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, accessories, and packaging around the chemistry. Plastic, foil, desiccant. The format dictates manufacturing, logistics, cold chain, and unit economics.
A continuous roll flips that. Chemistry stays. Packaging does not. Geometry replaces the housing. The strip becomes its own platform.
From there, everything cascades. Logistics scales with chemistry, not packaging. Manufacturing is built for industrial roll-to-roll lines, not 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. This masking needs no electronics. 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, extending the privacy rationale from the test surface to the point of care.
In the data path
Pseudonymized at the source.
Structured digital output in standard healthcare data formats feeds clinical and surveillance systems without exposing individual identifiers at the source. Real-time epidemiology, pseudonymized 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 demanding conditions
The dispenser continues feeding cleanly across the design environment, including humidity excursions beyond nominal storage conditions.
Plastic housing
Designed out
The rigid cassette shell is gone. The strip is its own platform, so no plastic housing is needed.
Each subsystem holds to a measured design target.
Four design targets, engineered together: membrane, flow, humidity, signal.
01
Stable without refrigeration
Ambient shelf-life design target, to be validated by CLSI EP25-A accelerated stability protocols.
The reagent matrix is designed to stay stable across the full ambient range and through freeze-thaw cycles.
Removes the cold chain that dominates LMIC LFA logistics, with stability targets covering the worst-case tropical range and beyond. For the buyer, that means no refrigerated shipping, no cold storage, and none of the wastage a broken cold chain causes.
02
Consistent flow across the operating range
Flow rate is designed to stay 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 headroom over peak 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 is designed to tolerate hemolyzed and discolored samples that would compromise visual reads.
Failure modes engineered out at the design stage, not managed procedurally.
Three 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
Output in standard healthcare data formats, 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.
Roll-to-roll manufacturing, designed in from day one.
The format was designed for roll-to-roll manufacturing from the outset, so reaching volume draws on mature industrial processes rather than a custom scale-up. Manufacturing route being established with an ISO 13485-certified Nordic roll-to-roll producer.
Regulatory pathway: lead indication and beyond.
Planned regulatory pathway: South African early access first, 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 will be 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.