The engineering behind the roll.
How CENTiV™ turns a continuous cellulose roll into up to 100 diagnostic tests.
Why a continuous roll changes the format.
Most of a rapid test by weight is the plastic cassette, the foil pouch, the drying sachet, and the rest of the packaging around a small strip of chemistry. That packaging decides how the test is made, shipped, and stored, and what it costs.
A continuous roll keeps the chemistry and drops most of the packaging. The strip is designed to stand on its own, so it needs no cassette, and a shipment of rolls is mostly tests.
The roll is designed for roll-to-roll printing, a mature industrial process already used for labels and flexible packaging. A cassette is a molded part that is filled, assembled, and boxed one test at a time.
The same roll works handheld, with the reader, or in a KiOSK.
A continuous roll is not a packaging change. It is a platform change.
Privacy in three layers: the strip, the KiOSK, the data.
Privacy is engineered into three layers of the platform.
At the test surface
Result visible only during the read window.
The person testing sees the result for a set time, and then it is hidden from anyone nearby. No electronics are needed for this. The reader still keeps its own record, so the result can be checked later.
At the KiOSK
Zero human interaction at the KiOSK.
At the KiOSK, nobody else is involved: no clinician, no pharmacist, and no one watching. Stigma and access barriers are well documented for HIV and sexually transmitted infection testing. The KiOSK is there to lower both.
In the data path
Pseudonymized at the source.
Results go out in standard healthcare data formats. The clinical record identifies the patient, as treatment requires. What goes to disease tracking is pseudonymized at the source, so it does not show who took the test.
A continuous cellulose roll becomes a 100-test dispenser through four pieces of engineering.
01
Strip material designed to last the whole roll
One target for the strip material: the hundredth test performs like the first.
02
A strip that holds its own shape
The strip is designed to stand on its own once dispensed, with no cassette around it.
03
A roll that unwinds cleanly after long storage
The strip material, and the way the roll is wound, are chosen so that it unwinds cleanly after long storage and in real field conditions, with the tests on it still working.
04
Designed for heat and humidity
The target is a dispenser that keeps working across its full storage temperature range, including short bursts of humidity above normal storage levels.
Plastic cassette
Designed out
There is no plastic cassette around each test. One housing serves all 100 tests on the roll.
Each part of the system has a measurable design target.
The strip, the sample flow, humidity control, and the reader signal are designed together.
01
Stable without refrigeration
Shelf life is set for storage without refrigeration and will be measured by standard accelerated stability studies (CLSI EP25).
The CENTiV target is storage up to 50°C, freezing included, chosen to cover the places the test will actually be used.
02
Steady sample flow across temperatures
How fast the sample moves along the strip changes with temperature and with small differences between strips. The design targets both.
The goal is one flow target across the whole temperature range the test is rated for, with no recalibration between batches.
03
Humidity managed by design
Humidity inside the dispenser has its own target for the whole shelf life, with a margin above the most humid tropical conditions.
The dispenser keeps moist air out while in use and between uses.
04
A reader more sensitive than the eye
The target for the reader is to pick up test lines too faint to see by eye on a conventional rapid test.
It applies to every sample type the platform accepts.
Fewer ways to fail, from the shipment to the waste bin.
Rapid tests are lost to heat before they are opened, to mistakes while they are run, and to results that are misread or never recorded. Each of those costs a testing program money, and so does throwing the test away. CENTiV builds the fixes into the roll and the reader instead of into staff training.
Before use: arriving in working order
Heat and humidity spoil tests before anyone opens them.
The storage and humidity targets above are there so that more of the tests reaching a clinic still work.
During use: fewer steps to get wrong
Buffer built in; it releases only when the sample is applied. Blood and urine stay clear of the mechanism that feeds out the strips.
Fewer steps leave fewer chances for error.
At the result: read and recorded by the reader
The reader sets itself up for whichever test is loaded, so one reader runs every test type with no setup by the user.
The result is recorded as it is read, so nobody copies it down or judges a faint line by eye. The reader works offline.
After use: less to throw away
Each test leaves under 3g of waste, in materials chosen to burn cleaner than a plastic cassette.
That means less waste to handle and less to pay for handling it.
In our own cost model, shipping is the largest saving, with staff time and waste handling adding a few percentage points on top.
Roll-to-roll manufacturing, designed in from day one.
CENTiV is designed for roll-to-roll production. Making it in volume can use existing industrial lines instead of a new, custom process. We are in discussion with EU manufacturers.
Class D, from the first panel.
Market entry is antenatal triple-elimination screening for HIV, syphilis, and hepatitis B. Under the EU diagnostics regulation (IVDR), the panel is Class D, the highest risk class.
Class D carries the most demanding review under the regulation.
Prequalification by the World Health Organization (WHO) is a separate review. It requires a finished design and the manufacturer's own validation data.