Evidence map›Paper›PMID 33021611›Full record

ArticleLab on a chip2020

Integrated nucleic acid testing system to enable TB diagnosis in peripheral settings.

Hsiang-Wei Lu, Rama Sakamuri, Pranav Kumar, Tanya M Ferguson, Robert W Doebler, Keith D Herrington, Ryan P Talbot, Kris M Weigel, Felicia K Nguyen, Gerard A Cangelosi and 3 more

Abstract read
In one paragraph

Article in Lab on a chip, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Article
  2. Review
  3. Review
  4. Long and short non-coding RNA and radiation response: a review.Translational research : the journal of laboratory and clinical medicine · 2021
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors.

Hsiang-Wei LuRiggs School of Applied Life Sciences, Keck Graduate Institute, 535 Watson Drive, Claremont, CA 91711, USA. aniemz@kgi.edu.
Rama SakamuriRiggs School of Applied Life Sciences, Keck Graduate Institute, 535 Watson Drive, Claremont, CA 91711, USA. aniemz@kgi.edu.
Pranav KumarRiggs School of Applied Life Sciences, Keck Graduate Institute, 535 Watson Drive, Claremont, CA 91711, USA. aniemz@kgi.edu.ORCID 0000-0002-9135-2217
Tanya M FergusonClaremont BioSolutions, 1182 Monte Vista Ave # 11, Upland, CA 91786, USA.
Robert W DoeblerClaremont BioSolutions, 1182 Monte Vista Ave # 11, Upland, CA 91786, USA.
Keith D HerringtonClaremont BioSolutions, 1182 Monte Vista Ave # 11, Upland, CA 91786, USA.
Ryan P TalbotClaremont BioSolutions, 1182 Monte Vista Ave # 11, Upland, CA 91786, USA.
Kris M WeigelDepartment of Environmental and Occupational Health Sciences, University of Washington, Seattle, WA 98195, USA.
Felicia K NguyenDepartment of Environmental and Occupational Health Sciences, University of Washington, Seattle, WA 98195, USA.
Gerard A CangelosiDepartment of Environmental and Occupational Health Sciences, University of Washington, Seattle, WA 98195, USA.
Masahiro NaritaSeattle & King County Tuberculosis Control Clinic, Harborview Medical Center, 325 9th Ave, Seattle, WA 98104, USA.
David S BoylePATH, 2201 Westlake Ave, Seattle, WA 98121, USA.
Angelika NiemzRiggs School of Applied Life Sciences, Keck Graduate Institute, 535 Watson Drive, Claremont, CA 91711, USA. aniemz@kgi.edu.ORCID 0000-0001-7385-1541

Funding

Rapid Diagnosis of MDR TB from Sputum using a Small Fully Integrated Nucleic AcidR01AI090831 · NIAID · KECK GRADUATE INST OF APPLIED LIFE SCIS · PI NIEMZ, ANGELIKA · 2010 to 2013
$3.5M
Integrated Cost-Effective Point of Care Nucleic Acid Testing for TB diagnosisR01AI111477 · NIAID · KECK GRADUATE INST OF APPLIED LIFE SCIS · PI CANGELOSI, GERARD A, DOEBLER, ROBERT WILLIAM · 2014 to 2017
$2.2M
NIAID NIH HHS R01 AI090831NIAID NIH HHS R01 AI111477
6 · The paper itself

Abstract

To facilitate treatment and limit transmission of tuberculosis (TB), new methods are needed to enable rapid and affordable diagnosis of the disease in high-burden low-resource settings. We have developed a prototype integrated nucleic acid testing device to detect Mycobacterium tuberculosis (M.tb) in sputum. The device consists of a disposable cartridge and compact, inexpensive instrument that automates pathogen lysis, nucleic acid extraction, isothermal DNA amplification and lateral flow detection. A liquefied and disinfected sputum sample is manually injected into the cartridge, and all other steps are automated, with a result provided in <1.5 h. Cell disruption and DNA extraction is executed within a four-port active valve containing a miniature bead blender (based on PureLyse® technology, Claremont BioSolutions LLC). The DNA-containing eluate is combined with dry master-mix reagents and target DNA is isothermally amplified. Amplified master-mix is then pumped into a lateral flow strip chamber for detection. The entire process is performed in a single-use closed-system cartridge to prevent amplicon carryover. For testing of M.tb-spiked sputum the system provided a limit of detection of 5 × 103 colony forming units (CFU) per mL. None of the negative sputum-only controls yielded a false-positive result. Testing of 45 clinical sputum specimens from TB cases and controls relative to a validated manual qPCR-based comparator method revealed a preliminary sensitivity of 90% and specificity of 96%. With further development, the herein described integrated nucleic acid testing device can enable TB diagnosis and treatment initiation in the same clinical encounter in near-patient low-resource settings of high TB burden countries.

Indexed as

Mycobacterium tuberculosisNucleic AcidsTuberculosisHumansNucleic Acid Amplification TechniquesSensitivity and SpecificitySputumNucleic Acids

Identifiers

PMID33021611
PMCPMC7787164

What OpenQuestion holds

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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.