title: Use of rapid HIV assays as supplemental tests in specimens with repeatedly reactive screening immunoassay results not confirmed by HIV-1 Western blot.
abstract: BACKGROUND
  An alternate HIV testing algorithm has been proposed which includes a fourth-generation immunoassay followed by an HIV-1/HIV-2 antibody differentiation supplemental test for reactive specimens and a nucleic acid test (NAT) for specimens with discordant results.
  
  
  OBJECTIVE
  To evaluate the performance of five rapid tests (Alere Clearview, Bio-Rad Multispot, OraSure OraQuick, MedMira Reveal, and Trinity Biotech Unigold) as the supplemental antibody assay in the algorithm.
  
  
  METHODS
  A total of 3273 serum and plasma specimens that were third-generation immunoassay repeatedly reactive and Western blot (WB) negative or indeterminate were tested with rapid tests and NAT. Specimens were classified by NAT: (1) HIV-1 infected (NAT-reactive; n=184, 5.6%), (2) HIV-status unknown (NAT nonreactive; n=3078, 94.2%) or by Multispot, (3) HIV-2 positive (n=5), and (4) HIV-1 and HIV-2 positive (n=6). Excluding HIV-2 positive specimens, we calculated the proportion of reactive rapid tests among specimens with reactive and nonreactive NAT.
  
  
  RESULTS
  The proportion of infected specimens with reactive rapid test results and negative or indeterminate WB ranged from 30.4% (56) to 47.8% (88) depending on the rapid test. From 1% to 2% of NAT-negative specimens had reactive rapid test results.
  
  
  CONCLUSIONS
  In these diagnostically challenging specimens, all rapid tests identified infections that were missed by the Western blot, but only Multispot could differentiate HIV-1 from HIV-2. Regardless of which rapid test is used as a supplemental test in the alternative algorithm, false-positive algorithm results (i.e., reactive screening and rapid test in uninfected person) may occur, which will need to be resolved during the baseline medical evaluation.
authors.affiliation: Division of HIV/AIDS Prevention, National Center for HIV, Hepatitis, STD & TB Prevention, Centers for Disease Control and Prevention (CDC), 1600 Clifton Road, MS-E46, Atlanta, GA 30333, USA. lig7@cdc.gov
authors.forename: Laura G
authors.initials: LG
authors.lastname: Wesolowski
authors.forename: Kevin P
authors.initials: KP
authors.lastname: Delaney
authors.forename: William A
authors.initials: WA
authors.lastname: Meyer
authors.forename: Amy J
authors.initials: AJ
authors.lastname: Blatt
authors.forename: Berry
authors.initials: B
authors.lastname: Bennett
authors.forename: Pollyanna
authors.initials: P
authors.lastname: Chavez
authors.forename: Timothy C
authors.initials: TC
authors.lastname: Granade
authors.forename: Michele
authors.initials: M
authors.lastname: Owen
mesh_terms: D000465:Algorithms; D019411:Clinical Laboratory Techniques / Q000379:methods*; D005189:False Positive Reactions; D015658:HIV Infections / Q000175:diagnosis*; D015497:HIV-1 / Q000235:genetics / Q000276:immunology / Q000302:isolation & purification*; D015498:HIV-2 / Q000235:genetics / Q000276:immunology / Q000302:isolation & purification*; D006801:Humans; D007118:Immunoassay / Q000379:methods; D021141:Nucleic Acid Amplification Techniques / Q000379:methods; D019095:Point-of-Care Systems
keywords: Algorithm; Diagnosis; HIV; IA; NAT; Rapid test; WB; Western blot; immunoassay; nucleic acid test