Point-of-care tests are diagnostic tests performed near the patient or clinical setting, allowing faster results and quicker decision-making.

Rapid diagnostic tests are evaluated primarily by sensitivity and specificity. Sensitivity measures the test’s ability to correctly identify individuals with the disease, while specificity measures its ability to correctly identify those without the disease. High sensitivity reduces false negatives, and high specificity reduces false positives, both of which are crucial for correct diagnosis and treatment decisions

Results from rapid diagnostic tests are usually available within 10 to 30 minutes after the sample has been collected. Molecular rapid tests take a slightly longer time but are still much faster than conventional laboratory tests.

The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating the UK medical devices market.

This guidance provides information on the UK system, including for:

• getting your device certified
• conformity marking your device
• registering your device with the MHRA

Yes, This will be stated above on each product page.

The CE mark(Conformité Européenne) is a certification that confirms a medical device complies with EU regulations. It demonstrates that the device has undergone a conformity assessment, which may include audits of the manufacturer’s quality system, review of technical documentation, and clinical evaluation depending on the device class. Medical devices are regulated under the EU Medical Device Regulation (MDR, EU 2017/745), which sets strict requirements for safety, performance, and labelling

Yes, this will be stated above on each product page.

The U.S. Food and Drug Administration (FDA) oversees the sale, distribution, and monitoring of medical devices in the United States, ensuring that devices are safe with quality and effective for their intended use.

Yes, this will be stated above on each product page.