Marcel Miedouge1, Monique Grèze, Agnès Bailly, Jacques Izopet. 1. Laboratoire de Virologie, Institut Fédératif de Biologie de Purpan, 330 avenue de Grande Bretagne, TSA 40031, 31059 Toulouse, Cédex 9, France. miedouge.m@chu-toulouse.fr
Abstract
BACKGROUND: The Common Technical Specifications for HIV-1 p24 assays published in 2009 fixed the lower limit of detection for obtaining C.E. approval at 2 IU/ml against the WHO standard (first international reference, code NIBSC 90/636); it was previously 50 pg/ml. Some recent fourth generation HIV assays that simultaneously detect antigen and antibody are equivalent to p24 assays, but they were mainly evaluated using p24 antigen standards in pg/ml and little is known of their performance with the IU/ml standard. OBJECTIVES: To evaluate four of the combined serological assays most commonly used for HIV diagnosis in France against the WHO standard in IU/ml. STUDY DESIGN: The analytical sensitivity of four combined p24 antigen and antibody assays (ARCHITECT HIV Ag/Ab Combo, AxSYM HIV Ag/Ab Combo, VIDAS HIV DUO Quick and VIDAS HIV DUO Ultra) and of one p24 assay (VIDAS HIV p24 II) were determined using dilutions of the WHO standard. RESULTS: Four of the five assays had a lower limit of detection below 2 IU/ml: 1.24 for ARCHITECT Combo, 0.66 for VIDAS DUO Ultra, 0.43 for VIDAS DUO Quick and 0.73 to 1.15 for VIDAS p24, while that of AxSYM was close to 2 (1.94-2.25). CONCLUSIONS: We have provided the first data on the lower limit of detection of HIV combined assays using the IU/ml WHO standard and demonstrated the need for a single international standard for comparing assays. We recommend the use of this approach in medical laboratory to validate on site their methods.
BACKGROUND: The Common Technical Specifications for HIV-1p24 assays published in 2009 fixed the lower limit of detection for obtaining C.E. approval at 2 IU/ml against the WHO standard (first international reference, code NIBSC 90/636); it was previously 50 pg/ml. Some recent fourth generation HIV assays that simultaneously detect antigen and antibody are equivalent to p24 assays, but they were mainly evaluated using p24 antigen standards in pg/ml and little is known of their performance with the IU/ml standard. OBJECTIVES: To evaluate four of the combined serological assays most commonly used for HIV diagnosis in France against the WHO standard in IU/ml. STUDY DESIGN: The analytical sensitivity of four combined p24 antigen and antibody assays (ARCHITECT HIV Ag/Ab Combo, AxSYM HIV Ag/Ab Combo, VIDAS HIV DUO Quick and VIDAS HIV DUO Ultra) and of one p24 assay (VIDAS HIV p24 II) were determined using dilutions of the WHO standard. RESULTS: Four of the five assays had a lower limit of detection below 2 IU/ml: 1.24 for ARCHITECT Combo, 0.66 for VIDAS DUO Ultra, 0.43 for VIDAS DUO Quick and 0.73 to 1.15 for VIDAS p24, while that of AxSYM was close to 2 (1.94-2.25). CONCLUSIONS: We have provided the first data on the lower limit of detection of HIV combined assays using the IU/ml WHO standard and demonstrated the need for a single international standard for comparing assays. We recommend the use of this approach in medical laboratory to validate on site their methods.
Authors: Lei Chang; David M Rissin; David R Fournier; Tomasz Piech; Purvish P Patel; David H Wilson; David C Duffy Journal: J Immunol Methods Date: 2012-02-20 Impact factor: 2.303
Authors: Maile Y Karris; Christy M Anderson; Sheldon R Morris; Davey M Smith; Susan J Little Journal: J Clin Microbiol Date: 2012-03-21 Impact factor: 5.948
Authors: François Cholette; Braedy Farmer; Olga Balakireva; Daria Pavlova; Anna Lopatenko; Iryna Chukhalova; Svitlana Bargan; Sharmistha Mishra; Marissa Becker; Emma R Lee; John Kim; Paul Sandstrom Journal: Sci Rep Date: 2022-06-17 Impact factor: 4.996
Authors: A Mühlbacher; H Schennach; J van Helden; T Hebell; G Pantaleo; P Bürgisser; C Cellerai; P Permpikul; M I Rodriguez; A Eiras; F Alborino; P Cunningham; M Axelsson; S Andersson; O Wetlitzky; C Kaiser; P Möller; G de Sousa Journal: Med Microbiol Immunol Date: 2012-06-17 Impact factor: 3.402
Authors: Kirsten A Veldsman; Barbara Laughton; Anita Janse van Rensburg; Peter Zuidewind; Els Dobbels; Shaun Barnabas; Samantha Fry; Mark F Cotton; Gert U van Zyl Journal: AIDS Date: 2021-07-01 Impact factor: 4.632