scholarly journals COVID-19 Antibody Detecting Rapid Diagnostic Tests Show High Cross-Reactivity When Challenged with Pre-Pandemic Malaria, Schistosomiasis and Dengue Samples

Diagnostics ◽  
2021 ◽  
Vol 11 (7) ◽  
pp. 1163
Author(s):  
Fien Vanroye ◽  
Dorien Van den Bossche ◽  
Isabel Brosius ◽  
Bieke Tack ◽  
Marjan Van Esbroeck ◽  
...  
Keyword(s):  
Retrospective Study ◽  
Whole Blood ◽  
Diagnostic Tests ◽  
Risk Mitigation ◽  
Plasmodium Species ◽  
Cross Reactivity ◽  
Rapid Diagnostic Tests ◽  
Middle Income ◽  
Middle Income Countries ◽  
Independent Evaluation

COVID-19 Antibody Detecting Rapid Diagnostic Tests (COVID-19 Ab RDTs) are the preferred tool for SARS-CoV-2 seroprevalence studies, particularly in low- and middle-income countries. The present study challenged COVID-19 Ab RDTs with pre-pandemic samples of patients exposed to tropical pathogens. A retrospective study was performed on archived serum (n = 94) and EDTA whole blood (n = 126) samples obtained during 2010–2018 from 196 travelers with malaria (n = 170), schistosomiasis (n = 25) and dengue (n = 25). COVID-19 Ab RDTs were selected based on regulatory approval status, independent evaluation results and detecting antigens. Among 13 COVID-19 Ab RDT products, overall cross-reactivity was 18.5%; cross-reactivity for malaria, schistosomiasis and dengue was 20.3%, 18.1% and 7.5%, respectively. Cross-reactivity for current and recent malaria, malaria antibodies, Plasmodium species and parasite densities was similar. Cross-reactivity among the different RDT products ranged from 2.7% to 48.9% (median value 14.5%). IgM represented 67.9% of cross-reactive test lines. Cross-reactivity was not associated with detecting antigens, patient categories or disease (sub)groups, except for schistosomiasis (two products with ≥60% cross-reactivity). The high cross-reactivity for malaria, schistosomiasis and—to a lesser extent—dengue calls for risk mitigation when using COVID-19 Ab RDTs in co-endemic regions.

scholarly journals Impact of a package of diagnostic tools, clinical algorithm, and training and communication on outpatient acute fever case management in low- and middle-income countries: protocol for a randomized controlled trial

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Olawale Salami ◽  
Philip Horgan ◽  
Catrin E. Moore ◽  
Abhishek Giri ◽  
Asadu Sserwanga ◽  
...  
Keyword(s):  
Clinical Outcomes ◽  
Diagnostic Tests ◽  
Antibiotic Prescription ◽  
Rapid Diagnostic Tests ◽  
Intervention Package ◽  
Middle Income ◽  
Middle Income Countries ◽  
Randomized Controlled ◽  
And Training ◽  
Low And Middle Income

Abstract Background The management of acute febrile illnesses places a heavy burden on clinical services in many low- and middle-income countries (LMICs). Bacterial and viral aetiologies of acute fevers are often clinically indistinguishable and, in the absence of diagnostic tests, the ‘just-in-case’ use of antibiotics by many health workers has become common practice, which has an impact on drug-resistant infections. Our study aims to answer the following question: in patients with undifferentiated febrile illness presenting to outpatient clinics/peripheral health centres in LMICs, can we demonstrate an improvement in clinical outcomes and reduce unnecessary antibiotic prescription over current practice by using a combination of simple, accurate diagnostic tests, clinical algorithms, and training and communication (intervention package)? Methods We designed a randomized, controlled clinical trial to evaluate the impact of our intervention package on clinical outcomes and antibiotic prescription rates in acute febrile illnesses. Available, point-of-care, pathogen-specific and non-pathogen specific (host markers), rapid diagnostic tests (RDTs) included in the intervention package were selected based on pre-defined criteria. Nine clinical study sites in six countries (Burkina Faso, Ghana, India, Myanmar, Nepal and Uganda), which represent heterogeneous outpatient care settings, were selected. We considered the expected seasonal variations in the incidence of acute febrile illnesses across all the sites by ensuring a recruitment period of 12 months. A master protocol was developed and adapted for country-specific ethical submissions. Diagnostic algorithms and choice of RDTs acknowledged current data on aetiologies of acute febrile illnesses in each country. We included a qualitative evaluation of drivers and/or deterrents of uptake of new diagnostics and antibiotic use for acute febrile illnesses. Sample size estimations were based on historical site data of antibiotic prescription practices for malarial and non-malarial acute fevers. Overall, 9 semi-independent studies will enrol a minimum of 21,876 patients and an aggregate data meta-analysis will be conducted on completion. Discussion This study is expected to generate vital evidence needed to inform policy decisions on the role of rapid diagnostic tests in the clinical management of acute febrile illnesses, with a view to controlling the rise of antimicrobial resistance in LMICs. Trial registration Clinicaltrials.gov NCT04081051. Registered on 6 September 2019. Protocol version 1.4 dated 20 December 2019

scholarly journals Impact of a Package of Diagnostic Tools, Clinical Algorithm, and Training and Communication on Outpatient Acute Fever Case Management in Low- and Middle-Income Countries: Protocol for a Randomized Controlled Trial

