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Evaluation of a mNGS Workflow for Infection Diagnosis Using Oxford Nanopore Sequencing.

NCT04864873 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2021-08-02

No results posted yet for this study

Summary

This is a laboratory evaluation of a new testing methodology for microbiological diagnosis, whereby participant samples received as part of routine care will be divided between the standard diagnostic pathway and this new pathway: metagenomic next generation sequencing (mNGS). Results obtained from the mNGS pathway will be compared against the standard diagnostic pathway in terms of sensitivity, specificity, accuracy and clinical impact. The samples will be identified at Wellington Southern Community Laboratories (WSCL), which provides laboratory services for Capital and Coast District Health Board, and forwarded to the Institute of Environmental Science and Research (ESR) to undergo mNGS testing.

Conditions

Interventions

DIAGNOSTIC_TEST

Metagenomic next generation sequencing using Oxford Nanopore

See previous.

DIAGNOSTIC_TEST

Standard microbiological diagnostic pathway

See previous.

Sponsors & Collaborators

  • Wellington Southern Community Laboratories

    collaborator UNKNOWN

  • Institute of Environmental Science and Research

    collaborator UNKNOWN

  • Capital and Coast District Health board

    lead OTHER_GOV

Principal Investigators

  • Maxim G Bloomfield, MBChB · Wellington Southern Community Laboratories, Capital and Coast District Health Board

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-01
Primary Completion
2022-05-31
Completion
2022-05-31

Countries

  • New Zealand

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04864873 on ClinicalTrials.gov