UC Davis

Whether treating an influenza-like illness or tending to a critical patient, laboratory testing is essential for making the correct medical diagnosis and corresponding decisions. According to the CDC providers rely on laboratory results in 70% of cases to aid in patient diagnoses and treatment. The provider having accurate, timely, and clearly communicated results is essential to patient treatment and patient safety. Information technology (IT) and other criteria for Point-of-Care (POC) testing include that there be fast turnaround times (TAT), ease of use, portability, robustness, and high sensitivity and specificity. The Covid-19 pandemic and other epidemics have brought to the forefront the urgent and growing need for POC testing. The development of new assays and emerging technologies, such as lateral flow immunoassays (LFIA), reverse transcription polymerase chain reaction (RT-PCR), quantitative PCR (qPCR), RT-qPCR, multiplexed point-of-care testing (xPOCT), and lab-on-a-chip (LoC) technology, has allowed companies to provide waived testing kits and other handheld or small footprint analyzers while keeping costs low and allows for testing to be done in the presence of the patient. However, the extent to which POC testing in healthcare is done in compliance with and/or adherence to laboratory regulatory and health informatics implementation standards is not well known and few studies have addressed this phenomenon in context. Therefore, the purpose of this study is focused on how point-of-care testing is currently implemented in healthcare in compliance with regulatory and implementation standards. The study is conducted with systematic narrative review methodology following PRISMA (preferred reporting items for systematic review and meta-analysis) criteria.