A study to evaluate the performance of a novel Lab-on-Chip device for rapid diagnosis of Covid-19 (SARS-CoV-2 infection)

A study to evaluate the performance of a Lab-on-Chip LAMP device for rapid SARS-CoV-2 diagnosis

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN58218165

Enrollment

Registered

2023-10-30

Start date

2022-07-01

Completion date

Unknown

Last updated

2024-02-19

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

Conditions

Assess the practicalities of undertaking a larger diagnostic accuracy study of the LoCKamp system for detecting SARS-CoV-2 Infections and Infestations

Interventions

Methodology: A pilot study to test the practicalities of undertaking a larger diagnostic accuracy study of the LoCKamp system. Feasibility issues will include: ability to recruit and patient acceptab

ability to warn of possible false positive/negative testing results

correlation of LoCKamp malfunction with usability and system acceptability

ability to take samples and clinician acceptance. 1. When patients arrive in RUH and test positive for SARS-CoV-2 with the standard PCR test, they will be screened for inclusion/exclusion in the stud

participants will be offered written information and the opportunity to ask any study-related questions before signing written consent. 3. For the consenting patients a nasopharyngeal swab will be co

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients with SARS-CoV-2 positive PCR test 2. Adult >18 years 3. Attendance at hospital 4. Consent gained for study

Exclusion criteria

Exclusion criteria: 1. Consent not gained for study 2. Child < 18 yrs 3. Adult without mental capacity to consent

Design outcomes

Primary

Measure	Time frame
1. Correlation between: 1.1.LoCKamp results for infection condition measured at a single time point. 1.2. Clinical decision of patient infection condition (using standard PCR lateral flow test, administered by health professionals at the RUH hospital site) measured using patient records at a single time point. 2. Data from the clinical record including temperature and any other known COVID-19 symptoms measured at a single time point.	—

Measure

Time frame

1. Correlation between: 1.1.LoCKamp results for infection condition measured at a single time point. 1.2. Clinical decision of patient infection condition (using standard PCR lateral flow test, administered by health professionals at the RUH hospital site) measured using patient records at a single time point. 2. Data from the clinical record including temperature and any other known COVID-19 symptoms measured at a single time point.

—

Secondary

Measure	Time frame
Assess the practicalities of undertaking a larger diagnostic accuracy study of the LoCKamp system by measuring the number of participants recruited during the LoCKamp study period, using patient records/case report forms, at the end of the study	—

Countries

England, United Kingdom

Contacts

Public ContactJune Mercer-Chalmers

j.d.mercer-chalmers@bath.ac.uk+44 1225 388388

Outcome results

None listed

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