WHN Statement on COVID-19 Testing Access and Regulatory Approval

Ensuring Global Access to Reliable COVID-19 Testing

The World Health Network (WHN) is committed to advocating for accessible, reliable, and high-quality COVID-19 testing worldwide. As new technologies emerge to enhance testing accuracy and usability, it is essential that regulatory processes keep pace with public health needs.

One such innovation is the PlusLife COVID-19 test, which has been approved in Germany and is actively used by individuals seeking reliable testing solutions. A key component of its success is a community-developed app that enhances at-home testing by providing real-time tracking of test progress, allowing users to better interpret their results. This effort demonstrates the power of community-driven innovation in pandemic response, ensuring that individuals can make informed health decisions based on precise and timely data. By displaying the time course of the testing process, the app provides additional insights that help users monitor their health and take necessary precautions to prevent transmission.

The Importance of PCR, LAMP, and Antigen Testing

Polymerase Chain Reaction (PCR) and Loop-mediated Isothermal Amplification (LAMP) tests are widely recognized for their high accuracy in detecting COVID-19. These molecular tests are highly sensitive and play a critical role in identifying infections early, even in asymptomatic individuals. Ensuring broad access to these types of tests is crucial for public health and individual safety.

Several molecular home testing options are currently available, including:

• Lucira – A home-based molecular test approved in the U.S. that provides PCR-level accuracy and is available for approximately $42 per test.
• Metrix – A home-based molecular test approved in the U.S. that costs $25 per test, requiring a separately purchased reusable reader for $50.
• PlusLife – A home-based molecular test approved in Germany that costs about $11 per test, requiring a separately purchased reusable reader for $250.

These differences highlight the varying cost structures for home-based molecular testing, with some requiring initial investments in reusable readers while others offer standalone tests at a higher per-test price. Other regions may have similar high-accuracy molecular testing solutions, and WHN encourages further global adoption of these technologies to strengthen diagnostic capabilities.

The PlusLife app represents a community-driven effort to improve public health by making at-home testing more accessible and understandable. Such initiatives, driven by expertise and dedication, play a vital role in pandemic response. While molecular tests provide a high degree of accuracy, additional tools—such as this app—are essential in ensuring test results are properly interpreted and used effectively.

In addition to these molecular tests, there are also Antigen tests, also known as Rapid Antigen Tests (RATs). While antigen tests were historically considered faster due to older PCR processing times, modern PCR and LAMP tests can now deliver results within a similar timeframe. Their accuracy is not as high as PCR or LAMP tests and decreases unless they are updated to match the currently circulating variant(s) at the time of testing.

Advocating for Expedited Review and Global Access

Given the ongoing risks associated with COVID-19 and the limitations of testing availability in many regions, WHN calls on regulatory bodies worldwide, including in the United States, to expedite the review and approval of high-quality COVID-19 tests like PlusLife. Expanding access to reliable testing remains a cornerstone of effective public health policy, allowing individuals and communities to make informed decisions about their health and safety.

To ensure responsible use, WHN encourages individuals to adhere to the regulatory guidelines in their respective countries while advocating for greater accessibility of advanced testing methods. Regulatory agencies play a crucial role in verifying the efficacy and safety of medical technologies, and WHN urges them to prioritize public health by streamlining approval processes for proven testing tools.

A Commitment to Public Health and Science

WHN remains dedicated to supporting science-based public health measures that empower individuals with the information they need to protect themselves and their communities. We will continue to advocate for policies that facilitate broad access to effective testing, recognizing the importance of timely and accurate diagnostic tools in controlling the spread of infectious diseases.

For more information about WHN’s work in pandemic response and public health advocacy, visit whn.global.

WHN supports the availability of reliable COVID-19 testing and encourages regulatory bodies worldwide to review and approve high-quality testing solutions, including PlusLife, to ensure individuals have access to the tools they need to protect public health.