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Review Article| Volume 29, ISSUE 3, P583-605, September 2009

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Point-of-Care Testing for Disasters: Needs Assessment, Strategic Planning, and Future Design

  • Gerald J. Kost
    Correspondence
    Corresponding author.
    Affiliations
    Department of Pathology and Laboratory Medicine, UC Davis-LLNL Point-of-Care Technologies Center [NIBIB, NIH], Point-of-Care Testing Center for Teaching and Research (POCT•CTR), School of Medicine, University of California, 3455 Tupper Hall, Davis, CA 95616, USA
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  • Kristin N. Hale
    Affiliations
    Department of Pathology and Laboratory Medicine, UC Davis-LLNL Point-of-Care Technologies Center [NIBIB, NIH], Point-of-Care Testing Center for Teaching and Research (POCT•CTR), School of Medicine, University of California, 3455 Tupper Hall, Davis, CA 95616, USA
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  • T. Keith Brock
    Affiliations
    Department of Pathology and Laboratory Medicine, UC Davis-LLNL Point-of-Care Technologies Center [NIBIB, NIH], Point-of-Care Testing Center for Teaching and Research (POCT•CTR), School of Medicine, University of California, 3455 Tupper Hall, Davis, CA 95616, USA
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  • Richard F. Louie
    Affiliations
    Department of Pathology and Laboratory Medicine, UC Davis-LLNL Point-of-Care Technologies Center [NIBIB, NIH], Point-of-Care Testing Center for Teaching and Research (POCT•CTR), School of Medicine, University of California, 3455 Tupper Hall, Davis, CA 95616, USA
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  • Nicole L. Gentile
    Affiliations
    Department of Pathology and Laboratory Medicine, UC Davis-LLNL Point-of-Care Technologies Center [NIBIB, NIH], Point-of-Care Testing Center for Teaching and Research (POCT•CTR), School of Medicine, University of California, 3455 Tupper Hall, Davis, CA 95616, USA
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  • Tyler K. Kitano
    Affiliations
    Department of Pathology and Laboratory Medicine, UC Davis-LLNL Point-of-Care Technologies Center [NIBIB, NIH], Point-of-Care Testing Center for Teaching and Research (POCT•CTR), School of Medicine, University of California, 3455 Tupper Hall, Davis, CA 95616, USA
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  • Nam K. Tran
    Affiliations
    Department of Pathology and Laboratory Medicine, UC Davis-LLNL Point-of-Care Technologies Center [NIBIB, NIH], Point-of-Care Testing Center for Teaching and Research (POCT•CTR), School of Medicine, University of California, 3455 Tupper Hall, Davis, CA 95616, USA
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      Keywords

      Goals and objectives

      The goals of point-of-care testing (POCT) are to facilitate rapid evidence-based decisions, to improve patient outcomes, and, ultimately, to be robust and reliable enough for on-site applications in emergency and disaster settings worldwide.
      The objectives of this article are (1) to review current POC technologies used in disaster and emergency care, (2) to understand first responder needs, (3) to outline device design criteria based on gap analysis, and (4) to present strategies for improving future POCT for efficiency, effectiveness, and targeted treatment during on-site field operations.
      This article is evidence-based in that it presents preliminary results of a needs assessment survey in the United States. Readers are encouraged to participate in the needs assessment survey. Please see the instructions provided in Table 1.
      Table 1SurveyMonkey Instructions
      StepInstruction and Access
      OneVisit UC Davis-LLNL POCT.
      Web site: http://www.ucdmc.ucdavis.edu/pathology/poctcenter
      TwoThe Clinical Needs Assessment survey link appears in the top right corner of the navigation bar. It is the first item under POC Technologies Center. Please click on “Needs Assessment Survey”
      ThreePlease contact Keith Brock, Research Specialist, at 530 752 8471, email: tkbrock@ucdavis.edu, to receive an accession number
      FourFollow the instructions on the screen to complete the survey. Note: Your progress will be saved after pressing the “next” button at the end of each page. Please note, your progress online is managed through your web browser cookies. Please complete the survey on the same computer and do not delete the cookies on your web browser before completion of the online survey
      FiveThank you for your time and input on the survey!
      The 2004 tsunami in Southeast Asia and Hurricane Katrina in the United States exposed the lack of disaster preparedness worldwide.
      • Kost G.J.
      • Tran N.K.
      • Tuntideelert M.
      • et al.
      Katrina, the tsunami and point-of-care testing: optimizing rapid response diagnosis in disasters.
      Although the feasibility of POCT was proven, and the disaster responses were extensive, follow-up studies showed rescue was slow and inadequate.
      • Kost G.J.
      • Tran N.K.
      • Tuntideelert M.
      • et al.
      Katrina, the tsunami and point-of-care testing: optimizing rapid response diagnosis in disasters.
      In Hurricane Katrina, flooded hospitals, roads, and communications hindered rescue efforts by first responders who carried limited POCT devices such as oxygen saturation monitors (pulse oximeters), blood glucose meters, and other small handhelds.
      • Kost G.J.
      • Tran N.K.
      • Tuntideelert M.
      • et al.
      Katrina, the tsunami and point-of-care testing: optimizing rapid response diagnosis in disasters.
      Furthermore, POCT instruments failed to operate effectively under adverse environmental conditions at respective disaster locations, where temperatures reached 110°F (43°C) or higher in hospitals.
      • Diiulio R.
      A New Orleans hospital weathers the storm.
      Katrina's death: who's to blame?.
      Broadly regional catastrophes, such as these recent “newdemics,”
      • Kost G.J.
      • Minear M.
      • Siegel P.M.
      • et al.
      Knowledge, education, mind connectivity: using telemedicine to achieve a global vision for point-of-care testing.
      • Kost G.J.
      Newdemics, public health, small-world networks, and point-of-care testing.
      lead to sequentially magnified setbacks. Others, such as the current novel H1N1 pandemic, threaten entire nations. Typically, communities lack the POCT resources necessary to effectively handle the disaster situations they face.
      • Kost G.J.
      • Tran N.K.
      • Tuntideelert M.
      • et al.
      Katrina, the tsunami and point-of-care testing: optimizing rapid response diagnosis in disasters.
      Conversely, newdemics highlight the significant potential for POCT to positively impact preparedness, disaster response, and patient outcomes. Current experiences, including the surprise appearance of the novel H1N1 pandemic in Mexico (unpublished observation), emphasize the need for new sturdy, handheld, and robust POC technologies capable of effectively operating in a variety of field locations.
      In the future, better prepared first responders will carry reliable POCT diagnostics wherever disaster and emergency situations arise. Thus, POC user needs are being established through objective evidence-based national surveys (see Table 1) as a first step in identifying suitable device designs, effective test clusters, and environmental operating conditions.
      • Louie R.F.
      • Sumner S.L.
      • Belcher S.
      • et al.
      Thermal stress and point-of-care testing performance: suitability of glucose test strips and blood gas cartridges for disaster response.
      The preliminary survey results are reported.

