IVD TRIALS

Our focus is 100% on IVD

From development to post-market: with our own donation centers, lab facilities, access to Europe’s largest commercial inventory of human biospecimens, and 23 professional experts to serve you – we want to be your professional, long-lasting partner.

Performance evaluation for In vitro Diagnostics

Do you want to develop an in vitro diagnostic and bring it to market? To do so, your product must meet certain performance requirements. In Europe, for example, performance is evaluated in accordance with the European In Vitro Diagnostics Regulation 2017/746 (IVDR). It covers three areas: Scientific validity, analytical performance, and clinical performance. In addition, you must evaluate performance both before and after market launch.

SEE OUR FAQ

Scientific validity means that an analyte is associated with a specific clinical condition or physiological state (IVDR, Article 2 (38)).

Analytical performance refers to the ability that a particular analyte can be correctly detected or measured (IVDR, Article 2 (40)).

Clinical performance describes the ability to provide results that correlate with a specific clinical condition or physiological or pathological process or state (IVDR, Article 2 (41)).

Before market introduction, manufacturers must identify all available data on the product, its intended use and safety, and fill data gaps in order to assess performance. Outstanding issues require the conduct of appropriate studies (IVDR, Annex XIII, Part A, 1.2).

After a product has been launched, manufacturers should proactively collect and evaluate performance and scientific data resulting from the product’s use to ensure safety, performance, and scientific validity throughout the product’s lifetime and to identify any risks (IVDR, Annex XIII, Part B, 4).

Analytical performance studies

Analytical performance is the basis for the clinical performance of a device and focuses on the analyte. Indicators of analytical performance are typically similar or even identical across IVD devices, and a number of Clinical & Laboratory Standards Institute (CLSI) documents provide guidance. IVD TRIALS offers studies for several scenarios, including:

Endogenous and exogenous interference, e.g., CLSI EP07-A2, as well as cross-reactivity, e.g., CLSI EP07-A2

Limit of Detection (LoD) for qualitative and quantitative tests, e.g., CLSI EP17-A2, Limit of Quantification (LoQ) for quantitative tests, e.g., CLSI EP17-A2, and Limit of Blank (LoB) required for quantitative tests and not listed in the IVDR, e.g., CLSI EP17-A2

Measuring range for qualitative and quantitative tests
Linearity for qualitative and quantitative tests, e.g., CLSI EP06A
Cut-off for qualitative and quantitative tests, e.g., CLSI EP24-A2
Trueness (bias), e.g., CLSI EP06-A or CLSI EP09-A3
Precision (repeatability and reproducibility), e.g., CLSI EP05-A3
Accuracy, resulting from trueness and precisions, e.g., CLSI EP21-A
Validation of specimen collection
Hook effect for immunological tests for qualitative tests – for quantitative tests it will be already included when measuring the range
Sample stability evaluation (freeze/thaw cycles, matrices, specimen type), e.g., CLSI EP25-A
Shipping and transport stability (only accelerated study)
Shelf life (only accelerated study)
Robustness studies (flex studies)
Carry-over/cross-contamination for multiple use devices, e.g., CLSI H26-A2

Clinical performance studies

A clinical performance study focuses on the user of your product. Depending on your product, demonstrating clinical performance may require different types of studies. IVD TRIALS offers studies for several scenarios, including:

Professional use studies are standard clinical performance evaluation studies conducted in a laboratory setting to assess whether the device performs reliably and accurately in the hands of trained users. These studies simulate real-world diagnostic workflows and ensure that results meet the required performance claims when operated by qualified personnel.

Near-patient-testing or point-of-care testing means carrying out a test by healthcare professionals in hospitals or in physicians’ offices using a device in the presence of the patient without the need to send a sample to a laboratory.

Products that are to be used by laypersons for self-testing must comply with certain specifications, e.g., in terms of safety, applicability, and significance of their results.

THE VARIOUS STEPS OF YOUR STUDy

Tailor made studies

You plan to include specific age groups, sites or disease states? You have specific needs?

As one of the very few CROs, we are able to tailor a study to your exact requirements.

GET IN TOUCH SEE OUR FAQ

How we adapt to your study requirements:

together, we select the exact required donors for your prospective collection.
if needed, let’s add retrospective samples from our biospecimen warehouse to complete your study design, e.g. with cross-reactivity testing or matched sets.

Getting your ivd approved

This is our portfolio

Chose from our portfolio of performance evaluations for professional use, point-of-care (PoC) applications, near-patient testing (NPT), and layperson (self-test) studies, as well as analytical performance studies.

Infectious disease serology

Infectious disease serology involves detecting antibodies or antigens in blood to identify infections. It helps diagnose diseases like HIV, hepatitis, and syphilis by analyzing the immune response. Serological tests are valuable when direct detection of a pathogen is difficult or when monitoring immune status. We also provide HBV, HCV- and HIV-NAT samples suitable for PCR validation.

