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Content and design of laboratory report forms for human immunodeficiency virus type 1 antibody testing
D J Hewitt1, K M Peddecord, D P Francis
1Laboratory Assurance Program, Graduate School of Public Health, San Diego State University, California 92182-0405.
Insights
Diverse human immunodeficiency virus (HIV) test report forms from California laboratories were confusing. A study evaluated 84 HIV-1 test report forms, finding significant differences in content and design across lab types.
Area of Science:
- Clinical diagnostics
- Laboratory medicine
- Public health
Background:
- Proficiency testing for human immunodeficiency virus (HIV) revealed diverse and confusing laboratory report forms.
- Standardization of HIV testing reporting is crucial for accurate clinical interpretation and patient care.
Purpose of the Study:
- To comprehensively study the content, design, and clarity of human immunodeficiency virus type 1 (HIV-1) report forms.
- To identify variations in HIV-1 report forms among different types of state-licensed laboratories in California.
Main Methods:
- Conducted a study involving state-licensed testing laboratories in California.
- Participants analyzed three serum samples with known HIV-1 antibody reactivity.
- Evaluated 84 submitted laboratory report forms for content, design, and clarity.
Main Results:
- Significant differences were observed in the content, design, and clarity of HIV-1 report forms.
- Variations were noted among commercial, hospital, and public health laboratories.
- The evaluated forms presented potentially confusing information to clinicians.
Conclusions:
- The design and content of HIV-1 laboratory report forms vary considerably, impacting clarity.
- Standardizing report forms could improve the interpretation of HIV diagnostic test results.
- The methodology can be applied to evaluate report forms for other diagnostic tests.
Abstract:
In a pilot study involving proficiency testing for human immunodeficiency virus, markedly diverse and potentially confusing test report forms were encountered among participating laboratories. Therefore, a comprehensive study of human immunodeficiency virus type 1 report forms was conducted from state-licensed testing laboratories in California. Participants analyzed three serum samples of known human immunodeficiency virus type 1 antibody reactivity and reported their results on forms that they would normally submit to clinicians. Report forms from 84 laboratories were evaluated for content, design, and clarity. Differences were found among commercial, hospital, and public health laboratories. The significance of these findings is discussed. This technique also may be applied to evaluate laboratory report form design and content for other diagnostic test results.