      Needs assessment survey: preliminary results

      Participants

      Forty disaster care experts were randomly selected from the editorial boards of the American Journal of Disaster Medicine (AJDM) and Disaster Medicine Public Health and Preparedness (DMPHP) using a random number generator (Minitab, State College, PA). This sample included physicians, public health officials, researchers, pathologists, first responders, and military personnel.

      Development

      A survey was developed based on literature review and multidisciplinary consultations that included professors of bioengineering, emergency medicine, infectious diseases, and critical care medicine. “Visual logistics,” defined as graphics and pictorial media for common sense portrayal of questions, concepts, and designs, are introduced to build survey questions with the objective of generating easy to comprehend concepts without laborious text or lengthy explanation. Set theory (eg, Venn diagrams) was used whenever possible to compare 2 or more visual concepts, questions, and the results.
      To encourage participation and simplify distribution and return, a visual logistics web-based survey was developed (SurveyMonkey, Portland, Oregon). Paper-based and web-based surveys used identical graphics and questions. The survey was divided into 4 parts: (1) demographic questions, (2) device design questions in 10 sections, (3) pathogen test cluster design questions in 4 sections, and (4) trade-off blocks that led to heuristic ranking of POC design features. At the time of this preliminary report, parts 1 to 3 were implemented.

      Procedures

      If possible, personal contact was initiated by phone followed by shipment of a FedEx package containing an invitation letter, the paper-based survey, and a prepaid return envelope. The invitation letter explained the goal of the survey, provided instructions for participation, and included a hyperlink to the web-based survey (see Table 1). Email also was used to distribute the survey request and hyperlink. This preliminary report reflects survey results obtained between March 1 and June 14, 2009. The survey was conducted in compliance with the UC Davis Institutional Review Board.

      Statistics

      Data obtained from the survey were analyzed using nonparametric Pearson chi-square exact tests (SAS, Gary, North Carolina). Statistical significance was defined as: ∗, P<.05; ∗∗, P<.01; and ∗∗∗, P<.001.
      Pathogen test cluster rank results were analyzed by assigning each pathogen a weighted score. The score for each rank was calculated using the following equation: Si=(11Ri). Ri is defined as the rank of each pathogen assigned by a survey participant, such that i=[1,n], where n is the number of ranks. When the respondent designated the same rank for 2 or more organisms, the average rank was calculated and assigned to each organism.
      The weighted score was calculated by summing the product of each score and corresponding frequency using the following equation: WSj=i=1Si×Fij. The frequency, Fij is defined as the number of times survey participants ranked a pathogen a specific value, such that j=[1,N], where N is the number of pathogens.

      Preliminary results

      Demography

      Of the 40 disaster medicine experts surveyed, 25 responses were received, giving a response rate of 62%. The respondents included 8 physicians (32%), 9 public health officials/hospital managers (36%), 3 pathologists (12%), and 5 emergency room doctors (20%).

      Device Design

      Fig. 1 illustrates visual logistics, specifically pictorial media that introduced the survey question on what the respondent preferred with regard to instrument formats for given clinical settings. The results showed that in disaster settings, respondents showed a significant preference for handheld diagnostics (Fig. 2) and cited increased portability and versatility as the rationale.
      Figure thumbnail gr1
      Fig. 1Device design format. Visual logistics were used to illustrate 3 device format selections for POCT instruments. (A) Transportable device on a cart. (B) Portable, bench-top device with a handle for carrying. (C) Small battery-operated handheld device.
      Figure thumbnail gr2
      Fig. 2Selection of format by survey respondents. In disaster settings, participants preferred handheld devices (∗∗∗P<.001). For urgent care and emergency-room settings, there were no statistically significant differences in preferences.
      When respondents were asked to choose between a device that tests multiple patient samples in parallel for a single pathogen versus a device that performs multiplex testing of several pathogens for a single patient sample (Fig. 3), respondents preferred a multiplex test in the urgent care and emergency room settings (Fig. 4). Participants cited the need to quickly screen a large volume of patients in a disaster setting, whereas a full workup is necessary in urgent care and emergency room settings. Several of the respondents who chose the device that parallel processes multiple patient samples for a single pathogen given a disaster setting, referenced biothreat or pandemic scenarios.
      Figure thumbnail gr3
      Fig. 3Multiple patients versus multiplex pathogens. Visual logistics were used to illustrate 2 testing methods for POCT devices. (A) Testing multiple patients for 1 pathogen. (B) Multiplex pathogen testing, in which 1 patient sample is simultaneously tested for the presence of multiple pathogens (underline).
      Figure thumbnail gr4
      Fig. 4Selection of testing method by survey respondents. In disaster settings, both approaches to pathogen detection may be useful. However, respondents preferred multiplex testing to testing multiple patients for 1 pathogen in urgent care (∗∗∗P<.001) and emergency room (∗∗P<.01) settings.
      Fig. 5 shows 2 different sample collection methods, a test cassette and vacutainer. A test cassette provides a housing platform in which one can automate preanalytical processing steps that are critical to subsequent analytical steps that follow on the POC device. Fig. 6 reflects general acceptance of test cassettes in disaster, urgent care, and emergency settings.
      Figure thumbnail gr5
      Fig. 5Test cassettes versus vacutainers. Visual logistics were used to illustrate 2 sample collection methods for POCT instruments. (A) A vacutainer is used to collect the blood sample, allowing for multiple blood collection tubes to be drawn at one time. (B) Test cassette blood sample collection; blood is drawn directly into a disposable test cassette, processed, and a result given. Graphics updated for the survey currently in use.
      Figure thumbnail gr6
      Fig. 6Selection of sample collection method by survey respondents. Test cassettes and vacutainers were equivalent in all but the disaster setting, but this result was not statistically significant in this preliminary survey report.
      Respondents were also asked to state their preference between 2 potential waste disposal methods (Fig. 7). The first scheme suggests an instrument that stores biohazard waste in a reusable waste storage reservoir to be emptied periodically. A test cassette, used to transport the sample to the instrument, would also need to be properly discarded after a single use. The second scheme shows an instrument that stores all biohazard waste in the disposable test cassette, which then is discarded after a single use. Fig. 8 shows a statistically significant preference of respondents for the disposable test cassette in the second scheme across all 3 clinical settings, with a higher level of statistical significance (P<.01) of the preference in disaster and emergency room settings.
      Figure thumbnail gr7
      Fig. 7Biohazard disposal methods. Visual logistics were used to illustrate 2 biohazard disposal methods for POCT devices. (A) Biohazard waste in a reusable waste storage reservoir that must be emptied periodically, and a disposable test cassette for single use. (B) A device that stores all biohazard waste in a disposable test cassette that is discarded after a single use. Graphics updated for the survey currently in use.
      Figure thumbnail gr8
      Fig. 8Uniform selection of waste disposal by disposable test cassette by survey respondents. There is a statistically significant preference for disposable test cassettes across all 3 clinical settings (P<.01, 0.05, and 0.01). See . Disposable test cassettes have merit for sample collection and waste disposal in disaster settings. ∗P<.05; ∗∗P<.01.

