Molecular detection and point-of-care testing in Ebola virus disease and other threats: a new global public health framework to stop outbreaks.

Ultrahigh sensitivity and specificity assays that detect Ebola virus disease or other highly contagious and deadly diseases quickly and successfully upstream in Spatial Care Paths™ can stop outbreaks from escalating into devastating epidemics ravaging communities locally and countries globally. Even had the WHO and CDC responded more quickly and not misjudged the dissemination of Ebola in West Africa and other world regions, mobile rapid diagnostics were, and still are, not readily available for immediate and definitive diagnosis, a stunning strategic flaw that needs correcting worldwide. This article strategizes point-of-care testing for diagnosis, triage, monitoring, recovery and stopping outbreaks in the USA and other countries; reviews Ebola molecular diagnostics, summarizes USA FDA emergency use authorizations and documents why they should not be stop-gaps; and reduces community risk from internal and external infectious disease threats by enabling public health at points of need.

The Ebola Spatial Care Path™: Accelerating point-of-care diagnosis, decision making, and community resilience in outbreaks.

OBJECTIVES: To present a vision where point-of-care testing (POCT) accelerates an Ebola Spatial Care Path™ (SCP) and future molecular diagnostics enable facilitated-access self-testing (FAST POC); to design an alternate care facility (ACF) for the SCP; to innovate an Ebola diagnostic center (DC); and to propel rapid POCT to the frontline to create resilience that stops future outbreaks. DESIGN: PubMed, literature, and web searches. Centers for Disease Control and Prevention (CDC), Food and Drug Administration (FDA), Medicine Without Frontiers, and World Health Organization (WHO) document analyses. Investigations in China, the Philippines, Thailand, and the United States. Review of SE Asia, US, and West Africa isolation-treatment centers. Innovation of a SCP, ACF, and DC suitable for American and other communities. OUTCOMES: The authors designed an ACF and DC to integrate SCP principles for urgent Ebola care. FDA emergency use authorizations for Ebola molecular diagnostics were discovered, but no portable, handheld, or self-contained molecular POC instruments are yet available, although feasible. The WHO initiated design criteria and an acceptance protocol for testing. Financial investment in POCT will downsize Ebola outbreaks. CONCLUSIONS: POCT is facilitating global health. Now, global health problems are elevating POCT to new levels of importance for accelerating diagnosis and evidence-based decision making during disease outbreaks. Authorities concur that rapid diagnosis has potential to stop disease spread. With embedded POCT, strategic SCPs planned by communities fulfill CDC recommendations. POC devices should consolidate multiplex test clusters supporting patients with Ebola in isolation. The ultimate future solution is FAST POC. New technologies offer minimally significant risks. Diagnostic centers in ACFs and transportable formats also will optimize Ebola SCPs.

Short-Term Thermal-Humidity Shock Affects Point-of-Care Glucose Testing: Implications for Health Professionals and Patients.

The objective was to assess the effects of short-term (≤1 hour) static high temperature and humidity stresses on the performance of point-of-care (POC) glucose test strips and meters. Glucose meters are used by medical responders and patients in a variety of settings including hospitals, clinics, homes, and the field. Reagent test strips and instruments are potentially exposed to austere environmental conditions. Glucose test strips and meters were exposed to a mean relative humidity of 83.0% (SD = 8.0%) and temperature of 42°C (107.6°F, SD = 3.2) in a Tenney BTRC environmental chamber. Stressed and unstressed glucose reagent strips and meters were tested with spiked blood samples (n = 40 measurements per time point for each of 4 trials) after 15, 30, 45, and 60 minutes of exposure. Wilcoxon's signed rank test was applied to compare measurements test strip and meter measurements to isolate and characterize the magnitude of meter versus test strip effects individually. Stressed POC meters and test strips produced elevated glucose results, with stressed meter bias as high as 20 mg/dL (17.7% error), and stressed test strip bias as high as 13 mg/dL (12.2% error). The aggregate stress effect on meter and test strips yielded a positive bias as high as 33 mg/dL (30.1% error) after 15 minutes of exposure. Short-term exposure (15 minutes) to high temperature and humidity can significantly affect the performance of POC glucose test strips and meters, with measurement biases that potentially affect clinical decision making and patient safety.

Effects of humidity on foil and vial packaging to preserve glucose and lactate test strips for disaster readiness.

OBJECTIVE: Efficient emergency and disaster response is challenged by environmental conditions exceeding test reagent storage and operating specifications. We assessed the effectiveness of vial and foil packaging in preserving point-of-care (POC) glucose and lactate test strip performance in humid conditions. METHODS: Glucose and lactate test strips in both packaging were exposed to mean relative humidity of 97.0 ± 1.1% in an environmental chamber for up to 168 hours. At defined time points, stressed strips were removed and tested in pairs with unstressed strips using whole blood samples spiked to glucose concentrations of 60, 100, and 250 mg/dL (n = 20 paired measurements per level). A Wilcoxon signed rank test was used to compare stressed and unstressed test strip measurements. RESULTS: Stressed glucose and lactate test strip measurements differed significantly from unstressed strips, and were inconsistent between experimental trials. Median glucose paired difference was as high as 12.5 mg/dL at the high glucose test concentration. Median lactate bias was -0.2 mmol/L. Stressed strips from vial (3) and foil (7) packaging failed to produce results. CONCLUSIONS: Both packaging designs appeared to protect glucose and lactate test strips for at least 1 week of high humidity stress. Documented strip failures revealed the need for improved manufacturing process.

