Clinical workflow
Test for Chlamydia trachomatis and Neisseria gonorrhoeae without adding a laboratory workflow.
Typical point-of-care testing
Preparing and processing a sample introduces additional tasks before a result is available.
Patient attends→Sample collected→Label sample; prepare tube→Pipette into cartridge→Load cartridge into instrument→Start test in software→Record and communicate result
With LotusDx
The patient provides a sample, and the diagnostic runs while clinical activity continues.
Patient attends→Sample collected→Introduce sample to test→Result ready for clinical action
Planned intended use
Qualitative point-of-care detection of CT and NG in men and women.
Symptomatic or asymptomatic · Self-collected vaginal swabs (women) · First-catch urine (men)
Clinical performance targets Planned, not yet demonstrated
≥95%Sensitivity / PPA95% CI lower bound ≥90%
≥99%Specificity / NPA95% CI lower bound ≥98%
≤2%First-attempt invalidsTarget across intended users
≤20 minTime to resultPositive / negative / invalid
Operational usability targets Planned, not yet demonstrated
≥95%Critical-task completionIntended user groups
≥99%Correct result interpretationCT / NG / invalid
≤1 minActive operator timeExcludes specimen collection
≤30 minTraining requirementTarget initial operator training
Clinical validation targetCT and NG evaluated separately in vaginal swabs and male first-catch urine against laboratory NAAT; target 2028.
Usability evidenceIEC 62366-1: intended-user tasks, operator time, training burden, use errors and result interpretation.
After launchComplaint trends, invalid and false results, corrective action and ongoing performance follow-up.
EU IVDR · Class C near-patient IVDNotified Body conformity assessment planned for near-patient use.
CE mark · EU Declaration of ConformityPlanned following successful conformity assessment.
International market authorisationRequired market-specific authorisations to be obtained before commercial deployment.
System integration
Testing runs independently while clinical care continues.
Patient / clinical staff
The sample goes straight to the device.
Collect sample
Introduce sample to device
LotusDx diagnostic device
The device runs and generates a digital result.
Device runs
Digital result generated
Results / clinical pathway
Results fit the existing clinical pathway.
Local display or electronic reporting
Continue clinical pathway
Staff continue usual activities
LotusDx meets integration requirements
Patient & test identificationScan or enter patient/sample ID; associate the cartridge identifier with the result.GS1 / UDI where applicable
Standalone operationDevice displays its result locally, without an EHR connection.IEC 62304 · IEC 62366-1
Electronic result transferOptional software interface to compatible EHR/LIS systems.HL7 v2 / FHIR where supported
Data securityProtect patient data and electronic results under applicable privacy law.IEC 81001-5-1
Clinical safety & exceptionsHandle invalid results, incorrect patient linkage and failed transfers.ISO 14971
Pricing
Scale CT/NG testing with minimal equipment investment and low per-test costs.
Equipment
Reusable diagnostic reader
Compact reader retained between tests; add readers to match each site’s needs.
Target price£50
Pricing unitPer reader
HardwareReusable
Scale-upAdd readers
Consumable
Single-use CT/NG cartridge
One disposable cartridge per patient, for combined chlamydia and gonorrhoea testing.
Target price£10
Pricing unitPer test
AssayCT + NG
CartridgeSingle-use
≤20 minTarget time to result
≤1 minTarget active operator time
≤30 minTarget initial training
≥18 monthsTarget cartridge shelf life
StandaloneLocal result display
OptionalElectronic reporting
Indicative development-stage pricing and operating targets; final prices and terms to be confirmed closer to launch.
Clinical deployment readiness
Clinical, regulatory and operational evidence to support safe, effective deployment across different care settings.
Regulatory & quality assuranceEU IVDR Class C conformity assessment, market-specific authorisations, ISO 13485 quality management and ISO 14971 risk management.
Clinical performance evidenceCT/NG validation in symptomatic and asymptomatic men and women; vaginal swabs and first-catch urine against laboratory NAAT.
Analytical performanceDetection limit, precision, inclusivity, cross-reactivity, interference, stability and robustness for CT and NG.
Operator usabilityIEC 62366-1 evaluation of critical tasks, result interpretation, hands-on time and training needs.
Clinical pathway & trainingPatient eligibility, specimen collection, SOPs, result interpretation, treatment/referral pathways and staff training.
Privacy & data governancePatient-data access, retention and sharing arrangements aligned to requirements in each deployment market.
Connectivity & cybersecurityStandalone results, optional EHR/LIS interfaces, secure transfer, access controls and failed-transfer handling.
Post-market surveillanceComplaints, invalid results, device traceability, incident reporting, corrective actions and performance monitoring.
Procurement & supportReader and cartridge supply, pricing, shelf life, replenishment, warranty, maintenance and technical support.