ArticleAmerican journal of clinical pathology2021
Digital Droplet PCR for SARS-CoV-2 Resolves Borderline Cases.
Article in American journal of clinical pathology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers, 1 of them a synthesis that pooled it.
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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
19 citing papers in PubMed, 1 synthesis or guideline pooled it, 23 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
- First insight into eosinophils as a biomarker for the early distinction of COVID-19 from influenza A in outpatients.Experimental and therapeutic medicine · 2025Article
- Article
- Optimization and application of digital droplet PCR for the detection of SARS-CoV-2 in saliva specimen using commercially available kit.Biology methods & protocols · 2024Article
- Manually pressurized droplet digital PCR chip for rapid SARS-CoV-2 diagnostics.Biomicrofluidics · 2024Article
- Article
- A culture-free method for rapidly and accurately quantifying active SARS-CoV-2.Analytical and bioanalytical chemistry · 2023Article
- Association between SARS-CoV-2 Viral Load and Patient Symptoms and Clinical Outcomes Using Droplet Digital PCR.Viruses · 2023Article
- Droplet digital PCR application for the detection of SARS-CoV-2 in air sample.Frontiers in public health · 2023Article
- Ready for new waves: optimizing SARS-CoV-2 variants monitoring in pooled samples with droplet digital PCR.Frontiers in public health · 2023Article
- Functional Analysis of Monkeypox and Interrelationship between Monkeypox and COVID-19 by Bioinformatic Analysis.Genetics research · 2023Article
- The Future of Point-of-Care Nucleic Acid Amplification Diagnostics after COVID-19: Time to Walk the Walk.International journal of molecular sciences · 2022Review
- Presence of entry receptors and viral markers suggest a low level of placental replication of hepatitis B virus in a proportion of pregnant women infected with chronic hepatitis B.Scientific reports · 2022Article
- Digital PCR Applications in the SARS-CoV-2/COVID-19 Era: a Roadmap for Future Outbreaks.Clinical microbiology reviews · 2022Review
- Hb New York, preliminary results concerning the hematologic characteristics and the effects on thalassemia.Molecular biology reports · 2022Article
- Advanced Molecular and Immunological Diagnostic Methods to Detect SARS-CoV-2 Infection.Microorganisms · 2022Review
- Tracking the temporal variation of COVID-19 surges through wastewater-based epidemiology during the peak of the pandemic: A six-month long study in Charlotte, North Carolina.The Science of the total environment · 2022Article
- Practical considerations to establish a validated platform for pooled detection of SARS-CoV-2 by droplet digital PCR.PloS one · 2022Article
- Diagnostic, Prognostic, and Therapeutic Value of Droplet Digital PCR (ddPCR) in COVID-19 Patients: A Systematic Review.Journal of clinical medicine · 2021Review
Corrections and comments
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Authors and funding
10 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivesThe Bio-Rad SARS-CoV-2 ddPCR Kit (Bio-Rad Laboratories) was the first droplet digital polymerase chain reaction (ddPCR) assay to receive Food and Drug Administration (FDA) Emergency Use Authorization approval, but it has not been evaluated clinically. We describe the performance of ddPCR-in particular, its ability to confirm weak-positive severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) results.
methodsWe clinically validated the Bio-Rad Triplex Probe ddPCR Assay. The limit of detection was determined by using serial dilutions of SARS-CoV-2 RNA in an artificial viral envelope. The ddPCR assay was performed according to the manufacturer's specifications on specimens confirmed to be positive (n = 48) or negative (n = 30) by an FDA-validated reverse transcription-polymerase chain reaction assay on the m2000 RealTime system (Abbott). Ten borderline positive cases were also evaluated.
resultsThe limit of detection was 50 copies/mL (19 of 20 positive). Forty-seven specimens spanning a range of quantification cycles (2.9-25.9 cycle numbers) were positive by this assay (47 of 48; 97.9% positive precent agreement), and 30 negative samples were confirmed as negative (30 of 30; 100% negative percent agreement). Nine of 10 borderline cases were positive when tested in triplicate.
conclusionsThe ddPCR of SARS-CoV-2 is an accurate method, with superior sensitivity for viral RNA detection. It could provide definitive evaluation of borderline positive cases or suspected false-negative cases.
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