ReviewThe Analyst2021
Current state of commercial point-of-care nucleic acid tests for infectious diseases.
Review in The Analyst, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers.
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.
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.
Who cites it
18 citing papers in PubMed.
- PEG-mediated viscous crowding controls dynamics and quantitative range in recombinase polymerase amplification nucleation site analysis.Sensors & diagnostics · 2026Article
- Extraction-Free Scalable Sample Preparation for the Rapid Detection of HIV in Blood Plasma.Analytical chemistry · 2026Article
- Bacteria as living biosensors for DNA.Nature reviews bioengineering · 2026Article
- Advances in Point-of-Care Infectious Disease Diagnostics: Integration of Technologies, Validation, Artificial Intelligence, and Regulatory Oversight.Diagnostics (Basel, Switzerland) · 2025Review
- Point-of-care and Home Use Influenza Diagnostics for Advancing Therapeutic and Public Health Strategies.The Journal of infectious diseases · 2025Review
- Laboratory Validation of a Fully Automated Point-of-Care Device for High-Order Multiplexing Real-Time PCR Detection of Respiratory Pathogens.Diagnostics (Basel, Switzerland) · 2025Article
- Review
- Revolutionary Point-of-Care Wearable Diagnostics for Early Disease Detection and Biomarker Discovery through Intelligent Technologies.Advanced science (Weinheim, Baden-Wurttemberg, Germany) · 2024Review
- Strengthening laboratory systems for ensuring accurate diagnoses in mother-to-child transmission (MTCT) prevention programs in Uganda: a narrative review.Annals of medicine and surgery (2012) · 2024Review
- Development of a Diagnostic Microfluidic Chip for SARS-CoV-2 Detection in Saliva and Nasopharyngeal Samples.Viruses · 2024Article
- SARS-CoV-2 recombinase polymerase amplification assay with lateral flow readout and duplexed full process internal control.Sensors & diagnostics · 2024Article
- Tackling Infectious Diseases with Rapid Molecular Diagnosis and Innovative Prevention.Infectious disease reports · 2024Review
- Miniaturization of CRISPR/Cas12-Based DNA Sensor Array by Non-Contact Printing.Micromachines · 2024Article
- Self-Powered Microfluidics for Point-of-Care Solutions: From Sampling to Detection of Proteins and Nucleic Acids.Methods in molecular biology (Clifton, N.J.) · 2024Article
- Development of a nucleic acid-based lateral flow device as a reliable diagnostic tool for respiratory viral infections.MethodsX · 2023Article
- Ultrasensitive chemiluminescent neuraminidase probe for rapid screening and identification of small-molecules with antiviral activity against influenza A virus in mammalian cells.Chemical science · 2022Article
- Clinical performance of SARS-CoV-2 detection on the cobas Liat using water gargle samples.Journal of clinical virology plus · 2022Article
- The Standardization and Control of Serology and Nucleic Acid Testing for Infectious Diseases.Clinical microbiology reviews · 2021Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors.
Funding
Abstract
The COVID-19 pandemic has put the spotlight on the urgent need for integrated nucleic acid tests (NATs) for infectious diseases, especially those that can be used near patient ("point-of-care", POC), with rapid results and low cost, but without sacrificing sensitivity or specificity of gold standard PCR tests. In the US, the Clinical Laboratory Improvement Amendments Certificate of Waiver (CLIA-waiver) is mandated by the Food and Drug Administration (FDA) and designated to any laboratory testing with high simplicity and low risk for error, suitable for application in the POC. Since the first issuance of CLIA-waiver to Abbot's ID NOW Influenza A&B in 2015, many more NAT systems have been developed, received the CLIA-waiver in the US or World Health Organization (WHO)'s pre-qualification, and deployed to the front line of infectious disease detection. This review highlights the regulatory process for FDA and WHO in evaluating these NATs and the technology innovation of existing CLIA-waived systems. Understanding the technical advancement and challenges, unmet needs, and the trends of commercialization facilitated through the regulatory processes will help pave the foundation for future development and technology transfer from research to the market place.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
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.