Evidence map›Paper›PMID 36120497›Full record

ArticleHeliyon2022

Agile design and development of a high throughput cobas SARS-CoV-2 RT-PCR diagnostic test.

Chitra Manohar, Jingtao Sun, Peter Schlag, Chris Santini, Marcel Fontecha, Pirmin Lötscher, Carolin Bier, Kristina Goepfert, Dana Duncan, Gene Spier and 2 more

Abstract read
In one paragraph

Article in Heliyon, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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

2 citing papers in PubMed.

  1. Article
  2. 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

12 authors.

Chitra ManoharRoche Molecular Systems, Inc., Pleasanton, United States.
Jingtao SunRoche Molecular Systems, Inc., Pleasanton, United States.
Peter SchlagRoche Molecular Systems, Inc., Pleasanton, United States.
Chris SantiniRoche Molecular Systems, Inc., Pleasanton, United States.
Marcel FontechaRoche Molecular Systems, Inc., Pleasanton, United States.
Pirmin LötscherRoche Diagnostics International AG, Rotkreuz, Switzerland.
Carolin BierRoche Diagnostics International AG, Rotkreuz, Switzerland.
Kristina GoepfertRoche Diagnostics International AG, Rotkreuz, Switzerland.
Dana DuncanRoche Molecular Systems, Inc., Pleasanton, United States.
Gene SpierRoche Molecular Systems, Inc., Pleasanton, United States.
Daniel JaremRoche Molecular Systems, Inc., Pleasanton, United States.
Dmitriy KosarikovRoche Molecular Systems, Inc., Pleasanton, United States.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Diagnostic testing is essential for management of the COVID-19 pandemic. An agile assay design methodology, optimized for the cobas® 6800/8800 system, was used to develop a dual-target, qualitative SARS-CoV-2 RT-PCR test using commercially available reagents and existing sample processing and thermocycling profiles. The limit of detection was 30-52 copies/mL for USA-WA1/2020. Assay sensitivity was confirmed for SARS-CoV-2 variants Alpha, Beta, Gamma, Delta and Kappa. The coefficients of variation of the cycle threshold number (Ct) were between 1.1 and 2.2%. There was no difference in Ct using nasopharyngeal compared to oropharyngeal swabs in universal transport medium (UTM). A small increase in Ct was observed with specimens collected in cobas PCR medium compared to UTM. In silico analysis indicated that the dual-target test is capable of detecting all >1,800,000 SARS-CoV-2 sequences in the GISAID database. Our agile assay design approach facilitated rapid development and deployment of this SARS-CoV-2 RT-PCR test.

Indexed as

COVID-19Diagnostic testingMolecular assay designPandemicRT-PCRSARS-CoV-2

Identifiers

PMID36120497
PMCPMC9464314

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.