Evidence map›Paper›PMID 33064884›Full record

ArticleTransfusion2020

Comparison of two nucleic acid amplification technology systems for detection of human immunodeficiency virus, hepatitis B virus, and hepatitis C virus.

Charl Coleman, Nico Lelie, Ronel Rademeyer, Harry van Drimmelen, Karin van den Berg, Marion Vermeulen

Open access · greenAbstract readComparative Study
In one paragraph

Article in Transfusion, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 1 pooled it
0.4field-weighted citation impact, top 38% 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

5 citing papers in PubMed, 1 synthesis or guideline pooled it, 9 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Article
  4. Article
  5. 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

6 authors at 3 institutions in 3 countries.

Charl ColemanSouth African National Blood Service, Roodepoort, South Africa.ORCID 0000-0003-3272-927X
Nico LelieLelie Research, Alkmaar, the Netherlands.ORCID 0000-0003-1043-661X
Ronel RademeyerSouth African National Blood Service, Roodepoort, South Africa.
Harry van DrimmelenBiologicals Quality Control B.V., Amsterdam, the Netherlands.
Karin van den BergSouth African National Blood Service, Roodepoort, South Africa.
Marion VermeulenSouth African National Blood Service, Roodepoort, South Africa.ORCID 0000-0003-4383-4526
South African National Blood Service · ZAMedisch Centrum Alkmaar · NLQuality Systems (United States) · US

Funding

Research training in HIV-related transfusion medicine and hematology in South AfricaD43TW010345 · FIC · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI UTE JENTSCH, EDWARD L MURPHY · 2017 to 2026
$3.0M
International Traineeships in AIDS Prevention Studies (ITAPS)R25MH123256 · NIMH · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI CHRISTINA P LINDAN · 2020 to 2026
$1.8M
FIC NIH HHS D43 TW010345Grifols Diagnostics NoneNIMH NIH HHS R25 MH123256Roche Diagnostics
6 · The paper itself

Abstract

Human immunodeficiency virus (HIV) and hepatitis B virus (HBV) are endemic in South Africa while hepatitis C virus (HCV) infection is rare. Two nucleic acid amplification technology platforms, the Procleix Ultrio Elite assay on the Panther instrument (Elite) and the cobas MPX assay on the cobas 6800 or 8800 system (MPX), are used worldwide. In 2015 these were evaluated in South African context. STUDY DESIGN AND

methodsThe sensitivity of HIV, HBV, and HCV was evaluated using reference panels and 2-fold dilutions of 51 positive plasma samples tested in 12 to 24 replicates. The 95% and 50% lower limits of detection (LOD) were estimated by probit analysis and window period (WP) risk days by the Weusten model. Specificity was established by testing 3646 blood donations individually and instrument performance by evaluating all runs.

resultsSpecificity was 99.94% for MPX and 99.97% for Elite. The following 95% LODs (95% confidence intervals [CIs]) were estimated for MPX and Elite, respectively: HBV, 17.8 (10.9-33.9) and 47.9 (29.1-92.4) cp/mL; HCV, 21.9 (15.3-34.6) and 13.8 (8.9-24.0) cp/mL; and HIV, 8.3 (5.5-14.7) and 10.4 (6.9-18.2) cp/mL. On SA HBV and HIV dilution panels, relative sensitivity (range) of MPX was 3.20 (1.26-6.50) and 1.42 (0.26-2.72) fold higher than Elite. Downtime on cobas 6800 was 26 hours vs 6.6 hours on Panther (P < .001). We estimated infectious WPs for HBV, HCV, and HIV-1 at 13.8, 1.8, and 2.6 days for Elite and 10.3, 2.1, and 2.4 days for MPX.

conclusionAlthough MPX was significantly more sensitive for HBV, Elite was implemented due to instrument reliability during evaluation.

Indexed as

Blood DonorsDNA, ViralHepatitis BHepatitis CHIV InfectionsNucleic Acid Amplification TechniquesRNA, ViralHepacivirusHepatitis B virusHIV-1HumansSensitivity and SpecificitySouth AfricaDNA, ViralRNA, Viral

Identifiers

PMID33064884
PMCPMC10936959
OpenAlexW3092744639

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.