ArticleJournal of virological methods2021
Evaluation of the analytical performance and specificity of a SARS-CoV-2 transcription-mediated amplification assay.
Article in Journal of virological methods, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers.
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Who cites it
16 citing papers in PubMed, 17 citations in OpenAlex.
- Development and Evaluation of Molecular Diagnostic Tests for SARS-CoV-2 at English NHS Sites Throughout the COVID-19 Pandemic.Viruses · 2026Review
- Role of Hologic® Panther AptimaTM SARS-CoV-2 assay in the detection of SARS-CoV-2: screening or diagnostic technique?Revista espanola de quimioterapia : publicacion oficial de la Sociedad Espanola de Quimioterapia · 2023Article
- Evaluation of SARS-CoV-2 Detection Systems Using Clinical Samples and Standard Material: A Comparative Study.Diagnostics (Basel, Switzerland) · 2023Article
- Article
- Similar Sensitivity of SARS-CoV-2 Detection in Oropharyngeal/Nasopharyngeal and Saliva Samples on the Hologic Panther Platform.Diagnostics (Basel, Switzerland) · 2023Article
- A precise review on NAATs-based diagnostic assays for COVID-19: A motion in fast POC molecular tests.European journal of clinical investigation · 2022Review
- An Overview of SARS-CoV-2 Molecular Diagnostics in Europe.Clinics in laboratory medicine · 2022Review
- Analytic and Clinical Performance of Major Commercial Severe Acute Respiratory Syndrome Coronavirus 2 Molecular Assays in the United States.Clinics in laboratory medicine · 2022Review
- Advances in laboratory detection methods and technology application of SARS-CoV-2.Journal of medical virology · 2022Review
- Longitudinal Immune Profiling of a Severe Acute Respiratory Syndrome Coronavirus 2 Reinfection in a Solid Organ Transplant Recipient.The Journal of infectious diseases · 2022Article
- Positivity rates of SAR-CoV-2 infection in orthodontic patients at the orthodontic clinic, University of Illinois Chicago.PloS one · 2022Article
- A Study of Analytical and Clinical Sensitivity of Aptima SARS-CoV-2 Assay (Hologic) and Proposals of Complementary Tests for SARS-CoV-2 Detection in Low Viral Load Specimens.Current microbiology · 2021Article
- Microorganisms as Shapers of Human Civilization, from Pandemics to Even Our Genomes: Villains or Friends? A Historical Approach.Microorganisms · 2021Review
- Point-of-Care Testing-The Key in the Battle against SARS-CoV-2 Pandemic.Micromachines · 2021Review
- Performance Evaluation of the BD SARS-CoV-2 Reagents for the BD MAX System.Journal of clinical microbiology · 2021Article
- The Hologic Aptima SARS-CoV-2 assay enables high ratio pooling saving reagents and improving turnaround time.Journal of clinical laboratory analysis · 2021Article
Corrections and comments
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Authors and funding
3 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
The ongoing severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic requires fast and accurate high-throughput diagnostic tools. To evaluate the analytical performance of the Hologic Aptima transcription-mediated amplification (TMA) assay for detection of SARS-CoV-2 RNA from respiratory samples we analysed 103 clinical and proficiency panel samples pre-tested by real-time RT-PCR (Altona, RealStar) and found a positive percent agreement (sensitivity) of 95.7 % and a negative percent agreement (specificity) of 100 %. The limit of detection of the Aptima test was 150 copies/mL determined as 95 % detection probability. To further assess the Aptima assay's specificity we prospectively analysed 7545 clinical specimens from the upper and lower respiratory tract sent for the purpose of routine SARS-CoV-2 screening. SARS-CoV-2 RNA was detected in 16/7545 (0.2 %) samples by the TMA assay and confirmed independently by the Xpert SARS-CoV-2 RT-PCR (Cepheid); in one case a previous discrepant result was confirmed as true SARS-CoV-2 infection in a subsequent sample from the same patient. Results from the Aptima SARS-CoV-2 TMA assay agreed well with RT-PCR and showed an excellent specificity in a large number of routine specimens despite the low prevalence at that time of the pandemic, indicating that this assay can be used even for screening purposes.
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