Regulated collection packs,
built for the job.
Our collection kits are regulated, assembled procedure packs, each with its own UDI, built around the right device, matrix and programme, so the patient gets it right the first time at home or at the point of care, and the laboratory gets a specimen it can trust.
An assembled pack, not parts.
A Humans Nexus kit is a Cell. A regulated collection pack assembled from a collection device, stabilisation, sealing and return packaging, brought together as one product with its own UDI. It is configured for a specific matrix and a specific programme, so what arrives at the patient’s door is a complete, traceable self-collection system rather than a box of loose components.
Every Cell is named for the sample it carries: Blood | Cell, Saliva | Cell, Urine | Cell, Stool | Cell, with the workflow noted beneath where it matters, Blood | Cell: Capillary, Stool | Cell: Microbiome. One family, every matrix: every Cell connects a human to the Nexus.
The device is chosen for the sample type and the assay; the rest of the Cell is built around it. See devices & kits →
What makes a pack clinical-grade.
Four things separate a regulated collection pack from a mail-in kit. Each is engineered into the pack, not assumed.
The collection device is matched to the matrix and the assay, so the sample is adequate in volume and quality on the first try: capillary blood formats for decentralised clinical trials and therapeutic drug monitoring, configured to the protocol’s volume and analyte.
The pack seals the sample to the patient’s identity with tamper-evident closure, provenance that resists substitution and supports sample-return compliance.
Stabilisation and return packaging are built in, matched to the matrix, so the sample travels at the right condition and survives the journey to the laboratory, with no work for the participant.
The pack returns under a documented chain of custody, closed when the accredited laboratory accessions the sample.
The transport behind the pack, stabilisation tiers and controlled-temperature only where the assay needs it, ambient where the format allows, is covered under logistics.
Sealed. Tracked.
Traceable.
What a Cell contains, whatever the matrix. Six things, one UDI.
Built per programme.
A pack is configured for what the programme needs: device, matrix, custody requirements and return logistics. Two representative programme packs:
Decentralised-trial kits.
The studies now travel to the patient.
A regulated collection pack for remote trial and therapeutic-drug-monitoring sampling: device matched to the protocol, return logistics built in, and custody documented so every sample is audit-ready.
Built for the protocol.
Decentralised trials and therapeutic drug monitoring move collection out of the site and into the participant’s home, but the sample still has to stand up to an audit. This pack is a regulated procedure pack with its own UDI, assembled around the device the protocol calls for, with stabilisation, ID-matched sealing and return logistics built in so the sample arrives at the laboratory complete and traceable. Regulatory guidance now describes the conditions under which trial activity, biological sample collection included, may take place away from the investigator site (Therapeutic Innovation and Regulatory Science, 2025); the pack is built to meet them.
Audit-ready by design.
Whoever runs the programme.
See how this fits a programme for pharma & CROs.
Good to know.
What is a Humans Nexus kit?
A regulated, assembled collection pack we call a Cell: a procedure pack built from a collection device, stabilisation, sealing and return packaging, brought together as one product with its own UDI and configured for a specific matrix and programme.
Why is it called a Cell?
Cell is our name for the collection-kit family: a self-contained unit that connects a human to the Nexus. Each is named for the sample it carries, Blood | Cell, Saliva | Cell, Urine | Cell, Stool | Cell, with the specimen type first and the vertical bar keeping the product name distinct from the biological term.
What is in the kit?
The collection device matched to the matrix and the assay; stabilisation matched to the sample, buffer, drying station or tube; an ID-matched, tamper-evident seal registered to the patient in Flow before collection; a tracked, prepaid UN3373 Category B return mailer; instructions for use on paper and in the app; and one UDI label for the whole pack.
What makes a pack clinical-grade rather than mail-in?
The right device for the matrix, ID-matched tamper-evident sealing, return packaging matched to the sample, and a documented chain of custody closed at the accredited laboratory.
How does a kit reach the patient and come back?
Shipped to the address the programme gives us, registered to the patient in Flow, collected with the app’s guidance, sealed, and returned in the prepaid tracked mailer, with courier pickup where a lane requires it; every hand-off is recorded in the chain of custody until the laboratory accessions it.
Does every kit need a cold chain?
No. Dried and buffered formats ship at ambient temperature. Controlled-temperature transport is applied only where the assay requires it, as the managed exception, temperature-logged end to end; see logistics.
Are the kits regulated?
Each Cell is a procedure pack with its own UDI, assembled under MDR and IVDR; the devices inside carry their makers’ CE marking; the sample is analysed in an ISO 15189-accredited laboratory.
Can you build a pack for our programme?
Yes. Beyond the representative programme packs, kits are configured on request around the right device, matrix and custody requirements. Talk to us about your programme.
What is the decentralised-trial kit?
A regulated collection pack for DCT and therapeutic-drug-monitoring sampling: a procedure pack with its own UDI, assembled around the protocol’s device with stabilisation, ID-matched sealing and return logistics built in.
How does it support anti-substitution?
The sample is sealed to the participant’s identity at the moment of collection with tamper-evident closure, and a timestamped chain of custody travels with it to laboratory accessioning, provenance that resists substitution.
Which device does it use?
The device is matched to the matrix and assay the protocol requires, typically a capillary blood format for DCT and TDM. See microsampling for blood for the formats available.
Can trial participants collect samples at home?
Yes, and guidance now sets out the conditions under which trial activity, sample collection included, may take place away from the investigator site (Therapeutic Innovation and Regulatory Science, 2025); a systematic review in the British Journal of Clinical Pharmacology in 2022 maps the methods decentralised trials have actually used, remote sample collection among them.
Put a regulated kit on your programme.
Talk to us about configuring collection packs for your matrix and programme.