ABSTRACT
Molecular multiplex assays (MPAs) for simultaneous detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), influenza and respiratory syncytial virus (RSV) in a single RT-PCR reaction reduce time and increase efficiency to identify multiple pathogens with overlapping clinical presentation but different treatments or public health implications. Clinical performance of XpertXpress® SARS-CoV-2/Flu/RSV (Cepheid, GX), TaqPath™ COVID-19, FluA/B, RSV Combo kit (Thermo Fisher Scientific, TP), and PowerChek™ SARS-CoV-2/Influenza A&B/RSV Multiplex RT-PCR kit II (KogeneBiotech, PC) was compared to individual Standards of Care (SoC). Thirteen isolates of SARS-CoV-2, human seasonal influenza, and avian influenza served to assess limit of detection (LoD). Then, positive and negative residual nasopharyngeal specimens, collected under public health surveillance and pandemic response served for evaluation. Subsequently, comparison of effectiveness was assessed. The three MPAs confidently detect all lineages of SARS-CoV-2 and influenza viruses. MPA-LoDs vary from 1 to 2 Log10 differences from SoC depending on assay and strain. Clinical evaluation resulted in overall agreement between 97 and 100%, demonstrating a high accuracy to detect all targets. Existing differences in costs, testing burden and implementation constraints influence the choice in primary or community settings. TP, PC and GX, reliably detect SARS-CoV-2, influenza and RSV simultaneously, with reduced time-to-results and simplified workflows. MPAs have the potential to enhance diagnostics, surveillance system, and epidemic response to drive policy on prevention and control of viral respiratory infections.
ABSTRACT
Background: Molecular multiplex assays (MPAs) for simultaneous detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), influenza and respiratory syncytial virus (RSV) in a single RT-PCR reaction reduce time and increase efficiency to identify multiple pathogens with overlapping clinical presentation but different treatments or public health implications. Methods: Clinical performance of XpertXpress ® SARS-CoV-2/Flu/RSV (Cepheid, GX), TaqPath™ COVID-19, FluA/B, RSV Combo kit (Thermo Fisher Scientific, TP), and PowerChek™ SARS-CoV-2/Influenza A&B/RSV Multiplex RT-PCR kit II (KogeneBiotech, PC) was compared to individual Standards of Care (SoC). Thirteen isolates of SARS-CoV-2, human seasonal influenza, and avian influenza served to assess limit of detection (LoD). Then, positive and negative residual nasopharyngeal specimens, collected under public health surveillance and pandemic response served for evaluation. Subsequently, comparison of effectiveness was assessed. Results: The three MPAs confidently detect all lineages of SARS-CoV-2 and influenza viruses. MPA-LoDs vary from 1-2 Log10 differences from SoC depending on assay and strain. Clinical evaluation resulted in overall agreement between 97% and 100%, demonstrating a high accuracy to detect all targets. Existing differences in costs, testing burden and implementation constraints influence the choice in primary or community settings. Conclusion: TP, PC and GX, reliably detect SARS-CoV-2, influenza and RSV simultaneously, with reduced time-to-results and simplified workflows. MPAs have the potential to enhancediagnostics, surveillance system, and epidemic response to drive policy on prevention and control of viral respiratory infections. IMPORTANCE: Viral respiratory infections represent a major burden globally, weighed down by the COVID-19 pandemic, and threatened by spillover of novel zoonotic influenza viruses. Since respiratory infections share clinical presentations, identification of the causing agent for patient care and public health measures requires laboratory testing for several pathogens, including potential zoonotic spillovers. Simultaneous detection of SARS-CoV-2, influenza, and RSV in a single RT-PCR accelerates time from sampling to diagnosis, preserve consumables, and streamline human resources to respond to other endemic or emerging pathogens. Multiplex assays have the potential to sustain and even expand surveillance systems, can utilize capacity/capability developed during the COVID-19 pandemic worldwide, thereby strengthening epidemic/pandemic preparedness, prevention, and response.
ABSTRACT
BACKGROUND: Obstetric infections are the third most common cause of maternal mortality, with the largest burden in low and middle-income countries (LMICs). We analyzed causes of infection-related maternal deaths and near-miss identified contributing factors and generated suggested actions for quality of care improvement. METHOD: An international, virtual confidential enquiry was conducted for maternal deaths and near-miss cases that occurred in 15 health facilities in 11 LMICs reporting at least one death within the GLOSS study. Facility medical records and local review committee documents containing information on maternal characteristics, timing and chain of events, case management, outcomes, and facility characteristics were summarized into a case report for each woman and reviewed by an international external review committee. Modifiable factors were identified and suggested actions were organized using the three delays framework. RESULTS: Thirteen infection-related maternal deaths and 19 near-miss cases were reviewed in 20 virtual meetings by an international external review committee. Of 151 modifiable factors identified during the review, delays in receiving care contributed to 71/85 modifiable factors in maternal deaths and 55/66 modifiable factors in near-miss cases. Delays in reaching a GLOSS facility contributed to 5/85 and 1/66 modifiable factors for maternal deaths and near-miss cases, respectively. Two modifiable factors in maternal deaths were related to delays in the decision to seek care compared to three modifiable factors in near-miss cases. Suboptimal use of antibiotics, missing microbiological culture and other laboratory results, incorrect working diagnosis, and infrequent monitoring during admission were the main contributors to care delays among both maternal deaths and near-miss cases. Local facility audits were conducted for 2/13 maternal deaths and 0/19 near-miss cases. Based on the review findings, the external review committee recommended actions to improve the prevention and management of maternal infections. CONCLUSION: Prompt recognition and treatment of the infection remain critical addressable gaps in the provision of high-quality care to prevent and manage infection-related severe maternal outcomes in LMICs. Poor uptake of maternal death and near-miss reviews suggests missed learning opportunities by facility teams. Virtual platforms offer a feasible solution to improve routine adoption of confidential maternal death and near-miss reviews locally.
