HIV-1 Antiretroviral Resistance Testing Laboratories

Louise K Hofherr; Diane P Francis; J Rex Astles; William O Schalla

doi:10.29074/ascls.15.4.213

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Louise K Hofherr, PhD⇑
1. is the Principal Investigator, Laboratory Assurance Program, Graduate School of Public Health, San Diego State University, San Diego CA
Diane P Francis, MPH
1. is Program Administrator, Laboratory Assurance Program at San Diego State University, San Diego CA
J Rex Astles, PhD
1. is Senior Health Scientist at CDC, Atlanta GA
William O Schalla, MS
1. is Senior Health Scientist at CDC, Atlanta GA

Address for correspondence: Louise K Hofherr PhD, Principal Investigator, Laboratory Assurance Program, Graduate School of Public Health, 6330 Alvarado Court, #208, San Diego, 92120. (619) 594-5006, (619) 594-8816 (fax). lhofherr{at}mail.sdsu.edu

Abstract

OBJECTIVE: To identify and to describe the genotyping and the phenotyping testing practices of U.S. laboratories performing patient HIV-1 antiretroviral resistance testing.

DESIGN: A self-report 44-item mailed questionnaire.

PARTICIPANTS: Laboratories potentially performing HIV-1 antiretroviral resistance testing.

MAIN OUTCOME MEASURE: Descriptive study.

RESULTS: Of 236 laboratories surveyed, 165 (69.9%) returned completed surveys, but only 23 performed HIV-1 antiretroviral resistance testing. Most were university hospitals (47.8%) or independent laboratories (26.1%). All 23 laboratories used genotypic methods, while nine (39.1%) used both genotyping and phenotyping. Most testing was used for clinical trials or laboratory research. The amount of patient information collected by laboratories varied, as did their type of quality assurance measures. Variation was found with regard to: testing volume, testing experience, testing reasons, testing methods availability, testing controls, specimen treatment, and storage stability.

CONCLUSIONS: Due to variation in practices in this area of patient testing, it may be advantageous for laboratory professionals to reach a consensus on what is the most acceptable.

ABBREVIATIONS: 3TC = lamivudine; AZT = zidovudine; CDC = Centers for Disease Control and Prevention; CLIA = Clinical Laboratory Improvement Amendments; CT = clinical trials; d4T = stavudine; ddc = zalcitabine; ddl = didanosine; DLV = delavirdine; DT = drug treatment; ENVA = Evaluation of New Antiviral Treatments; HAART = highly active antiretroviral therapy; HIV = human immunodeficiency virus; LAP = Laboratory Assurance Program; LR = laboratory research; MPEP = Model Performance Evaluation Program; NVP = nevirapine; PT = patient treatment; QA = quality assurance; QC = quality control; VL = viral load.