title: Nucleic acid testing by public health referral laboratories for public health laboratories using the U.S. HIV diagnostic testing algorithm.
abstract: BACKGROUND
  Many public health laboratories adopting the U.S. HIV laboratory testing algorithm do not have a nucleic acid test (NAT), which is needed when the third- or fourth-generation HIV screening immunoassay is reactive and the antibody-based supplemental test is non-reactive or indeterminate.
  
  
  OBJECTIVE
  Among public health laboratories utilizing public health referral laboratories for NAT conducted as part of the algorithm, we evaluated the percentage of screening immunoassays needing NAT, the number of specimens not meeting APTIMA (NAT) specifications, time to APTIMA result, the proportion of acute infections (i.e., reactive APTIMA) among total infections, and screening immunoassay specificity.
  
  
  METHODS
  From August 2012 to April 2013, 22 laboratories enrolled to receive free APTIMA (NAT) at New York or Florida public health referral laboratories. Data were analyzed for testing conducted until June 2013.
  
  
  RESULTS
  Submitting laboratories conducted a median of 4778 screening immunoassays; 0-1.3% (median 0.2%) needed NAT. Of 140 specimens received, 9 (6.4%) did not meet NAT specifications. The median time from specimen collection to reporting the 11 reactive NAT results was ten days, including six days from receipt in the submitting laboratory to shipment to the referral laboratory. Acute infections ranged from 0 to 12.5% (median 0%) of total infections. Third- and fourth-generation immunoassays met package insert specificity values.
  
  
  CONCLUSIONS
  Public health referral laboratories provide a feasible option for conducting NAT. Reducing the time from specimen collection to submission of specimens for NAT is an important step toward maximizing the public health impact of identifying acute infections.
authors.affiliation: Division of HIV/AIDS Prevention, Centers for Disease Control and Prevention, 1600 Clifton Rd., MS E-46, Atlanta, GA 30333, USA. Electronic address: lig7@cdc.gov.
authors.forename: Laura G
authors.initials: LG
authors.lastname: Wesolowski
authors.affiliation: Association of Public Health Laboratories, 8515 Georgia Ave #700, Silver Spring, MD 20910, USA.
authors.forename: Kelly
authors.initials: K
authors.lastname: Wroblewski
authors.affiliation: Florida Department of Health, Bureau of Public Health Laboratories, 1217 N. Pearl St., Jacksonville, FL 32202, USA.
authors.forename: Spencer B
authors.initials: SB
authors.lastname: Bennett
authors.affiliation: Wadsworth Center, New York State Department of Health, 120 New Scotland Ave. Albany, NY 12208, USA.
authors.forename: Monica M
authors.initials: MM
authors.lastname: Parker
authors.affiliation: Association of Public Health Laboratories, 8515 Georgia Ave #700, Silver Spring, MD 20910, USA.
authors.forename: Celia
authors.initials: C
authors.lastname: Hagan
authors.affiliation: Division of HIV/AIDS Prevention, Centers for Disease Control and Prevention, 1600 Clifton Rd., MS E-46, Atlanta, GA 30333, USA.
authors.forename: Steven F
authors.initials: SF
authors.lastname: Ethridge
authors.affiliation: ICF International, Inc. 3 Corporate Blvd. NE #370, Atlanta, GA 30329, USA.
authors.forename: Jeselyn
authors.initials: J
authors.lastname: Rhodes
authors.affiliation: Wadsworth Center, New York State Department of Health, 120 New Scotland Ave. Albany, NY 12208, USA.
authors.forename: Timothy J
authors.initials: TJ
authors.lastname: Sullivan
authors.affiliation: Florida Department of Health, Bureau of Public Health Laboratories, 1217 N. Pearl St., Jacksonville, FL 32202, USA.
authors.forename: Imelda
authors.initials: I
authors.lastname: Ignacio-Hernando
authors.affiliation: Bureau of Infectious Disease, MA Department of Public Health, 305 South Street, Jamaica Plain, MA 02130, USA.
authors.forename: Barbara G
authors.initials: BG
authors.lastname: Werner
authors.affiliation: Division of HIV/AIDS Prevention, Centers for Disease Control and Prevention, 1600 Clifton Rd., MS E-46, Atlanta, GA 30333, USA.
authors.forename: S Michele
authors.initials: SM
authors.lastname: Owen
mesh_terms: D015492:AIDS Serodiagnosis / Q000592:standards; D000465:Algorithms; D002487:Centers for Disease Control and Prevention, U.S.; D005431:Florida; D015658:HIV Infections / Q000175:diagnosis*; D015497:HIV-1 / Q000235:genetics / Q000302:isolation & purification*; D015498:HIV-2 / Q000235:genetics / Q000302:isolation & purification*; D006801:Humans; D007118:Immunoassay / Q000706:statistics & numerical data*; D007753:Laboratories / Q000592:standards / Q000706:statistics & numerical data; D008403:Mass Screening / Q000592:standards / Q000706:statistics & numerical data; D009518:New York; D021141:Nucleic Acid Amplification Techniques / Q000592:standards* / Q000706:statistics & numerical data; D012367:RNA, Viral / Q000032:analysis*; D012017:Referral and Consultation; D012680:Sensitivity and Specificity; D014481:United States
chemical_list: D012367:RNA, Viral
keywords: Algorithms; Diagnostic tests; HIV; Nucleic acid amplification test