      Pathogen Test Cluster Design

      Table 2 shows the weighted scores of the top 10 pathogens for each of 4 scenario sections. For a general disaster test cluster, Vibrio cholerae had the highest weighted score (117); whereas for a blood donor screening test cluster, HIV 1 and 2 had the highest weighted score (224). Depending on the clinical scenario, the specific pathogens a POC device would detect varies. For instance, methicillin-resistant Staphylococcus aureus (MRSA) had the highest weighted score at 147 for the bloodstream pathogen test cluster (see Table 2). However, in the pandemic test cluster, influenza A/B had the highest weighted score at 189, whereas MRSA was fifth with a weighted score of 112.5 (see Table 2).
      Table 2Pathogen test clusters
      Weighted ScorePathogen
      A. General disaster test cluster (n = 18)117Vibrio cholerae
      108Escherichia coli
      100Staphylococcus aureus
      77Yellow fever
      73Salmonella enterica
      66Pseudomonas aeruginosa
      62Plasmodium falciparum
      54Enterobacter species
      49Dengue fever virus
      38Klebsiella species
      B. Blood donor screening test cluster (n = 23)224HIV 1 and 2
      190Hepatitis B
      190Hepatitis C
      125.5Human T cell lymphotropic virus 1 and 2 (HTLV 1 and 2)
      109.5West Nile virus
      109Cytomegalovirus
      93Dengue fever
      77Parvovirus B19
      74Epstein-Barr virus
      46Chikungunya
      C. Bloodstream pathogen test cluster (n = 20)147Methicillin-resistant Staphylococcus aureus
      118Escherichia coli
      91Pseudomonas aeruginosa
      90.5Streptococcus pneumoniae
      90Enterobacter species
      87.5Methicillin-sensitive Staphylococcus aureus
      79Klebsiella species
      61Enterococcus faecalis
      50Streptococcus pyogenes
      48Coagulase-negative Staphylococcus
      D. Pandemic test cluster (n = 22)189Influenza A/B
      121.5Parainfluenza 1, 2, 3
      115.5Streptococcus pneumoniae
      112.5Respiratory syncytial virus
      112.5Methicillin-resistant Staphylococcus aureus
      100Haemophilus influenza
      90.5Mycobacterium tuberculosis
      87Adenovirus
      57Mycoplasm pneumoniae
      51.5Metapneumovirus

