Caregivers expect point-of-care testing (POCT) to be fast and accurate. And, while manufacturers design their POCTs with these goals in mind, real-world testing often defeats the purpose of the best designed POCT system or device. This talk will present real-world vignettes of POCT, highlighting the impact of non-laboratory test personnel, patient care time pressures, and less than orderly environments on POCT devices, their performance, and quality of test results. Suggestions for improved POCT design based on these known real-world pitfalls will be presented.

Point-of-care testing (POCT) is universal in modern healthcare. New and innovative technologies permit diagnostic tests to leave the confines of the centralized laboratory and migrate to the site of patient care. Unfortunately, the excitement of this technology is often lost due to an assortment of practical obstacles. Many of these challenges will be discussed and practical solutions will be offered.

Qorvo Biotechnologies OMNIA^TM platform creates a paradigm shift in point of need testing. By combining novel multi-GHz bulk acoustic wave detection arrays with microfluidics and electronics integration, centralized lab results at the true point of need are enabled. Dual-use capability across both Immunoassays and Molecular Dx make this a truly universal platform, not only to address gaps in traditional markets but also for high sensitivity and specificity COVID antibody and antigen assays.

Point-of-care testing is laboratory testing conducted close to the site of patient care. As tests migrate out of the laboratory, devices are subject to environmental extremes and operator variation that can impact patient results. Errors with point-of-care testing can come from a number of sources, including the instrument, the operator, the reagent, and the environment. Staff need to be cognizant of the probability for error and take actions to prevent and detect errors before they affect results and patient care. Risk management steps through the testing process detecting potential sources for error, then acts through training, maintenance, or the addition of control processes to minimize the potential for errors. This presentation will discuss the common sources of POCT error, describe how manufacturers are engineering their products to prevent errors, and will identify ways that institutions can design their quality control programs to minimize error.

IQCP provides laboratories with flexibility in customizing quality control (QC) policies and procedures for non-waived testing, based on the test systems in use and the unique aspects of each laboratory. IQCP is voluntary. Laboratories can achieve compliance by following manufacturer’s guidelines and all CLIA QC regulations as written. If those guidelines are less stringent than CLIA, or if the manufacturer does not provide guidelines, the laboratory must implement an IQCP.

Test operators in the CLIA-waived environment often have limited laboratory experience.  Instruments used in these areas should be equipped with failsafes to prevent the instrument from delivering bad test results. Failsafes can block the release of test results when there is operator error, humidity/temperature failures, or interfering substances. This presentation reviews common failsafes and highlights new design opportunities for manufacturers preparing for CLIA waiver.

Home-use tests can increase access to testing, safeguard privacy, empower individuals to take control of their healthcare decisions, and protect public health. However, these benefits come with significant risks and challenges, including how to demonstrate that the benefits outweigh the risks, how to address the need for infectious disease reporting, and post-market surveillance. This talk will describe how regulators deal with such issues to bring home-use tests to market.

The iwantthekit (IWTK) program offers internet-requested kits for home collection for screening of common STI. Other programs exist. We will discuss innovation programs and acceptability for home collection, and we will review published programs. Many studies reported use of and willingness to use home collection when available. There was willingness to pay an average of $10-30. User satisfaction was high for home collection.

Currently at-home testing is available in many formats including glucose, urine pregnancy, drug screens, HIV, STI’s and Strep A testing. There are manufacturers who provide the consumer with access to physician care for positive tests and some may even benefit surveillance studies by reporting to local health departments. The ability to give access to testing for those patient populations that may be underserved or underinsured also weigh heavily in the debate of OTC self-testing. Though many arguments support the use of consumer OTC self-testing, there are still some concerns from a quality assurance perspective from the medical technologist who currently oversee point of care testing in the health care setting. In this session, we will discuss some of those concerns from the point of care coordinator’s point of view.

Increasingly, we observe the adverse personal, societal, economic, and cultural impact of outbreaks, antimicrobial resistance, and disasters. Nations are not prepared! POC strategies can mitigate risk, reduce harm, and improve crisis standards of care. Global solutions integrate national POCT policy and guidelines, and distribute financial burden and reasonable business models.

Rapid, accurate, and affordable point-of-care (POC) diagnostics are key to detecting and subsequently mitigating the impact of disease outbreaks, particularly for emerging pathogens. Molecular approaches to detection offer speed, sensitivity, and specificity, but can introduce complexity and expense, making it difficult to achieve a POC diagnostic suitable for use outside a clinical setting. This talk will review the current state of the art for molecular diagnostics and examine the path forward to deployable POC diagnostics for outbreak settings, including some of the challenges being undertaken today.

High-quality recombinant SARS-CoV-2 antigens and antibodies are key reagents in the development of SARS-CoV-2 serological test kits. ACROBiosystems has developed a series of SARS-CoV-2 antigen and antibody products that can be used in serological tests.