Materiały źródłowe

• #1 Diagnostics of Ebola virus

  https://pmc.ncbi.nlm.nih.gov/articles/PMC9995846/

  Ebola is a highly pathogenic virus, which in humans reaches a mortality rate above 50%. […] Due to a lack of laboratories in territories where Ebola viruses are endemic and the limited number of surveillance programmes, tests for the confirmation of suspected cases of Ebola are often performed in Reference Laboratories. […] Molecular tests have been the most frequently used tool in Ebola diagnosis in recent outbreaks. […] One of the most commonly used molecular tests is the Real-Star Altona, which targets a conserved area of the L gene. […] The Cepheid system also showed good sensitivity (232 copies/mL). […] The LAMP platform is very promising because, being an isothermal reaction, it does not require high-precision instrumentation and can be considered a Point of Care (PoC) tool.

• #2 Diagnostics of Ebola virus – PubMed

  https://pubmed.ncbi.nlm.nih.gov/36908455/

  Ebola is a highly pathogenic virus, which in humans reaches a mortality rate above 50%. […] Due to a lack of laboratories in territories where Ebola viruses are endemic and the limited number of surveillance programmes, tests for the confirmation of suspected cases of Ebola are often performed in Reference Laboratories. […] Molecular tests have been the most frequently used tool in Ebola diagnosis in recent outbreaks. […] One of the most commonly used molecular tests is the Real-Star Altona, which targets a conserved area of the L gene. […] The Cepheid system also showed good sensitivity (232 copies/mL). […] The LAMP platform is very promising because, being an isothermal reaction, it does not require high-precision instrumentation and can be considered a Point of Care (PoC) tool.

• #3 Ebola virus disease | Nature Reviews Disease Primers

  https://www.nature.com/articles/s41572-020-0147-3

  Ebola virus disease (EVD) is a severe and frequently lethal disease caused by Ebola virus (EBOV). […] Diagnosis requires a combination of case definition and laboratory tests, typically real-time reverse transcription PCR to detect viral RNA or rapid diagnostic tests based on immunoassays to detect EBOV antigens. […] Erickson, B. R. et al. Ebola virus disease diagnostics, Sierra Leone: analysis of real-time reverse transcription-polymerase chain reaction values for clinical blood and oral swab specimens. […] World Health Organization. Urgently Needed: Rapid, Sensitive, Safe and Simple Ebola Diagnostic Tests. […] Nouvellet, P. et al. The role of rapid diagnostics in managing Ebola epidemics. […] Dhillon, R. S., Srikrishna, D., Garry, R. F. Chowell, G. Ebola control: rapid diagnostic testing. […] de La Vega, M.-A., Bello, A., Chaillet, P. Kobinger, G. P. Diagnosis and management of Ebola samples in the laboratory. […] Iwen, P. C. et al. Safety considerations in the laboratory testing of specimens suspected or known to contain Ebola virus.

• #4 Diagnosis of EVD and Other Laboratory Findings

  https://www.labce.com/spg4470917_diagnosis_of_evd_and_other_laboratory_findings.aspx?srsltid=AfmBOoqDQPh7PFVdMicegpcCHS-16TofeuG_o-cyDF0E0DrLJWGlEuJ6

  It is difficult to diagnose a patient who is in the early stages of EVD because the initial symptoms are nonspecific to Ebola and can be confused with other infectious diseases such as typhoid fever, malaria, and meningitis. […] The table below lists tests that are currently available to aid in the diagnosis of Ebola and the stages of the disease in which the tests are useful. […] It is important to emphasize again that samples from patients are an extreme biohazard risk; laboratory testing on non-inactivated samples should be conducted under maximum biological containment conditions. […] Diagnostic Tests Available Within a few days after signs/symptoms begin (generally 3-10 days) Antigen-capture enzyme-linked immunosorbent assay (ELISA) testing, IgM ELISA, Real-time polymerase chain reaction (RT-PCR), Virus isolation.

• #5

  https://www.who.int/news-room/fact-sheets/detail/ebola-disease

  It can be difficult to clinically distinguish Ebola disease from other infectious diseases such as malaria, typhoid fever, shigellosis, meningitis and other viral haemorrhagic fevers because symptoms at early stage of the disease are similar. […] Confirmation that the person has an Orthoebolavirus infection is made using the following diagnostic methods: reverse transcriptase polymerase chain reaction (RT-PCR) assay, antibody-capture enzyme-linked immunosorbent assay (ELISA), antigen-capture detection tests, virus isolation by cell culture. […] Samples collected from patients are an extreme biohazard risk; laboratory testing on non-inactivated samples should be conducted under maximum biological containment conditions. All non-inactivated biological specimens should be packaged using the triple packaging system when transported nationally and internationally.

• #6 Diagnostics of Ebola virus

  https://pmc.ncbi.nlm.nih.gov/articles/PMC9995846/

  Moreover, in November 2014, the WHO recommended the development of rapid diagnostic tests (RDT) according to ASSURED criteria. […] Several RDT assays have since been produced, most of which are rapid tests based on the search for antibody anti-Ebola viral proteins with immunochromatographic methods. […] From these results, it can be deduced that no RDT reaches the 99% sensitivity recommended by the WHO and therefore any RDT negative results in suspected cases should be confirmed with a molecular test. […] In addition, given that the clinical symptoms of Ebola are similar to those caused by other pathogens such as Yellow Fever virus (YFV), Rift Valley Fever virus (RVFV), Lassa virus (LASV), O’Nyong-Nyong virus (ONNV), rickettsias, Borrelia spp, Coxiella burnetii, and malaria, it is important to use diagnostic methods for differential diagnosis in order to administer a correct therapy and for proper patient management.

• #7 Diagnostics in Ebola Virus Disease in Resource-Rich and Resource-Limited Settings | PLOS Neglected Tropical Diseases

  https://journals.plos.org/plosntds/article?id=10.1371/journal.pntd.0004948

  The Ebola virus disease (EVD) outbreak in West Africa was unprecedented in scale and location. Limited access to both diagnostic and supportive pathology assays in both resource-rich and resource-limited settings had a detrimental effect on the identification and isolation of cases as well as individual patient management. […] Access to rapid, accurate diagnostic assays is essential to enable appropriate patient management and may be used to allow effective discharge planning. In addition, effective outbreak control requires the rapid diagnosis, isolation, and treatment of infected individuals, and the follow-up of their contacts. Early containment of the West Africa outbreak was undoubtedly hampered by a lack of rapid diagnostics that could differentiate EVD from other diseases, given its nonspecific clinical features.

• #8 Diagnostics of Ebola virus

  https://pmc.ncbi.nlm.nih.gov/articles/PMC9995846/

  Literature data report that Ebola viremia could be negative in the early phase of disease. […] For this reason, the test for Ebola virus should be repeated after 72 h if the first result is negative in subjects with clinical symptoms of EVD or who had strict (close) contact with EVD-positive people. […] Thanks to its specificity and sensitivity, RT-PCR is considered the Gold Standard in Ebola diagnosis. […] Patients with negative results, but which have suspected clinical symptoms or contact with Ebola positive subjects, should be retested after 24-48 hours to confirm the negative result. […] The difficulty in accessing an early and fast diagnosis that guarantees the efficient contact tracing and isolation of EVD positive patients limits the control of epidemics. […] Current molecular diagnostic methods such as the polymerase chain reaction require trained personnel and laboratory infrastructures, which hinder diagnostics at the point of need, particularly in outbreak settings and frequently the samples should be sent to a reference center to be analyzed with a delay in the availability of results. […] Therefore, a rapid diagnostic test that is used at a PoC should be compliant with ASSURED criteria. […] Although some of the RDTs show appreciable accuracy, to date, no commercial rapid diagnostic assays have reached the sensitivity and specificity indicated by WHO.

