ArticleMolecular diagnosis & therapy2021
Analytical and Clinical Performance of Droplet Digital PCR in the Detection and Quantification of SARS-CoV-2.
Article in Molecular diagnosis & therapy, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 14 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
14 citing papers in PubMed, 1 synthesis or guideline pooled it, 26 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
- Droplet Digital PCR or Real-Time PCR as a Method for Quantifying SARS-CoV-2 RNA in Plasma-Is There a Difference?Viruses · 2025Article
- Digital PCR in Virology: Current Applications and Future Perspectives.Molecular diagnosis & therapy · 2025Review
- Establishment and application of a dual chip digital PCR assay for detection of PDCoV and PEDV.Frontiers in veterinary science · 2025Article
- Advances and Challenges in SARS-CoV-2 Detection: A Review of Molecular and Serological Technologies.Diagnostics (Basel, Switzerland) · 2024Review
- 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
- Digital PCR Applications in the SARS-CoV-2/COVID-19 Era: a Roadmap for Future Outbreaks.Clinical microbiology reviews · 2022Review
- Application of digital PCR to determine the reliability of Xpert Xpress SARS-CoV-2 assay with envelope (E) gene negative and nucleocapsid (N2) gene positive results.Diagnostic microbiology and infectious disease · 2022Article
- A rapid water bath PCR combined with lateral flow assay for the simultaneous detection of SARS-CoV-2 and influenza B virus.RSC advances · 2022Article
- COVID-19 Diagnosis: Current and Future Techniques.International journal of biological macromolecules · 2021Review
- Diagnostic, Prognostic, and Therapeutic Value of Droplet Digital PCR (ddPCR) in COVID-19 Patients: A Systematic Review.Journal of clinical medicine · 2021Review
- Household Transmission of SARS-CoV-2: A Prospective Longitudinal Study Showing Higher Viral Load and Increased Transmissibility of the Alpha Variant Compared to Previous Strains.Microorganisms · 2021Article
- Diagnostic evaluation of qRT-PCR-based kit and dPCR-based kit for COVID-19.Genes & genomics · 2021Article
- Tracking the Transcription Kinetic of SARS-CoV-2 in Human Cells by Reverse Transcription-Droplet Digital PCR.Pathogens (Basel, Switzerland) · 2021Article
Corrections and comments
- Erratum issued
Authors and funding
9 authors at 3 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
BACKGROUND AND
objectiveSince the initial coronavirus disease outbreak in late 2019 (COVID-19), reverse-transcription real-time polymerase chain reaction (RT-qPCR) has become the gold standard test to detect severe acute respiratory syndrome-related coronavirus 2 (SARS-CoV-2). However, a more sensitive and accurate diagnostic tool was required. Therefore, droplet digital polymerase chain reaction (ddPCR) was suggested as an alternative method. Here, we evaluated the performance of ddPCR to detect SARS-CoV-2 and compared it to the performance of RT-qPCR.
methodsThe analytical performances, including limit of blank and limit of detection, were established using positive and negative SARS-CoV-2 reference materials. A total of 366 RNA extracts (173 positive and 193 negative by RT-qPCR) were collected from four institutions and tested with a Bio-Rad SARS-CoV-2 ddPCR kit that detects the SARS-CoV-2 genome using primers for N1 and N2.
resultsLimit of blank was set at 0, and the limits of detection of N1 and N2 were 1.99 copies/μL and 5.18 copies/μL, respectively. Linearity was evaluated using serial dilution samples, which demonstrated good results (R
conclusionsDroplet digital polymerase chain reaction demonstrated excellent sensitivity for SARS-Cov-2 detection and consistently agreed with the results from conventional RT-qPCR. Furthermore, ddPCR provided quantitative data that can be used to monitor changes in the viral load of patients with COVID-19.
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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.