      Preliminary results versus current disaster pathogens

      Various POCT devices that test for a variety of analytes and pathogens are used during disaster and emergency situations, such as Hurricane Katrina. Emergency medical responders, disaster medical assistance teams (DMATs), international medical-surgical response teams (IMSuRTs), and other first responders deploy to disaster sites carrying POCT devices.
      • Louie R.F.
      • Sumner S.L.
      • Belcher S.
      • et al.
      Thermal stress and point-of-care testing performance: suitability of glucose test strips and blood gas cartridges for disaster response.
      They use POCT devices to test, rapidly diagnose, and, as indicated, treat victims.
      • Louie R.F.
      • Sumner S.L.
      • Belcher S.
      • et al.
      Thermal stress and point-of-care testing performance: suitability of glucose test strips and blood gas cartridges for disaster response.
      Depending on where responders are deployed, the pathogens they encounter will vary, possibly unpredictably and unexpectedly. Table 3
      • Shaman J.
      • Day J.F.
      • Stieglitz M.
      Drought-induced amplification of Saint Louis encephalitis virus, Florida.
      • Shaman J.
      • Day J.K.
      • Stieglitz M.
      Drought-induced amplification and epidemic transmission of West Nile virus in southern Florida.
      • Bangs M.J.
      • Subianto D.B.
      El Nino and associated outbreaks of severe malaria in highland populations in Irian Jaya, Indonesia: a review and epidemiological perspective.
      • Schneider E.
      • Hajjeh R.A.
      • Spiegel R.A.
      • et al.
      A coccidioidomycosis outbreak following the Northridge, Calif, Earthquake.
      • Tao C.
      • Kang M.
      • Chen Z.
      • et al.
      Microbiologic study of the pathogens isolated from wound culture among Wengchuan earthquake survivors.
      • Bulut M.
      • Fedakar R.
      • Akkose S.
      • et al.
      Medical experience of university hospital in Turkey after the 1999 Marmara earthquake.
      • Kazancioglu R.
      • Cagatay A.
      • Colangu S.
      • et al.
      The characteristics of infections in crush syndrome.
      • Qadri F.
      • Khan A.
      • Faruque A.
      • et al.
      Enterotoxigenic Escherichia coli and Vibrio cholerae diarrhea, Bangladesh, 2004.
      World Health Organization
      Flooding and communicable diseases fact sheet: risk assessment and preventative measures.
      • Vollaard A.
      • Ali S.
      • Asten H.
      • et al.
      Risk factors for typhoid and paratyphoid fever in Jakarta, Indonesia.
      • Vernon D.
      • Banner W.
      • Cantwell P.
      • et al.
      Streptococcus pneumoniae bacteremia associated with near-drowning.
      • Ender P.
      • Dolan M.
      Pneumonia associated with near-drowning.
      Center for Disease Control and Prevention
      Update on CDC's response to Hurricane Katrina – September 19th, 2005.
      Centers for Disease Control and Prevention (CDC)
      Vibrio illnesses after Hurricane Katrina – multiple states, August – September 2005.
      Centers for Disease Control and Prevention (CDC)
      Infectious disease and dermatologic conditions in evacuees and rescue workers after Hurricane Katrina—multiple states, August-September, 2005.
      • MMWR
      Norovirus outbreak among evacuees from Hurricane Katrina – Houston, TX, September 2005.
      • Sinigalliano C.
      • Gidley M.
      • Shibata T.
      • et al.
      Impacts of Hurricanes Katrina and Rita on the microbial landscape of the New Orleans area.
      • Millie M.
      • Senkowski C.
      • Stuart L.
      • et al.
      Tornado disaster in rural Georgia: triage response, injury patterns, lessons learned.
      • Lupisan S.
      • Herva E.
      • Sombrero L.
      • et al.
      Invasive bacterial infections of children in a rural province in the central Philippines.
      • Hiransuthikul N.
      • Tantisiriwat W.
      • Lertutsahakul K.
      • et al.
      Skin and soft tissue infections among tsunami survivors in Southern Thailand.
      • Uckay I.
      • Sax H.
      • Harbarth S.
      • et al.
      Multi-resistant infections in repatriated patients after natural disasters: lessons learned from the 2004 tsunami for hospital infection control.
      • Rajendran P.
      • Murugan S.
      • Raju S.
      • et al.
      Bacteriological analysis of water samples from tsunami hit coastal areas of Kanyakumari district, Tamil Nadu.
      • Ivers L.C.
      • Ryan E.T.
      Infectious diseases of severe weather-related and flood-related natural disasters.
      • Thomas P.A.
      • Brackbill R.
      • Thalji L.
      • et al.
      Respiratory and other health effects reported in children exposed to the World Trade Center disaster of 11 September 2001.
      • de la Hoz R.E.
      • Christie J.
      • Teamer J.A.
      • et al.
      Reflux symptoms and disorders and pulmonary disease in former World Trade Center rescue and recovery workers and volunteers.
      • Farfel M.
      • DiGrande L.
      • Brackbill R.
      • et al.
      An overview of 9/11 experiences and respiratory and mental health conditions among World Trade Center health registry enrollees.
      documents the variety of pathogens present in several modern disasters, such as flooding, hurricanes, and earthquakes. When comparing the top 10 pathogens identified by preliminary needs assessment survey results in various disaster scenarios (see Table 2) with pathogens found in major disasters, there was substantial overlap.
      Table 3Pathogens in disasters
      ScenarioLocation, YearPathogens Detected (Isolation Site)Path of Infection
      DroughtFlorida, 5 epidemics since 1952
      • Shaman J.
      • Day J.F.
      • Stieglitz M.
      Drought-induced amplification of Saint Louis encephalitis virus, Florida.
      • Shaman J.
      • Day J.K.
      • Stieglitz M.
      Drought-induced amplification and epidemic transmission of West Nile virus in southern Florida.
      Saint Louis encephalitis (blood)Vector borne
      West Nile (blood)Vector borne
      Indonesia, 1997
      • Bangs M.J.
      • Subianto D.B.
      El Nino and associated outbreaks of severe malaria in highland populations in Irian Jaya, Indonesia: a review and epidemiological perspective.
      Malaria (blood)Vector borne
      EarthquakeCalifornia, 1994
      • Schneider E.
      • Hajjeh R.A.
      • Spiegel R.A.
      • et al.
      A coccidioidomycosis outbreak following the Northridge, Calif, Earthquake.
      Coccidioides immitis (skin)Dust cloud
      China, 2008
      • Tao C.
      • Kang M.
      • Chen Z.
      • et al.
      Microbiologic study of the pathogens isolated from wound culture among Wengchuan earthquake survivors.
      Staphylococcus aureus (pus and wound)Wound
      Escherichia coli (pus and wound)Wound
      Acinetobacter baumannii (pus and wound)Wound
      Enterobacter cloacae (pus and wound)Wound
      Pseudomonas aeruginosa (pus and wound)Wound
      Turkey, 1999
      • Bulut M.
      • Fedakar R.
      • Akkose S.
      • et al.
      Medical experience of university hospital in Turkey after the 1999 Marmara earthquake.
      Pseudomonas aeruginosa (wound)Wound
      Acinetobacter baumannii (wound)Wound
      Methicillin-resistant
      Staphylococcus aureus (wound)Wound
      Candida species (wound)Wound
      Turkey, 1999
      • Kazancioglu R.
      • Cagatay A.
      • Colangu S.
      • et al.
      The characteristics of infections in crush syndrome.
      Acinetobacter species (wound)Wound
      Pseudomonas aeruginosa (wound, blood, urine)Wound
      Methicillin-resistant
      Staphylococcus aureus (wound, blood, urine)Wound
      Serratia marcescens (wound)Wound
      Klebsiella pneumoniae (wound)Wound
      Enterobacter species (wound)Wound
      Candida albicans (wound)Wound
      FloodingBangladesh, 2004
      • Qadri F.
      • Khan A.
      • Faruque A.
      • et al.
      Enterotoxigenic Escherichia coli and Vibrio cholerae diarrhea, Bangladesh, 2004.
      Escherichia coli (blood)Water, food borne
      Vibrio cholerae (stool)
      Global, 1980–2008
      World Health Organization
      Flooding and communicable diseases fact sheet: risk assessment and preventative measures.
      Malaria (blood)Vector borne
      Yellow fever (blood)Vector borne
      West Nile (blood)Vector borne
      Dengue (blood)Vector borne
      Indonesia, 2004
      • Vollaard A.
      • Ali S.
      • Asten H.
      • et al.
      Risk factors for typhoid and paratyphoid fever in Jakarta, Indonesia.
      Salmonella paratyphi (blood)Water, food borne
      Nonspecific
      • Vernon D.
      • Banner W.
      • Cantwell P.
      • et al.
      Streptococcus pneumoniae bacteremia associated with near-drowning.
      • Ender P.
      • Dolan M.
      Pneumonia associated with near-drowning.
      Streptococcus pneumoniae (blood)Inhalation
      Hurricanes/tornadoesKatrina, 2005
      Center for Disease Control and Prevention
      Update on CDC's response to Hurricane Katrina – September 19th, 2005.
      Centers for Disease Control and Prevention (CDC)
      Vibrio illnesses after Hurricane Katrina – multiple states, August – September 2005.
      Centers for Disease Control and Prevention (CDC)
      Infectious disease and dermatologic conditions in evacuees and rescue workers after Hurricane Katrina—multiple states, August-September, 2005.
      • MMWR
      Norovirus outbreak among evacuees from Hurricane Katrina – Houston, TX, September 2005.
      • Sinigalliano C.
      • Gidley M.
      • Shibata T.
      • et al.
      Impacts of Hurricanes Katrina and Rita on the microbial landscape of the New Orleans area.
      Nontoxigenic Vibrio cholerae O1 (blood)Food borne
      Vibrio cholerae non-O1 (blood)Water borne
      Vibrio vulnificus (blood)Wound, food borne
      Vibrio parahaemolyticus (blood)Wound, food borne
      Methicillin-resistantWound
      Staphylococcus aureus (wound)
      Norovirus (stool)Water borne
      Vibrio species (lake surface water)Water borne
      Legionella species (lake surface water)Water borne
      Cryptosporidium (interior canal water)Water borne
      Giardia (interior canal water)Water borne
      Escherichia coli (shoreline canal water)Water borne
      Bifidobacterium (shoreline canal water)Water borne
      Georgia, 2000
      • Millie M.
      • Senkowski C.
      • Stuart L.
      • et al.
      Tornado disaster in rural Georgia: triage response, injury patterns, lessons learned.
      Serratia marcescens (wound)Wound
      Pseudomonas aeruginosa (wound)Wound
      Enterococcus (wound)Wound
      Low-resource settings/rural areasIndonesia, 2001–2003
      • Vollaard A.
      • Ali S.
      • Asten H.
      • et al.
      Risk factors for typhoid and paratyphoid fever in Jakarta, Indonesia.
      Salmonella enterica (blood)Food, water borne
      Salmonella paratyphi (blood)Food, water borne
      Salmonella typhi (blood)Food, water borne
      Philippines, 1994–1996
      • Lupisan S.
      • Herva E.
      • Sombrero L.
      • et al.
      Invasive bacterial infections of children in a rural province in the central Philippines.
      Streptococcus pneumoniae (blood)Inhalation
      Haemophilus influenzae (blood)Inhalation
      TsunamisThailand, 2004
      • Hiransuthikul N.
      • Tantisiriwat W.
      • Lertutsahakul K.
      • et al.
      Skin and soft tissue infections among tsunami survivors in Southern Thailand.
      • Uckay I.
      • Sax H.
      • Harbarth S.
      • et al.
      Multi-resistant infections in repatriated patients after natural disasters: lessons learned from the 2004 tsunami for hospital infection control.
      • Rajendran P.
      • Murugan S.
      • Raju S.
      • et al.
      Bacteriological analysis of water samples from tsunami hit coastal areas of Kanyakumari district, Tamil Nadu.
      • Ivers L.C.
      • Ryan E.T.
      Infectious diseases of severe weather-related and flood-related natural disasters.
      Aeromonas (pus and wound)Wound
      Escherichia coli (stool)Water, food borne
      Klebsiella pneumoniae (pus and wound)Wound
      Pseudomonas aeruginosa (pus and wound)Wound
      Burkolderia pseudomallei (blood)Soil, water borne
      Acinetobacter baumannii (blood)Soil, water borne
      Stenotrophomonas (blood)Soil, water borne
      Methicillin-resistant
      Staphylococcus aureus (wound)Wound
      Staphylococcus aureus (wound)Wound
      Candida species (blood)Inhalation, wound
      Aspergillus species (blood)Inhalation, wound
      Scedosporium species (blood)Inhalation, wound
      Salmonella species (well water)Water borne
      Clostridium species (wound)Soil
      Aeromonas species (wound)Water borne
      World Trade Center disasterNew York, 2001
      • Thomas P.A.
      • Brackbill R.
      • Thalji L.
      • et al.
      Respiratory and other health effects reported in children exposed to the World Trade Center disaster of 11 September 2001.
      • de la Hoz R.E.
      • Christie J.
      • Teamer J.A.
      • et al.
      Reflux symptoms and disorders and pulmonary disease in former World Trade Center rescue and recovery workers and volunteers.
      • Farfel M.
      • DiGrande L.
      • Brackbill R.
      • et al.
      An overview of 9/11 experiences and respiratory and mental health conditions among World Trade Center health registry enrollees.
      Asthma and WTC cough (pathogens not named)
      During Hurricane Katrina, for example, various pathogens were identified that also were selected and ranked by experts and surveyed as high priority for general disaster, blood donor screening, bloodstream pathogen, and pandemic test clusters. Specifically, in Table 2 for the general disaster scenario and in Table 3 for Hurricane Katrina, there is overlap for Vibrio cholerae, MRSA, and Escherichia coli. Thus, preliminary survey results demonstrate that survey experts identified pathogens encountered at disaster sites (see Table 3) as important for having POCT devices capable of detecting these organisms (see Table 2).
      A similar finding was observed when comparing pathogens detected at the tsunami disaster site in Southeast Asia (see Table 3) versus the general disaster and bloodstream pathogen test clusters ranked highly in Table 2. Survey results identified several pathogens in the general disaster and bloodstream pathogen test clusters, such as Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa, MRSA, and Salmonella species. These pathogens also were detected at tsunami disaster sites in Southeast Asia. Having POCT devices capable of testing for these pathogens found at particular disaster sites can facilitate rapid diagnosis. Targeted therapy, in turn, can conserve drugs (eg, antimicrobials) that become depleted quickly during the initial crisis stages. These survey results should be used as a guide for development of new POCT devices capable of timely pathogen detection at disaster sites.