• #9 Laboratory Testing for Ebola | NETEC

  https://netec.org/2022/10/11/laboratory-testing-for-ebola/

  Ebolavirus can be detected in blood after the onset of symptoms. However, it may take up to three days after symptoms start for the virus to reach detectable levels. […] Polymerase chain reaction (PCR) is one of the most commonly used diagnostic methods because of its ability to detect low levels of virus. […] As a result, laboratory diagnostics have focused on identifying that species and testing is available in more than 200 laboratories in the United States. However diagnostic testing for Sudan ebolavirus, the species seen in the current outbreak in Uganda, is not as widespread. […] If your facility has a person under investigation (PUI) for a suspected Ebolavirus, contact your public health department for testing options and specific specimen information. […] If a person under investigation (PUI) meets the Ebolavirus testing criteria, minimize the risk to personnel by doing a risk assessment prior to specimen collection.

• #10

  https://www.who.int/news-room/fact-sheets/detail/ebola-disease

  It can be difficult to clinically distinguish Ebola disease from other infectious diseases such as malaria, typhoid fever, shigellosis, meningitis and other viral haemorrhagic fevers because symptoms at early stage of the disease are similar. […] Confirmation that the person has an Orthoebolavirus infection is made using the following diagnostic methods: reverse transcriptase polymerase chain reaction (RT-PCR) assay, antibody-capture enzyme-linked immunosorbent assay (ELISA), antigen-capture detection tests, virus isolation by cell culture. […] Samples collected from patients are an extreme biohazard risk; laboratory testing on non-inactivated samples should be conducted under maximum biological containment conditions. All non-inactivated biological specimens should be packaged using the triple packaging system when transported nationally and internationally.

• #11 Azthena logo with the word Azthena

  https://www.news-medical.net/health/Ebola-Virus-Diagnosis-and-Treatment.aspx

  Ebola hemorrhagic fever can be suspected in a person with a fever and a history of travel to an endemic area, although it is hard to pinpoint the exact cause based only on the early, non-specific symptoms. […] If a person shows early symptoms of Ebola, and was in contact with a blood or bodily fluids of an infected patient or animal, isolation and notification of public health professionals are mandatory. Samples taken from the patient are then collected in order to confirm the infection by laboratory tests, usually carried out in national and international reference centers. […] Laboratory diagnosis of Ebola is achieved in two ways: detection of infectious particles (or particle components) in affected individuals and measurement of specific immune responses to Ebola virus. Real-time polymerase chain reaction (RT-PCR) and ELISA antigen detection assay represent principal methods to diagnose an acute infection.

• #12 Diagnostics of Ebola virus

  https://pmc.ncbi.nlm.nih.gov/articles/PMC9995846/

  Ebola is a highly pathogenic virus, which in humans reaches a mortality rate above 50%. […] Due to a lack of laboratories in territories where Ebola viruses are endemic and the limited number of surveillance programmes, tests for the confirmation of suspected cases of Ebola are often performed in Reference Laboratories. […] Molecular tests have been the most frequently used tool in Ebola diagnosis in recent outbreaks. […] One of the most commonly used molecular tests is the Real-Star Altona, which targets a conserved area of the L gene. […] The Cepheid system also showed good sensitivity (232 copies/mL). […] The LAMP platform is very promising because, being an isothermal reaction, it does not require high-precision instrumentation and can be considered a Point of Care (PoC) tool.

• #13 Diagnostics of Ebola virus – PubMed

  https://pubmed.ncbi.nlm.nih.gov/36908455/

  Ebola is a highly pathogenic virus, which in humans reaches a mortality rate above 50%. […] Due to a lack of laboratories in territories where Ebola viruses are endemic and the limited number of surveillance programmes, tests for the confirmation of suspected cases of Ebola are often performed in Reference Laboratories. […] Molecular tests have been the most frequently used tool in Ebola diagnosis in recent outbreaks. […] One of the most commonly used molecular tests is the Real-Star Altona, which targets a conserved area of the L gene. […] The Cepheid system also showed good sensitivity (232 copies/mL). […] The LAMP platform is very promising because, being an isothermal reaction, it does not require high-precision instrumentation and can be considered a Point of Care (PoC) tool.

• #14 Diagnostics of Ebola virus

  https://pmc.ncbi.nlm.nih.gov/articles/PMC9995846/

  Ebola is a highly pathogenic virus, which in humans reaches a mortality rate above 50%. […] Due to a lack of laboratories in territories where Ebola viruses are endemic and the limited number of surveillance programmes, tests for the confirmation of suspected cases of Ebola are often performed in Reference Laboratories. […] Molecular tests have been the most frequently used tool in Ebola diagnosis in recent outbreaks. […] One of the most commonly used molecular tests is the Real-Star Altona, which targets a conserved area of the L gene. […] The Cepheid system also showed good sensitivity (232 copies/mL). […] The LAMP platform is very promising because, being an isothermal reaction, it does not require high-precision instrumentation and can be considered a Point of Care (PoC) tool.

• #15 Diagnostics in Ebola Virus Disease in Resource-Rich and Resource-Limited Settings | PLOS Neglected Tropical Diseases

  https://journals.plos.org/plosntds/article?id=10.1371/journal.pntd.0004948

  In both resource-rich and resource-limited settings, the predominant issue at the outbreak onset was limited or absent access to diagnostics allowing EVD to be differentiated from other febrile illnesses. […] Here, we review the assays currently available in resource-rich and resource-limited settings as well as some in development that could play a role in the diagnosis and clinical management of EVD. […] The preferred diagnostic method is via direct detection of viral RNA using a nucleic acid amplification test (NAAT). […] As patients may have an undetectable viraemia in the early stages of disease, it is recommended that tests should be repeated if the clinical suspicion of EVD remains until 72 hours into the illness. […] The provision of supportive assays in a resource-limited setting is challenging and is unavailable in most settings due to expensive equipment and reagents, availability of trained staff to perform the assays and interpret the results, provision of continuous power supply, and refrigeration and appropriate environmental temperatures. […] The unprecedented scale and duration of the West Africa outbreak has resulted in the development of new technologies being offered for trial and approval.

• #16 Laboratory Testing for Ebola | NETEC

  https://netec.org/2022/10/11/laboratory-testing-for-ebola/

  While specimen type may vary, most PCR tests utilize whole blood collected in an EDTA tube (purple top). […] Note: If the person under investigations (PUIs) symptoms have been present for 3 days, a second specimen may be required and collected after 72 hours of symptom onset to definitively rule out Ebola. […] Clinical specimens from PUIs being evaluated for Ebolavirus are considered Category A diagnostic specimens and must be packaged and shipped following specific regulations. […] While routine laboratory specimens suspected or confirmed to contain Ebolavirus can be managed safely in the laboratory, there are many considerations to take into account prior to implementing routine testing.

• #17 Ebola – Wikipedia

  https://en.wikipedia.org/wiki/Ebola

  Ebola virus disease is diagnosed by testing blood samples for the presence of viral RNA, viral antibodies, or the virus itself. […] The specific diagnosis of EVD is confirmed by isolating the virus, detecting its RNA or proteins, or detecting antibodies against the virus in a person’s blood. […] The most common and sensitive diagnostic methods are real-time PCR and ELISA. […] In 2015, a rapid antigen test which gives results in 15 minutes was approved for use by WHO. […] The specific diagnosis of EVD is confirmed by isolating the virus, detecting its RNA or proteins, or detecting antibodies against the virus in a person’s blood. […] Detecting antibodies against the virus is most reliable in the later stages of the disease and in those who recover. […] IgM antibodies are detectable two days after symptom onset and IgG antibodies can be detected six to 18 days after symptom onset.

• #18

• #19 Ebola Virus Infection Workup: Approach Considerations, Laboratory Studies, Histologic Findings

  https://emedicine.medscape.com/article/216288-workup

  The indirect fluorescence antibody test (IFAT) is associated with false-positive results. Concerns over the sensitivity and utility of this test have resulted in the development of confirmatory serologic tests. In infected patients who survive long enough to develop an immune response, the immunoglobulin M (IgM) and immunoglobulin G (IgG) enzyme-linked immunosorbent assay (ELISA) tests may be useful in the diagnosis of Ebola virus infection. Both ELISA tests have been demonstrated to be sensitive and specific. […] An antigen detection ELISA test is available that identifies Ebola virus antigens. […] Tests used to confirm the diagnosis of Ebola virus infection include an immunohistochemical test performed on formalin-fixed postmortem skin taken from patients who have died of Ebola hemorrhagic fever. This test is safe, sensitive, and specific, and it can be used for diagnosis and surveillance.

