Online healthcare partners
LotusDx allows the diagnostic test to be completed at home, removing return-sample postage and central laboratory processing from the chlamydia pathway.
Typical postal self-sampling pathway
The patient collects a sample at home, but the diagnostic test still happens after the sample is returned.
Order online→Kit delivered→Collect sample→Return sample→Laboratory processing→Result→Existing clinical pathway
Your pathway with LotusDx
The patient completes the diagnostic test at home in ≤20 minutes, and the result is returned immediately into the provider’s existing pathway.
Order online→Kit delivered→Test at home→Existing clinical pathway
Planned intended use
Qualitative at-home detection of Chlamydia trachomatis from a self-collected vulvovaginal swab in symptomatic and asymptomatic women.
Clinical performance targets Planned, not yet demonstrated
≥95%Sensitivity / PPALower 95% CI ≥90%
≥99%Specificity / NPALower 95% CI ≥98%
≤2%First-attempt invalidsTarget for home testing
≤20 minTime to resultPositive / negative / invalid
Home-use usability targets Planned, not yet demonstrated
≥95%Critical-task completionUntrained intended users
≥99%Result interpretationAgreement with correct result
≥95%Correct next-step understandingPositive / negative / invalid
≥300Lay-user participantsUnsupervised home setting
Clinical validation targetSymptomatic and asymptomatic women, self-collected vulvovaginal swab, laboratory PCR comparator. Target: 2028.
Usability evidenceIEC 62366-1 usability work: critical tasks, instructions, use errors and user comprehension.
After launchComplaint trends, invalid and false results, corrective action and ongoing performance follow-up.
EU IVDR · Class C self-testNotified Body assessment planned for self-testing.
CE mark · EU Declaration of ConformityPlanned after successful conformity assessment.
Great Britain · MHRA registrationRegistration required before GB market placement.
System integration
LotusDx automatically sends test results into provider systems.
Partner system
The provider uses existing ordering and fulfilment.
Customer purchase
Kit fulfilment
→
LotusDx diagnostic layer
LotusDx guides testing and generates the result.
Test activation
Digital instructions
Test at home
Result + traceability package
→
Partner system
The provider receives results into its existing clinical pathway.
Diagnostic output received
Existing clinical pathway
LotusDx meets integration requirements
Identity & test linkagePatient identifiers or activation codes link each test to the correct journey.ISO/IEC 27001
Secure interoperabilityStructured results and metadata are sent to authenticated interfaces.IEC 62304 · IEC 81001-5-1
Privacy & governanceDefine lawful processing, data ownership, minimisation and retention.UK GDPR · ISO/IEC 27701
Security & access controlAuthentication, access permissions, encryption and audit trails.ISO/IEC 27001 · IEC 81001-5-1
Clinical safety & exceptionsEscalation for invalid results, activation failures and failed handoffs.IEC 81001-5-1
Pricing
Starter and refill packs offer high gross margins with no setup fee or mandatory consultation.
Starter pack
Reader + 1 chlamydia cartridge
Everything a new patient needs for one at-home test.
Wholesale£25.00
Recommended RRP£39.99
Gross profit£14.99
Gross margin37.5%
Refill pack
2 chlamydia cartridges
For patients who already own the reusable LotusDx reader.
Wholesale£15.00
Recommended RRP£24.99
Gross profit£9.99
Gross margin40.0%
≥18 monthsShelf life on delivery
12 unitsMixed opening order
£0Setup fee
15 minOptional team briefing
IncludedDigital IFU & activation
2 yearsReader warranty
Pilot diligence
Before any partner pilot, the deploying organisation receives the regulatory, clinical, governance, training and commercial materials needed to assess the service.
Regulatory & manufacturer assuranceIVDR Class C and GB market-access plans; ISO 13485 QMS and ISO 14971 risk evidence.
Clinical protocolWomen’s study protocol, PCR comparator, statistics, acceptance criteria and 2028 timeline.
Analytical packageDetection limit, precision, inclusivity, interference, stability and robustness.
Home-use evidencePrinted/digital IFU, IEC 62366-1 usability work, critical tasks and interpretation.
Clinical pathway & trainingEligibility, referral guidance, implementation SOPs and team-training materials.
Data protectionDPIA, privacy notice, controller mapping, retention and data-sharing agreements.
CybersecurityAccess controls, penetration-test summary, vulnerability and incident management.
Post-marketComplaint handling, lot traceability, follow-up, corrective action and recalls.
CommercialPrice list, opening order, shelf life, returns, warranty, margin and pilot terms.