دورية أكاديمية

3-Dimensional Printed Alternative to the Standard Synthetic Flocked Nasopharyngeal Swabs Used for Coronavirus Disease 2019 Testing.

التفاصيل البيبلوغرافية
العنوان: 3-Dimensional Printed Alternative to the Standard Synthetic Flocked Nasopharyngeal Swabs Used for Coronavirus Disease 2019 Testing.
المؤلفون: Decker SJ; University of South Florida, Morsani College of Medicine, Tampa, Florida, USA., Goldstein TA; Northwell Health System, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, New Hyde Park, New York, USA., Ford JM; University of South Florida, Morsani College of Medicine, Tampa, Florida, USA., Teng MN; University of South Florida, Morsani College of Medicine, Tampa, Florida, USA., Pugliese RS; Thomas Jefferson University, Philadelphia, Pennsylvania, USA., Berry GJ; Northwell Health System, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, New Hyde Park, New York, USA., Pettengill M; Thomas Jefferson University, Philadelphia, Pennsylvania, USA., Silbert S; Tampa General Hospital, Tampa, Florida, USA., Hazelton TR; University of South Florida, Morsani College of Medicine, Tampa, Florida, USA., Wilson JW; University of South Florida, Morsani College of Medicine, Tampa, Florida, USA., Shine K; Thomas Jefferson University, Philadelphia, Pennsylvania, USA., Wang ZX; Thomas Jefferson University, Philadelphia, Pennsylvania, USA., Hutchinson M; Thomas Jefferson University, Philadelphia, Pennsylvania, USA., Castagnaro J; Northwell Health System, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, New Hyde Park, New York, USA., Bloom OE; Northwell Health System, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, New Hyde Park, New York, USA., Breining DA; Northwell Health System, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, New Hyde Park, New York, USA., Goldsmith BM; Thomas Jefferson University, Philadelphia, Pennsylvania, USA., Sinnott JT; University of South Florida, Morsani College of Medicine, Tampa, Florida, USA., O'Donnell DG; Thomas Jefferson University, Philadelphia, Pennsylvania, USA., Crawford JM; Northwell Health System, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, New Hyde Park, New York, USA., Lockwood CJ; University of South Florida, Morsani College of Medicine, Tampa, Florida, USA., Kim K; University of South Florida, Morsani College of Medicine, Tampa, Florida, USA.
المصدر: Clinical infectious diseases : an official publication of the Infectious Diseases Society of America [Clin Infect Dis] 2021 Nov 02; Vol. 73 (9), pp. e3027-e3032.
نوع المنشور: Clinical Trial; Journal Article; Multicenter Study
اللغة: English
بيانات الدورية: Publisher: Oxford University Press Country of Publication: United States NLM ID: 9203213 Publication Model: Print Cited Medium: Internet ISSN: 1537-6591 (Electronic) Linking ISSN: 10584838 NLM ISO Abbreviation: Clin Infect Dis Subsets: MEDLINE
أسماء مطبوعة: Publication: Jan. 2011- : Oxford : Oxford University Press
Original Publication: Chicago, IL : The University of Chicago Press, c1992-
مواضيع طبية MeSH: COVID-19* , COVID-19 Testing*, Humans ; Nasopharynx ; Printing, Three-Dimensional ; SARS-CoV-2 ; Specimen Handling
مستخلص: Background: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes coronavirus disease 2019 (COVID-19), can be detected in respiratory samples by real-time reverse transcriptase polymerase chain reaction (RT-PCR) or other molecular methods. Accessibility of diagnostic testing for COVID-19 has been limited by intermittent shortages of supplies required for testing, including flocked nasopharyngeal (FLNP) swabs.
Methods: We developed a 3-dimensional printed nasopharyngeal (3DP) swab as a replacement of the FLNP swab. The performance of 3DP and FLNP swabs were compared in a clinical trial of symptomatic patients at 3 clinical sites (n = 291) using 3 SARS-CoV-2 emergency use authorization tests: a modified version of the Centers for Disease Control and Prevention (CDC) RT-PCR Diagnostic Panel and 2 commercial automated formats, Roche Cobas and NeuMoDx.
Results: The cycle threshold-C(t)-values from the gene targets and the RNase P gene control in the CDC assay showed no significant differences between swabs for both gene targets (P = .152 and P = .092), with the RNase P target performing significantly better in the 3DP swabs (P < .001). The C(t) values showed no significant differences between swabs for both viral gene targets in the Roche cobas assay (P = .05 and P = .05) as well as the NeuMoDx assay (P = .401 and P = .484). The overall clinical correlation of COVID-19 diagnosis between all methods was 95.88% (Kappa 0.901).
Conclusions: The 3DP swabs were equivalent to standard FLNP in 3 testing platforms for SARS-CoV-2. Given the need for widespread testing, 3DP swabs printed onsite are an alternate to FLNP that can rapidly scale in response to acute needs when supply chain disruptions affect availability of collection kits.
(© The Author(s) 2020. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail: journals.permissions@oup.com.)
التعليقات: Comment in: Clin Infect Dis. 2021 Nov 2;73(9):e3033-e3035. (PMID: 32949233)
فهرسة مساهمة: Keywords: SARS-CoV-2; 3D-printed swabs; COVID-19; molecular diagnostics; nasopharyngeal
تواريخ الأحداث: Date Created: 20200910 Date Completed: 20211108 Latest Revision: 20220531
رمز التحديث: 20240829
مُعرف محوري في PubMed: PMC7499529
DOI: 10.1093/cid/ciaa1366
PMID: 32910817
قاعدة البيانات: MEDLINE
الوصف
تدمد:1537-6591
DOI:10.1093/cid/ciaa1366