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How to Evaluate IVD Quality and Performance


In vitro diagnostics (IVD) are pivotal in modern healthcare, providing critical information influencing patient care, management, and outcomes. Ensuring the quality and performance of IVD products is essential for maintaining accurate and reliable test results, which, in turn, supports effective clinical decision-making. In this article, we will explore the various aspects of IVD quality and performance evaluation, offering guidance on essential factors to consider when selecting and using IVD products.

Understanding the Fundamentals: IVD Quality and Performance Parameters

When assessing the quality and performance of IVD products, several key parameters must be taken into account:

  • Sensitivity: Sensitivity refers to an IVD’s ability to identify true positive results correctly. A highly sensitive test will produce fewer false negatives, ensuring that individuals with the condition being tested are accurately identified.
  • Specificity: Specificity measures an IVD’s ability to identify true negative results correctly. A test with high specificity will produce fewer false positives, reducing the likelihood of unnecessary follow-up testing or treatment for individuals who do not have the condition.
  • Precision: Precision, or repeatability, assesses the consistency of results obtained from an IVD when the same sample is tested multiple times. High precision is crucial for minimizing variability and ensuring the reliability of test results.
  • Accuracy: Accuracy measures how closely an IVD’s test results align with the true value or reference standard. Accurate test results are essential for guiding appropriate clinical decisions and patient management.
  • Reportable range: The reportable range, or linear range, of an IVD, refers to the span of test values for which the assay can produce accurate and precise results. An IVD with a broad reportable range is desirable, as it can accurately detect and quantify a more comprehensive range of analyte concentrations.
  • Robustness: Robustness evaluates the ability of an IVD to maintain its performance characteristics under varying conditions, such as temperature, humidity, or sample quality. A robust IVD ensures reliable test results even when faced with minor deviations from optimal testing conditions.

Evaluating IVD Quality and Performance: A Step-by-Step Approach

To ensure the selection and use of high-quality IVD products, consider the following steps:

  • Review regulatory approvals: IVD products must undergo rigorous evaluation and receive approval from regulatory authorities, such as the US Food and Drug Administration (FDA) or the European Medicines Agency (EMA), to ensure their safety and efficacy. Reviewing the regulatory status of an IVD is a crucial first step in evaluating its quality and performance.
  • Assess validation data: Validation studies provide valuable information about an IVD’s performance characteristics, such as sensitivity, specificity, precision, and accuracy. Review the available validation data to ensure the IVD meets the performance requirements for your intended testing application.
  • Evaluate manufacturer reputation: The reputation of the IVD manufacturer can offer insights into the quality and reliability of their products. Research the manufacturer’s history, track record, and customer feedback to gauge their commitment to quality and performance.
  • Consider ease of use: An IVD’s ease of use can impact its performance, particularly in settings with limited resources or inexperienced personnel. Assess factors such as user-friendly interfaces, clear instructions, and straightforward sample preparation and analysis procedures to ensure the IVD is suitable for your testing environment.
  • Perform in-house verification: Before implementing a new IVD in your laboratory or clinical setting, it is essential to perform in-house verification to confirm its performance characteristics. This process involves testing the IVD using known positive and negative samples to assess its sensitivity, specificity, precision, and accuracy under your specific conditions.
  • Monitor ongoing performance: Regularly monitoring the performance of IVDs in your laboratory or clinical setting is crucial for maintaining quality and reliability. Establish quality control measures, such as the use of control samples and periodic calibration, to ensure the IVD continues to meet performance expectations.
  • Participate in proficiency testing programs: Proficiency testing programs provide an external assessment of your laboratory’s testing capabilities by comparing your results to those of other laboratories using the same IVD products. Participation in such programs can help identify potential performance issues and offer valuable insights into the quality and accuracy of your IVD testing.

The Importance of Rigorous IVD Evaluation

The quality and performance of IVD products significantly impact patient care and clinical decision-making. Ensuring the selection and use of high-quality IVDs requires a thorough evaluation of key performance parameters, such as sensitivity, specificity, precision, and accuracy. By reviewing regulatory approvals, assessing validation data, evaluating manufacturer reputation, considering ease of use, and performing in-house verification and ongoing performance monitoring, healthcare professionals can confidently rely on the results obtained from IVD testing.

Emphasizing the importance of rigorous IVD evaluation not only ensures the delivery of accurate and reliable test results but also safeguards patient safety and improves healthcare outcomes. As the field of in vitro diagnostics continues to evolve and expand, a steadfast commitment to quality and performance assessment will remain essential for maintaining the highest standards of patient care.


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McCudden, C. R., & Henderson, M. P. A. (2017). Verification of in vitro medical diagnostics (IVD) performance: a guide to statistical approaches. The Clinical Biochemist Reviews, 38(1), 15-34.