2021
DOI: 10.3390/cimb43020068
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Assessment and Clinical Utility of a Non-Next-Generation Sequencing-Based Non-Invasive Prenatal Testing Technology

Abstract: Background: Rolling-circle replication (RCR) is a novel technology that has not been applied to cell-free DNA (cfDNA) testing until recently. Given the cost and simplicity advantages of this technology compared to other platforms currently used in cfDNA analysis, an assessment of RCR in clinical laboratories was performed. Here, we present the first validation study from clinical laboratories utilizing RCR technology. Methods: 831 samples from spontaneously pregnant women carrying a singleton fetus, and 25 syn… Show more

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Cited by 8 publications
(13 citation statements)
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“…Figure S1: Forest Plots of all Data. References [ 25 , 26 , 27 , 28 , 29 , 30 , 31 , 32 , 33 , 34 , 35 , 36 , 37 , 38 , 39 , 40 , 41 , 42 , 43 , 44 , 45 , 46 , 47 , 48 , 49 , 50 , 51 , 52 , 53 , 54 , 55 , 56 , 57 , 58 , 59 , 60 , 61 , 62 , 63 , 64 , 65 , 66 , 67 , 68 , 69 , 70 , 71 , 72 , 73 , 74 , 75 , 76 , 77 , 78 , 79 , 80 , 81 , 82 , …”
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“…Figure S1: Forest Plots of all Data. References [ 25 , 26 , 27 , 28 , 29 , 30 , 31 , 32 , 33 , 34 , 35 , 36 , 37 , 38 , 39 , 40 , 41 , 42 , 43 , 44 , 45 , 46 , 47 , 48 , 49 , 50 , 51 , 52 , 53 , 54 , 55 , 56 , 57 , 58 , 59 , 60 , 61 , 62 , 63 , 64 , 65 , 66 , 67 , 68 , 69 , 70 , 71 , 72 , 73 , 74 , 75 , 76 , 77 , 78 , 79 , 80 , 81 , 82 , …”
unclassified
“…However, an argument can be made that these samples could be considered as true additional FNs. To account for that possibility, if we compared the performance of the system with these FN excluded; with these FN included; and with how the system has performed based on a summary of the eight previously published Vanadis‐based studies, 10 , 11 , 12 , 13 , 17 , 18 , 19 , 20 it would show a consistent 99.8% specificity and sensitivities of 96.7%, 90.6%, and 99.5% respectively.…”
Section: Resultsmentioning
confidence: 99%
“… 10 , 11 While NGS‐based NIPT testing has been suggested to be this first‐line screen, some drawbacks have prevented its widespread implementation, including the cost and complexity of NGS analysis, which requires complex bioinformatic analysis, high run costs, and extensive hands‐on time. 12 With the lower degree of complexity and substantially automated workflow associated with the Vanadis system, this methodology provided a solution for our clinicians and patients. Our laboratory experienced a reduced start‐up time and decreased costs, by eliminating the need for building and developing dedicated pre‐ and post‐PCR rooms and complicated bioinformatics servers.…”
Section: Discussionmentioning
confidence: 99%
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