Exploring beyond the limit: How comparative stochastic performance affects retesting outcomes in six commercial SARS CoV-2 nucleic acid amplification tests.

Hiu Tat Chan, Marco H T Keung, Ivy Nguyen, Ellen L O Ip, Su M Chew, Danielle Siler, Marion Saville, David Hawkes

Abstract read

In one paragraph

Article in Journal of clinical virology plus, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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1 · What the graph read from it

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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.

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5 · Who and what money

Authors and funding

8 authors.

Hiu Tat ChanVCS Pathology, Australian Centre for the Prevention of Cervical Cancer, 265 Faraday Street, Carlton South, VIC 3053, Australia.

Marco H T KeungVCS Pathology, Australian Centre for the Prevention of Cervical Cancer, 265 Faraday Street, Carlton South, VIC 3053, Australia.

Ivy NguyenVCS Pathology, Australian Centre for the Prevention of Cervical Cancer, 265 Faraday Street, Carlton South, VIC 3053, Australia.

Ellen L O IpVCS Pathology, Australian Centre for the Prevention of Cervical Cancer, 265 Faraday Street, Carlton South, VIC 3053, Australia.

Su M ChewVCS Pathology, Australian Centre for the Prevention of Cervical Cancer, 265 Faraday Street, Carlton South, VIC 3053, Australia.

Danielle SilerIPC Health, Deer Park, VIC 3023, Australia.

Marion SavilleVCS Pathology, Australian Centre for the Prevention of Cervical Cancer, 265 Faraday Street, Carlton South, VIC 3053, Australia.

David HawkesVCS Pathology, Australian Centre for the Prevention of Cervical Cancer, 265 Faraday Street, Carlton South, VIC 3053, Australia.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Objectives: To examine the comparative stochasticity profile of six commercial SARS-CoV-2 nucleic acid amplification tests (NAATs) and how this may affect retesting paradigms. Methods: Commercial quality control (QC) material was serially diluted in viral transport media to create a panel covering 10-10,000 copies/ml. The panel was tested across six commercial NAATs. A subset of high cycle threshold results was retested on a rapid PCR assay to simulate retesting protocols commonly used to discriminate false positives. Results: Performance beyond the LOD differed among assays, with three types of stochasticity profiles observed. The ability of the rapid PCR assay to reproduce a true weak positive specimen was restricted to its own stochastic performance at the corresponding viral concentration. Conclusion: Stochastic performance of various NAATs overlap across low viral concentrations and affect retesting outcomes. Relying on retesting alone to discriminate false positives risk missing true positives even when a more sensitive assay is deployed for confirmatory testing.

Indexed as

Comparative sensitivityFalse negativeFalse positiveLimit of detectionNucleic acid amplification testsSARS-CoV-2Stochastic performance

Identifiers

PMID35528049

DOI10.1016/j.jcvp.2022.100079

PMCPMC9055756

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