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Analytic sensitivity and specificity of enzyme immunoassay results in testing for human immunodeficiency virus type 1
G D Cross1, W O Schalla, J S Hancock
1Laboratory Practice Assessment Branch, Centers for Disease Control, US Department of Health and Human Services, Atlanta, Ga 30333.
Insights
The Centers for Disease Control
Area of Science:
- Clinical diagnostics
- Public health surveillance
- Virology
Background:
- Established in 1986, the Centers for Disease Control (CDC) Model Performance Evaluation Program (MPEP) aims to ensure laboratory testing quality.
- The program specifically targets human immunodeficiency virus type 1 (HIV-1) antibody testing.
- It identifies and addresses challenges encountered during the HIV-1 testing process.
Purpose of the Study:
- To evaluate the performance quality of laboratories conducting HIV-1 antibody testing.
- To identify any difficulties or problems in the HIV-1 testing procedures.
- To assess the reliability and reproducibility of HIV-1 antibody test results.
Main Methods:
- Laboratories participated in the CDC MPEP for HIV-1 antibody testing.
- Participants received and tested performance evaluation panels in August and November 1989.
- Panels comprised 10 unique and duplicate samples, both antibody-negative and antibody-positive.
Main Results:
- Most laboratories demonstrated proficiency in testing the provided evaluation panels.
- Low rates of false-negative and false-positive results were observed.
- High intrashipment and intershipment reproducibility indicated consistent testing accuracy.
Conclusions:
- Laboratories generally performed well in HIV-1 antibody testing during the evaluation period.
- The CDC MPEP effectively monitors and ensures the quality of HIV-1 diagnostic testing.
- The findings suggest a high level of competence in HIV-1 testing among participating laboratories.
Abstract:
In 1986, a performance evaluation program at the Centers for Disease Control was implemented to assess the quality of performance of laboratories testing for human immunodeficiency virus type 1 antibody and to identify problems that occur during the testing process. Laboratories participating in the Centers for Disease Control Model Performance Evaluation Program for human immunodeficiency virus type 1 antibody testing furnished enzyme immunoassay results after they tested performance evaluation panels that were sent to them in August and November 1989. The panels consisted of 10 individual samples containing antibody-negative and antibody-positive samples, some of which were duplicates. Not all laboratories received the same panel of samples. Low false-negative and false-positive rates, as well as high intrashipment and intershipment reproducibility, indicate that most laboratories did not experience difficulty in testing performance evaluation samples sent to them in August and November 1989.
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