Methods to Increase the Percentage of Free Fetal DNA Recovered From the Maternal Circulation

Dhallan, Ravinder; Au, Wei-Chun; Mattagajasingh, Subhendra N.; Emche, Sarah; Bayliss, Philip; Damewood, Marian D.; Cronin, Michael J.; Chou, Victoria B; Mohr, Michelle

doi:10.1097/01.ogx.0000134241.78653.43

Cited by 18 publications

(23 citation statements)

References 13 publications

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“…Transportation of blood samples from the site of phlebotomy to another facility is commonly required for molecular diagnostic testing. In this regard, several studies have focused on preanalytical variables that might compromise the accuracy cfDNA measurements, including the selection of blood collection devices, sample storage, and shipping conditions . Each of these parameters affects the amount of nucleated blood cell lysis that occurs postphlebotomy.…”

Section: Discussionmentioning

confidence: 99%

A New Blood Collection Device Minimizes Cellular DNA Release During Sample Storage and Shipping When Compared to a Standard Device

Norton¹,

Luna²,

Lechner³

et al. 2013

Clinical Laboratory Analysis

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BackgroundCell-free DNA (cfDNA) circulating in blood is currently used for noninvasive diagnostic and prognostic tests. Minimizing background DNA is vital for detection of low abundance cfDNA. We investigated whether a new blood collection device could reduce background levels of genomic DNA (gDNA) in plasma compared to K3EDTA tubes, when subjected to conditions that may occur during sample storage and shipping.MethodsBlood samples were drawn from healthy donors into K3EDTA and Cell-Free DNA™ BCT (BCT). To simulate shipping, samples were shaken or left unshaken. In a shipping study, samples were shipped or not shipped. To assess temperature variations, samples were incubated at 6°C, 22°C, and 37°C. In all cases, plasma was harvested by centrifugation and total plasma DNA (pDNA) assayed by quantitative real-time polymerase chain reaction (qPCR).ResultsShaking and shipping blood in K3EDTA tubes showed significant increases in pDNA, whereas no change was seen in BCTs. Blood in K3EDTA tubes incubated at 6°C, 22°C, and 37°C showed increases in pDNA while pDNA from BCTs remained stable.ConclusionsBCTs prevent increases in gDNA levels that can occur during sample storage and shipping. This new device permits low abundance DNA target detection and allows accurate cfDNA concentrations.

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Section: Discussionmentioning

confidence: 99%

A New Blood Collection Device Minimizes Cellular DNA Release During Sample Storage and Shipping When Compared to a Standard Device

Norton¹,

Luna²,

Lechner³

et al. 2013

Clinical Laboratory Analysis

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“…No information on Ravgen's single‐gene disorder tests and their costs is currently available. Ravgen's laboratory has received CAP accreditation and CLIA certification, and the company has published at least three peer‐reviewed papers detailing methods for cffDNA processing and determination of fetal aneuploidies and paternity …”

Section: Commercial Landscape Of Cffdna‐based Niptmentioning

confidence: 99%

Commercial landscape of noninvasive prenatal testing in the United States

et al. 2013

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Cell-free fetal DNA-based noninvasive prenatal testing (NIPT) could significantly change the paradigm of prenatal testing and screening. Intellectual property (IP) and commercialization promise to be important components of the emerging debate about clinical implementation of these technologies. We have assembled information about types of testing, prices, turnaround times and reimbursement of recently launched commercial tests in the United States from the trade press, news articles, and scientific, legal, and business publications. We also describe the patenting and licensing landscape of technologies underlying these tests and ongoing patent litigation in the United States. Finally, we discuss how IP issues may affect clinical translation of NIPT and their potential implications for stakeholders. Fetal medicine professionals (clinicians and researchers), genetic counselors, insurers, regulators, test developers and patients may be able to use this information to make informed decisions about clinical implementation of current and emerging noninvasive prenatal tests.

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“…If blood is processed within 8 h of blood draw, there is no significant increase in maternal plasma DNA concentration or subsequent decrease in percentage of fetal DNA . Solutions proposed for longer term storage of blood during transportation between laboratories include the use of formaldehyde as a stabilizing agent (these experiments have not been reproducible), a formaldehyde‐free stabilization cocktail, or the use of cfDNA blood collection tubes (BCTs) . BCTs are more expensive than K 3 ‐EDTA tubes, and it has been shown that they are sensitive to fluctuations in temperature, with a significant decrease in fetal fraction in samples collected in BCTs and transported at 4°C .…”

Section: Introductionmentioning

confidence: 99%

Stability of cell-free DNA from maternal plasma isolated following a single centrifugation step

et al. 2014

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Methods to Increase the Percentage of Free Fetal DNA Recovered From the Maternal Circulation

Cited by 18 publications

References 13 publications

A New Blood Collection Device Minimizes Cellular DNA Release During Sample Storage and Shipping When Compared to a Standard Device

A New Blood Collection Device Minimizes Cellular DNA Release During Sample Storage and Shipping When Compared to a Standard Device

Commercial landscape of noninvasive prenatal testing in the United States

Stability of cell-free DNA from maternal plasma isolated following a single centrifugation step

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