Evidence map›Paper›PMID 24291345›Full record

ArticleJournal of immunological methods2014

Optimization and validation of the TZM-bl assay for standardized assessments of neutralizing antibodies against HIV-1.

Marcella Sarzotti-Kelsoe, Robert T Bailer, Ellen Turk, Chen-li Lin, Miroslawa Bilska, Kelli M Greene, Hongmei Gao, Christopher A Todd, Daniel A Ozaki, Michael S Seaman and 2 more

Abstract readValidation Study
In one paragraph

Article in Journal of immunological methods, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 437 papers.

0numbers the graph read from it
0cells of the map it votes in
437citing papers in PubMed
7.2field-weighted citation impact, top 2% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

437 citing papers in PubMed, 570 citations in OpenAlex.

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377 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors at 4 institutions in 1 country.

Marcella Sarzotti-KelsoeDepartment of Immunology, Duke University Medical Center, Durham, NC, United States; Department of Surgery, Duke University Medical Center, Durham, NC, United States. Electronic address: marcella.sarzottikelsoe@dm.duke.edu.
Robert T BailerVaccine Research Center, National Institutes of Health (NIH), Bethesda, MD, United States.
Ellen TurkVaccine Research Center, National Institutes of Health (NIH), Bethesda, MD, United States.
Chen-li LinVaccine Research Center, National Institutes of Health (NIH), Bethesda, MD, United States.
Miroslawa BilskaDepartment of Surgery, Duke University Medical Center, Durham, NC, United States.
Kelli M GreeneDepartment of Surgery, Duke University Medical Center, Durham, NC, United States.
Hongmei GaoDepartment of Surgery, Duke University Medical Center, Durham, NC, United States.
Christopher A ToddDepartment of Surgery, Duke University Medical Center, Durham, NC, United States.
Daniel A OzakiDepartment of Surgery, Duke University Medical Center, Durham, NC, United States.
Michael S SeamanBeth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, United States.
John R MascolaVaccine Research Center, National Institutes of Health (NIH), Bethesda, MD, United States.
David C MontefioriDepartment of Surgery, Duke University Medical Center, Durham, NC, United States.
Duke Medical Center · USNational Institutes of Health · USDuke University Hospital · USHarvard University · US

Funding

LC: HIV Vaccine Trials NetworkUM1AI068618 · NIAID · FRED HUTCHINSON CANCER RESEARCH CENTER · PI Margaret Juliana McElrath · 2011 to 2026
$483.6M
HVTN Laboratory ProgramU01AI068618 · NIAID · FRED HUTCHINSON CANCER RESEARCH CENTER · PI MCELRATH, MARGARET JULIANA · 2006 to 2010
$82.6M
Social and Behavioral Sciences CoreP30AI064518 · NIAID · DUKE UNIVERSITY · PI Nwora Lance Okeke · 2005 to 2026
$50.5M
NIAID NIH HHS 5P30 AI064518NIAID NIH HHS AI068618NIAID NIH HHS AI46705NIAID NIH HHS HHSN272201100016CNIAID NIH HHS N01 AI030034NIAID NIH HHS P30 AI064518NIAID NIH HHS U01 AI068618NIAID NIH HHS UM1 AI068618PHS HHS HHSN272200110016C
6 · The paper itself

Abstract

The TZM-bl assay measures antibody-mediated neutralization of HIV-1 as a function of reductions in HIV-1 Tat-regulated firefly luciferase (Luc) reporter gene expression after a single round of infection with Env-pseudotyped viruses. This assay has become the main endpoint neutralization assay used for the assessment of pre-clinical and clinical trial samples by a growing number of laboratories worldwide. Here we present the results of the formal optimization and validation of the TZM-bl assay, performed in compliance with Good Clinical Laboratory Practice (GCLP) guidelines. The assay was evaluated for specificity, accuracy, precision, limits of detection and quantitation, linearity, range and robustness. The validated manual TZM-bl assay was also adapted, optimized and qualified to an automated 384-well format.

Indexed as

Antibodies, NeutralizingAutomation, LaboratoryBiomarkersGuideline AdherenceHeLa CellsHigh-Throughput Screening AssaysHIV-1HIV AntibodiesHIV InfectionsHumansLimit of DetectionNeutralization TestsObserver VariationPractice Guidelines as TopicPredictive Value of TestsQuality ControlAntibodies, NeutralizingBiomarkersHIV AntibodiesAssay validationGCLPHIVNeutralizing antibodyTZM-bl cells

Identifiers

PMID24291345
PMCPMC4040342
OpenAlexW2082208556

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.