      Current use of POCT in disasters in the United States

      New POC devices must be capable of testing for a variety of pathogens present at a particular disaster site, and also properly integrated and used to decrease response times and improve patient outcomes. During Hurricane Katrina, a variety of different locations and types of POCT were used featuring an array of POC tests covering chemistry, hematology, and other analyte categories.
      Fig. 9 highlights POC instruments, including the various locations and POCT operators in Hurricane Katrina. Hospitals, evacuation sites, and local agencies were not prepared for the disaster and offered few POCT devices and tests. Hurricane Katrina is an example of a newdemic.
      • Kost G.J.
      Newdemics, public health, small-world networks, and point-of-care testing.
      Supplies depleted quickly. Needs for chronic monitoring, such as outpatient glucose monitoring, were not met.
      Figure thumbnail gr9
      Fig. 9Locations and types of POCT in Hurricane Katrina. Hospitals, evacuation sites, and local agencies were not prepared fully to assist quickly with POCT. They carried few POCT instruments. In contrast, US military ships and combat support units were equipped with POCT devices, including a variety of tests to facilitate rapid diagnosis and treatment. Donations of glucose meters proved valuable, but not fast enough or adequate for the large numbers of diabetic victims involved in the disaster. POC tests used during the disaster include: ALP, alkaline phosphatase; ALT, alanine aminotransferase; aPTT, activated partial thromboplastin time; AST, aspartate aminotransferase; BNP, B-type natriuretic peptide; BUN, blood (serum) urea nitrogen; CK, creatine kinase; cTn, cardiac troponin; GGT, γ-glutamyltransferase; Hb, hemoglobin; Hct, hematocrit; HDL, high-density lipoprotein; INR, international normalized ratio; LD, lactate dehydrogenase; MB, MB fraction of CK; PT, prothrombin time; SO2, oxygen saturation measured by pulse oximetry; TCO2, total carbon dioxide content; TP, total protein. Instrument identifications: Bayer Acsensia, http://www.bayercarediabetes.com; Cardiac STATus, http://www.spectraldx.com; Cell-Dyn, http://www.abbottdiagnostics.com; i-STAT, http://www.i-stat.com; Ortho Diagnostics blood typing, http://www.orthoclinical.com; Piccolo, http://www.abaxis.com; Rapidpoint coag, http://www.bayer-poct.co.uk; and Triage, http://www.biosite.com. (From Kost GJ, Tran NK, Tuntideelert M, et al. Hurricane Katrina, the tsunami and point-of-care testing: optimizing rapid response diagnosis in disasters. Am J Clin Pathol 2006;126:513–20. © 2006 American Society for Clinical Pathology; Courtesy of Knowledge Optimization, Davis, CA; with permission.)
      Fig. 10 displays Hurricane Katrina disaster sites, arrival, and responses of mostly military assets, and a suggested optimal POCT plan (upper right in figure) for timely disaster response. Fig. 10 also documents that the disaster response time was slow. Current POCT disaster preparation does not meet adequate standards and must be improved for future preparedness. Proper strategic placement of POCT, possibly in alternate medical care facilities, is needed to facilitate rapid diagnosis and treatment.
      • Lam C.
      • Waldhorn R.
      • Toner E.
      • et al.
      The prospect of using alternative medical care facilities in an influenza pandemic.
      Figure thumbnail gr10
      Fig. 10Hurricane Katrina disaster areas, arrival times of military and civilian assets, sequential responses, and optimal POCT plan for disaster response. Mobile and military resources, including POCT, arrived on days 1, 3 to 5, 9, and 24. At the community and regional hospitals surveyed, beds averaged 154 (SD, 66; median, 173; range, 60–211) and 397 (SD, 249; median, 326; range, 174–763), respectively. Physicians ranged from 50 to 900. Displacement of 5944 physicians from the disaster area (223,000 km2) hampered an already devastated health care infrastructure. The authors recommend (upper right) optimizing disaster response by prepositioning POCT for emergency use during the first 2 critical days. ICU, intensive care unit; OR, operating room. (From Kost GJ, Tran NK, Tuntideelert M, et al. Hurricane Katrina, the tsunami and point-of-care testing: optimizing rapid response diagnosis in disasters. Am J Clin Pathol 2006;126:513–20. © 2006 American Society for Clinical Pathology; Courtesy of Knowledge Optimization, Davis, CA; with permission.)
      Pandemic influenza strains, such as novel H1N1, have the potential to significantly increase mortality and morbidity, as well as quickly deplete resources of current health care infrastructures. Thus, for example, rapidly diagnosing a particular influenza strain using POCT devices is advantageous. Furthermore, the World Health Organization (WHO) strongly recommends the use of POCT devices for quick influenza diagnosis. Commercially available POC tests for influenza A and B are listed in Table 4.
      • Ginocchio C.C.
      • Lotlikar M.
      • Falk L.
      • et al.
      Clinical performance of the 3M Rapid Detection Flu A+B Test compared to R-mix culture, DFA, and BinaxNow Influenza A+B Test.
      • Grondhal B.
      • Puppe W.
      • Weigl J.
      • et al.
      Comparison of the BD Directigin Flu A+B kit and the Abbott TestPack RSV with a multiplex RT-PCR ELISA for rapid detection of influenza viruses and respiratory synctial virus.
      • Hurt A.C.
      • Alexander R.
      • Hibbert J.
      • et al.
      Performance of six influenza rapid tests in detecting human influenza in clinical specimens.
      • Cazacu A.C.
      • Demmler G.J.
      • Neuman M.A.
      • et al.
      Comparison of a new lateral-flow chromatographic membrane immunoassay to viral culture for rapid detection and differentiation of influenza A and B viruses in respiratory specimens.
      • Pabbaraju K.
      • Tokaryk K.L.
      • Wong S.
      • et al.
      Comparison of the Luminex xTAG respiratory viral panel with in-house nucleic acid amplification tests for diagnosis of respiratory virus infections.
      Several of the tests currently available are immunoassays that target nucleoprotein or matrix protein to identify influenza A or B types, but rarely offer further subtyping.
      Table 4POC influenza diagnostic tests
      Instrument/ManufacturerPerformance Characteristics (%)
      Immunoassay TestsTypeTargetTimeSensitivitySpecificityPPVNPV
      3M Rapid Detection Flu A+B
      • Ginocchio C.C.
      • Lotlikar M.
      • Falk L.
      • et al.
      Clinical performance of the 3M Rapid Detection Flu A+B Test compared to R-mix culture, DFA, and BinaxNow Influenza A+B Test.
      FDA-approved.
      http://www.3M.com, St. Paul, MN
      Chromatographic immunoassayInfluenza A15 min701009993
      Influenza B (nucleoprotein)87998898
      BD Directigen EZ Flu A+B,
      FDA-approved.
      CE-approved.
      http://www.bd.com, Franklin Lakes, NJ
      Chromatographic immunoassayInfluenza A15 min77–9186–9960–9893–95
      Influenza B69–10099–10093–9893–100
      BD Directigen Flu A Kit
      FDA-approved.
      CE-approved.
      http://www.bd.com, Franklin Lakes, NJ
      ImmunoassayInfluenza A (nucleoprotein)15 min67–9688–97NANA
      BD Directigen Flu A + BKit
      • Grondhal B.
      • Puppe W.
      • Weigl J.
      • et al.
      Comparison of the BD Directigin Flu A+B kit and the Abbott TestPack RSV with a multiplex RT-PCR ELISA for rapid detection of influenza viruses and respiratory synctial virus.
      CE-approved.
      http://www.bd.com, Franklin Lakes, NJ
      ImmunoassayInfluenza A15 min77–9690–9163–7194–99
      Influenza B (nucleoprotein)71–8898–10082–10098–100
      BinaxNOW Influenza A&B
