Validation of a Low-Volume (100 μL) Plasma Protocol for HIV-1 RNA Quantification Using the Hologic Aptima HIV-1 Quant Dx Assay.

Lorna S Madurai, Kiveshan Reddy, Someshni Nair, Bhavani Manivannan, Kayla Pillay, Sharana Mahomed

Abstract readValidation Study

In one paragraph

Article in The Journal of molecular diagnostics : JMD, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it

0cells of the map it votes in

0citing papers in PubMed

–field-weighted citation impact

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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

6 authors.

Lorna S MaduraiUniversal Pathology Laboratory, Prospecton, South Africa; CAPRISA, Centre for the AIDS Programme of Research in South Africa, Durban, South Africa.

Kiveshan ReddyUniversal Pathology Laboratory, Prospecton, South Africa.

Someshni NairUniversal Pathology Laboratory, Prospecton, South Africa.

Bhavani ManivannanBest Care Diagnostics Centre, Chennai, India.

Kayla PillayUniversal Pathology Laboratory, Prospecton, South Africa.

Sharana MahomedUniversal Pathology Laboratory, Prospecton, South Africa; CAPRISA, Centre for the AIDS Programme of Research in South Africa, Durban, South Africa; Department of Medical Microbiology, University of KwaZulu-Natal, Durban, South Africa. Electronic address: sharana.mahomed@caprisa.org.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Pediatric HIV-1 viral load monitoring is often limited by the small blood volumes that can be safely obtained from infants and young children. Standard assays typically require 0.5 to 0.7 mL of plasma, which can pose challenges in these settings. This study evaluated a modified low-volume protocol using 100 μL of plasma, diluted for use with the Hologic Aptima HIV-1 Quant Dx assay, to determine whether performance was equivalent to the standard 700 μL protocol. An analytical validation was conducted by using de-identified EDTA plasma samples spanning a wide range of HIV-1 RNA concentrations. Each specimen was tested by using both protocols on the Panther system. Agreement between methods was assessed by using log

Indexed as

HIV-1HIV InfectionsRNA, ViralViral LoadHumansReproducibility of ResultsSensitivity and SpecificityRNA, Viral

Identifiers

PMID41936820

DOI10.1016/j.jmoldx.2026.03.006

PMCPMC13269340

What OpenQuestion holds

Textmetadata

LicenceCC BY-NC

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.