• #20 Diagnosis of EVD and Other Laboratory Findings

  https://www.labce.com/spg4470917_diagnosis_of_evd_and_other_laboratory_findings.aspx?srsltid=AfmBOoqDQPh7PFVdMicegpcCHS-16TofeuG_o-cyDF0E0DrLJWGlEuJ6

  Later in the disease course or after recovery IgM and IgG antibodies (also used to monitor immune response). […] Retrospectively in deceased patients Immunohistochemistry (IHC) testing, PCR, Virus isolation. […] In these patients, additional laboratory findings can include, but are not limited to: Decreased white blood cell (WBC) count, Elevated liver enzymes, Decreased platelet count, Increased prothrombin time (PT), Increased activated partial thromboplastin time (aPTT).

• #21 Ebola Virus Disease and Its Diagnosis

  https://www.ajpmph.com/ajpmph-articles/ebola-virus-disease-and-its-diagnosis-90083.html

  The methods that work best in the early stages of the disease and for detecting the virus in human remains are cell culture virus isolation, Polymerase Chain Reaction (PCR) virus detection of viral RNA, and Enzyme-Linked Immunosorbent Assay (ELISA) virus detection of viral proteins. […] The best results for finding anti-virus antibodies are shown in patients who have recovered and in the later stages of the illness. IgG antibodies can be found 6 to 18 days after the onset of symptoms, while IgM antibodies can be found two days after the onset of symptoms. It is frequently impossible to isolate the virus using cell culture techniques during an outbreak. […] Differential diagnosis: Early signs of EVD may resemble those of dengue fever and malaria, two illnesses that are widespread in Africa. […]

• #22 Diagnostics of Ebola virus

  https://pmc.ncbi.nlm.nih.gov/articles/PMC9995846/

  Moreover, in November 2014, the WHO recommended the development of rapid diagnostic tests (RDT) according to ASSURED criteria. […] Several RDT assays have since been produced, most of which are rapid tests based on the search for antibody anti-Ebola viral proteins with immunochromatographic methods. […] From these results, it can be deduced that no RDT reaches the 99% sensitivity recommended by the WHO and therefore any RDT negative results in suspected cases should be confirmed with a molecular test. […] In addition, given that the clinical symptoms of Ebola are similar to those caused by other pathogens such as Yellow Fever virus (YFV), Rift Valley Fever virus (RVFV), Lassa virus (LASV), O’Nyong-Nyong virus (ONNV), rickettsias, Borrelia spp, Coxiella burnetii, and malaria, it is important to use diagnostic methods for differential diagnosis in order to administer a correct therapy and for proper patient management.

• #23 Diagnostics of Ebola virus – PubMed

  https://pubmed.ncbi.nlm.nih.gov/36908455/

  Moreover, in November 2014, the WHO recommended the development of rapid diagnostic tests (RDT) according to ASSURED criteria. […] Several RDT assays have since been produced, most of which are rapid tests based on the search for antibody anti-Ebola viral proteins with immunochromatographic methods. […] From these results, it can be deduced that no RDT reaches the 99% sensitivity recommended by the WHO and therefore any RDT negative results in suspected cases should be confirmed with a molecular test.

• #24 Diagnostics of Ebola virus

  https://pmc.ncbi.nlm.nih.gov/articles/PMC9995846/

  Moreover, in November 2014, the WHO recommended the development of rapid diagnostic tests (RDT) according to ASSURED criteria. […] Several RDT assays have since been produced, most of which are rapid tests based on the search for antibody anti-Ebola viral proteins with immunochromatographic methods. […] From these results, it can be deduced that no RDT reaches the 99% sensitivity recommended by the WHO and therefore any RDT negative results in suspected cases should be confirmed with a molecular test. […] In addition, given that the clinical symptoms of Ebola are similar to those caused by other pathogens such as Yellow Fever virus (YFV), Rift Valley Fever virus (RVFV), Lassa virus (LASV), O’Nyong-Nyong virus (ONNV), rickettsias, Borrelia spp, Coxiella burnetii, and malaria, it is important to use diagnostic methods for differential diagnosis in order to administer a correct therapy and for proper patient management.

• #25 Diagnostics of Ebola virus

  https://pmc.ncbi.nlm.nih.gov/articles/PMC9995846/

  Literature data report that Ebola viremia could be negative in the early phase of disease. […] For this reason, the test for Ebola virus should be repeated after 72 h if the first result is negative in subjects with clinical symptoms of EVD or who had strict (close) contact with EVD-positive people. […] Thanks to its specificity and sensitivity, RT-PCR is considered the Gold Standard in Ebola diagnosis. […] Patients with negative results, but which have suspected clinical symptoms or contact with Ebola positive subjects, should be retested after 24-48 hours to confirm the negative result. […] The difficulty in accessing an early and fast diagnosis that guarantees the efficient contact tracing and isolation of EVD positive patients limits the control of epidemics. […] Current molecular diagnostic methods such as the polymerase chain reaction require trained personnel and laboratory infrastructures, which hinder diagnostics at the point of need, particularly in outbreak settings and frequently the samples should be sent to a reference center to be analyzed with a delay in the availability of results. […] Therefore, a rapid diagnostic test that is used at a PoC should be compliant with ASSURED criteria. […] Although some of the RDTs show appreciable accuracy, to date, no commercial rapid diagnostic assays have reached the sensitivity and specificity indicated by WHO.

• #26 FDA allows marketing of first rapid diagnostic test for detecting Ebola virus antigens | FDA

  https://www.fda.gov/news-events/press-announcements/fda-allows-marketing-first-rapid-diagnostic-test-detecting-ebola-virus-antigens

  Today, the U.S. Food and Drug Administration allowed marketing of a rapid diagnostic test (RDT) to detect Ebola virus antigens (proteins) in human blood from certain living individuals and samples from certain recently deceased individuals suspected to have died from Ebola (cadaveric oral fluid). The OraQuick Ebola Rapid Antigen Test is the first rapid diagnostic test the FDA has allowed to be marketed in the U.S. for the Ebola Virus Disease (EVD). The test provides a rapid, presumptive diagnosis that must be confirmed. […] This marketing authorization may provide additional assurances to health care professionals seeking to use these types of rapid diagnostics. The ability to use this test to promptly make a presumptive Ebola diagnosis could help providers to more quickly isolate patients and begin treatments that can be potentially life-saving.

• #27 FDA allows marketing of first rapid diagnostic test for detecting Ebola virus antigens | FDA

  https://www.fda.gov/news-events/press-announcements/fda-allows-marketing-first-rapid-diagnostic-test-detecting-ebola-virus-antigens

  The FDA has authorized a number of diagnostic tests for EVD under the EUA pathway to assist with the public health response. […] For the OraQuick Ebola Test submission, the FDA reviewed data from multiple clinical studies of blood samples and cadaveric oral fluid from the 2014 West African outbreak and from a variety of analytical studies. […] The studies demonstrated the importance of testing only symptomatic individuals so that the amount of virus is high enough to be detectable by this test. Therefore, the OraQuick Ebola Test is intended for use in patients suspected of and with signs or symptoms consistent with EVD, and when the patient meets the CDCs Ebola virus epidemiological criteria, such as history of residence in or travel to a geographic region with active EVD transmission at the time of travel.

• #28 Ebola Virus Infection Workup: Approach Considerations, Laboratory Studies, Histologic Findings

  https://emedicine.medscape.com/article/216288-workup

  The US Food and Drug Administration (FDA) has granted emergency authorization for 2 new tests for detecting Ebola in humans. The tests, which can detect Ebola in blood or urine samples in 1 hour, can be performed on-site in hospitals with the proper lab equipment from the tests manufacturer, BioFire Defense. In other tests, samples must be sent from hospitals to be run in specialized labs and require 24 to 48 hours to produce results. Emergency use authorizations by the FDA permit the use of unapproved medical products in dealing with life-threatening illnesses when no approved or available alternatives exist. […] Definitive diagnosis rests on isolation of the virus by means of tissue culture or reverse-transcription polymerase chain reaction (RT-PCR) assay. However, isolation of Ebola virus in tissue culture is a high-risk procedure that can be performed safely only in a few high-containment laboratories throughout the world.

