Field-deployable, rapid diagnostic testing of saliva for SARS-CoV-2

被引:0
作者
Shan Wei
Hemant Suryawanshi
Alexandre Djandji
Esther Kohl
Stephanie Morgan
Eldad A. Hod
Susan Whittier
Kevin Roth
Raymond Yeh
Juan Carlos Alejaldre
Elaine Fleck
Stephen Ferrara
Daniel Hercz
David Andrews
Lilly Lee
Kristopher A. Hendershot
Joshua Goldstein
Yousin Suh
Mahesh Mansukhani
Zev Williams
机构
[1] Columbia University Irving Medical Center,
[2] New York Presbyterian Hospital,undefined
[3] Jackson Memorial Hospital,undefined
来源
Scientific Reports | / 11卷
关键词
D O I
暂无
中图分类号
学科分类号
摘要
To safely re-open economies and prevent future outbreaks, rapid, frequent, point-of-need, SARS-CoV-2 diagnostic testing is necessary. However, existing field-deployable COVID-19 testing methods require the use of uncomfortable swabs and trained providers in PPE, while saliva-based methods must be transported to high complexity laboratories for testing. Here, we report the development and clinical validation of High-Performance Loop-mediated isothermal Amplification (HP-LAMP), a rapid, saliva-based, SARS-CoV-2 test with a limit of detection of 1.4 copies of virus per µl of saliva and a sensitivity and specificity with clinical samples of > 96%, on par with traditional RT-PCR based methods using swabs, but can deliver results using only a single fluid transfer step and simple heat block. Testing of 120 patient samples in 40 pools comprised of 5 patient samples each with either all negative or a single positive patient sample was 100% accurate. Thus, HP-LAMP may enable rapid and accurate results in the field using saliva, without need of a high-complexity laboratory.
引用
收藏
相关论文
共 27 条
  • [1] Weissleder R(2020)COVID-19 diagnostics in context Sci Transl Med 12 1931-675
  • [2] Lee H(2020)Saliva or nasopharyngeal swab specimens for detection of SARS-CoV-2 N Engl J Med 26 672-24458
  • [3] Ko J(2020)Temporal dynamics in viral shedding and transmissibility of COVID-19 Nat Med 117 24450-4812
  • [4] Pittet MJ(2020)Clinical course and molecular viral shedding among asymptomatic and symptomatic patients With SARS-CoV-2 infection in a Community Treatment Center in the Republic of Korea JAMA Intern Med 11 4812-63
  • [5] Wyllie AL(2020)Rapid and extraction-free detection of SARS-CoV-2 from saliva by colorimetric reverse-transcription loop-mediated isothermal amplification Clin Chem 28 63e-977
  • [6] He X(2020)SARS-CoV-2 detection using isothermal amplification and a rapid, inexpensive protocol for sample inactivation and purification Proc. Natl. Acad. Sci. 15 e0234682-577
  • [7] Lee S(2020)Massive and rapid COVID-19 testing is feasible by extraction-free SARS-CoV-2 RT-PCR Nat. Commun. 66 975-998
  • [8] Lalli MA(2000)Loop-mediated isothermal amplification of DNA Nucleic Acids Res. 43 D571-D490
  • [9] Rabe BA(2020)Rapid detection of novel coronavirus/Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) by reverse transcription-loop-mediated isothermal amplification PLoS ONE 52 991-1006
  • [10] Cepko C(2020)Rapid detection of COVID-19 Coronavirus using a reverse transcriptional loop-mediated isothermal amplification (RT-LAMP) Diagnostic Platform Clin Chem 21 5380-8