Evidence map›Paper›PMID 31977972›Full record

ArticleSexually transmitted diseases2020

Could HIV-1 RNA Testing be an Option as the Second Step in the HIV Diagnostic Algorithm?

Silvina Masciotra, Wei Luo, Rebecca Rossetti, Tara Smith, Steven Ethridge, Kevin P Delaney, Laura G Wesolowski, S Michele Owen

Open access · greenAbstract read
In one paragraph

Article in Sexually transmitted diseases, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
0.5field-weighted citation impact, top 37% 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

4 citing papers in PubMed, 7 citations in OpenAlex.

  1. Estimating the Economic Consequences of Leveraging the Novel cobas HIV-1/HIV-2 Qualitative Nucleic Acid Amplification Test in Routine HIV Testing.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2025
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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

8 authors at 1 institution in 1 country.

Silvina MasciotraFrom the Division of HIV/AIDS Prevention, Centers for Disease Control and Prevention.
Wei LuoFrom the Division of HIV/AIDS Prevention, Centers for Disease Control and Prevention.
Rebecca RossettiFrom the Division of HIV/AIDS Prevention, Centers for Disease Control and Prevention.
Tara SmithORISE, Oak Ridge, Tennessee, USA/ICF, Atlanta, GA.
Steven EthridgeFrom the Division of HIV/AIDS Prevention, Centers for Disease Control and Prevention.
Kevin P DelaneyFrom the Division of HIV/AIDS Prevention, Centers for Disease Control and Prevention.
Laura G WesolowskiFrom the Division of HIV/AIDS Prevention, Centers for Disease Control and Prevention.
S Michele OwenFrom the Division of HIV/AIDS Prevention, Centers for Disease Control and Prevention.
Oak Ridge Associated Universities · US

Funding

Intramural CDC HHS CC999999
6 · The paper itself

Abstract

backgroundThere is benefit to early HIV-1 diagnosis and treatment, but there is no Food and Drug Administration-approved quantitative assay with a diagnostic claim. We compared the performance of the Hologic Aptima HIV-1 Quant (APT-Quant) and Aptima HIV-1 Qual (APT-Qual) assays for diagnostic use and the performance of a diagnostic algorithm consisting of Bio-Rad BioPlex 2200 HIV Ag-Ab assay (BPC) followed by APT-Quant (2-test) compared with BPC followed by Geenius HIV-1/2 supplemental assay (Geenius) with reflex to APT-Qual (3-test).

methodsFive hundred twenty-four plasma, which included 419 longitudinal specimens from HIV-1 seroconverters (78 were after initiating antiretroviral therapy [ART]) and 105 from ART-naive persons with established HIV-1 infections, were used to evaluate APT-Quant performance for diagnostic use. Specimens from 200 HIV-negative persons were used to measure specificity. For the algorithm comparison, BPC-reactive specimens were evaluated with the 2-test or 3-test algorithm. McNemar's test was used to compare performance.

resultsThe APT-Quant detected more samples early in infection compared with APT-Qual. The APT-Quant specificity was 99.8%. Before ART initiation, the algorithms performed similarly among samples from different stages of infection. After ART initiation, the 3-test algorithm performed significantly better (P = 0.0233).

conclusionsThe APT-Quant has excellent performance for diagnostic use. The 2-test algorithm works well in ART-naive samples, but its performance decreases after the IgG response is elicited and with ART-induced suppressed viremia. Providing confirmation and viral load assay with 1 test result could be advantageous for patient care. However, additional factors and challenges associated with the implementation of this 2-test algorithm, such as cost, specimen type, and collection need further evaluation.

Indexed as

AlgorithmsHIV-1HIV AntibodiesHIV InfectionsHumansNucleic Acid Amplification TechniquesPolymerase Chain ReactionReagent Kits, DiagnosticReproducibility of ResultsRNA, ViralSensitivity and SpecificityViral LoadHIV AntibodiesReagent Kits, DiagnosticRNA, Viral

Identifiers

PMID31977972
PMCPMC11111260
OpenAlexW3000758842

What OpenQuestion holds

Textmetadata
LicenceTDM
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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.