Lab diagnostics demystified — regulation, technology, care delivery.
In-depth articles for decision-makers: how home-sampling is classified under EU regulation, how ISO standards underpin test-kit quality, how lab data integrates via FHIR, and which reimbursement paths health funds can use.
Regulation & Quality
ISO 13485 explained: what a QMS does — and why Probatix test kits are built on one
ISO 13485 is the international standard for the quality management systems of medical device manufacturers. Probatix operates in conformity with ISO 13485 — which is why the development, assembly and post-market surveillance of our test kits are traceable, reproducible and safe. This article explains exactly what the standard ensures, how it interacts with ISO 15189 (laboratory) and ISO 27001 (information security), and why poor kit quality is the most common but quietest cause of unusable results.
IVDR & test kits: approval, classes and the difference between self-test and home sampling
A home-sampling kit whose sample is analysed in an accredited laboratory is, in regulatory terms, a different product from a self-test that is evaluated at home — with a different risk and approval profile. Probatix operates in the former, lower-classified domain. This article frames the IVDR, EUDAMED and the classification logic so that you, as a partner, know what you are getting into.
Diagnostics Knowledge
What can be tested from home? Blood, urine, saliva, swab, stool — and what really matters
In principle anything that a laboratory can analyse from the relevant sample can be tested by home sampling — provided the stability of the parameter on the uncontrolled shipping route has been validated by the lab. This is exactly where serious diagnostics part ways with risk. This article frames the sample types, the associated panels and the quality question so that you, as a product or programme owner, know what to look out for.
Why home sampling? The benefits of professional laboratory diagnostics with sample collection at home
Home sampling combines the convenience of sample collection at home with the reliability of genuine laboratory diagnostics — that is the central difference from self-tests with self-interpretation. This article shows the benefits in detail and makes clear how to spot a serious provider.
Industry & Use Cases
Financing prevention: reimbursement and care models for diagnostics under SGB V
Probatix-powered diagnostics can be financed through several SGB V models — first and foremost selective contracts under §140a — and embedded low-threshold into prevention programmes. This article frames the relevant sections, shows typical usage patterns and outlines what implementation looks like in practice. Not legal advice.
From longevity to fertility: use cases for laboratory diagnostics as a service
Home-sampling diagnostics fits anywhere lab values can make an offering more precise, more accessible or more controllable — across sectors. This article shows typical use cases without making medical efficacy claims, focusing on the programme value in each case. The diagnostic result always comes from an accredited laboratory, never from the end user.
What does laboratory diagnostics as a service cost? Setup, pay-per-use and the dropshipping model
Getting started is low-threshold: from €1,000 setup, then pay-per-use depending on the test and panel. No warehouse to build, thanks to dropshipping — Probatix produces, stores and ships under partner branding. This article explains what the setup includes, how the pay-per-use price is composed and which access tier is worthwhile for which volume.