Who writes them
Catenix guides are written and reviewed by the Catenix team: people who have run point-of-care services and laboratory quality systems, clinical scientists with a biochemistry background, and the engineers who build the connectivity and quality software. Guides carry a team byline rather than individual names. That is a deliberate policy for a small company, not a way to hide who is responsible: the company is responsible for every word, and the contact address below reaches the people who wrote it.
What they are checked against
Every guide names the documents it relies on. Where a guide says what a standard or a regulator asks for, the claim is checked against the current text before publication, and the source is listed at the end of the page.
- Laboratory and POCT standards: ISO 15189:2022 including Annex A for point-of-care testing, the CLSI evaluation protocols (EP05, EP06, EP09, EP15, EP17, EP28), Westgard multirule quality control.
- UK guidance: MHRA guidance on the management and use of IVD point-of-care test devices, UKAS requirements for accredited laboratories, NHS England publications, NICE guidance and the Royal College of Pathologists.
- US guidance, on pages marked United States: the CLIA regulations at 42 CFR Part 493, the CAP Point-of-Care Testing Checklist, COLA and CMS publications.
- Connectivity standards: HL7 v2, HL7 FHIR R4, CLSI POCT1-A2 and ASTM E1381 and E1394.
What they never do
- They do not give clinical advice, interpret results or suggest treatment. Where a test is discussed, the guide covers workflow, governance and connectivity only.
- They do not make performance claims about any analyser. Analytical performance belongs to the manufacturer's instructions for use and to your own verification.
- They do not invent numbers. A figure is either attributed to a named published source or left out.
- Comparison pages describe other products from those vendors' own public materials, state when something could not be confirmed, and ask you to confirm details with the vendor.
How often they are reviewed
Each guide shows its publication date and, where it has been revisited, a last-reviewed date. Guides are reviewed at least once a year, and sooner when a standard, regulation or piece of national guidance they cite changes. Vendor comparisons are reviewed when a vendor announces a material change.
Corrections
If you find an error, a claim that has gone out of date or a source we have misread, email contact@catenix.com with the page address and the point in question. Corrections are made on the page itself and the review date is updated. We would rather be told than be wrong.
What this site is
Catenix is point-of-care testing software. These guides exist because the people who buy and run that software asked the same questions on every call, and a written answer with the clause numbers in it is more useful than a sales conversation. Where a guide mentions Catenix by name it does so in one clearly marked section. Catenix does not interpret clinical results and provides no clinical decision support.