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Credibility

FAQ

Credibility

Homed-IQ is committed to transparency and providing the highest quality home medical testing services.
Read more about the validation process of home health tests, the credibility of our labs, and the interpretation of test results here.

Laboratory

Test Validation

Test Results

Laboratory

Homed-IQ works with certified partner laboratories to analyse our test samples. The laboratories that process our tests are ISO 15189 and DAkkS accredited. These labs comply with all EU regulations regarding laboratory diagnostics in addition to performing frequent internal quality checks and testing. ISO 15189 certified laboratories must also undergo regular inspections validating the accuracy of their testing. These laboratories do not only work with Homed-IQ- they process hundreds of thousands of samples each year for doctors, clinics, universities, and governments. 

*The laboratories that analyze Homed-IQ test samples are ISO 15189 accredited. The only test performed in a non-ISO accredited laboratory is the Allergy Test. This test is performed in a smaller laboratory that is compliant to the Guidelines of the German Federal Medical Council (RiLiBÄK 2019). 

Homed-IQ partners with some of the most prominent certified labs in the EU that conduct specialty medical diagnostics. These labs perform regular quality assurance testing and are the same labs many physicians use to perform their diagnostics. All tests that Homed-IQ offers have been validated by these laboratories to be suitable for home use. If you want to find out more about their validation processes, please contact us at [email protected] .

Homed-IQ offers at-home health testing that has been verified to be just as accurate as tests you receive at a doctor’s office or clinic. All of the at-home sample collection testing we offer has been thoroughly validated against traditional testing methods as conducted in doctor’s offices and clinics. That data is reviewed and approved by the certified Laboratory Director at each lab in our network and the Homed-IQ Medical Support Team.

Variation in test results is normal between labs, and is even possible within repeat tests in the same lab. However, all labs that Homed-IQ works with must demonstrate that their results meet a certain standard to ensure an acceptable level of precision with their reporting. While we have ensured that all of our partner laboratories meet and/or exceed the minimum standard for acceptable variation, you will always see a certain degree of variation in results between different labs. Variation between test results does not mean the overall interpretation has changed.

Test Validation

The testing equipment used by our partner laboratories are comparable to—and often the same as—those used by a doctor or blood collection clinic. Homed-IQ only sells home tests that have been validated to provide results comparable to samples taken in a doctor’s office or blood collection clinic. This means all medical diagnostics offered by Homed-IQ’s partner laboratories are comparable in quality to tests you would get from a doctor. 

Before a test traditionally performed in a clinical setting can be sold for home use, it must undergo extensive testing. This testing checks that samples taken using self-sampling methods (finger prick Dried Blood Spot or capillary samples) yield comparable results to samples taken using clinical blood sampling methods, which is usually a venous (vein) blood draw. To test this, several test subjects provide a sample of venous blood as well as the collection method being tested. Laboratory scientists then analyse the samples and check how different the two samples are from each other. All tests approved for home sample collection use show a high level of correlation between venous samples collected in a clinical setting, and samples collected using self-sampling methods.

In addition to checking that the results from a home sample are similar to venous lab samples, test validation often also includes stability testing. This involves allowing the samples to sit for several days before analysis, mimicking the conditions that occur when a user collects the sample and mails it to the lab. Different temperatures and storage conditions may be tested to establish how long a sample can sit before analysis without compromising the test results. In order to pass scientific validation, home tests must show they are highly correlated with laboratory venous samples after several days of transport time.

Although both samples are collected at home, rapid health tests are less reliable than a self-sampling test certified by a laboratory. This is because laboratory analysis can provide more information not available with a rapid test. Laboratory analysis can detect if there is an error with the sample and performs follow-up testing to confirm positive or abnormal test results. Rapid tests, lacking additional testing, rely on user interpretation, which increases the risk of error. Rapid home tests also require additional testing by a doctor to confirm the results. The test results from Homed-IQ include a downloadable laboratory report that can be presented directly to your doctor. However, in some cases, your doctor may request confirmatory testing, such as following a positive HIV test result.

Test Results

In most cases, tests that use the same test method and sample type but are conducted in different laboratories will have very similar results, but not exactly the same. This is expected because each laboratory establishes its own reference ranges and individually calibrates their equipment. Reference ranges are the span of measured values in which patient samples are considered normal and/or abnormal. Before offering a test for home use, Homed-IQ’s partner laboratories check the test’s validity by testing multiple samples and ensuring the results are not outside the acceptable range set by German/EU guidelines. 

Many health tests can be tested using different sample types, or a different testing method. If the sample type and/or the test method differ from your Homed-IQ test, you may notice that the result values are different. 

Sample types

Many, if not most, testing methods performed in doctor’s offices or clinics use a venous (vein) blood draw for their samples. This requires customers to visit a blood draw facility and trained phlebotomy staff to draw a blood sample. Venous blood draws may yield blood, serum, or plasma. Of these, serum is most frequently required for testing. Serum and other sample types may not yield the same values on the same test. One common reason is that serum contains protein that can bind to many substances, and this may interfere with measurements. Furthermore, samples collected using different collection methods may yield different results. For example, a serum sample collected from a venous blood draw could show slightly different results than a serum sample obtained from a Dried Blood Spot test. This is due to differences in where the sample is collected from, how it is stored, and how the sample is prepared. However, the results should be comparable.

Test methods

There are many tests used to measure the same analytes. An analyte is the material being tested. For example, cholesterol is the analyte in a cholesterol test from a serum sample. Cholesterol in serum may be measured by immunoassay or by spectrophotometry, two different test methods. The two results may not be directly comparable, because they come from two different tests. However, the reference ranges for the two tests should yield the same diagnosis from an individual, and Homed-IQ’s partner laboratories operate under certifications that ensure the test is operating as intended and can be used for self-sampling. If your test results differ significantly, consider first whether the sample type and test methods are really the same. 

Homed-IQ always recommends that you discuss your test results with your doctor if you have any questions or concerns. All Homed-IQ test results come with a downloadable laboratory report that you can bring to your doctor for further evaluation and discussion. 

While Homed-IQ tests provide information about specific health markers, they are not intended to diagnose a medical condition. Formal diagnosis and treatment recommendations should always be made by a physician upon seeing your test results or performing follow-up testing.

All medical tests, even those performed by a doctor or in a blood collection clinic, have a chance of a false positive or negative test result. With many tests, this chance is very small. All Homed-IQ tests have a defined sensitivity and specificity. Sensitivity is the ability of a test to correctly designate an individual with a disease or condition as positive. Specificity is the ability of a test to correctly designate an individual without a disease or condition as negative. For more information on the sensitivity and specificity of Homed-IQ tests, contact us.  

Do you have more questions about our test validation process, test results, or partner laboratories?
Send us a message. We are happy to answer your questions.
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