Resources
A Knowledge Base for Collection Kit Programs
Reference material for the people who design, validate, and run specimen collection kit programs. Nothing here is gated and none of it asks for your email.
Guides are grouped by the decision they help you make, not by what we sell. Several of them will tell you not to build a kit. Start anywhere.
Packaging and artwork
Packaging is where kit program budgets get wasted most often, usually by committing to custom tooling before the design is settled.
Packaging resources for collection kits
Materials, box styles, color, and the order to make the decisions. Includes a glossary and an artwork checklist.
Choosing a kit box material
Corrugated grades, rigid setup boxes, and folding cartons, and what each one is actually good for.
CMYK or Pantone for packaging
When process color is fine, when you need a spot color, and what drives the difference in cost.
Collection devices by matrix
Reference pages on the device categories a kit is usually built around. Devices are described by mechanism rather than by brand.
Capillary blood devices
Fingerstick and upper-arm collection formats, metered and unmetered.
Blood collection tubes
Additives, draw volumes, and order of draw.
Integrated collection and stabilization kits
Formats where collection and preservation happen in one step.
Nasopharyngeal swab devices
Swab construction, transport media pairing, and handling.
Oral fluid collection devices
Collection formats used for oral fluid testing.
Specimen containers
Container types, closures, and leak considerations.
Stool collection kits
Collection formats, stabilization, and return handling.
Viral transport media
Media types and what they preserve.
Sampling and preservation
What patient centric sampling actually means
A design requirement, not a device category, and the three questions that decide whether it fits.
Capillary collection or venipuncture
How to choose between the two for an at-home program.
How to choose a preservation medium
What stabilizes the sample once it leaves the patient.
When stock stabilization media does not fit
Why an off-the-shelf medium often fails a specific assay.
From prototype to shelf
Building a kit around a collection device that nothing off the shelf fits.
Regulatory and quality
Regulatory status and claim language always belong to your own regulatory lead. These pages explain the frameworks, not your obligations under them.
Regulatory and compliance
How quality systems, documentation, and traceability apply to kit manufacturing.
What FDA QMSR means for at-home test kit companies
The shift from 21 CFR Part 820 and what changes in practice.
AQL sampling plans for kit inspection
How inspection levels are set and what an AQL does and does not tell you.
Process development before validation
Why validating an unsettled process is the expensive way to do it.
Cold chain and shipping
Opening an international specimen lane
What gets a lane approved, and what stops one cold.
Prepaid return labels and expiration
Why return labels stop working and what it costs when they do.
Choosing and scoping a partner
Contract manufacturer, 3PL, or fulfillment vendor
What the difference is and what it costs you to get it wrong.
Audit your specimen kit supplier
A side-by-side criteria sheet you can use on any vendor.
What your kit BOM needs before anyone can quote it
The line items that have to be settled before a price means anything.
What a paid scoping engagement should buy you
What you should get for it, and when it is worth paying for.
What to ask before you build the integration
The questions that decide whether an integration works or gets rebuilt.
Ordering and operations
Building a gated B2B ordering portal for clinic buyers
What clinic buyers need from an ordering flow, and what breaks when they do not get it.