2020 ◽  
Author(s):  
Olawale Salami ◽  
Philip Horgan ◽  
Catrin E Moore ◽  
Abhishek Giri ◽  
Asadu Sserwanga ◽  
...  
Keyword(s):  
Clinical Outcomes ◽  
Diagnostic Tests ◽  
Antibiotic Prescription ◽  
Rapid Diagnostic Tests ◽  
Intervention Package ◽  
Middle Income ◽  
Middle Income Countries ◽  
The Impact ◽  
And Training ◽  
Low And Middle Income

Abstract Background.The management of acute febrile illnesses places a heavy burden on clinical services in many low- and middle-income countries (LMICs). Bacterial and viral aetiologies of acute fevers are often clinically indistinguishable and, in the absence of diagnostic tests, the ‘just-in-case’ use of antibiotics by many health workers has become common practice, which has an impact on drug-resistant infections.Our study aims to answer the following question: in patients with undifferentiated febrile illness presenting to outpatient clinics/peripheral health centres in LMICs, can we demonstrate an improvement in clinical outcomes and reduce unnecessary antibiotic prescription over current practice by using a combination of simple, accurate diagnostic tests, clinical algorithms, and training and communication (intervention package)?Methods.We designed a randomized, controlled clinical trial to evaluate the impact of our intervention package on clinical outcomes and antibiotic prescription rates in acute febrile illnesses. Available, point-of-care, pathogen-specific and non-pathogen specific (host markers), rapid diagnostic tests (RDTs) included in the intervention package were selected based on pre-defined criteria. Nine clinical study sites in six countries (Burkina Faso, Ghana, India, Myanmar, Nepal and Uganda), which represent heterogeneous outpatient care settings, were selected. We considered the expected seasonal variations in the incidence of acute febrile illnesses across all the sites by ensuring a recruitment period of 12 months. A master protocol was developed and adapted for country-specific ethical submissions. Diagnostic algorithms and choice of RDTs acknowledged current data on aetiologies of acute febrile illnesses in each country. We included a qualitative evaluation of drivers and/or deterrents of uptake of new diagnostics and antibiotic use for acute febrile illnesses. Sample size estimations were based on historical site data of antibiotic prescription practices for malarial and non-malarial acute fevers. Overall, 9 semi-independent studies will enrol a minimum of 21,876 patients and an aggregate data meta-analysis will be conducted on completion.DiscussionThis study is expected to generate vital evidence needed to inform policy decisions on the role of rapid diagnostic tests in the clinical management of acute febrile illnesses, with a view to controlling the rise of antimicrobial resistance in LMICs.Trial registration: Clinicaltrials.gov, identifier NCT04081051, registered 06 SEP 2019.Protocol version 1.4 Date 20 December 2019

scholarly journals Impact of a package of diagnostic tools, clinical algorithm, and training and communication on outpatient acute fever case management in low- and middle-income countries:  protocol for a randomized controlled trial

2020 ◽  
Author(s):  
Olawale Salami ◽  
Philip Horgan ◽  
Catrin E Moore ◽  
Abhishek Giri ◽  
Asadu Sserwanga ◽  
...  
Keyword(s):  
Clinical Outcomes ◽  
Diagnostic Tests ◽  
Antibiotic Prescription ◽  
Rapid Diagnostic Tests ◽  
Intervention Package ◽  
Middle Income ◽  
Middle Income Countries ◽  
Randomized Controlled ◽  
And Training ◽  
Low And Middle Income