      • Hurt A.C.
      • Alexander R.
      • Hibbert J.
      • et al.
      Performance of six influenza rapid tests in detecting human influenza in clinical specimens.
      ,
      FDA-approved.
      CE-approved.
      CLIA-waived.
      http://www.binax.com, Scarborough, ME
      Chromatographic immunoassayInfluenza A15 min77–8396–9988–9795–96
      Influenza B (nucleoprotein)50–6910082–10099
      ESPLINE Influenza A&B,
      • Hurt A.C.
      • Alexander R.
      • Hibbert J.
      • et al.
      Performance of six influenza rapid tests in detecting human influenza in clinical specimens.
      http://www.fujirebio.co.jp, Tokyo, Japan
      Chromatographic immunoassayInfluenza A15 min6710010089
      Influenza B (nucleoprotein)3010010096
      fluID Rapid Influenza Test,
      In development.
      http://www.hxdiagnostics.com, Emeryville, CA
      Lateral flow immunoassayInfluenza ANANANANANA
      Influenza BNANANANANA
      Subtype A/H1NANANANANA
      Subtype A/H3NANANANANA
      Influ-A&B Respi-Strip, http://www.corisbio.com, Gembloux, BelgiumChromatographic immunoassayInfluenza A15 min9710010098
      Influenza B (nucleoprotein)9710010098
      OSOM Influenza A & B Test,
      FDA-approved.
      CLIA-waived.
      http://www.genzymediagnostics.com, Framingham, MA
      Chromatographic immunoassayInfluenza A10 min74969090
      Influenza B (nucleoprotein)60967394
      panfluID Rapid Influenza Test,
      In development.
      http://www.hxdiagnostics.com, Emeryville, CA
      Lateral flow immunoassayAvian InfluenzaNANANANANA
      QuickVue Influenza A+B Test,
      CLIA-waived.
      http://www.quidel.com, San Diego, CA
      Lateral flow immunoassayInfluenza A10 min77–9489–9962–9195–99
      Influenza B (nucleoprotein)62–8297–9980–9094–97
      QuickVue Influenza Test,
      CE-approved.
      CLIA-waived.
      http://www.quidel.com, San Diego, CA
      Lateral flow immunoassayInfluenza A+B10 min73–8196–9992–9685–93
      No differentiation (nucleoprotein)
      Rockeby Influenza A Test,
      • Hurt A.C.
      • Alexander R.
      • Hibbert J.
      • et al.
      Performance of six influenza rapid tests in detecting human influenza in clinical specimens.
      ,
      CE-approved.
      http://www.rockeby.com, Singapore
      ImmunoassayInfluenza A (nucleoprotein)10 min1010010074
      SAS FluAlert, http://www.sascientific.com, San Antonio, TXChromatographic immunoassayInfluenza A15 min76989391
      Influenza B (nucleoprotein)15 min9199–10010099
      Xpect Flu A&B Test Kit,
      • Cazacu A.C.
      • Demmler G.J.
      • Neuman M.A.
      • et al.
      Comparison of a new lateral-flow chromatographic membrane immunoassay to viral culture for rapid detection and differentiation of influenza A and B viruses in respiratory specimens.
      http://www.remelinc.com, Lenexa, KS
      Chromatographic immunoassayInfluenza A15 min90–10010010097–100
      Influenza B (nucleoprotein)83–10010010099–100
      Nucleic Acid Tests
      Primer design, http://www.primerdesign.co.uk, Southampton, UKReal time qPCRH1N1 (swine flu)<2 hNANANANA
      proFLU plus,
      CE-approved.
      http://www.prodesse.com, Waukesha, WI
      Real time RT-PCRInfluenza A (matrix)3 h1009371100
      Influenza B (nonstructural NS1 & NS2)989980100
      Instrument/ManufacturerPerformance Characteristics (%)
      Nucleic Acid TestsTypeTargetTimeSensitivitySpecificityPPVNPV
      xTAG Respiratory viral panel,
      • Pabbaraju K.
      • Tokaryk K.L.
      • Wong S.
      • et al.
      Comparison of the Luminex xTAG respiratory viral panel with in-house nucleic acid amplification tests for diagnosis of respiratory virus infections.
      FDA-approved.
      Luminex, http://www.luminexcorp.com, Austin, TX
      Flow through microsphere arrayInfluenza A<4 h9810099100
      H1
      H3
      H5
      CE-approved.
      Influenza B94100100100
      SARS
      CE-approved.
      Corona virus NL63
      CE-approved.
      Corona virus 229E
      CE-approved.
      Corona virus OC43
      CE-approved.
      Corona virus HKU1
      CE-approved.
      RSV, subtype A
      RSV, subtype B
      Parainfluenza 1
      Parainfluenza 2
      Parainfluenza 3
      Parainfluenza 4
      CE-approved.
      Metapneumovirus
      Rhinovirus/
      Enterovirus
      Adenovirus
      Data shown in the table are from product inserts unless otherwise noted.
      Abbreviations: BD, Becton-Dickinson; NA, not available; NPV, negative predictive value; PPV, positive predictive value; qPCR, quantitative polymerase chain reaction; RSV, respiratory syncytial virus; RT, reverse transcriptase; SARS, severe acute respiratory syndrome.
      a FDA-approved.
      b CE-approved.
      c CLIA-waived.
      d In development.
      However, nucleic acid recognition (NAR) for detection of influenza A or B has shown promising benefits (see Table 4). These NAR devices exhibit greater sensitivity and can provide subtyping data. Once a subtype of influenza is positively identified, health care personnel and public health workers have the ability to start surveillance of new strains in a particular area. In addition, subtyping of influenza has the ability to guide antiviral treatment by identifying particular influenza strains that may be resistant or sensitive to antiviral treatment.
      For instance, several H1N1 strains of influenza were resistant to oseltamivir in fall 2008; however, in spring 2009, the novel H1N1 influenza strain (“swine flu”) was sensitive to oseltamivir. Furthermore, in a recent study conducted by Dr Nishiura and colleagues,
      • Nishiura H.
      • Wilson N.
      • Baker M.G.
      Quarantine for pandemic influenza control at the borders of small island nations.
      the use of quarantine and rapid diagnostic testing to prevent or delay the spread of pandemic influenza across island nations was evaluated. In order for quarantine strategy to be effective in preventing or delaying the spread of pandemic influenza, rapid and reliable diagnostic testing must be used to positively identify index cases (first victims) with influenza.
      • Nishiura H.
      • Wilson N.
      • Baker M.G.
      Quarantine for pandemic influenza control at the borders of small island nations.
      Thus, the use of POCT to rapidly diagnose and subtype influenza has significant potential to refine pandemic disaster response and prevent newdemics from spreading outside the bounds of initial disaster or emergency locations.
      This concept is important for disasters on the horizon, such as extensively drug-resistant malaria and tuberculosis. Globally, tuberculosis represents a major problem, especially in low-resource settings, such as impoverished African nations. Current tests available often fail to correctly identify tuberculosis, are not rapid, and cannot identify drug resistance.
      • Grandjean L.
      • Moore D.A.
      Tuberculosis in the developing world: recent advances in diagnosis with special consideration of extensively drug-resistant tuberculosis.
      Rapid-liquid culture shows promising results for tuberculosis detection by improving the sensitivity, speed, reliability, and multidrug-resistant tuberculosis detection.
      • Grandjean L.
      • Moore D.A.
      Tuberculosis in the developing world: recent advances in diagnosis with special consideration of extensively drug-resistant tuberculosis.
      Future thinking is required for developing POCT devices that are proven to simultaneously be rapid, simple, reliable, and cost-effective for diagnosing extensively drug-resistant tuberculosis.
      • Grandjean L.
      • Moore D.A.
      Tuberculosis in the developing world: recent advances in diagnosis with special consideration of extensively drug-resistant tuberculosis.

