2012
DOI: 10.1016/j.jim.2011.09.007
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Development and implementation of an international proficiency testing program for a neutralizing antibody assay for HIV-1 in TZM-bl cells

Abstract: Recent advances in assay technology have led to major improvements in how HIV-1 neutralizing antibodies are measured. A luciferase reporter gene assay performed in TZM-bl (JC53bl-13) cells has been optimized and validated. Because this assay has been adopted by multiple laboratories worldwide, an external proficiency testing program was developed to ensure data equivalency across laboratories performing this neutralizing antibody assay for HIV/AIDS vaccine clinical trials. The program was optimized by conducti… Show more

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Cited by 73 publications
(77 citation statements)
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“…NAbs against HIV-1 in serum from each immunized rhesus macaque were analyzed by using the TZM-bl cell assay and the more sensitive A3R5 cell assay, as previously described (62)(63)(64)(65). For the TZM-bl assay, the following isolates carrying Envs were used: BaL.26 (tier 1B, clade B), Ce1086 (tier 2, clade C), Ce1176 (tier 2, clade C), Ce2010 (tier 2, clade C), Du151.2 (tier 2, clade C), MN.3 (tier 1A, clade B), MW965.26 (tier 1A, clade C), SF162.LS (tier 1A, clade B), TH023.6 (tier 1, clade AE), TV1.21 (tier 2, clade C), and MuLV (as a negative control).…”
Section: Methodsmentioning
confidence: 99%
“…NAbs against HIV-1 in serum from each immunized rhesus macaque were analyzed by using the TZM-bl cell assay and the more sensitive A3R5 cell assay, as previously described (62)(63)(64)(65). For the TZM-bl assay, the following isolates carrying Envs were used: BaL.26 (tier 1B, clade B), Ce1086 (tier 2, clade C), Ce1176 (tier 2, clade C), Ce2010 (tier 2, clade C), Du151.2 (tier 2, clade C), MN.3 (tier 1A, clade B), MW965.26 (tier 1A, clade C), SF162.LS (tier 1A, clade B), TH023.6 (tier 1, clade AE), TV1.21 (tier 2, clade C), and MuLV (as a negative control).…”
Section: Methodsmentioning
confidence: 99%
“…Neutralization of sera was assessed using the TZM-bl cell assay and the more sensitive A3R5 cell assay, as described previously (44,45), by the Comprehensive Antibody Vaccine Immune Monitoring Consortium (CA-VIMC). For the TZM-bl assay (Seaman lab), pseudoviruses carrying the following Envs were used: BaL.26 (tier 1B, clade B), Bx08.16 (tier 1B, clade B), MN (tier 1A, clade B), SS1196.1 (tier 1B, clade B), SHIV-SF162P4 (tier 1A, clade B), SHIV-SF162P3 (tier 2, clade B), MW965.26 (tier 1A, clade C), TV1.21 (tier 1, clade C), and murine leukemia virus (MuLV) (as a negative control).…”
Section: Methodsmentioning
confidence: 99%
“…Any samples that did not meet the predefined criteria for equivalency (ID 50 agreement within a 3-fold difference range among the laboratories for all 3 viruses) were not included. All three laboratories also participated in a formal proficiency testing program for the TZM-bl assay (62) during the course of this study. As an additional control for uniform assay performance, HIVIG (polyclonal IgG from a pool of HIV-1-positive plasma samples) was assayed with a single virus (SS1196.1) for each batch of assays performed.…”
Section: Methodsmentioning
confidence: 99%