• #29 Diagnosis of EVD and Other Laboratory Findings

  https://www.labce.com/spg4470917_diagnosis_of_evd_and_other_laboratory_findings.aspx?srsltid=AfmBOoqDQPh7PFVdMicegpcCHS-16TofeuG_o-cyDF0E0DrLJWGlEuJ6

  It is difficult to diagnose a patient who is in the early stages of EVD because the initial symptoms are nonspecific to Ebola and can be confused with other infectious diseases such as typhoid fever, malaria, and meningitis. […] The table below lists tests that are currently available to aid in the diagnosis of Ebola and the stages of the disease in which the tests are useful. […] It is important to emphasize again that samples from patients are an extreme biohazard risk; laboratory testing on non-inactivated samples should be conducted under maximum biological containment conditions. […] Diagnostic Tests Available Within a few days after signs/symptoms begin (generally 3-10 days) Antigen-capture enzyme-linked immunosorbent assay (ELISA) testing, IgM ELISA, Real-time polymerase chain reaction (RT-PCR), Virus isolation.

• #30 What Is Ebola? Symptoms, Causes, Diagnosis, Treatment, and Prevention

  https://www.everydayhealth.com/ebola/guide/

  Diagnosing Ebola can be tricky. Some of the symptoms mimic those of other illnesses, such as malaria and typhoid fever. […] According to the CDC, the criteria for determining if a person has Ebola early on includes both of the following: A combination of symptoms suggestive of the virus; A possible exposure to Ebola within 21 days of when symptoms started. […] If someone does show early signs of the virus and has a possible exposure, public health authorities should be notified. Additionally, the patient should be isolated and given a blood test. […] Ebola can be detected in a person’s blood, but it may take up to three days after symptoms begin for the virus to reach measurable levels. A positive blood test indicates that Ebola was identified and confirmed. […] Some blood tests that are used to detect Ebola are: Enzyme-linked immunosorbent assay (ELISA); Reverse transcriptase polymerase chain reaction (PCR).

• #31 Ebola Virus Disease

  https://www.webmd.com/a-to-z-guides/ebola-fever-virus-infection

  How Is Ebola Diagnosed? […] Tests of blood and tissues are the best ways to diagnose Ebola. Doctors can test for the virus or antibodies to the virus. […] If you have Ebola, youll be isolated from other people right away to prevent spreading the disease to others.

• #32 Ebola disease – Diagnosis Approach | BMJ Best Practice US

  https://bestpractice.bmj.com/topics/en-us/1210/diagnosis-approach

  Ebola disease is a notifiable disease. The case definition is very broad and includes a long list of possible differential diagnoses. […] The main confirmatory test is a positive reverse transcriptase-polymerase chain reaction (RT-PCR) for an Orthoebolavirus. This test should be ordered in all patients with suspected infection while the patient is in isolation. It has the advantage of returning a result 24 to 48 hours before enzyme-linked immunosorbent assay (ELISA) testing. […] It is recommended that appropriate confirmatory tests for Ebola disease are performed before, or in tandem with, differentiating tests for other suspected conditions if Ebola disease is suspected. […] Rapid PCR testing remains a major hurdle for effective, targeted isolation of affected patients. Current tests take an average of 4 hours to perform with a fully equipped level 3 or 4 biosafety laboratory close at hand, but results may take several days to arrive in remote areas.

• #33

• #34

  https://www.who.int/news-room/fact-sheets/detail/ebola-disease

  It can be difficult to clinically distinguish Ebola disease from other infectious diseases such as malaria, typhoid fever, shigellosis, meningitis and other viral haemorrhagic fevers because symptoms at early stage of the disease are similar. […] Confirmation that the person has an Orthoebolavirus infection is made using the following diagnostic methods: reverse transcriptase polymerase chain reaction (RT-PCR) assay, antibody-capture enzyme-linked immunosorbent assay (ELISA), antigen-capture detection tests, virus isolation by cell culture. […] Samples collected from patients are an extreme biohazard risk; laboratory testing on non-inactivated samples should be conducted under maximum biological containment conditions. All non-inactivated biological specimens should be packaged using the triple packaging system when transported nationally and internationally.

• #35 Diagnostics of Ebola virus

  https://pmc.ncbi.nlm.nih.gov/articles/PMC9995846/

  Moreover, in November 2014, the WHO recommended the development of rapid diagnostic tests (RDT) according to ASSURED criteria. […] Several RDT assays have since been produced, most of which are rapid tests based on the search for antibody anti-Ebola viral proteins with immunochromatographic methods. […] From these results, it can be deduced that no RDT reaches the 99% sensitivity recommended by the WHO and therefore any RDT negative results in suspected cases should be confirmed with a molecular test. […] In addition, given that the clinical symptoms of Ebola are similar to those caused by other pathogens such as Yellow Fever virus (YFV), Rift Valley Fever virus (RVFV), Lassa virus (LASV), O’Nyong-Nyong virus (ONNV), rickettsias, Borrelia spp, Coxiella burnetii, and malaria, it is important to use diagnostic methods for differential diagnosis in order to administer a correct therapy and for proper patient management.

• #36 Ebola Virus Infection Differential Diagnoses

  https://emedicine.medscape.com/article/216288-differential

  Ebola hemorrhagic fever should be considered in patients who have recently traveled to areas where Ebola has been reported or in patients who have been exposed to known cases and who exhibit signs and symptoms consistent with Ebola virus infection. […] A main concern in dealing with Ebola virus infections is the potential for human-to-human spread of virus before the correct diagnosis is made. This risk includes all medical personnel in direct contact with the patient, the patients blood, or other body fluids or tissues. Family members who care for patients or who are involved in burial ceremonies and come into contact with the body, blood, or other body fluids are also at high risk for Ebola virus infection. […] In addition to the conditions listed in the differential diagnosis, other problems to be considered include the following: […] Laboratory Studies

• #37 Diagnosing Ebola virus

  https://www.mymed.com/diseases-conditions/ebola-virus-disease-evd/diagnosing-ebola-virus

  The driving factor for an Ebola virus diagnosis is typically during an active outbreak when a confirmed epidemic is occurring. An isolated incidence which presents suspicious indications associated with Ebola virus, like haemorrhage accompanied by fever and other flu-like symptoms, anywhere in the world will also prompt case reporting and diagnosis. […] It is standard practice for several differential diagnostic procedures to be implemented when an unwell individual presents a set of symptoms similar to those experienced with an Ebola infection. Before a diagnosis of Ebola is made, it is likely that any collected samples may also be screened for other acute (sometimes fatal) illnesses like malaria, Marburg virus disease (previously known as Marburg haemorrhagic fever) and Lassa fever (also known as Lassa haemorrhagic fever).

• #38 Ebola Virus Disease and Its Diagnosis

  https://www.ajpmph.com/ajpmph-articles/ebola-virus-disease-and-its-diagnosis-90083.html

  The methods that work best in the early stages of the disease and for detecting the virus in human remains are cell culture virus isolation, Polymerase Chain Reaction (PCR) virus detection of viral RNA, and Enzyme-Linked Immunosorbent Assay (ELISA) virus detection of viral proteins. […] The best results for finding anti-virus antibodies are shown in patients who have recovered and in the later stages of the illness. IgG antibodies can be found 6 to 18 days after the onset of symptoms, while IgM antibodies can be found two days after the onset of symptoms. It is frequently impossible to isolate the virus using cell culture techniques during an outbreak. […] Differential diagnosis: Early signs of EVD may resemble those of dengue fever and malaria, two illnesses that are widespread in Africa. […]

• #39 Diagnostics of Ebola virus

  https://pmc.ncbi.nlm.nih.gov/articles/PMC9995846/

  Moreover, in November 2014, the WHO recommended the development of rapid diagnostic tests (RDT) according to ASSURED criteria. […] Several RDT assays have since been produced, most of which are rapid tests based on the search for antibody anti-Ebola viral proteins with immunochromatographic methods. […] From these results, it can be deduced that no RDT reaches the 99% sensitivity recommended by the WHO and therefore any RDT negative results in suspected cases should be confirmed with a molecular test. […] In addition, given that the clinical symptoms of Ebola are similar to those caused by other pathogens such as Yellow Fever virus (YFV), Rift Valley Fever virus (RVFV), Lassa virus (LASV), O’Nyong-Nyong virus (ONNV), rickettsias, Borrelia spp, Coxiella burnetii, and malaria, it is important to use diagnostic methods for differential diagnosis in order to administer a correct therapy and for proper patient management.

