Invited Product Profile – Cobas Liat System: CLIA-Waived PCR Analyzer for Infectious Diseases

Abstract

R espiratory tract infections are a worldwide public health problem caused by ubiquitous organisms (viruses and bacteria). Several notable pathogens that can cause respiratory infections are influenza A/B, respiratory syncytial virus (RSV), and group A streptococcus (GAS). Influenza viruses cause annual epidemics typically between November andMarch in the northern hemisphere and are responsible for 3000 to 49,000 deaths in the United States each year. Respiratory syncytial virus is the most common cause of bronchiolitis and pneumonia, with most individuals recovering in a week or two. However, RSV can be serious in infants and older adults. The majority of patients seeking care for influenza and other respiratory viruses typically present to emergency departments or other urgent care settings, where rapid diagnosis is critical. Group A streptococcus is a pervasive human-specific pathogen responsible for more than 10 million infections each year in the United States, with typical human-to-human transmission occurring via respiratory droplets or skin contact. Without proper treatment, GAS can progress into acute rheumatic fever, rheumatic heart disease, and other potentially life-threatening conditions. A significant overlap exists in the clinical manifestations of the different types of respiratory infections, making it difficult for clinicians to properly diagnose on the basis of clinical symptoms alone. In addition, the treatments are markedly different. Thus, the need for an accurate in vitro diagnostic test that health care professionals can use at the point of care to differentiate the pathogens that cause respiratory infections is paramount.