Evaluation of Four Qualitative Third-Generation HIV Antibody Assays and the Fourth-Generation Abbott HIV Ag/Ab Combo Test.
Objective: Compare the agreement between four third-generation rapid or automated human immunodeficiency virus (HIV) tests vs the fourth-generation Abbott ARCHITECT HIV Ag/Ab Combo assay (Combo Test) (Abbott Laboratories, Abbott Park, IL) in 7 clinical laboratories located throughout the Dallas-Fort...
| Publicado en: | Laboratory Medicine Vol. 42; no. 9; pp. 523 - 536 |
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| Autores principales: | , , , , , , , , , , , |
| Formato: | algorithm pictorial research tables/charts Journal Article |
| Publicado: |
Oxford University Press / USA
Sep2011
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| Acceso en línea: | Ver este registro en EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=104626561&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 104626561 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 00075027 4CY jtl: Laboratory Medicine issn: 00075027 maglogo: N pubinfo: dt: Sep2011 vid: 42 iid: 9 pid: 10398 pub: Oxford University Press / USA artinfo: ui: 104626561 70268071 10.1309/LM38NCGQ0GWJIMZV 104626561 ppf: 523 ppct: 13 formats: fmt: @attributes: type: P tig: atl: Evaluation of Four Qualitative Third-Generation HIV Antibody Assays and the Fourth-Generation Abbott HIV Ag/Ab Combo Test. aug: au: Wians Jr, Frank H. Moore, Holly A. Briscoe, Donna Anderson, Kathy M. Hicks, Pamela S. Smith, Debbie L. Clark, Tammy A. Preston, Maggie M. Gammons, Beckie Ray, Cynthia S. Bond, Christine West, Joshua T. affil: Department of Pathology, Baylor University Medical Center, Dallas sug: subj: AIDS Serodiagnosis Methods Chemistry, Clinical Methods Human Immunodeficiency Virus Analysis Antigens, Viral Blood Antibodies, Viral Blood Human Comparative Studies Geographic Factors McNemar's Test Nucleic Acid Amplification Techniques Blotting, Western Time Factors Early Diagnosis Immunoenzyme Techniques Sensitivity and Specificity Predictive Value of Tests Confidence Intervals Reagent Kits, Diagnostic Evaluation False Negative Results False Positive Results Funding Source Seroconversion ab: Objective: Compare the agreement between four third-generation rapid or automated human immunodeficiency virus (HIV) tests vs the fourth-generation Abbott ARCHITECT HIV Ag/Ab Combo assay (Combo Test) (Abbott Laboratories, Abbott Park, IL) in 7 clinical laboratories located throughout the Dallas-Fort Worth, TX, metroplex area. Methods: We tested a total of 220 specimens from the general population of patients being screened for HIV antibody status, including Western blot (WB) and HIV-1 RNA viral load by NAAT in patients with initially positive HIV screening tests. We performed a method precision study of the Combo Test and evaluated the agreement between the 4 comparative methods (CMs) against the Combo Test method (TM) using a 2 × 2 contingency table to determine values for positive percent agreement (PPA), negative percent agreement (NPA), and overall percent agreement (OPA) according to the guideline (EP12-A2) for the evaluation of qualitative assays published by the Clinical Laboratory Standards Institute (CLSI). Results: The Combo Test yielded consistent (reproducible) results when the HIV antibody (or p24 antigen) concentration was 20% away or more from C50. In addition, values for PPA, NPA, and OPA for CM vs TM results were all 100%, or not significantly different from 100%. Conclusion: The high detection rate of the Combo Test, when coupled with its high diagnostic sensitivity and specificity, rapid TAT (<30 minutes) of test results using a fully automated instrument (ARCHITECT), and excellent agreement with HIV-1/2 antibody results by several commercially available HIV-1/2 screening tests and with WB and NAAT results, indicate that the Abbott HIV-1/2 Ab/Ag Test is a useful screening test in the identification of HIV-infected individuals. pubtype: Academic Journal doctype: algorithm pictorial research tables/charts Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
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