The engineering behind the roll.
How CENTiV™ turns a continuous cellulose roll into 100 reliable diagnostic tests.
Why a continuous roll changes the format.
Most of a rapid test is not chemistry. It is the cassette around the chemistry. Plastic, foil, desiccant. The format dictates manufacturing, logistics, cold chain, and unit economics.
A continuous roll inverts this. Chemistry stays. Packaging does not. Geometry replaces plastic. The strip becomes its own platform.
From there, everything cascades. Logistics scales with chemistry, not packaging. Manufacturing runs on industrial roll-to-roll equipment, not adapted from laboratory batch processes. One reader serves the full assay menu. One consumable serves handheld, reader, and kiosk deployment.
A continuous roll is not a packaging change. It is a platform change.
Privacy in three layers. Test surface, deployment, data path.
Privacy is not bolted on as a digital feature. It is engineered into three layers of the platform.
At the test surface
Result visible only during the read window.
The result is visible to the user during a defined read window, then masked from bystanders. Digital audit by the reader is preserved, so privacy and verifiability do not trade off.
At the deployment
Zero human interaction at the kiosk.
In the kiosk format, no clinician, no pharmacist, no third party is in the testing path. This reduces stigma and access barriers documented for HIV and STI testing in published research (Pulerwitz & Bongaarts 2014; Spence et al. 2020), extending the privacy rationale from the test surface to the point of care.
In the data path
Anonymized at the source.
Structured digital output via HL7/FHIR feeds clinical and surveillance systems without exposing individual identifiers at the source. Real-time epidemiology, anonymous by default.
A continuous cellulose roll becomes a 100-test dispenser through four engineered subsystems.
01
Membrane integrity across the roll
Substrate architecture preserves chemistry performance and pore integrity across the full 100-test roll lifetime.
02
Self-supporting strip geometry
The strip is its own rigid platform. Flat in storage, structurally supported on dispense. No plastic cassette required.
03
Reliable unwind across shelf life
The roll unwinds cleanly across extended storage and the full operating environment, with chemistry intact at every test position.
04
Dispense reliability in worst-case conditions
The dispenser continues feeding cleanly across the design environment, including humidity excursions beyond nominal storage conditions.
Plastic replaced
~4 g per kit
Cassette housing conventionally provides handling stiffness. Here, geometry does.
Each subsystem holds to a measured design target.
Four subsystems inside the roll, engineered together: membrane, flow, humidity, signal. Each is a design target, not an assumption.
01
Stable without refrigeration
Ambient shelf-life design target, to be validated by CLSI EP25-A accelerated stability protocols.
Reagent matrix stays stable across the full ambient range and through freeze-thaw cycles.
Removes the cold-chain dependence that dominates LMIC LFA logistics, with stability targets covering and beyond the worst-case tropical range.
02
Consistent flow across the operating range
Flow rate stays stable across membrane variability and temperature.
Flow variation across the operating range holds to a design target, with no batch-by-batch recalibration.
03
Humidity managed by design
Internal humidity holds to a design target across the full shelf life, with significant headroom over worst-case tropical loads.
The dispense path seals against ambient humidity during use and between uses.
04
Optical readout designed for sample interferents
Reader optics target lower limits of detection than visual lateral-flow readouts.
Readout tolerates hemolyzed and discolored samples that would compromise visual reads.
Failure modes engineered out at the design stage, not managed procedurally.
Four mechanisms remove failure modes that cassette LFAs manage with training and procedure.
Biosafety by design
Sample is applied to the strip only after separation from the dispenser. Biological material is kept out of the dispensing path.
Cross-contamination is structurally prevented rather than managed procedurally.
Automatic assay recognition
The reader auto-configures for the assay loaded.
One reader serves the full menu without user setup.
Structured digital output
HL7/FHIR output direct from the reader. Quantitative measurement removes manual transcription and interpretation drift.
The reader connects via Bluetooth, Wi-Fi, Ethernet, or cellular, and buffers locally when offline so a network drop does not lose data.
Result privacy
The result is visible to the user during a defined read window, then masked from bystanders.
Digital audit by the reader is preserved through the masking, so privacy and verifiability do not trade off.
Roll-to-roll manufacturing, designed in from day one.
The platform is designed around industrial roll-to-roll equipment from the outset, not adapted from laboratory batch processes. Manufacturing collaboration with an ISO 13485-certified Nordic roll-to-roll producer.
Regulatory pathway: lead indication and beyond.
Phased regulatory pathway: South African early-access engagement, with EU CE mark scaling the platform thereafter.
Lead indication: blood-borne pathogen donor screening (HIV, HBV, HCV, syphilis) under IVDR Class D. Platform extends to additional rapid diagnostic categories.
Conformity assessment is routed through an EU reference laboratory with scope covering the lead indications.
WHO prequalification strategy uses established regulatory reliance pathways to accelerate LMIC market entry.
Regulatory tailwind
Commission Implementing Regulation (EU) 2025/1197 excludes Chinese suppliers from EU public medical-device tenders above EUR 5 million, in force from 30 June 2025 for five years. The regulation also caps Chinese-origin content at 50 percent of contract value. CENTiV is EU-origin (Lund, SE), with component supply auditable for the cap.