Evidence map›Paper›PMID 36930653›Full record

ArticlePLoS neglected tropical diseases2023

Standardized evaluation of Zika nucleic acid tests used in clinical settings and blood screening.

Mars Stone, Sonia Bakkour, Eduard Grebe, Devy M Emperador, Camille Escadafal, Xutao Deng, Honey Dave, Cassandra Kelly-Cirino, Eve Lackritz, Diana P Rojas and 3 more

Open access · goldAbstract read
In one paragraph

Article in PLoS neglected tropical diseases, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
2.3field-weighted citation impact, top 13% 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

3 citing papers in PubMed, 8 citations in OpenAlex.

  1. Article
  2. Article
  3. Article
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

13 authors at 4 institutions in 2 countries.

Mars StoneVitalant Research Institute, San Francisco, California, United States of America.
Sonia BakkourVitalant Research Institute, San Francisco, California, United States of America.
Eduard GrebeVitalant Research Institute, San Francisco, California, United States of America.
Devy M EmperadorPandemic Threats Program, FIND, Geneva, Switzerland.ORCID 0000-0002-8228-1824
Camille EscadafalPandemic Threats Program, FIND, Geneva, Switzerland.
Xutao DengVitalant Research Institute, San Francisco, California, United States of America.
Honey DaveVitalant Research Institute, San Francisco, California, United States of America.
Cassandra Kelly-CirinoElizabeth Glaser Pediatric AIDS Foundation, Geneva, Switzerland.
Eve LackritzWorld Health Organization, Geneva, Switzerland.
Diana P RojasWorld Health Organization, Geneva, Switzerland.
Graham SimmonsVitalant Research Institute, San Francisco, California, United States of America.
Ingrid B RabeWorld Health Organization, Geneva, Switzerland.
Michael P BuschVitalant Research Institute, San Francisco, California, United States of America.
University of California, San Francisco · USWorld Health Organization · CHFIND · CHPacific Research Institute · US

Funding

World Health Organization 001
6 · The paper itself

Abstract

Early detection of Zika virus (ZIKV) transmission within geographic regions informs implementation of community mitigation measures such as vector reduction strategies, travel advisories, enhanced surveillance among pregnant women, and possible implementation of blood and organ donor screening or deferral. Standardized, comparative assessments of ZIKV assay and testing lab performance are important to develop optimal approaches to ZIKV diagnostic testing and surveillance. We conducted an expanded blinded panel study to characterize and compare the analytical performance of fifteen diagnostic and blood screening ZIKV NAT assays, including detection among single- and multiplex assays detecting ZIKV, dengue virus (DENV) and chikungunya virus (CHIKV). A 300 member blinded panel was constructed, consisting of 11 serial half-log dilutions ranging from ~104 to 10-1 genome equivalents/mL in 25 replicates each of the Tahitian Asian ZIKV isolate in ZIKV-negative human serum. Additionally, clinical samples from individuals with DENV-like syndrome or suspected ZIKV infection in Brazil were evaluated. The majority of assays demonstrated good specificity. Analytical sensitivities varied 1-2 logs, with a substantially higher limit of detection (LOD) in one outlier. Similar analytical sensitivity for ZIKV RNA detection in singleplex and multiplex assays of the Grifols and ThermoFisher tests were observed. Coefficient of Assay Efficiency (CE), calculated to characterize assays' RNA extraction and amplification efficiency, ranged from 0.13 for the Certest VIASURE multiplex and 0.75 for the Grifols multiplex assays. In general, assays using transcription mediated amplification (TMA) technology had greater CE compared to assays using conventional PCR technology. Donor screening NAT assays were significantly more sensitive than diagnostic RT-qPCR assays, primarily attributable to higher sample input volumes. However, ideal assays to maximize sensitivity and throughput may not be a viable option in all contexts, with other factors such as cost, instrumentation, and regulatory approval status influencing assay availability and selection, particularly in resource constrained settings.

Indexed as

Chikungunya FeverDengueDengue VirusZika VirusZika Virus InfectionFemaleHumansPregnancyReal-Time Polymerase Chain ReactionRNARNA

Identifiers

PMID36930653
PMCPMC10072466
OpenAlexW4327684928

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.