We offer robust capabilities for HBV diagnostics, combining prospective collections and an extensive biobank of well-characterized samples, as well as prospectively collect HBsAg samples from our local clinical site. Use our biobank to include a wide range of HBV samples covering all key biomarkers:

HBsAg: Featuring all major genotypes (A–H), various subtypes, and numerous clinically relevant mutations – including vaccine escape variants.
Anti-HBs: Over 100 samples from vaccinated individuals and over 100 from naturally infected persons.
Anti-HBc, HBeAg, and Anti-HBe markers are also well represented.
Samples span the full spectrum of HBV infection stages—acute, chronic, and recovered—with corresponding biomarkers available.
HBV seroconversion panels with well-characterized member samples are available, as well as HBV-NAT samples for PCR validation.

All samples are stored in a state-of-the-art warehouse at below -20°C with continuous temperature monitoring. Our local laboratory provides access to several CLIA comparator (reference) assays. As of May 2025, our team has supported over 20 clinical studies for IVDs targeting these HBV markers.

Our HCV biobank offers a rich resource of well-characterized anti-HCV samples, supporting a wide range of diagnostic studies. The collection includes all major genotypes (1–6), with detailed subtype coverage for genotype 4 (including 4a, 4b, 4d, 4f, 4k, 4r).

Samples span different stages of infection—acute, chronic, and recovered—and include well-documented seroconversion panels. All specimens are stored in a modern warehouse at below -20°C with continuous temperature monitoring to ensure sample integrity. Our local laboratory offers several CLIA comparator (reference) assays to support assay validation, and our team has successfully conducted over 10 clinical studies for IVDs targeting HCV markers as of May 2025.

Use our extensive expertise in HIV diagnostics, supported by both prospective collections and a comprehensive biobank. At a local German clinical site, our colleagues collect samples every month. In May 2025, our biobank includes over 200 HIV-2 samples from a mobile site in Burkina Faso (all subtyped) and over 700 HIV-1 samples from Cameroon (fully subtyped), covering Group O, all major CRFs (e.g., 01\_AE, 02\_AG, 11, 13, 18), and subtypes A–K. Additionally, we hold over 200 HIV-1 subtype B samples from the local European population.

The collection also includes HIV seroconversion panels, 50 well-characterized HIV-Ag samples, and 50 HIV-1 culture supernatants—readily available for testing. All samples are stored in a well-equipped warehouse at below -20°C with constant temperature monitoring. As of May 2025, we have validated 8 different HIV rapid antibody tests and 10 CLIA-based systems (HIV Ab/Ag). Our local laboratory supports validation studies with a broad portfolio of CLIA comparator and confirmatory assays.

Our syphilis biobank provides a valuable collection of well-characterized anti-Treponema pallidum (anti-TP) samples. This includes over 200 anti-TP samples from Peru with detailed infection stage documentation, as well as more than 200 additional samples sourced from Africa and Europe. All samples are securely stored at below -20°C in a modern warehouse with continuous temperature monitoring to ensure stability and integrity. Our local laboratory is equipped with both CLIA comparator (reference) and confirmatory assays to support syphilis IVD studies. As of May 2025, our expert team has successfully conducted four clinical studies involving the anti-TP marker.

Respiratory analytes

Each year, from September to March, when respiratory viruses are most prevalent in Germany, manufacturers have the opportunity to conduct prospective or retrospective studies with us. These studies cover a broad range of sample types, including positive, negative, and hospitalized patient samples, as well as cross-reactants for robust analytical validation. We provide comprehensive support for combo tests, with access to a large panel of relevant viral and bacterial cross-reactants. This includes rare strains and coronaviruses like NL63, as well as bacterial species expressing protein A and protein G.

Our team conducts prospective sample collections for influenza A and B each winter. All samples are securely stored in UTM at temperatures below -20 °C in our well-equipped warehouse, with continuous temperature monitoring ensuring sample integrity. To date, five different rapid tests have been successfully validated using these samples (as of May 2025).

Each winter season, we carry out prospective sample collections. These samples are stored in UTM at below -20 °C in our state-of-the-art warehouse, where continuous temperature monitoring ensures optimal storage conditions. Two different rapid tests have already been successfully validated using these samples (as of May 2025).

Since the initial emergence of SARS-CoV-2 in 2020, our team has conducted over 200 clinical studies for the validation of rapid tests and diagnostic devices.

Further analytes and testing services

Beyond standard diagnostics, additional analytes and testing services support broader clinical needs. These include, for example, HbA1c for diabetes monitoring, H. pylori and Strep A detection for gastrointestinal and respiratory infections, and Vitamin D testing for nutritional assessment.

We offer point-of-care (PoC) applications, near-patient testing (NPT), layperson (self-test) studies and performance evaluations for professional use including specialized services such as matched set testing (blood/serum/plasma equivalency), analysis of hospitalized patient samples, sample stability studies, and cross-reactivity validation to ensure assay reliability and clinical relevance across diverse conditions and sample types. Ask us if your parameter is not shown here.

Meet Ling Cheng – Head of China Desk

Getting your IVD approved means: “Helping our Asian customers to access different geographical markets.“

MEET OUR COLLEAGUES

Your specialized IVD Contract Research Organization (CRO)