Pandemic Testing: How Can Laboratories Prevent Errors?

Why does laboratory quality matter for pandemic preparedness?

Access to diagnostic tests featured in WHO's May 2024 update on pandemic agreement negotiations. That announcement was a historical milestone: the World Health Assembly subsequently adopted the WHO Pandemic Agreement on May 20, 2025. Article 6 of the adopted text addresses laboratory and diagnostic capacity, including relevant standards, protocols and participation in laboratory networks. These provisions recognize that preparedness depends partly on the services that turn a patient's sample into usable medical information. [WHO's 2024 negotiations update](https://www.who.int/news/item/10-05-2024-governments-agree-to-continue-their-steady-progress-on-proposed-pandemic-agreement-ahead-of-the-world-health-assembly). [Adopted WHO Pandemic Agreement](https://apps.who.int/gb/ebwha/pdf_files/WHA78/A78_R1-en.pdf).

WHO's laboratory guidance connects testing quality directly with treatment, prevention and disease control. It describes three stages requiring oversight: the work before a sample is analyzed, the analysis itself and the reporting that follows. Internal quality controls, proficiency testing and continuous improvement address different parts of this process. The practical implication is that purchasing additional testing machines cannot, by itself, establish a reliable diagnostic service; quality management must accompany expanded capacity. [WHO external quality assessment manual](https://www.who.int/publications/i/item/9789241549677).

How can an infection test produce a misleading result?

A laboratory result depends on several linked steps. WHO's examples of quality indicators include correct patient identification, appropriate sample containers, collection timing, sample integrity, transportation and storage. After analysis, reporting accuracy and delivery time also matter. These indicators illustrate why an assessment of testing performance must examine what happens around the instrument: a sample linked to the wrong patient or a report delivered too late can compromise the usefulness of otherwise accurate analysis. [WHO laboratory quality indicators](https://extranet.who.int/hslp/who-hslp-download/package/501/material/291).

A negative result does not necessarily mean that a laboratory made a mistake or that infection is absent. COVID-19 provides a familiar example. CDC explains that a test may be negative before the virus reaches detectable levels, and antigen tests are generally less sensitive than nucleic acid amplification tests, including PCR. Results therefore need interpretation alongside symptoms, timing and the test used. CDC advises following the recommended repeat-testing instructions after a negative antigen result. This is a limitation of detection and timing, separate from preventable failures in laboratory practice. [CDC guidance on COVID-19 testing](https://www.cdc.gov/covid/testing/).

How can health services make outbreak testing more reliable?

WHO describes a laboratory quality framework with 12 essential elements. Its separate toolkit for testing outside laboratories adapts that framework into six pillars covering organization, workforce, supplies, process assessment, information management and monitoring product performance after distribution. That toolkit specifically focuses on rapid serological tests such as those for HIV, viral hepatitis and syphilis; it is not a universal testing protocol for every emerging infection. Its broader relevance is organizational: expanding access requires a plan for maintaining quality at every testing location. [WHO quality management toolkit](https://www.who.int/tools/quality-management-system-for-non-laboratory-settings).

Independent assessment adds another safeguard. WHO defines external quality assessment as comparing a laboratory's performance with an outside source, such as a reference laboratory or a group of laboratories. This can reveal performance problems that require investigation and corrective action. Alongside those comparisons, services can monitor sample integrity, reporting accuracy and turnaround times using WHO's quality indicators. Together, these measures provide a more informative assessment of readiness than the number of tests performed alone; they examine whether results are dependable and reach care teams when needed. [WHO explanation of external quality assessment](https://www.who.int/publications/m/item/overview-of-external-quality-assessment-eqa). [WHO laboratory quality indicators](https://extranet.who.int/hslp/who-hslp-download/package/501/material/291).