Evaluation of digital microfluidic molecular point-of-care testing for the diagnosis of respiratory pathogens

Study for multiplex assessment and respiratory test evaluation

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN57715622

Enrollment

400

Registered

2025-10-24

Start date

2025-12-01

Completion date

Unknown

Last updated

2025-12-01

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

Conditions

Point-of-care testing for diagnosis of respiratory infections in the Emergency Department setting of Addenbrooke's Hospital. Infections and Infestations

Interventions

This is a prospective, single-centre, diagnostic accuracy study. There is no therapeutic agent and no randomisation. Study participants will have 2 nasopharyngeal swabs taken simultaneously (one from

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Male or female 2. Any age 3. Presenting to the CUH Emergency Department 4. Symptomatic of respiratory tract infection as evidenced clinically by the presence of any of the following indicators: 4.1. Acute onset of persistent cough (with or without sputum) 4.2. Hoarseness 4.3. Nasal discharge or congestion 4.4. Shortness of breath 4.5. Sore throat 4.6. Wheezing 4.7. Sneezing 4.8. Persistent Acute respiratory distress syndrome 4.9. Influenza-like illness 4.10. Fever = 37.8 degrees C 4.11. Any other symptom known to be indicative of acute respiratory episode such as palpitations, headache, anosmia (COVID) or gastrointestinal symptoms (diarrhoea) (influenza) 5. Signed consent form for participation 6. Requiring standard of care diagnostic testing as per CUH Trust IPC policy 7. Able to read and/or understand the age-appropriate participant information sheet in English

Exclusion criteria

Exclusion criteria: 1. Unwilling or unable to comply with study nasopharyngeal swabbing procedures 2. Those who are incapacitated or deemed to be lacking capacity to provide informed consent to participate 3. Prisoners or young offenders

Design outcomes

Primary

Measure	Time frame
The sensitivity and accuracy of the Logicore System POC diagnostic test compared to the gold standard POC multiplex test (Cepheid GeneXpert), including Positive Predictive Value (PPV), Negative Predictive Value (NPV) and specificity measured using data collected at the time of the test during a single visit	—

Secondary

Measure	Time frame
1. Determination of turnaround time for Logicore System, measured using time recorded by the Logicore System and documented in patients’ medical notes by research staff, and Cepheid tests measured using time documented in patients’ medical notes by research staff, at one timepoint 2. Evaluation of the acceptability of the Logicore System POCT to study participants and staff, measured using a simple Likert scale, at a single timepoint 3. Monetised savings from avoided testing and operational savings due to the reduction in time spent in ED or in isolation within the ED measured using data collected from patient medical records at one timepoint	—

Measure

Time frame

1. Determination of turnaround time for Logicore System, measured using time recorded by the Logicore System and documented in patients’ medical notes by research staff, and Cepheid tests measured using time documented in patients’ medical notes by research staff, at one timepoint 2. Evaluation of the acceptability of the Logicore System POCT to study participants and staff, measured using a simple Likert scale, at a single timepoint 3. Monetised savings from avoided testing and operational savings due to the reduction in time spent in ED or in isolation within the ED measured using data collected from patient medical records at one timepoint

—

Countries

England, United Kingdom

Contacts

Public ContactJuliet Connor

juliet_connor@outlook.com+44 (0)7968272331

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026