful. Part of the problem relates to the setting in which the report is being used. Information from a laboratory supporting a clinical trial unit may be used quite differently than information provided to a physician who is screening an occasional patient for anti-HIV.
that influence the results and how they might apply to diverse patients, it is best that reports not contain information that could be misleading. Qualitative tests should be reported in qualitative terms just as quantitative tests should include normal ranges for the method based on a defined population. The limited information on the report does not preclude providing additional interpretation in a specific clinical situation or setting. In fact, this provides a unique opportunity for the clinical pathologist to serve as a consultant. Failure to use standard nomenclature for HIV was observed in 25% of the reports. I am surprised that this did not occur more frequently because the accepted terminology has changed several times since the virus now called HIV-1 was first identified as lymphodenopathy-associated virus (LAV)5 or human T-cell leukemia/lymphoma-virus (HTLV-III).6 Developing and using standard terminology is helpful to ensure that all practitioners know what test method was used for each agent. The clinical consequences of a confirmed positive test for the acquired immune deficiency syndrome (AIDS), antibody, antiHTLV-III, and anti-HIV-1 are identical; however, there is continued controversy about the criteria needed to classify a western blot as positive rather than indeterminate.7"9 The clinical importance of standardizing terminology was demonstrated dramatically more than 50 years ago when two widely accepted numeric systems for classifying blood groups were used.10 In one system, group AB blood was designated by " I " and group O was "IV," whereas in the other system AB was "IV" and O was "I". Not only did this make clear communication impossible but it was an invitation to disaster. Other features of the report that were evaluated were whether the name of the testing facility appeared (absent in 4%), if the analytical method was identified (absent in 40%), and the use of highlighting to call attention to abnormal results (present in 14%). The differences observed in the format, length, and information on the reports suggests that quality assurance should include evaluation of the output as well as the sample and the analytical process. One way to avoid some of the pitfalls found in this study is to establish a checklist to review the content of all forms and computer-generated output before they are used routinely." After reading the paper by Hewitt and associates,1 I
An analogous situation is observed in following antiD titers during pregnancy. It has been well demonstrated that the same sample tested in multiple laboratories gives a wide range of results.4 Similarly, the same sample tested in one laboratory by different methods (i.e., enzyme or antiglobulin) may result in different end-point values. Thus a titer of 1:32 obtained in one setting has a different clinical significance than the same titer obtained elsewhere. Because it is impossible to include all the variables
148
Downloaded from http://ajcp.oxfordjournals.org/ by guest on June 6, 2016
In this issue of the American Journal of Clinical Pathology, Hewitt and associates1 evaluated the content and design of reports on results of anti-human immunodeficiency virus type 1 (HIV-1) testing on a set of three samples sent to randomly selected public health (PH) and non-public health (NPH) laboratories in California. The primary issue examined was the clarity of the message. It is clear from this study that "static" is common when anti-HIV test results are reported. In the worst-case example, a negative anti-HIV-1 supplemental test, 23% of PH and 73% of NPH laboratories included extraneous information on the report. In the best case examined, an enzyme immunoassay (EIA)-negative sample, none of the PH and 44% of the NPH laboratories included statements related to the quality of the specimen or that affected the interpretation of test results.
AMERICAN JOURNAL OF CLINICAL PATHOLOGY
149
Editorial wondered what would be revealed if all the reports issued by laboratories were subjected to similar scrutiny. Is the analytical result provided to the end user clear, concise, and appropriate? Do the format and content of the messages we send reflect the same care and concern we have used in obtaining the correct answer?
4. 5. 6.
HERBERT F. POLESKY, M.D.
Department of Laboratory Medicine and Pathology University of Minnesota School of Medicine Minneapolis, Minnesota
7. 8.
References 9. 10. 11.
Vol. 98 • No. 2
Downloaded from http://ajcp.oxfordjournals.org/ by guest on June 6, 2016
1. Hewitt DJ, Peddecord KM, Francis DP, et al. Content and design of laboratory report forms for human immunodeficiency virus type 1 antibody testing. AJCP 1992;98:199-204. 2. Polesky HF, Hanson M. Practice guidelines for reporting HIV test results. Abstract presented at the Association of State and Territorial Public Health Laboratory Directors Sixth Annual Conference on Human Retrovirus Testing. Kansas City, MO, March 1991. 3. Association of State and Territorial Public Health Laboratory Directors Committee on Human Retrovirus Testing. Report and
Recommendations. Fifth Consensus Conference on Testing for Human Retroviruses. Iowa City, IA: University of Iowa, 1990. Cooper ES, Polesky HF, Schmidt PJ, et al. The 1988 Comprehensive Blood Bank Survey of the College of American Pathologists. Arch Pathol Lab Med 1990;114:1206-1210. Montagnier L, Gruest J, Chamaret S. Adaptation of lymphadenopathy associated virus (LAV) to replication in EBV-transformed B lymphoblastoid cell lines. Science 1984;225:63-66. Popvic M, Sarngadharan MG, Read E, Gallo RC. Detection, isolation and continuous production of cytopathic retrovirus (HTLV-III) from patients with AIDS and pre-AIDS. Science 1984,224:497500. The Consortium for Retrovirus Serology Standardization. Serological diagnosis of human immunodeficiency virus infection by Western blot testing. JAMA 1988;260:674-679. Sandler SG, Dodd RY, Fang CT. Diagnostic tests for HIV infection. In: DeVita VT, Hellman S, Rosenberg SA, eds. AIDS: Etiology, Diagnosis, Treatment, and Prevention. Philadelphia: JB Lippincott, 1988, pp 121-136. Centers for Disease Control. Interpretive criteria used to report western blot results for HIV-1-antibody testing—United States. MMWR 1991;40:692-695. Prokop O, Gohler W. Human Blood Groups. Montreal, Canada: Denis J. Paradis Editions Inc., 1986, pp 23-24. Chou D, Connelly DP, Fine JS. Quality assurance and laboratory informationflow.In: Howanitz PJ, Howanitz JH, eds. Laboratory Quality Assurance. New York, NY: McGraw-Hill, 1987, pp 354370.
