Innovative COVID-19 point-of-care diagnostics suitable for tuberculosis diagnosis: a scoping review protocol

Introduction In 2014, the WHO published high-priority target product profiles (TPPs) for new tuberculosis (TB) diagnostics to align end-user needs with test targets and specifications; nevertheless, no TB test meets these targets to date. The COVID-19-driven momentum in the diagnostics world offers...

Full description

Saved in:
Bibliographic Details
Main Authors: Claudia M Denkinger, Adithya Cattamanchi, Seda Yerlikaya, Lydia Marie-Luise Holtgrewe, Tobias Broger, Chris Isaacs, Payam Nahid
Format: Article
Language:English
Published: BMJ Publishing Group 2023-02-01
Series:BMJ Open
Online Access:https://bmjopen.bmj.com/content/13/2/e065194.full
Tags: Add Tag
No Tags, Be the first to tag this record!
_version_ 1850033702044696576
author Claudia M Denkinger
Adithya Cattamanchi
Seda Yerlikaya
Lydia Marie-Luise Holtgrewe
Tobias Broger
Chris Isaacs
Payam Nahid
author_facet Claudia M Denkinger
Adithya Cattamanchi
Seda Yerlikaya
Lydia Marie-Luise Holtgrewe
Tobias Broger
Chris Isaacs
Payam Nahid
author_sort Claudia M Denkinger
collection DOAJ
description Introduction In 2014, the WHO published high-priority target product profiles (TPPs) for new tuberculosis (TB) diagnostics to align end-user needs with test targets and specifications; nevertheless, no TB test meets these targets to date. The COVID-19-driven momentum in the diagnostics world offers an opportunity to address the long-standing lack of innovation in the field of TB diagnostics. This scoping review aims to summarise point-of-care (POC) molecular and antigen tests for COVID-19 diagnosis that, when applied to TB, potentially meet WHO TPPs. This summary of currently available innovative diagnostic tools will guide the development of novel TB diagnostics toward the WHO-set targets.Methods and analysis We will follow the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension Scoping Reviews recommendations. MEDLINE (via PubMed), bioRxiv, MedRxiv and other publicly available in vitro diagnostic test databases were searched on 23 November 2022. POC antigen or molecular tests developed for SARS-CoV-2 detection that meet the eligibility criteria will be included in the review. Developer description, test description, operation characteristics, pricing information, performance and commercialisation status of diagnostic tests identified will be extracted using a predefined standardised data extraction form. Two reviewers will independently perform the screening and data extraction. A narrative synthesis of the final data will be provided.Ethics and dissemination No ethical approval is required because individual patient data will not be included. The findings will be published in open-access scientific journals.
format Article
id doaj-art-c1b7582c8d4a42468aef0760cddb0eee
institution DOAJ
issn 2044-6055
language English
publishDate 2023-02-01
publisher BMJ Publishing Group
record_format Article
series BMJ Open
spelling doaj-art-c1b7582c8d4a42468aef0760cddb0eee2025-08-20T02:58:07ZengBMJ Publishing GroupBMJ Open2044-60552023-02-0113210.1136/bmjopen-2022-065194Innovative COVID-19 point-of-care diagnostics suitable for tuberculosis diagnosis: a scoping review protocolClaudia M Denkinger0Adithya Cattamanchi1Seda Yerlikaya2Lydia Marie-Luise Holtgrewe3Tobias Broger4Chris Isaacs5Payam Nahid6Division of Infectious Disease and Tropical Medicine, Heidelberg University, Heidelberg, GermanyUCSF Center for Tuberculosis, University of California San Francisco (UCSF), San Francisco, California, USADivision of Infectious Disease and Tropical Medicine, Heidelberg University, Heidelberg, GermanyDivision of Infectious Disease and Tropical Medicine, Heidelberg University, Heidelberg, GermanyDivision of Infectious Disease and Tropical Medicine, Heidelberg University, Heidelberg, GermanyConnected Diagnostics Limited, London, UKUCSF Center for Tuberculosis, University of California San Francisco (UCSF), San Francisco, California, USAIntroduction In 2014, the WHO published high-priority target product profiles (TPPs) for new tuberculosis (TB) diagnostics to align end-user needs with test targets and specifications; nevertheless, no TB test meets these targets to date. The COVID-19-driven momentum in the diagnostics world offers an opportunity to address the long-standing lack of innovation in the field of TB diagnostics. This scoping review aims to summarise point-of-care (POC) molecular and antigen tests for COVID-19 diagnosis that, when applied to TB, potentially meet WHO TPPs. This summary of currently available innovative diagnostic tools will guide the development of novel TB diagnostics toward the WHO-set targets.Methods and analysis We will follow the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension Scoping Reviews recommendations. MEDLINE (via PubMed), bioRxiv, MedRxiv and other publicly available in vitro diagnostic test databases were searched on 23 November 2022. POC antigen or molecular tests developed for SARS-CoV-2 detection that meet the eligibility criteria will be included in the review. Developer description, test description, operation characteristics, pricing information, performance and commercialisation status of diagnostic tests identified will be extracted using a predefined standardised data extraction form. Two reviewers will independently perform the screening and data extraction. A narrative synthesis of the final data will be provided.Ethics and dissemination No ethical approval is required because individual patient data will not be included. The findings will be published in open-access scientific journals.https://bmjopen.bmj.com/content/13/2/e065194.full
spellingShingle Claudia M Denkinger
Adithya Cattamanchi
Seda Yerlikaya
Lydia Marie-Luise Holtgrewe
Tobias Broger
Chris Isaacs
Payam Nahid
Innovative COVID-19 point-of-care diagnostics suitable for tuberculosis diagnosis: a scoping review protocol
BMJ Open
title Innovative COVID-19 point-of-care diagnostics suitable for tuberculosis diagnosis: a scoping review protocol
title_full Innovative COVID-19 point-of-care diagnostics suitable for tuberculosis diagnosis: a scoping review protocol
title_fullStr Innovative COVID-19 point-of-care diagnostics suitable for tuberculosis diagnosis: a scoping review protocol
title_full_unstemmed Innovative COVID-19 point-of-care diagnostics suitable for tuberculosis diagnosis: a scoping review protocol
title_short Innovative COVID-19 point-of-care diagnostics suitable for tuberculosis diagnosis: a scoping review protocol
title_sort innovative covid 19 point of care diagnostics suitable for tuberculosis diagnosis a scoping review protocol
url https://bmjopen.bmj.com/content/13/2/e065194.full
work_keys_str_mv AT claudiamdenkinger innovativecovid19pointofcarediagnosticssuitablefortuberculosisdiagnosisascopingreviewprotocol
AT adithyacattamanchi innovativecovid19pointofcarediagnosticssuitablefortuberculosisdiagnosisascopingreviewprotocol
AT sedayerlikaya innovativecovid19pointofcarediagnosticssuitablefortuberculosisdiagnosisascopingreviewprotocol
AT lydiamarieluiseholtgrewe innovativecovid19pointofcarediagnosticssuitablefortuberculosisdiagnosisascopingreviewprotocol
AT tobiasbroger innovativecovid19pointofcarediagnosticssuitablefortuberculosisdiagnosisascopingreviewprotocol
AT chrisisaacs innovativecovid19pointofcarediagnosticssuitablefortuberculosisdiagnosisascopingreviewprotocol
AT payamnahid innovativecovid19pointofcarediagnosticssuitablefortuberculosisdiagnosisascopingreviewprotocol