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Jacksonville Beach, FL, United States

Patel P.,Centers for Disease Control and Prevention | Mackellar D.,Centers for Disease Control and Prevention | Simmons P.,Bureau of HIV AIDS | Uniyal A.,Sexually Transmitted Disease Program | And 8 more authors.
Archives of Internal Medicine | Year: 2010

Background: The yield of nucleic acid amplification testing (NAAT) after routine screening for human immunodeficiency virus (HIV) antibody to detect acute HIV infection (AHI) may vary with different HIV-antibody assays. Methods: From April 24, 2006, through March 28, 2008, patients underwent routine HIV-antibody screening using a first-generation assay at 14 county sexually transmitted disease (STD) clinics and 1 community clinic serving homosexual patients in Los Angeles; using a secondgeneration rapid test at 3 municipal STD clinics in New York; and using a third-generation assay at 80 public health clinics in Florida. To identify AHI, seronegative specimens were pooled for NAAT, followed by individual NAAT of specimens with positive findings. All AHI samples screened by first- and second-generation assays also underwent third-generation testing. Results: We screened 37 012 persons using NAAT after first-generation testing; 35 AHIs were identified, increasing HIV case detection by 8.2%. After a second-generation rapid test, 6547 persons underwent NAAT; 7 AHIs were identified, increasing HIV case detection by 24.1%. After third-generation testing, 54 948 persons underwent NAAT; 12 AHI cases were identified, increasing HIV case detection by 1.4%. Overall, pooled NAAT after negative third-generation test results detected 26 AHI cases, increasing HIV case detection by 2.2%. Most of the AHI cases from Los Angeles (26 of 35 [74%]) were identified at the community clinic where NAAT after third-generation testing increased HIV case detection by 11.9%. Conclusions: Pooled NAAT after third-generation testing increases HIV case detection, especially in venues of high HIV seropositivity. Therefore, targeted AHI screening using pooled NAAT after third-generation testing may be most effective, warranting a cost-benefit analysis. ©2010 American Medical Association. All rights reserved. Source

Patel P.,Centers for Disease Control and Prevention | Bennett B.,Florida Bureau of Laboratories | Sullivan T.,New York State Department of Health | Parker M.M.,New York State Department of Health | And 2 more authors.
Journal of Clinical Virology | Year: 2012

Background: Although rapid HIV tests increase the number of persons who are aware of their HIV status, they may fail to detect early HIV infection. Objectives: To evaluate the sensitivity for early HIV infection of several rapid tests and third- and fourth-generation assays compared with nucleic acid amplification testing (NAAT). Study design: Sensitivity for early HIV infection was evaluated using 62 NAAT-positive/WB-negative or indeterminate specimens from the CDC Acute HIV Infection study. Specimens underwent third-generation testing with Genetic Systems 1/2+O ® and rapid testing with Multispot HIV-1/HIV-2. A subset was also tested with four FDA-approved rapid tests and Determine HIV-1 Antigen/Antibody Rapid Test ® and Architect HIV Antigen/Antibody Combo ®, both fourth-generation tests. Results: Of 99,111 specimens screened from April 2006 to March 2008, 62 met the definition for early HIV infection (60 NAAT-positive/seronegative and 2 NAAT-positive/Western blot indeterminate). Third-generation testing correctly detected antibody in 34 specimens (55%; 95% confidence interval (CI): 42-67); Multispot detected antibody in 16 (26%; 95% CI: 16-38). Of the 62 specimens, 33 (53%) had sufficient quantity for further testing. Rapid test sensitivities for early HIV infection ranged from 22-33% compared with 55-57% for the third-generation assay and 76-88% for the fourth-generation tests. Conclusions: Many rapid HIV tests failed to detect half of the early HIV infection cases in whom antibody was present. Programs that screen high-incidence populations with rapid tests should consider supplemental testing with NAAT or other antigen-based tests. These data support the need for more sensitive antigen-based point-of-care screening tests for early HIV infection. © 2012. Source

Wesolowski L.G.,Centers for Disease Control and Prevention | Delaney K.P.,Centers for Disease Control and Prevention | Meyer W.A.,Quest Diagnostics | Blatt A.J.,Quest Diagnostics | And 4 more authors.
Journal of Clinical Virology | Year: 2013

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. Study design: 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. © 2013 . Source

Hutchinson A.B.,Centers for Disease Control and Prevention | Patel P.,Centers for Disease Control and Prevention | Sansom S.L.,Centers for Disease Control and Prevention | Farnham P.G.,Centers for Disease Control and Prevention | And 6 more authors.
PLoS Medicine | Year: 2010

Background: Detection of acute HIV infection (AHI) with pooled nucleic acid amplification testing (NAAT) following HIV testing is feasible. However, cost-effectiveness analyses to guide policy around AHI screening are lacking; particularly after more sensitive third-generation antibody screening and rapid testing. Methods and Findings: We conducted a cost-effectiveness analysis of pooled NAAT screening that assessed the prevention benefits of identification and notification of persons with AHI and cases averted compared with repeat antibody testing at different intervals. Effectiveness data were derived from a Centers for Disease Control and Prevention AHI study conducted in three settings: municipal sexually transmitted disease (STD) clinics, a community clinic serving a population of men who have sex with men, and HIV counseling and testing sites. Our analysis included a micro-costing study of NAAT and a mathematical model of HIV transmission. Cost-effectiveness ratios are reported as costs per quality-adjusted life year (QALY) gained in US dollars from the societal perspective. Sensitivity analyses were conducted on key variables, including AHI positivity rates, antibody testing frequency, symptomatic detection of AHI, and costs. Pooled NAAT for AHI screening following annual antibody testing had cost-effectiveness ratios exceeding US$200,000 per QALY gained for the municipal STD clinics and HIV counseling and testing sites and was cost saving for the community clinic. Cost-effectiveness ratios increased substantially if the antibody testing interval decreased to every 6 months and decreased to cost-saving if the testing interval increased to every 5 years. NAAT was cost saving in the community clinic in all situations. Results were particularly sensitive to AHI screening yield. Conclusions: Pooled NAAT screening for AHI following negative third-generation antibody or rapid tests is not costeffective at recommended antibody testing intervals for high-risk persons except in very high-incidence settings. Source

Ethridge S.F.,Centers for Disease Control and Prevention | Hart C.,Centers for Disease Control and Prevention | Hanson D.L.,Centers for Disease Control and Prevention | Parker M.M.,New York State Department of Health | And 5 more authors.
Journal of Clinical Microbiology | Year: 2010

The Aptima HIV-1 RNA qualitative assay tested with a WHO-approved HIV type 1 RNA standard in 16- and 32-member pools detected 100% of the pools (1,070 and 2,130 HIV-1 RNA copies/ml/pool, respectively), thus exceeding the FDA-required lower limit of detection. The Aptima test can be used to screen for acute-phase HIV infection. Copyright © 2010, American Society for Microbiology. All Rights Reserved. Source

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