Homed-IQ - Laboratory

Table of Contents

• Our Partner Laboratories
• How do I know if a laboratory is accredited?
• What is the process of an accreditation?
• Do laboratories use different reference ranges?
• Can results vary within a sample?
• Can results be false positive or false negative?
• Can I trust a home test sample?
• Commitment to Confidentiality

Our Partner Laboratories

At Homed-IQ we work with certified laboratories that meet the highest international standards for medical testing and diagnostics. 

The Deutsche Akkreditierungsstelle (DAkkS) is the national accreditation body in Germany. It acts in the interests of the state, the economy, society and the environment. In order to perform tests in laboratories, the laboratory must be accredited by the DAkkS to operate in Germany.

Furthermore, laboratories must also comply with ISO/IEC 17025 and typically also require ISO 15189. 

• ISO/IEC 17025: Focuses on general requirements for the competence of testing and calibration laboratories, ensuring valid results. It covers management system requirements, technical competence, equipment calibration, and result traceability. 
• ISO 15189: Specifically for medical laboratories, it combines quality and technical requirements for accurate diagnostics, patient safety, staff competence, and effective processes tailored to healthcare needs. 

Our laboratories are DAkkS-accredited, and meet the requirements of ISO/IEC 17025 and ISO 15189. The only exception is the allergy test, which is carried out in a smaller laboratory that follows the guidelines of the German Medical Association (RiLiBÄK 2019) instead of ISO accreditation.

This ensures that every sample is handled with precision and care, providing trustworthy results to help you make informed health decisions. 

How do I know if a laboratory is accredited?

• Want to know more about who is ISO/IEC 17025 verified? Visit the DAkkS database.
• Want to know more about who is ISO 15189 verified? Visit the DAkkS database .

What is the process of an accreditation?

The tests from Homed-IQ are conducted in laboratories accredited by DAkkS, ensuring compliance with stringent standards such as ISO/IEC 17025 or ISO 15189. These laboratories undergo:

• Application: Submit required documents to DAkkS.
• Assessment: Experts review documents and visit the site to check compliance with standards.
• Decision: DAkkS decides if accreditation is granted.
• Monitoring: Regular checks, including onsite visits to the laboratory, ensure ongoing compliance.

Source: Deutsche Akkreditierungsstelle, n.d.

Do laboratories use different reference ranges?

A reference range is the normal range of values for a lab test based on healthy people. It helps doctors see if your results are typical or if there may be a health problem – values outside the range can indicate potential health problems, but need to be assessed in the context of your medical history and lifestyle.

Laboratories may use different reference ranges. These ranges are dependent on, for example, test methods, equipment, and reagents. When interpreting your results, check which reference range applies to your particular laboratory and you will be able to interpret your result accurately.

Can results vary within a sample?

Yes, it is possible for variation to occur within samples. However, correct sample collection, storage, and analytic techniques can minimize the impact of this on the validity of test results. Some possible variations may occur due to:

Before the test (preanalytical factors):

• Sample collection: If a sample is collected incorrectly (e.g. using the wrong container or method) or mixed incorrectly, test results may be inconsistent.
• Storage conditions: Samples can deteriorate if stored at the wrong temperature or if transport is delayed.
• Natural variation: Some markers change naturally during the day (e.g. iron levels can vary by 30-50%) or due to stress.
• Lifestyle factors: What you eat or drink (such as caffeine or alcohol), medication or whether you have fasted can all affect test results.

During the test (analytical variation):

• Equipment limitations: Even when testing the same sample, there can be slight variations due to differences in laboratory equipment or methods.
• Interpretation of changes: Laboratories use a calculation (Reference Change Value, RCV) to determine whether a change in results is meaningful or just natural variation.

Source: Pradhan, S., Gautam, K., & Pant, V. , 2022

Can results be false positive or false negative? 

Yes, test results can be false positive (a condition is mistakenly detected) or false negative (a condition is missed). This depends on the sensitivity (ability to detect true positives) and specificity (ability to exclude false positives) of the test. Every laboratory test carries a risk of false positives or negatives, regardless of the provider. All Homed-IQ tests have high sensitivity and specificity, ensuring reliable results.

Can I trust a home test sample?

Homed-IQ tests are conducted in the same certified, high quality laboratories as a doctor’s test, but the sample is collected at home for added convenience. All home tests are scientifically validated to be comparable or equal in quality to tests performed in a clinical setting. We only sell tests that have been thoroughly validated. The following table shows the key similarities between a Homed-IQ test and a doctor’s test:

Commitment to Confidentiality

At Homed-IQ, your privacy is our top priority. We are fully committed to protecting your personal information and ensuring that your test results remain confidential. Your data is handled securely and in accordance with strict data protection regulations, including GDPR. When you submit an STI sample, is anonymised before analysis, so your identity is never directly linked to the testing process. When your results are ready, they are delivered to you via a secure online platform. This ensures that you can review your results privately and with complete peace of mind, knowing that your confidentiality is fully protected every step of the way.