• #40 Diagnosis of EVD and Other Laboratory Findings

  https://www.labce.com/spg4470917_diagnosis_of_evd_and_other_laboratory_findings.aspx?srsltid=AfmBOoqDQPh7PFVdMicegpcCHS-16TofeuG_o-cyDF0E0DrLJWGlEuJ6

  Later in the disease course or after recovery IgM and IgG antibodies (also used to monitor immune response). […] Retrospectively in deceased patients Immunohistochemistry (IHC) testing, PCR, Virus isolation. […] In these patients, additional laboratory findings can include, but are not limited to: Decreased white blood cell (WBC) count, Elevated liver enzymes, Decreased platelet count, Increased prothrombin time (PT), Increased activated partial thromboplastin time (aPTT).

• #41 Ebola Virus Disease and Its Diagnosis

  https://www.ajpmph.com/ajpmph-articles/ebola-virus-disease-and-its-diagnosis-90083.html

  Ebola Virus Disease and Its Diagnosis […] Ebola is a viral hemorrhagic fever that affects humans and other primates and is brought on by ebolaviruses. […] Blood samples are examined for viral RNA, viral antibodies, or the virus itself to confirm the diagnosis. […] Travel, employment history, and animal exposure are significant considerations when it comes to further diagnostic efforts when EVD is suspected. […] Laboratory testing: Low platelet counts, initially decreased white blood cell counts followed by increases in white blood cell counts, elevated levels of the liver enzymes Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST), abnormalities in blood clotting that are frequently indicative of Disseminated Intravascular Coagulation (DIC), such as prolonged prothrombin times, partial thromboplastin times, and bleeding times are all potential non-specific laboratory indicators of EVD. […] By isolating the virus, identifying its RNA or proteins, or identifying antibodies to the virus in a persons blood, the precise diagnosis of EVD can be established.

• #42 Diagnostics in Ebola Virus Disease in Resource-Rich and Resource-Limited Settings | PLOS Neglected Tropical Diseases

  https://journals.plos.org/plosntds/article?id=10.1371/journal.pntd.0004948

  In both resource-rich and resource-limited settings, the predominant issue at the outbreak onset was limited or absent access to diagnostics allowing EVD to be differentiated from other febrile illnesses. […] Here, we review the assays currently available in resource-rich and resource-limited settings as well as some in development that could play a role in the diagnosis and clinical management of EVD. […] The preferred diagnostic method is via direct detection of viral RNA using a nucleic acid amplification test (NAAT). […] As patients may have an undetectable viraemia in the early stages of disease, it is recommended that tests should be repeated if the clinical suspicion of EVD remains until 72 hours into the illness. […] The provision of supportive assays in a resource-limited setting is challenging and is unavailable in most settings due to expensive equipment and reagents, availability of trained staff to perform the assays and interpret the results, provision of continuous power supply, and refrigeration and appropriate environmental temperatures. […] The unprecedented scale and duration of the West Africa outbreak has resulted in the development of new technologies being offered for trial and approval.

• #43 Diagnosis of Ebola Virus Disease and Protein Antigen Detection

  https://www.itmedicalteam.pl/articles/diagnosis-of-ebola-virus-disease-and-protein-antigen-detection-121546.html

  Ebola virus disease laboratory diagnosis is crucial to outbreak response efforts; However, it is still extremely difficult to develop risk-free and speedy testing strategies for this pathogen with a high biosafety level in environments with limited resources. […] Diagnostic techniques have shifted toward faster, more accurate molecular assays ever since the 1976 discovery of the Ebola virus through conventional viral culture methods and electron microscopy. […] Importantly, efforts to support decentralized diagnostic testing capacity that can be utilized at or close to the point of care for patients have increased alongside technological advancements. […] The unprecedented scope of the West Africa Ebola epidemic in 2014 and 2015 sparked a lot of innovation in this area. […] A number of new diagnostic platforms have made it into the field, and they have the potential to change how outbreaks are handled in the future and immediately improve surveillance efforts in West Africa.

• #44 Ebola disease – Diagnosis Approach | BMJ Best Practice US

  https://bestpractice.bmj.com/topics/en-us/1210/diagnosis-approach

  Several different technologies are being evaluated by WHO for use in field conditions. These include numerous RT-PCR-based assays that have been made simpler to use with a shorter turnaround time of 1 hour. […] A GeneXpert diagnostic tool has been developed and trialed in the field. The Xpert Ebola is an automated cartridge-based system that requires minimal laboratory skill.

• #45 Development and Evaluation of a Rapid and Sensitive EBOV-RPA Test for Rapid Diagnosis of Ebola Virus Disease | Scientific Reports

  https://www.nature.com/articles/srep26943

  Confirming Ebola virus disease (EVD), a deadly infectious disease, requires real-time RT-PCR, which takes up to a few hours to yield results. Therefore, a rapid diagnostic assay is imperative for EVD diagnosis. A rapid nucleic acid test based on recombinase polymerase amplification (EBOV-RPA) was developed to specifically detect the 2014 outbreak strains. The EBOV-RPA assay was evaluated by testing samples from suspected EVD patients in parallel with RT-PCR. An EBOV-RPA, which could be completed in 20min, was successfully developed. Of 271 patients who tested positive for Ebola virus by RT-PCR, 264 (sensitivity: 97%, 95% CI: 95.599.3%) were positive by EBOV-RPA; 101 of 104 patients (specificity: 97%, 95% CI: 93.9100%) who tested negative by RT-PCR were also negative by EBOV-RPA. The EBOV-RPA assay showed 97% sensitivity and 97% specificity for all EVD samples tested, making it a rapid and sensitive test for EVD diagnosis.

• #46 Characterization and analytical validation of a new antigenic rapid diagnostic test for Ebola virus disease detection | PLOS Neglected Tropical Diseases

  https://journals.plos.org/plosntds/article?id=10.1371/journal.pntd.0007965

  Hemorrhagic fever outbreaks are difficult to diagnose and control in part because of a lack of low-cost and easily accessible diagnostic structures in countries where etiologic agents are present. […] Current molecular diagnostic methods such as polymerase chain reaction require trained personnel and laboratory infrastructure, hindering diagnostics at the point of need, particularly in outbreak settings. Therefore, rapid diagnostic tests such as lateral flow can be broadly deployed and are typically well-suited to rapidly diagnose hemorrhagic fever viruses, such as Ebola virus. Early detection and control of Ebola outbreaks require simple, easy-to-use assays that can detect very low amount of virus in blood. Here, we developed and characterized an immunoassay test based on immunochromatography coupled to silver amplification technology to detect the secreted glycoprotein of EBOV. The glycoprotein is among the first viral proteins to be detected in blood. This strategy aims at identifying infected patients early following onset of symptoms by detecting low amount of sGP protein in blood samples. The limit of detection achieved by this sGP-targeted kit is 2.2 x 10^4 genome copies/ml in plasma as assayed in a monkey analytical cohort. Clinical performance evaluation showed a specificity of 100% and a sensitivity of 85.7% when evaluated with plasma samples from healthy controls and patients infected with Zaire Ebola virus from Macenta, Guinea. This rapid and accurate diagnostic test could therefore be used in endemic countries for early detection of infected individuals in point of care settings.

