ArticleJournal of clinical virology : the official publication of the Pan American Society for Clinical Virology2020
High-Throughput Transcription-mediated amplification on the Hologic Panther is a highly sensitive method of detection for SARS-CoV-2.
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 59 papers, 1 of them a synthesis that pooled it.
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Who cites it
59 citing papers in PubMed, 1 synthesis or guideline pooled it, 103 citations in OpenAlex.
- Laboratory-based molecular test alternatives to RT-PCR for the diagnosis of SARS-CoV-2 infection.The Cochrane database of systematic reviews · 2024Pooled it
- Same-day SARS-CoV-2 antigen test screening in an indoor mass-gathering live music event: a randomised controlled trial.The Lancet. Infectious diseases · 2021Trial
- Indiscriminate Trans-Cleavage Activity of CRISPR/SuCas12a2 Enables Sensitive Detection of SARS-CoV-2.ACS sensors · 2026Article
- Development and Evaluation of Molecular Diagnostic Tests for SARS-CoV-2 at English NHS Sites Throughout the COVID-19 Pandemic.Viruses · 2026Review
- Sewage surveillance of SARS-CoV-2 in Tokyo (May 2020-June 2022): method using high-throughput, fully-automated platform.Virusdisease · 2024Article
- Review of adverse events associated with COVID-19 vaccines, highlighting their frequencies and reported cases.Journal of Taibah University Medical Sciences · 2023Review
- Despite low viral titer in saliva samples, Sanger-based SARS-CoV-2 spike gene sequencing is highly applicable for the variant identification.BMC medical genomics · 2023Article
- RNA extraction-free workflow integrated with a single-tube CRISPR-Cas-based colorimetric assay for rapid SARS-CoV-2 detection in different environmental matrices.Journal of hazardous materials · 2023Article
- Agnostic Sequencing for Detection of Viral Pathogens.Clinical microbiology reviews · 2023Review
- Investigation of SARS-CoV-2 using RT-PCR in vaginal swab samples of female patients with a diagnosis of severe COVID-19.Taiwanese journal of obstetrics & gynecology · 2023Article
- Similar Sensitivity of SARS-CoV-2 Detection in Oropharyngeal/Nasopharyngeal and Saliva Samples on the Hologic Panther Platform.Diagnostics (Basel, Switzerland) · 2023Article
- Portable high-throughput multimodal immunoassay platform for rapid on-site COVID-19 diagnostics.Analytica chimica acta · 2023Article
- COVID-19 diagnostic approaches with an extensive focus on computed tomography in accurate diagnosis, prognosis, staging, and follow-up.Polish journal of radiology · 2023Review
- Article
- Choice of SARS-CoV-2 diagnostic test: challenges and key considerations for the future.Critical reviews in clinical laboratory sciences · 2022Review
- A precise review on NAATs-based diagnostic assays for COVID-19: A motion in fast POC molecular tests.European journal of clinical investigation · 2022Review
- Forty Years of Molecular Diagnostics for Infectious Diseases.Journal of clinical microbiology · 2022Review
- Exploring beyond the limit: How comparative stochastic performance affects retesting outcomes in six commercial SARS CoV-2 nucleic acid amplification tests.Journal of clinical virology plus · 2022Article
- Review
- Altered subgenomic RNA abundance provides unique insight into SARS-CoV-2 B.1.1.7/Alpha variant infections.Communications biology · 2022Article
Corrections and comments
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Authors and funding
7 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundAs the demand for laboratory testing for SARS-CoV-2 increases, additional varieties of testing methodologies are being considered. While real time polymerase chain reaction (RT-PCR) has performed as the main method for virus detection, other methods are becoming available, including transcription mediated amplification (TMA). The Hologic Aptima SARS-CoV-2 Assay utilizes TMA as a target amplification mechanism, and it has only recently received Emergency Use Authorization (EUA) by the Food and Drug Administration (FDA).
objectivesWe sought to compare the sensitivity and specificity of the Aptima SARS-CoV-2 Assay to RTPCR as a means of SARS-CoV-2 detection in a diagnostic setting. STUDY
designWe performed a limit-of-detection study (LoD) to assess the analytical sensitivity of TMA and RT-PCR. This preceded a comparison of the methods using previously evaluated clinical specimens (nasopharyngeal swabs) using 116 human specimens tested by both methodologies. Specimens included sixty-one (61) specimens found reactive by real-time PCR, fifty-one (51) found non-reactive, and four (4) deemed inconclusive.
resultsThe Aptima SARS-CoV-2 Assay showed a markedly higher analytical sensitivity than RT-PCR by LoD study. Evaluation of clinical specimens resulted in fewer inconclusive results by the SARS-CoV-2 assay, leading to potentially higher clinical sensitivity.
conclusionsHigher analytical sensitivity may explain TMA's ability to ascertain for the presence of SARS-CoV-2 genome in human specimens deemed inconclusive by real-time PCR. TMA provides an effective, highly sensitive means of detection of SARS-CoV-2 in nasopharyngeal specimens.
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