Factors associated with incorrect identification of recent HIV infection using the BED capture immunoassay.
The BED capture enzyme immunoassay (BED-CEIA) was developed for estimating HIV incidence from cross-sectional data. This assay misclassifies some individuals with nonrecent HIV infection as recently infected, leading to overestimation of HIV incidence. We analyzed factors associated with misclassification by the BED-CEIA. We analyzed samples from 383 men who were diagnosed with HIV infection less than 1 year after a negative HIV test (Multicenter AIDS Cohort Study). Samples were collected 2-8 years after HIV seroconversion, which was defined as the midpoint between the last negative and first positive HIV test. Samples were analyzed using the BED-CEIA with a cutoff of OD-n ≤ 0.8 for recent infection. Logistic regression was used to identify factors associated with misclassification. Ninety-one (15.1%) of 603 samples were misclassified. In multivariate models, misclassification was independently associated with highly active antiretroviral treatment (HAART) for >2 years, HIV RNA <400 copies/ml, and CD4 cell count <50 or <200 cells/mm(3); adjusted odds ratios (OR) and 95% confidence intervals (CI) were 4.72 (1.35-16.5), 3.96 (1.53-10.3), 6.85 (2.71-17.4), and 11.5 (3.64-36.0), respectively. Among 220 men with paired samples, misclassification 2-4 years after seroconversion was significantly associated with misclassification 6-8 years after seroconversion [adjusted OR: 25.8 (95% CI: 8.17-81.5), p<0.001] after adjusting for race, CD4 cell count, HIV viral load, and HAART use. Low HIV viral load, low CD4 cell count, and >2 years of HAART were significantly associated with misclassification using the BED-CEIA. Some men were persistently misclassified as recently infected up to 8 years after HIV seroconversion.
National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland 21205, USA. olaeyen1@jhmi.edu
Oliver
O
Laeyendecker
Ron
R
Brookmeyer
Amy E
AE
Oliver
Caroline E
CE
Mullis
Kevin P
KP
Eaton
Amy C
AC
Mueller
Lisa P
LP
Jacobson
Joseph B
JB
Margolick
Joelle
J
Brown
Charles R
CR
Rinaldo
Thomas C
TC
Quinn
Susan H
SH
Eshleman
D000328:Adult; D000368:Aged; D023241:Antiretroviral Therapy, Highly Active; D018791:CD4 Lymphocyte Count; D015331:Cohort Studies; D003951:Diagnostic Errors; D015658:HIV Infections / Q000175:diagnosis* / Q000188:drug therapy / Q000276:immunology; D006679:HIV Seropositivity; D006801:Humans; D007124:Immunoenzyme Techniques / Q000379:methods*; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D019562:Viral Load; D055815:Young Adult