• #47 Diagnosis of Ebola Virus Disease and Protein Antigen Detection

  https://www.itmedicalteam.pl/articles/diagnosis-of-ebola-virus-disease-and-protein-antigen-detection-121546.html

  Ebola virus disease laboratory diagnosis is crucial to outbreak response efforts; However, it is still extremely difficult to develop risk-free and speedy testing strategies for this pathogen with a high biosafety level in environments with limited resources. […] Diagnostic techniques have shifted toward faster, more accurate molecular assays ever since the 1976 discovery of the Ebola virus through conventional viral culture methods and electron microscopy. […] Importantly, efforts to support decentralized diagnostic testing capacity that can be utilized at or close to the point of care for patients have increased alongside technological advancements. […] The unprecedented scope of the West Africa Ebola epidemic in 2014 and 2015 sparked a lot of innovation in this area. […] A number of new diagnostic platforms have made it into the field, and they have the potential to change how outbreaks are handled in the future and immediately improve surveillance efforts in West Africa.

• #48 Diagnosis of Ebola Virus Disease and Protein Antigen Detection

  https://www.itmedicalteam.pl/articles/diagnosis-of-ebola-virus-disease-and-protein-antigen-detection-121546.html

  We discuss the development of Ebola virus disease diagnostic testing and initiatives to establish field diagnostic laboratories during previous outbreaks in this review. […] The difficulties associated with diagnostic testing and the significance of rapid and accurate diagnosis of the Ebola virus disease (EVD) have been brought to light by the most recent outbreak in West Africa. […] During the outbreaks of 2014 and 2015, diagnosis was primarily based on testing venepuncture blood samples from symptomatic individuals in a bio containment laboratory facility. […] As a direct consequence of this, there was a previously unheard-of uptick in the creation of brand-new EVD diagnostic techniques due to the demand for speedy and, in particular, point-of-care diagnostics. […] The evolution of laboratory-based methods for EVD diagnosis, their application for field-based testing during outbreaks, and recent advancements in diagnostic tools that are likely to benefit future clinical and surveillance efforts are all summarized in this review.

• #49 Diagnostics of Ebola virus

  https://pmc.ncbi.nlm.nih.gov/articles/PMC9995846/

  Despite the efforts made in the last decade in RD regarding a PoC set-up, including microfluidics that use low-cost materials and which can be used on a wide scale in PoC units, the accuracy of current assays are not yet optimal and often they need to be confirmed by a molecular test. […] In this review, after a brief description of the general aspects of the Ebola viruses, we give an overview of the characteristics of molecular tests, rapid diagnostic tests (RDT)s and tests for differential diagnosis, highlighting the aspects concerning the sensitivity and specificity of the single assays. […] The main advantages of a mobile laboratory are: centralization of diagnostics, rapid result delivery, while the main disadvantages regard the fact it is difficult to obtain a negative pressure environment.

• #50 Diagnosing Ebola in the Field | The Brink | Boston University

  https://www.bu.edu/articles/2019/ebola-rapid-portable-diagnostic/

  Ebola virus, pictured here, can cause fevers that are hard to distinguish from malaria and other infections at their outset. A new diagnostic system could make it easier for clinicians working in remote locations to quickly weed out who really has Ebola and who doesn’t. […] The standard diagnostic tests that exist are very good, but they’re hard to do out in the field in the middle of an outbreak like we saw in West Africa, says John Connor, a Boston University School of Medicine associate professor of microbiology. […] We set out to create a rapid, point-of-care diagnostic that could look for malaria, Ebola, and other pathogens that are often found in these regions, says Connor, a virologist at the BU National Emerging Infectious Diseases Laboratories (NEIDL), which contains a Biosafety Level-4 laboratory that has been working with Ebola virus since August 2018.

• #51 Diagnosing Ebola in the Field | The Brink | Boston University

  https://www.bu.edu/articles/2019/ebola-rapid-portable-diagnostic/

  Analyzing the barcode of light that flashes back from a sample, the machine provides a readout of the presence of malarial parasites or Ebola, Marburg, or Lassa viruses. […] From sample-taking to final readout, the entire process can be completed in a half hour or less. […] A key advantage of this platform, Mboup says, is its ability to detect multiple deadly infections all from a single patient sample contained within one test tube. […] The implications for getting good diagnostics to remote places are huge, says Connor, who is a corresponding author of the study. […] Connor adds that the system could be custom-tailored to detect and differentiate virtually any combination of pathogensbacterial, viral, fungal, or parasitic. […] The reason I find this system so promising is that it can diagnose more than one thing, which is important in the real-world context of infectious diseases, Connor says.

• #52 Africa’s Increased Capacity to Diagnose and Contain Ebola and other Zoonotic Diseases with Nuclear-Derived Techniques | IAEA

  https://www.iaea.org/newscenter/news/africas-increased-capacity-to-diagnose-and-contain-ebola-and-other-zoonotic-diseases-with-nuclear-derived-techniques

  Nuclear-derived techniques have been well established as an important diagnostic tool to rapidly and reliably identify many diseases spreading from animals to humans, such as Ebola Virus Disease, Highly Pathogenic Avian Influenza, Middle East Respiratory Syndrome and others. […] With more veterinary officials now able to diagnose the disease rapidly and reliably, these countries are better prepared for early detection to prevent major outbreaks and have advanced in tracing the molecular epidemiology of Ebola and other viral haemorrhagic fevers (VHFs) with the help of molecular genetic tools. […] Through nuclear-derived techniques such as the enzyme linked immunosorbent assay (ELISA) and the real-time reverse transcription-polymerase chain reaction (RT-PCR), scientists are able to diagnose Ebola much faster than with conventional methods.

• #53 Africa’s Increased Capacity to Diagnose and Contain Ebola and other Zoonotic Diseases with Nuclear-Derived Techniques | IAEA

  https://www.iaea.org/newscenter/news/africas-increased-capacity-to-diagnose-and-contain-ebola-and-other-zoonotic-diseases-with-nuclear-derived-techniques

  The IAEA, through its technical cooperation programme, provided assistance to experts from Africa on the use of these techniques. […] Proper handling of Ebola samples was a major focus of several of the 17 trainings delivered in 8 countries under the IAEA technical cooperation programme. […] The most recent outbreaks of Ebola in the DRC killed more than 2,500 people since 2018. […] The enzyme-linked immunosorbent assay (ELISA) and the real time reverse transcription-polymerase chain reaction (real time RT-PCR) are two nuclear-derived techniques commonly used for disease diagnosis. […] ELISA is often used as initial tests and is mainly (but not exclusively) used for antibody detection. […] Real time RT-PCR is a technique that involves more sophisticated equipment and procedures than ELISA, and is highly sensitive and accurate, making it well-suited for identifying specific viral and bacterial genomes.

• #54 Ebola Virus: Causes, Symptoms, Treatment & Prevention

  https://my.clevelandclinic.org/health/diseases/15606-ebola-virus-disease

  Ebola can be difficult to diagnose because it shares symptoms with other illnesses, including yellow fever, malaria and typhoid fever. Healthcare providers will first: […] If they suspect you have Ebola, they’ll recommend a PCR test to diagnose Ebola. PCR tests are a type of blood test. […] Yes, there are Ebola treatments. Healthcare providers use two monoclonal antibody treatments for Ebola virus disease. Monoclonal antibodies work like your immune system’s natural antibodies. They help fight off the infection while your body builds its own defenses. The monoclonal antibody treatments include: […] If you’re at risk of Ebola exposure and you develop symptoms, see a healthcare provider right away. You may be at risk if you live in an area with animals that carry it, or you’ve traveled to an area with an outbreak.

• #55 Ebola Virus: Causes, Symptoms, Treatment & Prevention

  https://my.clevelandclinic.org/health/diseases/15606-ebola-virus-disease

  The Ervebo vaccine helps protect people who are at high risk of contracting Ebola virus. This includes people who work with orthoebolaviruses in a lab and healthcare workers who treat people who have Ebola. It can also act as a type of pre-exposure prophylaxis for people traveling to areas with Ebola outbreaks. It’s effective during outbreaks, too. […] It’s important to get a proper diagnosis and treatment as soon as you can to increase your chances of a full recovery. […] If you have Ebola, it’s important to get treatment as soon as possible.

