Evidence map›Paper›PMID 37649536›Full record

ArticlePractical laboratory medicine2023

Analytical performance verification of a high throughput system for Hepatitis B and Hepatitis C viral load quantifications.

Javeria Aijaz, Jibran Khan, Fouzia Naseer, Dheeraj Kumar, Shakir Hussain

Abstract read
In one paragraph

Article in Practical laboratory medicine, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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

1 citing paper in PubMed.

  1. 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

5 authors.

Javeria AijazMolecular Biology Section, Pathology Department, Indus Hospital & Health Network, Korangi Crossing, Karachi, 75190, Pakistan.
Jibran KhanMolecular Biology Section, Pathology Department, Indus Hospital & Health Network, Korangi Crossing, Karachi, 75190, Pakistan.
Fouzia NaseerMolecular Biology Section, Pathology Department, Indus Hospital & Health Network, Korangi Crossing, Karachi, 75190, Pakistan.
Dheeraj KumarMolecular Biology Section, Pathology Department, Indus Hospital & Health Network, Korangi Crossing, Karachi, 75190, Pakistan.
Shakir HussainMolecular Biology Section, Pathology Department, Indus Hospital & Health Network, Korangi Crossing, Karachi, 75190, Pakistan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Objective: To verify the analytical performance of cobas® HBV PCR and cobas® HCV PCR assays with Abbott m2000 RealTime System as the reference method. Design: De-identified residual, archived patient specimens, and College of American Pathologists (CAP) proficiency testing samples were used. Analytical parameters verified were accuracy, precision, limit of detection (LOD), linear range, and cross-contamination. Experiments were designed in accordance with Clinical Laboratories Standards Institute (CLSI) guidelines and CAP standards. Analysis of accuracy was done through regression plots and Bland Altman analyses. Precision was analyzed through coefficient of variation and ANOVA; LOD through probit analysis; and linear range through polynomial fit analysis. Results: The regression plots for accuracy showed a slope nearing 1, with a y-intercept close to zero, while Bland Altman analyses also showed no systematic evidence of bias, though concordance of results was not perfect near the lower limit of quantification. Coefficients of variation were all below 15%, while ANOVA returned p-values above 0.99, indicating no statistically significant imprecision. The LOD verified were an order of magnitude higher than the manufacturer reported ones for both assays, while the linear range verified was more limited. Within the verified range, polynomial fit analysis showed line to be the best fit for the data. Conclusions: cobas® HBV PCR and cobas® HCV PCR assays showed acceptable accuracy, acceptable precision, as well as no evidence of cross-contamination. The LOD verified were higher, and linear ranges more limited than those reported by the manufacturer. Verifications of these may be limited by availability of appropriate testing specimens.

Indexed as

Analyticalcobas®HBVHCVRocheVerification

Identifiers

PMID37649536
PMCPMC10462671

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Registered trials

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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.