Health care workers' hand contamination levels and antibacterial efficacy of different hand hygiene methods used in a Vietnamese hospital.

BACKGROUND: Handwashing with soap or another antisepsis disinfectant solution is a common practice in Vietnam, but the availability and quality of tap water is unpredictable. We assessed the risk for hand contamination and compared the efficacy of 5 hand hygiene methods in a tertiary Vietnamese hospital. METHODS: Five fingertip imprints of the dominant hand of 134 health care workers (HCWs) were sampled to establish the average bacterial count before and after hand hygiene action using (1) alcohol-based handrub (ABHR), (2) plain soap and water handwashing with filtered and unfiltered water, or (3) 4% chlorhexidine gluconate hand antisepsis with filtered and unfiltered water. RESULTS: Average bacterial contamination of hands before hand hygiene was 1.65 log(10). Acinetobacter baumannii, Klebsiella pneumoniae, and Staphylococcus aureus were the most commonly isolated bacterial pathogens. The highest average count before hand hygiene was recovered from HCWs without direct patient contact (2.10 ± 0.11 log(10)). Bacterial counts were markedly reduced after hand hygiene with ABHR (1.4 log(10); P < .0001) and 4% chlorhexidine gluconate with filtered water (0.8 log(10); P < .0001). Use of unfiltered water was associated with minimal nonsignificant bacterial reduction. CONCLUSIONS: HCWs carry high levels of bacteria on their dominant hand, even without direct patient contact. ABHR as an additional step may overcome the effect of high bacterial counts in unfiltered water when soap and water handwashing is indicated.

Innovations in point-of-care testing for enhanced United States disaster caches.

OBJECTIVE: To describe, innovate, recommend, and foster the implementation of point-of-care (POC) testing in disaster caches to enhance crisis standards of care and to improve triage, diagnosis, monitoring, treatment, and management of victims and volunteers in complex emergencies and disasters. DESIGN AND SETTINGS: The authors compared POC testing in United States disaster caches to commercially available POC testing to enhance the caches and to reflect current state-of-the-art diagnostic capabilities. The authors also provided recommendations based on literature review and knowledge from newly developed POC technologies from the UC Davis Point-of-Care Technologies Center. RESULTS: Presently, US POC testing caches comprise chemistry/electrolytes, pregnancy, hemoglobin, cardiac biomarkers, hematology, fecal occult blood, drugs of abuse, liver function, blood gases, and limited infectious diseases. Deficiencies with existing POC tests for cardiac biomarkers, hematology, and infectious diseases should be eliminated. POC resources can be customized for pandemics, complex emergencies, or disasters based on geographic location and potential infectious diseases. Additionally, a new thermally stabilized container can help alleviate environmental stresses that reduce test quality. CONCLUSIONS: Innovations in POC technologies can improve response preparedness with enhanced diagnostic capabilities. Several innovations, such as the i-STAT® Wireless, OraQuick ADVANCE® HIV-1/2, VereTrop™ Lab-on-a-Chip, and new compact hematology analyzers will improve test clusters that facilitate evidence-based decision making and crisis standards of care during US national disaster responses. Additionally, strategic resources and operator training should be globally harmonized to improve the efficiency of international responses.

Report on Japan-Vietnam collaboration in nosocomial infection control at Bach Mai Hospital, Hanoi from 2000 to 2006

Since 2000, the authors have been conducting technical cooperation on nosocomial infection control at Bach Mai Hospital (BMH) in Vietnam, which is the first trial in the country. The main contents include: (1) Consolidation of the bases of nosocomial infection control at BMH, which include setting up the appropriate control system and providing training for hospital staff, (2) Cooperation in the SARS outbreak, (3) Fact-finding survey on nosocomial infection, and (4) Preparation against avian influenza at hospitals. As a result of these activities, nosocomial infection control at BMH has been enhanced and the staff is providing technical guidance to other hospitals in recent years with the aim to disseminate skills and knowledge widely in Vietnam. The questionnaire survey on preparedness against SARS, including awareness among staff, training situation, infection control system in hospital, etc., showed comparatively good results in Vietnamese hospitals. The present paper summarizes the collaboration on nosocomial infection control between Vietnam and Japan.<br>Nosocomial infection control is considered essential to upgrade the quality of medical care. Also, constant efforts to upgrade the skills and knowledge of medical staff and to set up an efficient infection control system will be useful in dealing with the potential risk of resurgence of SARS or human influenza pandemic. Nosocomial infection control is one of the most appropriate subjects for technical cooperation at hospitals in developing countries.