Analytic results of HIV-1 testing using blind proficiency testing.

Area of Science:

• Clinical Laboratory Science
• Infectious Disease Diagnostics
• Public Health Surveillance

Background:

• Accurate human immunodeficiency virus type 1 (HIV-1) antibody testing is critical for patient care and public health.
• Proficiency testing (PT) is essential for monitoring and ensuring laboratory testing quality.
• Blind PT, where testing is disguised as routine patient samples, offers a realistic assessment of laboratory performance.

Purpose of the Study:

• To evaluate the analytic performance of HIV-1 antibody testing using blind proficiency testing (PT).
• To assess the accuracy and reliability of HIV-1 screening and supplemental tests in various laboratory settings.
• To identify potential sources of error and areas for improvement in HIV-1 diagnostic testing.

Main Methods:

• A blind PT study was conducted involving 32 diverse laboratories (hospital, blood bank, public health, commercial).
• Test sera were submitted as routine clinical specimens for HIV-1 antibody testing.
• Results from 306 screening tests and 192 supplemental tests were analyzed.

Main Results:

• Overall screening and supplemental testing performance for HIV-1 antibodies was excellent.
• Accuracy levels were comparable to those reported in open PT and performance evaluation surveys in the U.S.
• Nearly 30% of one positive specimen yielded indeterminate results, attributed to interpretive criteria, not laboratory error.

Conclusions:

• Blind PT is a valuable tool for assessing and improving the analytic performance of HIV-1 antibody testing.
• The study underscores the importance of standardized interpretive criteria to minimize indeterminate results.
• Enhancing laboratory testing quality through blind PT ultimately improves patient care and public health outcomes.