Evidence map›Paper›PMID 28366544›Full record

ArticleJournal of clinical virology : the official publication of the Pan American Society for Clinical Virology2017

Evaluation of dried blood spot protocols with the Bio-Rad GS HIV Combo Ag/Ab EIA and Geenius™ HIV 1/2 Supplemental Assay.

Wei Luo, Geoff Davis, LiXia Li, M Kathleen Shriver, Joanne Mei, Linda M Styer, Monica M Parker, Amanda Smith, Gabriela Paz-Bailey, Steve Ethridge and 3 more

Open access · greenAbstract readComparative StudyEvaluation Study
In one paragraph

Article in Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
0.8field-weighted citation impact, top 33% 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

8 citing papers in PubMed, 11 citations in OpenAlex.

  1. Validation of mailedGlobal health & medicine · 2021
    Article
  2. Article
  3. Article
  4. Article
  5. Article
  6. Article
  7. Article
  8. 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 1 country.

Wei LuoCenters for Disease Control and Prevention, Atlanta, GA, USA.
Geoff DavisBio-Rad Laboratories, Redmond, WA, USA.
LiXia LiCenters for Disease Control and Prevention, Atlanta, GA, USA.
M Kathleen ShriverBio-Rad Laboratories, Redmond, WA, USA.
Joanne MeiCenters for Disease Control and Prevention, Atlanta, GA, USA.
Linda M StyerWadsworth Center, New York State Department of Health, Albany, NY, USA.
Monica M ParkerWadsworth Center, New York State Department of Health, Albany, NY, USA.
Amanda SmithCenters for Disease Control and Prevention, Atlanta, GA, USA.
Gabriela Paz-BaileyCenters for Disease Control and Prevention, Atlanta, GA, USA.
Steve EthridgeCenters for Disease Control and Prevention, Atlanta, GA, USA.
Laura WesolowskiCenters for Disease Control and Prevention, Atlanta, GA, USA.
S Michele OwenCenters for Disease Control and Prevention, Atlanta, GA, USA.
Silvina MasciotraCenters for Disease Control and Prevention, Atlanta, GA, USA. Electronic address: svm6@cdc.gov.
Centers for Disease Control and Prevention · USBio-Rad (United States) · USNew York State Department of Health · USWadsworth Center · US

Funding

Intramural CDC HHS CC999999
6 · The paper itself

Abstract

objectiveFDA-approved antigen/antibody combo and HIV-1/2 differentiation supplemental tests do not have claims for dried blood spot (DBS) use. We compared two DBS-modified protocols, the Bio-Rad GS HIV Combo Ag/Ab (BRC) EIA and Geenius™ HIV-1/2 (Geenius) Supplemental Assay, to plasma protocols and evaluated them in the CDC/APHL HIV diagnostic algorithm.

methodsBRC-DBS p24 analytical sensitivity was calculated from serial dilutions of p24. DBS specimens included 11 HIV-1 seroconverters, 151 HIV-1-positive individuals, including 20 on antiretroviral therapy, 31 HIV-2-positive and one HIV-1/HIV-2-positive individuals. BRC-reactive specimens were tested with Geenius using the same DBS eluate. Matched plasma specimens were tested with BRC, an IgG/IgM immunoassay and Geenius. DBS and plasma results were compared using the McNemar's test. A DBS-algorithm applied to 348 DBS from high-risk individuals who participated in surveillance was compared to HIV status based on local testing algorithms.

resultsBRC-DBS detects p24 at a concentration 18 times higher than in plasma. In seroconverters, BRC-DBS detected more infections than the IgG/IgM immunoassay in plasma (p=0.0133), but fewer infections than BRC-plasma (p=0.0133). In addition, the BRC/Geenius-plasma algorithm identified more HIV-1 infections than the BRC/Geenius-DBS algorithm (p=0.0455). The DBS protocols correctly identified HIV status for established HIV-1 infections, including those on therapy, HIV-2 infections, and surveillance specimens.

conclusionsThe DBS protocols exhibited promising performance and allowed rapid supplemental testing. Although the DBS algorithm missed some early infections, it showed similar results when applied to specimens from a high-risk population. Implementation of a DBS algorithm would benefit testing programs without capacity for venipuncture.

Indexed as

Dried Blood Spot TestingImmunoenzyme TechniquesAIDS SerodiagnosisAlgorithmsEpidemiological MonitoringHIV-1HIV-2HIV AntibodiesHIV AntigensHIV InfectionsHumansReagent Kits, DiagnosticRisk FactorsRNA, ViralSensitivity and SpecificityHIV AntibodiesHIV AntigensReagent Kits, DiagnosticRNA, ViralDBS testingHIV diagnosticsSurveillance

Identifiers

PMID28366544
PMCPMC11111259
OpenAlexW2598020091

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.