Reliability
Reliable remote diagnostics so you can be sure of a correct result: ISO 15189-certified examination, authorisation of results by our medical microbiologist and documented processes. Read all about the reliability of our tests!
Reliable remote diagnostics so you can be sure of a correct result: ISO 15189-certified examination, authorisation of results by our medical microbiologist and documented processes. Read all about the reliability of our tests!
Product
Our tests fall under the so-called ‘medical devices for in-vitro diagnostics’ (IVD). Samples taken from the human body (e.g. blood or urine) are examined outside the body. Other well-known examples of IVDs are blood glucose meters, pregnancy tests, and urine tests.
All our products are compliant with the requirements of the IVD Directive 98/79/EC and are CE-certified. This ensures that our tests are safe to use and meet the requirements of the European Union. In addition, the functioning of the tests and the technical documentation are recorded in a technical file that is checked by the Inspectorate for Health and Youth Care. The statutory guarantee applies to all our products.
Declaration of conformity
The declaration of conformity is a document on which the legality of a CE marking is based. The purpose of this declaration is to provide assurance on the conformity of the product concerned and that it meets specific requirements. But also to clarify who is responsible for this conformity. The declaration of conformity must be based on the results of research, following guidelines and correct documentation. View our declaration of conformity.
Laboratory
Testalize.me offers the same reliable test as your GP or municipal health service. The analyses are performed by Diagnostiek voor U in Eindhoven. This GP laboratory is ISO-15189-accredited. Analyses are performed on the Hologic platform using the PCR technique. This guarantees the correct result. The results are authorised by a microbiologist. The microbiologist bears ultimate medical responsibility.
Tip: The technology behind our tests is explained in this virtual lab.
Sensitivity & specificity
Tabel 1: Test results of the Aptima comboTM 2 assay, Hologic. AW-20535-001 Rev.004. AW-17946 rev. 002.
Aptima CV/TV Assay 9 AW-18812-001 Rev. 004 en Aptima BV Assay 26 AW-18811-1501 Herz. 003
| Sensitivity* | Specificity* | |
|---|---|---|
| Chlamydia (swab) | 97,2% | 98,5% |
| Chlamydia (urine) | 95,2% | 99,8% |
| Gonorrhea (swab) | 97,7% | 99,6% |
| Gonorrhea (urine) | 98,7% | 99,7% |
| Mycoplasma (swab) | 98,9% | 98,5% |
| Mycoplasma (urine) | 90,9% | 99,4% |
| Bacteriële Vaginose (swab) | 98,1% | 85,1% |
| Trichomonas Vaginalis (swab) | 97,0% | 98,4% |
| Candida Species (swab) | 90,7% | 91,2% |
| Candida Glabrata (swab) | 91,2% | 99,2% |
*95% confidence interval
The sensitivity of a test describes how many percent of people with an actual Chlamydia, Gonorrhoea or Mycoplasma infection actually test positive in the assay used. The higher the sensitivity, the better the test detects people with a Chlamydia, Gonorrhoea or Mycoplasma infection. The lower the sensitivity of a test, the greater the chance that people will get a false negative result when they, in fact, do have an infection.
The specificity says something about how specific a test result is, in other words, that a positive result is indeed caused by someone who indeed has a Chlamydia, Gonorrhoea or Mycoplasma infection. And that the result is not falsely positive because the test measures something other than Chlamydia, Gonorrhoea or Mycoplasma (false positive result). The higher the specificity, the better the test correctly generates positive and negative results. The lower the specificity, the greater the chance that people will receive a false positive result.
The best tests have a sensitivity and specificity of 100% but in reality, this is almost impossible. This means the sensitivity and specificity are usually below, but close to, 100%.
Packaging
Your body material is also shipped safely. Body material is packaged airtight and watertight. Moreover, our return box can take a beating. All this to keep your sample undamaged and stable during transport.
Our packaging is tested and approved by the Belgian Packaging Institute (IBE-BVI). This means the return box is approved by PostNL and Deutsche Post as medical post (P650).
IT
Anonymous testing is only possible by focusing on IT. For example, we do not use name and address details, but codes. These codes serve as identification. Test codes are encrypted (hashing) by testalize.me making them impossible to guess by patients (non-sequential test codes). This is for follow-up treatment in the event of a positive result, for example.
The code and results system is secured. Our IT is ISO 27001-certified. Connections are SSL-secured and customer data is automatically removed from our system after 14 days (this can also be done earlier on request). We also have dedicated managed hosting (ISO27001 and NEN7510-certified) with 24/7 server monitoring.
- Results are sent in HL7 v2 standard (Health Level 7)
- The connection between the lab and testalize.me is VPN-based and exclusive
- Data transmission runs via TCP/IP
- Our HL7 server and CRM server are separated