• #56 Ebola Outbreak 2018: Diagnostics Again are Essential to Minimize Spread and to Control Disease

  https://blog.seracare.com/molecular-serology-blog/ebola-outbreak-2018-diagnostics-again-are-essential-to-minimize-spread-and-to-control-disease

  There are many new tools to fight the spread of EVD that were not available in the massive 2014-2016 outbreak in Guinea, Liberia and Sierra Leone. […] Finally, and possibly most importantly, rapid, commercially manufactured Ebola virus molecular diagnostics are more widely available. These tests detect viral RNA by real-time reverse transcription polymerase chain reaction (RT-PCR). […] Robust diagnostic testing is essential for controlling the outbreak because it detects EVD cases in new clusters, confirms or excludes suspected cases for effective contact tracing and surveillance, monitors patients in treatment centers, and informs decisions on whether recovered patients are safe for discharge. […] Without diagnostic testing, vaccination programs would be less effective because it would be unclear which contacts should receive vaccination; without the insights into viral load provided by testing, it would not be possible to monitor patient response to selected therapeutics.

• #57 Diagnostics in Ebola Virus Disease in Resource-Rich and Resource-Limited Settings | PLOS Neglected Tropical Diseases

  https://journals.plos.org/plosntds/article?id=10.1371/journal.pntd.0004948

  The Ebola virus disease (EVD) outbreak in West Africa was unprecedented in scale and location. Limited access to both diagnostic and supportive pathology assays in both resource-rich and resource-limited settings had a detrimental effect on the identification and isolation of cases as well as individual patient management. […] Access to rapid, accurate diagnostic assays is essential to enable appropriate patient management and may be used to allow effective discharge planning. In addition, effective outbreak control requires the rapid diagnosis, isolation, and treatment of infected individuals, and the follow-up of their contacts. Early containment of the West Africa outbreak was undoubtedly hampered by a lack of rapid diagnostics that could differentiate EVD from other diseases, given its nonspecific clinical features.

• #58 Diagnosing Ebola virus

  https://www.mymed.com/diseases-conditions/ebola-virus-disease-evd/diagnosing-ebola-virus

  A diagnosis of Ebola virus infection in individuals suspected to be infected with it is essential even though, to date, there are no formally approved therapies specifically for the treatment of the condition. The earlier a person is diagnosed; the sooner supportive care and appropriate treatment can be implemented so as to increase the odds of survival and reduce the risk of further transmission. […] A diagnosis confirms what healthcare personnel are dealing with when providing care and enables the mobilisation of teams to ensure that strategies for larger population safety can be swiftly implemented. […] Testing for Ebola virus infection is required in the diagnosis of the virus and involves coordinated efforts between the local health authorities where the incidence (or outbreak) is suspected to have occurred, as well as the CDC and WHO. The attending medical professional/s will also need to request the assistance of an infectious disease specialist as quickly as possible and implement isolation and barrier protection protocols.

• #59 Diagnostics of Ebola virus

  https://pmc.ncbi.nlm.nih.gov/articles/PMC9995846/

  Despite the efforts made in the last decade in RD regarding a PoC set-up, including microfluidics that use low-cost materials and which can be used on a wide scale in PoC units, the accuracy of current assays are not yet optimal and often they need to be confirmed by a molecular test. […] In this review, after a brief description of the general aspects of the Ebola viruses, we give an overview of the characteristics of molecular tests, rapid diagnostic tests (RDT)s and tests for differential diagnosis, highlighting the aspects concerning the sensitivity and specificity of the single assays. […] The main advantages of a mobile laboratory are: centralization of diagnostics, rapid result delivery, while the main disadvantages regard the fact it is difficult to obtain a negative pressure environment.

• #60 Diagnostics of Ebola virus

  https://pmc.ncbi.nlm.nih.gov/articles/PMC9995846/

  Literature data report that Ebola viremia could be negative in the early phase of disease. […] For this reason, the test for Ebola virus should be repeated after 72 h if the first result is negative in subjects with clinical symptoms of EVD or who had strict (close) contact with EVD-positive people. […] Thanks to its specificity and sensitivity, RT-PCR is considered the Gold Standard in Ebola diagnosis. […] Patients with negative results, but which have suspected clinical symptoms or contact with Ebola positive subjects, should be retested after 24-48 hours to confirm the negative result. […] The difficulty in accessing an early and fast diagnosis that guarantees the efficient contact tracing and isolation of EVD positive patients limits the control of epidemics. […] Current molecular diagnostic methods such as the polymerase chain reaction require trained personnel and laboratory infrastructures, which hinder diagnostics at the point of need, particularly in outbreak settings and frequently the samples should be sent to a reference center to be analyzed with a delay in the availability of results. […] Therefore, a rapid diagnostic test that is used at a PoC should be compliant with ASSURED criteria. […] Although some of the RDTs show appreciable accuracy, to date, no commercial rapid diagnostic assays have reached the sensitivity and specificity indicated by WHO.

• #61 Diagnosis of Ebola Virus Disease and Protein Antigen Detection

  https://www.itmedicalteam.pl/articles/diagnosis-of-ebola-virus-disease-and-protein-antigen-detection-121546.html

  The most common method for diagnosing EVD is real-time RT-PCR, which is a precise and fast method. […] The World Health Organization (WHO) and the Food and Drug Administration (FDA) have approved a number of standard real-time RT-PCR tests for use in emergency situations. […] Four of these tests are available as kits in the market. […] The development of practical improvements to pre- and post-analytic processes and the training of local laboratory technicians in molecular diagnostic techniques, biosafety practices, and quality control are two ways in which international partners and national health ministries can strengthen laboratory capacity in Ebola-endemic regions. […] Moving forward, novel diagnostic platforms like automated NAATs and rapid antigen detection tests that can be utilized in decentralized health care settings with minimal laboratory infrastructure are likely to play a significant role.

• #62 Reagents for Rapid Ebola Diagnostics – The Native Antigen Company

  https://thenativeantigencompany.com/reagents-for-rapid-ebola-diagnostics/

  Diagnosing Ebola […] Diagnostics are therefore crucial in distinguishing Ebola infection during routine surveillance and the screening of patients. […] PCR reference tests show very high sensitivity and specificity, making them the gold standard for accurate EBOV diagnosis. […] Combined, these factors have led to greater interest in rapid diagnostics that can effectively detect and interrupt disease transmission. […] Rapid and accurate POC tests for Ebola could therefore drastically improve detection of infected patients. […] Serological assays such as IgG and IgM ELISAs offer a faster, higher-throughput system for EBOV diagnosis, but equally require sterile conditions and a degree of technical skill that make them difficult to deploy for field use. […] A more viable alternative is the detection of viral antigens circulating in the blood, which are typically detectable within days of disease onset.

• #63 Ebola Outbreak 2018: Diagnostics Again are Essential to Minimize Spread and to Control Disease

  https://blog.seracare.com/molecular-serology-blog/ebola-outbreak-2018-diagnostics-again-are-essential-to-minimize-spread-and-to-control-disease

  One of the lessons learned from the experiences of mobile testing laboratories during the 2014 2016 outbreak was that molecular diagnostic test systems require quality assurance. […] In addition to the lack of validation, training, and quality control materials in the labs, developers of diagnostic assays also did not have access to the disease state materials they needed for assay development. […] AccuPlex Ebola material, which is US-IVD and CE marked, was used by assay developers to speed up development and authorization of Emergency Use of their diagnostic assays and was also formulated into training panels for use in testing labs. […] Stability of reference materials is critical, especially if they are to be useful to mobile labs deployed near outbreak sites. […] The stability of the materials at elevated temperatures make these reference materials ideal for training and validation activities. […] However, surveillance is not effective without rapid, robust molecular diagnostics to quickly confirm or exclude cases.

