The timeframe within which an over-the-counter (OTC) COVID-19 test remains reliable for use is not fixed. Manufacturers assign an initial period of validity based on stability data. However, this designated period can be prolonged following further evaluation that demonstrates the test’s continued accuracy beyond the original expiry date. Such an extension signifies that scientific evidence supports the ongoing efficacy of the test kit.
Extending the usability period of these diagnostic tools is particularly important during periods of high demand or supply chain constraints. It ensures that existing test kits do not go to waste unnecessarily, thereby maximizing available resources. This practice also reduces potential disruptions in testing availability and can help to maintain public health surveillance efforts. Regulatory agencies, such as the FDA, play a crucial role in reviewing data submitted by manufacturers to determine whether extensions are warranted, thereby safeguarding the publics trust in test reliability.