      Preparedness: gap analysis

      POCT devices typically encounter harsh environmental conditions, temperature extremes, and high humidity in emergency and disaster care. Despite substantial improvements, gaps still exist between current POCT technologies and real-world needs. Inability of POCT instruments and reagents to withstand harsh conditions present at disaster and emergency sites compromises performance.
      • Louie R.F.
      • Sumner S.L.
      • Belcher S.
      • et al.
      Thermal stress and point-of-care testing performance: suitability of glucose test strips and blood gas cartridges for disaster response.
      For example, glucose test strips and blood gas cartridges may not provide accurate measurements at disaster sites because thermal stresses adversely and inconsistently affect performance.
      • Louie R.F.
      • Sumner S.L.
      • Belcher S.
      • et al.
      Thermal stress and point-of-care testing performance: suitability of glucose test strips and blood gas cartridges for disaster response.
      Because of these types of limitations and the obvious technical gaps in POC devices as we know them today, the United States and other countries are not prepared for disasters.
      Box 1 highlights gaps between current POC devices and various problems with technologies currently available. Without durable and robust POCT equipment, diagnosis and treatment of victims at disaster sites becomes increasingly complicated and hindered. To effectively and efficiently diagnose, monitor, and treat patients, the current gaps in POCT technologies and devices must be closed. The POC Technologies Center (http://www.ucdmc.ucdavis.edu/pathology/poctcenter) is currently conducting static and dynamic environmental stress tests to understand the environmental limitations of POC devices and reagents in more detail.
      Strategic planning for POCT in disaster settings: gap analysis

        Discovery

      • Novel new POC technologies for complex POCT in different global settings

        Operational characteristics

      • Native sample testing from complex matrices with minimal prenalytical processing
      • Cassette-contained sample processing to avoid (pathogen) contamination
      • Back-end biohazard disposal in the same cassette, which can be disposed of intact
      • Internal, automated, and electronic quality control; external proficiency testing
      • Battery operation with flexible multiple power supplies

        Format, licensing, and standardization

      • Durable handheld and portable formats for different emergency settings
      • Simple, fast, smart, and easy use codified to achieve CLIA-waived status
      • Competency demonstrated beforehand as part of preparedness in disaster plan
      • Standardized test results verified with “new math” (eg, LS MAD curves)