Abstract Background. The management of acute febrile illnesses places a heavy burden on clinical services in many low- and middle-income countries (LMICs). Bacterial and viral aetiologies of acute fevers are often clinically indistinguishable and, in the absence of diagnostic tests, the ‘just-in-case’ use of antibiotics by many health workers has become common practice, which has an impact on drug-resistant infections.Our study aims to answer the following question: in patients with undifferentiated febrile illness presenting to outpatient clinics/peripheral health centres in LMICs, can we demonstrate an improvement in clinical outcomes and reduce unnecessary antibiotic prescription over current practice by using a combination of simple, accurate diagnostic tests, clinical algorithms, and training and communication (intervention package)? Methods. We designed a randomized, controlled clinical trial to evaluate the impact of our intervention package on clinical outcomes and antibiotic prescription rates in acute febrile illnesses. Available, point-of-care, pathogen-specific and non-pathogen specific (host markers), rapid diagnostic tests (RDTs) included in the intervention package were selected based on pre-defined criteria. Nine clinical study sites in six countries (Burkina Faso, Ghana, India, Myanmar, Nepal and Uganda), which represent heterogeneous outpatient care settings, were selected. We considered the expected seasonal variations in the incidence of acute febrile illnesses across all the sites by ensuring a recruitment period of 12 months. A master protocol was developed and adapted for country-specific ethical submissions. Diagnostic algorithms and choice of RDTs acknowledged current data on aetiologies of acute febrile illnesses in each country. We included a qualitative evaluation of drivers and/or deterrents of uptake of new diagnostics and antibiotic use for acute febrile illnesses. Sample size estimations were based on historical site data of antibiotic prescription practices for malarial and non-malarial acute fevers. Overall, 9 semi-independent studies will enrol a minimum of 21,876 patients and an aggregate data meta-analysis will be conducted on completion. Discussion. This study is expected to generate vital evidence needed to inform policy decisions on the role of rapid diagnostic tests in the clinical management of acute febrile illnesses, with a view to controlling the rise of antimicrobial resistance in LMICs. Trial registration: Clinicaltrials.gov, identifier NCT04081051, registered 06 SEP 2019.Protocol version 1.4 Dated 20 December 2019

scholarly journals Impact of a package of diagnostic tools, clinical algorithm, and training and communication on outpatient acute fever case management in low- and middle-income countries:  protocol for a randomized controlled trial

2020 ◽  
Author(s):  
Olawale Salami ◽  
Philip Horgan ◽  
Catrin E Moore ◽  
Abhishek Giri ◽  
Asadu Sserwanga ◽  
...  
Keyword(s):  
Clinical Outcomes ◽  
Diagnostic Tests ◽  
Antibiotic Prescription ◽  
Rapid Diagnostic Tests ◽  
Intervention Package ◽  
Middle Income ◽  
Middle Income Countries ◽  
Randomized Controlled ◽  
And Training ◽  
Low And Middle Income

Abstract Background. The management of acute febrile illnesses places a heavy burden on clinical services in many low- and middle-income countries (LMICs). Bacterial and viral aetiologies of acute fevers are often clinically indistinguishable and, in the absence of diagnostic tests, the ‘just-in-case’ use of antibiotics by many health workers has become common practice, which has an impact on drug-resistant infections.Our study aims to answer the following question: in patients with undifferentiated febrile illness presenting to outpatient clinics/peripheral health centres in LMICs, can we demonstrate an improvement in clinical outcomes and reduce unnecessary antibiotic prescription over current practice by using a combination of simple, accurate diagnostic tests, clinical algorithms, and training and communication (intervention package)? Methods. We designed a randomized, controlled clinical trial to evaluate the impact of our intervention package on clinical outcomes and antibiotic prescription rates in acute febrile illnesses. Available, point-of-care, pathogen-specific and non-pathogen specific (host markers), rapid diagnostic tests (RDTs) included in the intervention package were selected based on pre-defined criteria. Nine clinical study sites in six countries (Burkina Faso, Ghana, India, Myanmar, Nepal and Uganda), which represent heterogeneous outpatient care settings, were selected. We considered the expected seasonal variations in the incidence of acute febrile illnesses across all the sites by ensuring a recruitment period of 12 months. A master protocol was developed and adapted for country-specific ethical submissions. Diagnostic algorithms and choice of RDTs acknowledged current data on aetiologies of acute febrile illnesses in each country. We included a qualitative evaluation of drivers and/or deterrents of uptake of new diagnostics and antibiotic use for acute febrile illnesses. Sample size estimations were based on historical site data of antibiotic prescription practices for malarial and non-malarial acute fevers. Overall, 9 semi-independent studies will enrol a minimum of 21,876 patients and an aggregate data meta-analysis will be conducted on completion. Discussion. This study is expected to generate vital evidence needed to inform policy decisions on the role of rapid diagnostic tests in the clinical management of acute febrile illnesses, with a view to controlling the rise of antimicrobial resistance in LMICs. Trial registration: Clinicaltrials.gov, identifier NCT04081051, registered 06 SEP 2019.Protocol version 1.4 Dated 20 December 2019

scholarly journals Cost Effectiveness of Environmental Lead Risk Mitigation in Low- and Middle-Income Countries

