Clinical performance evaluation of a Randox Respiratory-fleX device for respiratory infections

Clinical performance evaluation of the Randox Respiratory-fleX qPCR

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN15859597

Enrollment

525

Registered

2026-04-02

Start date

2026-03-30

Completion date

Unknown

Last updated

2026-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Detection and discrimination of causative pathogens of respiratory infections. Infections and Infestations

Interventions

An observational clinical performance study will be conducted to demonstrate that, under routine use conditions and following device instructions for use, the Respiratory-fleX device family will meet

Eligibility

Sex/Gender

All

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Persons who are suspected of having a respiratory infection, at an increased risk of respiratory infection, or believed to have a previous exposure to a respiratory pathogen and require screening. 2. Individuals aged 18 or over. 3. Samples with appropriate consent for use for performance evaluation testing.

Exclusion criteria

Exclusion criteria: 1. Contamination and/or deterioration of the specimen or nucleic acid isolate from a specimen that, in the investigator's professional opinion, may impact the handling of the specimen or analysis of the test result.

Countries

Northern Ireland, United Kingdom

Contacts

Public ContactHelena Murray

helena.murray@randox.com+44 (0)2894422413

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Apr 17, 2026