What is the primary goal of regulatory oversight for POCT?

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The primary goal of regulatory oversight for Point-of-Care Testing (POCT) is to ensure quality and accuracy in testing. This oversight is essential because POCT is often conducted outside of traditional laboratory settings, which can lead to variations in test performance. Regulatory bodies are tasked with establishing standards and requirements to verify that devices used in POCT deliver reliable, accurate results. This ensures that health care providers and patients can trust the outcomes of tests performed, which is vital for effective diagnosis and treatment.

The emphasis on quality and accuracy helps to prevent errors that could arise from improper testing procedures, inadequate training, or faulty devices. By enforcing regulations, agencies aim to safeguard patient health and improve health care outcomes. This focus on maintaining high standards is crucial for the acceptance and integration of POCT into clinical practice.

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