ArticleJournal of clinical virology : the official publication of the Pan American Society for Clinical Virology2020
Pushing beyond specifications: Evaluation of linearity and clinical performance of the cobas 6800/8800 SARS-CoV-2 RT-PCR assay for reliable quantification in blood and other materials outside recommendations.
Article in Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 25 papers.
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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.
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Who cites it
25 citing papers in PubMed, 31 citations in OpenAlex.
- Efficacy of the tetravalent protein COVID-19 vaccine, SCTV01E: a phase 3 double-blind, randomized, placebo-controlled trial.Nature communications · 2024Trial
- Infectivity of SARS-CoV-2 on Inanimate Surfaces: Don't Trust Ct Value.International journal of environmental research and public health · 2022Article
- Clinical efficacy and in vitro neutralization capacity of monoclonal antibodies for severe acute respiratory syndrome coronavirus 2 delta and omicron variants.Journal of medical virology · 2022Article
- Agile design and development of a high throughput cobas SARS-CoV-2 RT-PCR diagnostic test.Heliyon · 2022Article
- Impact of Oral Rinsing with Octenidine Based Solution on SARS-CoV-2 Loads in Saliva of Infected Patients an Exploratory Study.International journal of environmental research and public health · 2022Article
- The blood-brain barrier is dysregulated in COVID-19 and serves as a CNS entry route for SARS-CoV-2.Stem cell reports · 2022Article
- Comparison of SARS-CoV-2 detection with the Cobas® 6800/8800 system on gargle samples using two sample processing methods with combined oropharyngeal/nasopharyngeal swab.Journal of medical virology · 2021Article
- A method for measuring the experimental resolution of laboratory assays (clinical biochemical, blood count, immunological, and qPCR) to evaluate analytical performance.Journal of clinical laboratory analysis · 2021Article
- Clinical establishment of a laboratory developed quantitative HDV PCR assay on the cobas6800 high-throughput system.JHEP reports : innovation in hepatology · 2021Article
- Multicenter Evaluation of a Fully Automated High-Throughput SARS-CoV-2 Antigen Immunoassay.Infectious diseases and therapy · 2021Article
- Finding the Middle Ground with the Clinical Laboratory's Role in SARS-CoV-2 Genomic Surveillance.Journal of clinical microbiology · 2021Article
- Clinical performance and accuracy of a qPCR-based SARS-CoV-2 mass-screening workflow for healthcare-worker surveillance using pooled self-sampled gargling solutions: A cross-sectional study.The Journal of infection · 2021Article
- SARS-CoV-2 Blood RNA Load Predicts Outcome in Critically Ill COVID-19 Patients.Open forum infectious diseases · 2021Article
- Rapid Automated Screening for SARS-CoV-2 B.1.617 Lineage Variants (Delta/Kappa) through a Versatile Toolset of qPCR-Based SNP Detection.Diagnostics (Basel, Switzerland) · 2021Article
- The handling of SARS-CoV-2 associated deaths - infectivity of the body.Forensic science, medicine, and pathology · 2021Article
- Evaluation of a fully automated high-throughput SARS-CoV-2 multiplex qPCR assay with built-in screening functionality for del-HV69/70- and N501Y variants such as B.1.1.7.Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology · 2021Article
- Fatal COVID-19 in a Child with Persistence of SARS-CoV-2 Despite Extensive Multidisciplinary Treatment: A Case Report.Children (Basel, Switzerland) · 2021Article
- Tools and Techniques for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)/COVID-19 Detection.Clinical microbiology reviews · 2021Review
- Allogeneic stem cell transplantation in acute leukemia patients after COVID-19 infection.Bone marrow transplantation · 2021Article
- SARS-CoV-2 Reinfection in a Healthcare Worker Despite the Presence of Detectable Neutralizing Antibodies.Viruses · 2021Article
Corrections and comments
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Authors and funding
10 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe ongoing SARS-CoV-2 pandemic presents a unique challenge to diagnostic laboratories. There are preliminary studies correlating qRT-PCR results from different materials to clinical outcomes, yet, comparability is limited due to the plethora of different assays used for diagnostics. In this study we evaluate clinical performance and linear range for the SARS-CoV-2 IVD (cobas6800/8800 system, a fully automated sample-to-result platform) in different clinically relevant matrix materials outside official specifications.
methodsAssay performance was assessed in human plasma, BAL/BL and transport medium following chemical inactivation. For analytical evaluation, respective matrix materials were spiked with SARS-CoV-2 RNA in ten-fold dilution series. The efficacy of chemical inactivation by guanidine hydrochloride solution was confirmed in cell culture infectivity experiments. For correlation, a total of 289 predetermined clinical samples including respiratory swabs, plasma and lower respiratory tract specimens were subjected to the SARS-CoV-2 IVD test and results were compared.
resultsThe SARS-CoV-2 IVD showed excellent linearity over four to six log steps depending on matrix material. Chemical inactivation resulted in a reduction in plaque forming units of at least 3.5 log steps, while having no significant impact on assay performance. Inter-run consistency from three different testing sites demonstrated excellent comparability of RT-PCR results (maximum deviation was 1.53 CT). Clinical evaluation for respiratory swabs showed very good agreement with the comparator assay (Positive agreement 95.7 %, negative agreement 98.9 %).
conclusionThe SARS-CoV-2 IVD test for the cobas6800/8800 systems offers excellent linear range and inter-run consistency for quantification of SARS-CoV-2 RNA in different matrices outside official specifications.
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Registered trials
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