• #64 Development and Evaluation of a Rapid and Sensitive EBOV-RPA Test for Rapid Diagnosis of Ebola Virus Disease | Scientific Reports

  https://www.nature.com/articles/srep26943

  Considering this situation, the development of a rapid test with high sensitivity is urgently needed. Here, we report the evaluation of a new nucleic acid (NA)-based test, EBOV-RPA, for rapid and sensitive EVD diagnosis. The EBOV-RPA is based on recombinase polymerase amplification (RPA) technology, which is performed at a constant temperature and has a run time shorter than 15min. The aim of the study was to assess the test performance of the EBOV-RPA assay. […] The overall sensitivity, specificity, PPV, and NPV of the EBOV-RPA assay for the panel of 375 samples demonstrated suitable performance of the assay for rapid EVD diagnosis. Most importantly, the PPV for all tested samples was 100%, i.e., the samples positive by EBOV-RPA were true positive samples. For samples with Ct values 34 (representing 94.1% of the samples), the sensitivity was 100% for both sample types. Therefore, EBOV-RPA is very accurate for EVD diagnosis.

• #65 Towards detection and diagnosis of Ebola virus disease at « metajournal.com

  https://www.metajournal.com/articles/307752/towards-detection-diagnosis-ebola-virus-disease-point-care?from_stub=true

  Ebola outbreak-2014 (mainly Zaire strain related Ebola virus) has been declared most widely spread deadly persistent epidemic due to unavailability of rapid diagnostic, detection, and therapeutics. […] Currently, rapid blood tests to diagnose EBOV infection include the antigen or antibodies capture using ELISA and RNA detection using RT/Q-PCR within 3-10 days after the onset of symptoms. […] Thus developing a cost-effective, rapid, sensitive, and selective sensor to detect EVD at point-of-care (POC) is certainly worth exploring to establish rapid diagnostics to decide therapeutics. […] This review highlights SoA of Ebola diagnostics and also a call to develop rapid, selective and sensitive POC detection of EBOV for global health care. […] We propose that adopting miniaturized electrochemical EBOV immunosensing can detect virus level at pM concentration within 40min compared to 3 days of ELISA test at nM levels.

• #66 Healthcare Resources for Suspected Ebola Cases | ACEP

  https://www.acep.org/by-medical-focus/infectious-diseases/infectious-diseases/healthcare-resources-for-suspected-ebola-cases

  Clinical Alert: Due to new Ebola outbreaks in the Democratic Republic of Congo, North Kivu Province and in Guinea, NZerekore Prefecture, EDs are encouraged to review Ebola protocols and screening procedures. […] CDC Health Alert Network: Guidance for using Rapid Diagnostic Tests for Ebola in the US (December 2019) […] Frequently Asked Questions on Screening for Ebola Virus Disease for Providers, Healthcare Facilities and Health Departments […] Identify, Isolate, Inform: Emergency Department Evaluation and Management for Patients Who Present with Possible Ebola Virus Disease (October 2014) Flow chart algorithm […] Guidance on Personal Protective Equipment (PPE) To Be Used By Healthcare Workers during Management of Patients with Confirmed Ebola or Persons under Investigation (PUIs) for Ebola who are Clinically Unstable or Have Bleeding, Vomiting, or Diarrhea in U.S. Hospitals, Including Procedures for Donning and Doffing PPE […] Guidance for Screening and Caring for Pregnant Women with Ebola Virus Disease for Healthcare Providers in U.S. Hospitals […] Interim Guidance for Specimen Collection, Transport, Testing, and Submission of Specimens Testing.

• #67 Diagnostic Testing: Ebola Information for Health Professionals – MN Dept. of Health

  https://www.health.state.mn.us/diseases/ebola/hcp/testing.html

  If evaluating a patient suspected to have Ebola virus disease, call the Minnesota Department of Health at 651-201-5414. […] The Minnesota Department of Health Public Health Laboratory (MDH-PHL) will provide Ebola virus testing 24/7 after consultation with MDH Epidemiologists at 651-201-5414. […] MDH-PHL utilizes the FDA Emergency Use Authorization Ebola Zaire Polymerase Chain Reaction assay to detect Ebola Zaire. It does not detect any other viral hemorrhagic fever (VHF) viruses (i.e. Lassa fever, Ebola Reston, etc.). […] MDH-PHL will submit specimen to CDC for additional testing for VHF viruses. […] The estimated turnaround time for presumptive results is 4- 6 hours upon receipt of sample for a single specimen and may be longer for multiple specimens. […] All specimens tested at MDH-PHL will also be forwarded to CDC for more extensive laboratory testing.

• #68 Viral Haemorrhagic Fevers – Including Ebola Disease | Public Health Ontario

  https://www.publichealthontario.ca/en/Laboratory-Services/Test-Information-Index/VHF-Diagnostic-Serology

  This page provides information on testing available at Public Health Ontario (PHO) for viruses that are associated with severe systemic hemorrhagic syndromes referred to as viral hemorrhagic fevers (VHF). […] A clinical risk assessment is required prior to requesting VHF testing. This should include a review of the clinical status, travel and exposure history and consideration of alternative differential diagnoses for all individuals suspected of a VHF infection. […] VHF infection should be initially suspected if, within 21 days (3 weeks) prior to illness onset, the individual has developed fever and has a: […] Testing of high-risk pathogens requires the involvement of a PHO Microbiologist and approval to proceed with testing. […] A PHO Microbiologist is available through the PHO Customer Service Centre at:

• #69 Viral Haemorrhagic Fevers – Including Ebola Disease | Public Health Ontario

  https://www.publichealthontario.ca/en/Laboratory-Services/Test-Information-Index/VHF-Diagnostic-Serology

  VHF testing requires the concurrence of a PHO Microbiologist. Do not collect specimens for microbiological examination before consulting with a PHO Microbiologist. […] Each VHF test that is approved by the PHO Microbiologist (e.g. Lassa virus PCR) should be indicated on the General Test Requisition. […] PHO will only test for the specific VHF-causing viruses that have been approved after a discussion between the PHO Microbiologist and the requesting healthcare provider(s). […] All results should be interpreted in the context of the clinical history and other pathological findings. […] A laboratory-confirmed VHF infection requires: (i) Detection of the genetic targets of a particular virus AND (ii) Confirmatory testing performed by the NML. […] The reporting plan will be communicated to stakeholders at the time of testing. The report issued by PHO for any VHF testing is considered preliminary and requires confirmation by the NML.

• #70 Diagnosing Ebola virus

  https://www.mymed.com/diseases-conditions/ebola-virus-disease-evd/diagnosing-ebola-virus

  Testing is typically performed in maximum-containment laboratories (biosafety level 4) which can safely handle high-risk microbes (pathogens) associated with infectious diseases, like Ebola. […] Laboratory personnel are required to wear positive-pressure protective suits equipped with umbilical-fed air supply.

• #71 Diagnostics in Ebola Virus Disease in Resource-Rich and Resource-Limited Settings | PLOS Neglected Tropical Diseases

  https://journals.plos.org/plosntds/article?id=10.1371/journal.pntd.0004948

  The Ebola virus disease (EVD) outbreak in West Africa was unprecedented in scale and location. Limited access to both diagnostic and supportive pathology assays in both resource-rich and resource-limited settings had a detrimental effect on the identification and isolation of cases as well as individual patient management. […] Access to rapid, accurate diagnostic assays is essential to enable appropriate patient management and may be used to allow effective discharge planning. In addition, effective outbreak control requires the rapid diagnosis, isolation, and treatment of infected individuals, and the follow-up of their contacts. Early containment of the West Africa outbreak was undoubtedly hampered by a lack of rapid diagnostics that could differentiate EVD from other diseases, given its nonspecific clinical features.

• #72 Diagnosing Ebola virus

  https://www.mymed.com/diseases-conditions/ebola-virus-disease-evd/diagnosing-ebola-virus

  A diagnosis of Ebola virus infection in individuals suspected to be infected with it is essential even though, to date, there are no formally approved therapies specifically for the treatment of the condition. The earlier a person is diagnosed; the sooner supportive care and appropriate treatment can be implemented so as to increase the odds of survival and reduce the risk of further transmission. […] A diagnosis confirms what healthcare personnel are dealing with when providing care and enables the mobilisation of teams to ensure that strategies for larger population safety can be swiftly implemented. […] Testing for Ebola virus infection is required in the diagnosis of the virus and involves coordinated efforts between the local health authorities where the incidence (or outbreak) is suspected to have occurred, as well as the CDC and WHO. The attending medical professional/s will also need to request the assistance of an infectious disease specialist as quickly as possible and implement isolation and barrier protection protocols.

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