Clinical Laboratories
Droplet Digital PCR delivers peace of mind in your nucleic acid quantification results. Absolute quantification of nucleic acids and industry-leading precision in variant allele frequency and copy number determination are standard with
ddPCR.
Visit the Bio‑Rad publication database to review examples of how ddPCR is improving clinical and translational research and testing.
Example publication from the Bio-Rad ddPCR publication database
| Title | TERT, BRAF, and NRAS mutational heterogeneity between paired primary and metastatic melanoma tumors |
| Date | 9 Feb, 2020 |
| Journal | J Invest Dermatol |
| Author | Chang, GA et al. |
Search the Bio‑Rad ddPCR publication database
- Go to https://www.bio-rad.com/ddPCR/publications
- Under Application Type, select Liquid Biopsy or Cancer from the dropdown menu
Example publication from the Bio-Rad ddPCR publication database
| Title | Comparison of real-time quantitative PCR and Digital Droplet PCR for BCR-ABL1 monitoring in patients with chronic myeloid leukemia |
| Date | 24 Oct, 2019 |
| Journal | J Mol Diagn |
| Author | Franke, GN et al. |
Search the Bio‑Rad ddPCR publication database
- Go to https://www.bio-rad.com/ddPCR/publications
- Under Keyword, type in BCR-ABL
Example publication from the Bio-Rad ddPCR publication database
| Title | Plasma AR status and cabazitaxel in heavily treated metastatic castration-resistant prostate cancer |
| Date | 1 Jul, 2019 |
| Journal | Eur J Cancer |
| Author | Conteduca, V et al. |
Search the Bio‑Rad ddPCR publication database
- Go to https://www.bio-rad.com/ddPCR/publications
- Under Application Type, select Copy Number Variation from the dropdown menu
- Under Keyword, type in Cancer
Example publication from the Bio-Rad ddPCR publication database
| Title | Analytical comparisons of SARS-COV-2 detection by qRT-PCR and ddPCR with multiple primer/probe sets |
| Date | 20 May, 2020 |
| Journal | Emerg Microbes Infect |
| Author | Liu, X et al. |
Search the Bio‑Rad ddPCR publication database
- Go to https://www.bio-rad.com/ddPCR/publications
- Under Keyword, type in COVID
Example publication from the Bio-Rad ddPCR publication database
| Title | Ultra-deep next-generation sequencing of plasma cell–free DNA in patients with advanced lung cancers: results from the Actionable Genome Consortium |
| Date | 20 Mar, 2019 |
| Journal | Ann Oncol |
| Author | Li, BT et al. |
Search the Bio‑Rad ddPCR publication database
- Go to https://www.bio-rad.com/ddPCR/publications
- Under Application Type, select Next Generation Sequencing from the dropdown menu
Standards Companies
Reference Materials and Controls
When your business is standards and reference materials, the technology of choice for nucleic acid quantification is Droplet Digital PCR by Bio-Rad.
Droplet Digital PCR delivers peace of mind in nucleic acid quantification. If your controls and reference materials are accurately quantified by ddPCR, then you can rest assured that your clinical and research measurement values are accurate and precise.
Proficiency Testing and Quality Assurance
Proficiency Testing (PT) and External Quality Assessment (EQA)
All clinical labs must participate in external quality assessment programs or proficiency tests for each of their provided clinical tests. The use of Droplet Digital PCR can be beneficial at several stages for providers of PTs and EQAs.
First, in the generation of control materials for distribution across interlaboratory groups, accurate and precise quantification of nucleic acids is essential.
| Title | One byte at a time: evidencing the quality of clinical service next generation sequencing of germ line and somatic variants |
| Date | March 2020 |
| Journal | Eur J Human Gen |
| Author | Gutowska-Ding, M et al. |
Second, for EQAs/PTs that generate nucleic acid material as an output (for example, nucleic acid extraction), quantification of those materials by ddPCR provides unequivocal results for interlab comparison.
Metrology Laboratories
Metrology: The Science of Measurement
Metrology labs globally have adopted Droplet Digital PCR with a focus on improving the precision and accuracy in measuring nucleic acids.
All national institutes of metrology have a common metrological focus to improve measurement processes and practices in science. However individual research areas differ across the globe and between NMIs.
Application areas that have benefited from metrological support with ddPCR are:
Please hover over to view the reference.
GMO
Virology
Oncology
- Kosir AB et al. (2019). Digital PCR as an effective tool for GMO quantification in complex matrices. Food Chem 294, 73–78.
- Grohmann L et al. (2017). Screening for six genetically modified soybean lines by an event-specific multiplex PCR method: Collaborative trial validation of a novel approach for GMO detection. J Consum Prot Food Saf 12, 23–36.
- Whale AS et al. (2016). Detection of rare drug resistance mutations by digital PCR in a human influenza A virus model system and clinical samples. J Clin Microbiol 54, 392–400.
- Cleveland MH et al. (2018). Certification of Standard Reference Material 2365 BK Virus DNA Quantitative Standard. National Institute of Standards and Technology. U.S. Department of Commerce. NIST Standard Reference Materials Publication 260-191.
- Dobnik D et al. (2019). Accurate quantification and characterization of adeno-associated viral vectors. Front Microbiol 10, 1,570.
- He H-J et al. (2019). Development and interlaboratory evaluation of a NIST reference material RM 8366 for EGFR and MET gene copy number measurements. Clin Chem Lab Med 57, 1,142–1,152.
- Whale AS et al. (2018). Assessment of digital PCR as a primary reference measurement procedure to support advances in precision medicine. Clin Chem 64, 1,296–1,307