GeoHealth ◽  
2018 ◽  
Vol 2 (2) ◽  
pp. 87-101 ◽  
Author(s):  
Bret Ericson ◽  
Jack Caravanos ◽  
Conrado Depratt ◽  
Cynthia Santos ◽  
Mishelle Gomez Cabral ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Risk Mitigation ◽  
Middle Income ◽  
Environmental Lead ◽  
Middle Income Countries ◽  
Low And Middle Income

scholarly journals Rapid diagnostic tests as a source of DNA for Plasmodium species-specific real-time PCR

2011 ◽  
Vol 10 (1) ◽  
Author(s):  
Lieselotte Cnops ◽  
Merel Boderie ◽  
Philippe Gillet ◽  
Marjan Van Esbroeck ◽  
Jan Jacobs
Keyword(s):  
Real Time ◽  
Real Time Pcr ◽  
Diagnostic Tests ◽  
Plasmodium Species ◽  
Rapid Diagnostic Tests ◽  
Species Specific

scholarly journals Sensitivity and Specificity Evaluation of Pre- and Post-Expiration of Rapid Diagnostic Tests Used in Routine Screening of Donated Whole Blood Products

2015 ◽  
Vol 144 (suppl 2) ◽  
pp. A212-A212
Author(s):  
Ron Christian Sison ◽  
Billy Joseph David ◽  
Fatima Jusay ◽  
Ma. Katrina Monica Rodriguez ◽  
Shanna Bernadette Rosero ◽  
...  
Keyword(s):  
Sensitivity And Specificity ◽  
Whole Blood ◽  
Diagnostic Tests ◽  
Rapid Diagnostic Tests ◽  
Routine Screening ◽  
Blood Products

scholarly journals Using prenatal blood samples to validate COVID-19 rapid serologic tests

2020 ◽  
Author(s):  
Jackeline Alger ◽  
Maria Luisa Cafferata ◽  
Tito Alvarado ◽  
Alvaro Ciganda ◽  
Arturo Corrales ◽  
...  
Keyword(s):  
Diagnostic Tests ◽  
Population Based ◽  
Cross Reactivity ◽  
Rapid Diagnostic Tests ◽  
Serum Samples ◽  
Serologic Tests ◽  
Rapid Tests ◽  
Unique Source ◽  
Blood Specimens ◽  
One Year

Abstract IntroductionBackground cross-reactivity with other coronaviruses may reduce the specificity of COVID-19 rapid serologic tests. Blood collected during prenatal care is a unique source of population-based samples appropriate for validation studies. We used stored 2018 serum samples from an existing pregnancy cohort study to evaluate the specificity of COVID-19 serologic rapid diagnostic tests. MethodsWe randomly selected 120 stored serum samples from pregnant women enrolled in a cohort in 2018, at least one year before the COVID-19 pandemic. We used stored serum to evaluate four lateral flow rapid diagnostic tests, following manufacturers’ instructions. Pictures were taken for all tests and read by two blinded trained evaluators. Results We evaluated 120, 80, 90, and 90 samples, respectively. Specificity for both IgM and IgG was 100% for the first two tests. The third test had a specificity of 98.9% for IgM and 94.4% for IgG. The fourth test had a specificity of 88.9% for IgM and 100% for IgG.Discussion COVID-19 serologic rapid tests are of variable specificity. Blood specimens from sentinel prenatal clinics provide an opportunity to validate serologic tests with population-based samples.

scholarly journals Rapid Diagnostics for Hepatitis B and C Viruses in Low- and Middle-Income Countries

2021 ◽  
Vol 1 ◽  
Author(s):  
Juliet A. Shenge ◽  
Carla Osiowy
Keyword(s):  
Hepatitis B ◽  
Global Health ◽  
Diagnostic Tests ◽  
Health Sector ◽  
Linkage To Care ◽  
World Health ◽  
Rapid Diagnostics ◽  
Middle Income ◽  
Middle Income Countries ◽  
Low And Middle Income

The global health challenge posed by hepatitis B virus (HBV) and hepatitis C virus (HCV) persists, especially in low-and-middle-income countries (LMICs), where underdiagnosis of these viral infections remains a barrier to the elimination target of 2030. HBV and HCV infections are responsible for most liver-related mortality worldwide. Infected individuals are often unaware of their condition and as a result, continue to transmit these viruses. Although conventional diagnostic tests exist, in LMIC they are largely inaccessible due to high costs or a lack of trained personnel, resulting in poor linkage to care and increased infections. Timely and accurate diagnosis is needed to achieve elimination of hepatitis B and C by the year 2030 as set out by the World Health Organization Global Health Sector Strategy. In this review rapid diagnostic tests allowing for quick and cost-effective screening and diagnosis of HBV and HCV, are discussed, as are their features, including suitability, reliability, and applicability in LMIC, particularly those within Africa.

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