        Environmental robustness

      • Sensors on board to document location and environmental conditions
      • Durable reagents and equipment not susceptible to environmental stresses
      • Environmental certification based on dynamic stress testing
      • Suitability for meteorologic profiles of disaster sites worldwide

        Diagnostic performance

      • Quantitative POC tests capable of satisfactory accuracy, sensitivity, and specificity
      • Multiplex or multiple patient testing with needs-based test clusters
      • Index case (eg, H1N1) and risk (eg, HIV 1/2 in emergency blood donors) identification
      • Broad-spectrum pathogen surveillance for hazards (eg, World Trade Center [WTC] cough)
      • Mutations and detection of multiresistant strains (eg, tuberculosis) in challenging environments

        Knowledge optimization

      • Full user awareness of performance characteristics based on field evaluations
      • Informatics compatibility, connectivity, and archival in small-world networks
      • Risk indexing of diagnostic targets, wireless results reporting, and outcomes monitoring
      • Cost-effectiveness for implementation in low-resource settings
      Dynamic tests simulate realistic meteorologic conditions found in world regions with high risk for newdemics. US Food and Drug Administration (FDA)-approved product labelings typically state temperature limits, but current limits are inadequate for most disaster conditions. Also, a POCT method that may be proven to work in environmental extremes must also be validated for critically ill patient populations, which few currently do.
      Problems with preanalytical processing present an additional major challenge for reliable POCT device performance. For example, in a recent study conducted by Dighe and colleagues,
      • Dighe A.S.
      • Jones J.B.
      • Parham S.
      • et al.
      Survey of critical value reporting and reduction of false-positive critical value results.
      unusually high false-positive potassium critical values led the laboratory to investigate the preanalytical processing after concluding that the instrument was not the source of the errors. Laboratory personnel noted that when false-positive potassium critical values were seen, a hemoglobin A1C test was also ordered.
      On investigation of the sample processing, Dighe and colleagues
      • Dighe A.S.
      • Jones J.B.
      • Parham S.
      • et al.
      Survey of critical value reporting and reduction of false-positive critical value results.
      found that both tubes were being packaged with ice and transported to the testing facility. Icing blood tubes has been shown to lyse red blood cells and falsely elevate potassium levels.
      • Dighe A.S.
      • Jones J.B.
      • Parham S.
      • et al.
      Survey of critical value reporting and reduction of false-positive critical value results.
      Laboratory technologists subsequently altered the transport requirement for hemoglobin A1C and observed a substantial decrease in potassium false-positive values in ensuing months.
      • Dighe A.S.
      • Jones J.B.
      • Parham S.
      • et al.
      Survey of critical value reporting and reduction of false-positive critical value results.
      When POCT devices are reliable, these types of preanalytical problems can be minimized or eliminated. To ensure best patient care, preanalytical processing methods used on field-worthy POCT devices should be self-contained and disposable, but free from confounding preanalytical errors.
      Box 1 lists several other gaps that need to be addressed. For example, the introduction of locally smooth median absolute difference (LS MAD) curves as a mathematical statistical method to visually analyze the accuracy of POCT blood glucose meters shows that performance in hypoglycemic and hyperglycemic ranges of most blood glucose meters in current use exceeds error tolerance limits for adult critically ill patient populations.
      • Kost G.J.
      • Tran N.K.
      • Sifontes J.R.
      • et al.
      Locally smoothed median absolute difference curves and the first global performance cooperative.
      • Kost G.J.
      • Tran N.K.
      • Louie R.F.
      • et al.
      Assessing the performance of handheld glucose testing for critical care.
      POCT technologies intended for emergency and disaster settings and critically ill patient populations can be improved, standardized, and verified with this new math (see Box 1) to enable better performance and patient outcomes.
      The search and discovery of novel new POC technologies should be actively pursued by researchers. Devices are needed in various global environments across the world. In these different conditions, POCT will encounter new challenges to be overcome. As noted above, POCT instruments must be environmentally robust and capable of withstanding dynamic stresses (see Box 1). In addition, POCT devices should be capable of diagnosing multiple pathogens with adequate clinical sensitivity and specificity (see Box 1), ideally including extensively drug-resistant tuberculosis, malaria, and influenza. New and novel POCT devices will be created in the future featuring improved operational characteristics, environmental robustness, diagnostic performance, and knowledge optimization that enable disaster responders to rapidly diagnose and treat victims and fill current technology gaps.

      Integration strategy: POCT and small-world networks

      Strategic placement of POCT devices within small-world networks (SWN) will effectively facilitate rapid evidence-based medical decisions.
      • Kost G.J.
      Newdemics, public health, small-world networks, and point-of-care testing.
      SWNs enable information to be transmitted quickly from site to site and facilitate quick triage of patients to appropriate points of evaluation.
      • Kost G.J.
      Newdemics, public health, small-world networks, and point-of-care testing.
      SWNs can help manage POCT operations to improve overall efficiency and cost-effectiveness by integrating health care delivery components, including home monitoring, primary care unit testing, mobile medical unit, alternate medical care site, triage, emergency room, and local hospital resources.
      • Kost G.J.
      Newdemics, public health, small-world networks, and point-of-care testing.
      Thus, when a disaster situation arises, such as Hurricane Katrina, the tsunami in Southeast Asia, or the novel H1N1 (swine flu) pandemic, SWNs can effectively allocate POCT resources to allow for rapid and cost-effective patient care or isolation of index cases, as needed, that is also efficient within the context of regional resources. This strategic integration of POCT into regional aspects of disaster and emergency response will ensure that patient care will be rapid and effective.

      Summary

      Use of POCT in disaster and emergency situations will efficiently facilitate rapid evidence-based diagnosis at the site of patient care. A variety of tests are currently available for POCT in hospitals, but the spectrum of POC tests for emergency and disaster care must be broadened.
      The development of pathogen test clusters, based on needs assessment survey results, must be incorporated into new POCT device designs. Besides developing innovative POCT devices, current gaps in POCT technology and availability must be filled to ensure optimal patient care wherever the patient might be.
      Integration and global use of POCT in emergencies will help prevent newdemics from accelerating as seen during Hurricane Katrina and the current influenza pandemic (novel H1N1), while simultaneously improving immediate patient care.
      When a disaster or emergency strikes and as POCT use becomes standard for SWN preparedness, emergency medical responders, alternate medical facilities, and hospitals will be ready to deal effectively with the crises and avoid the pitfalls of the past, when adequate POCT was not available or not used efficiently.
      However, given current state-of-the-art POCT, the United States and other countries are not prepared. Having environmentally robust and rapid POCT devices that are deployable to disaster and emergency sites, and also validated for the care of the critically ill, will bring care to the point of need where physicians and nurses can make fast, evidence-based decisions for triage and treatment.

      Acknowledgments

      The authors thank the needs assessment survey respondents for their valuable contributions. Figures and tables were provided with permission and courtesy of Knowledge Optimization, Davis, CA.

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