Research

29 pages, 2112 KiB

Open AccessArticle

Optimizing Public Health Preparedness for Highly Infectious Diseases in Central Vietnam

by Amanullah Zadran, An V. D. Ho, Layma Zadran, Irene J. Ventura Curiel, Tang-Tung Pham, Duong Thi Bich Thuan and Gerald J. Kost

Diagnostics 2022, 12(9), 2047; https://0-doi-org.brum.beds.ac.uk/10.3390/diagnostics12092047 - 24 Aug 2022

Cited by 2 | Viewed by 2463

Abstract

Our primary objectives were (a) to determine the need for and the availability of point-of-care testing (POCT) for infectious diseases and (b) to recommend point-of-care testing strategies and Spatial Care Paths^TM (SCPs) that enhance public health preparedness in the regional districts of [...] Read more.

Our primary objectives were (a) to determine the need for and the availability of point-of-care testing (POCT) for infectious diseases and (b) to recommend point-of-care testing strategies and Spatial Care Paths^TM (SCPs) that enhance public health preparedness in the regional districts of Thua Thien Hue Province (TTHP), Central Vietnam, where we conducted field surveys. Medical professionals in seven community health centers (CHCs), seven district hospitals (DHs) and one provincial hospital (PH) participated. Survey questions (English and Vietnamese) determined the status of diagnostic testing capabilities for infectious diseases and other acute medical challenges in TTHP. Infectious disease testing was limited: six of seven CHCs (86%) lacked infectious disease tests. One CHC (14%, 1/7) had two forms of diagnostic tests available for the detection of malaria. All CHCs lacked adequate microbiology laboratories. District hospitals had few diagnostic tests for infectious diseases (tuberculosis and syphilis), blood culture (29%, 2/7), and pathogen culture (57%, 4/7) available. The PH had broader diagnostic testing capabilities but lacked preparedness for highly infectious disease threats (e.g., Ebola, MERS-CoV, SARS, Zika, and monkeypox). All sites reported having COVID-19 rapid antigen tests; COVID-19 RT-PCR tests were limited to higher-tier hospitals. We conclude that infectious disease diagnostic testing should be improved and POC tests must be supplied near patients’ homes and in primary care settings for the early detection of infected individuals and the mitigation of the spread of new COVID-19 variants and other highly infectious diseases. Full article

(This article belongs to the Special Issue Point-of-Care Diagnostics for Low-Resource Settings)

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21 pages, 2423 KiB

Open AccessArticle

Field Experiences with Handheld Diagnostic Devices to Triage Children under Five Presenting with Severe Febrile Illness in a District Hospital in DR Congo

by Bieke Tack, Daniel Vita, Irène Mansosa, Thomas Nsema Mbaki, Naomie Wasolua, Aimée Luyindula, Jaan Toelen, Octavie Lunguya and Jan Jacobs

Diagnostics 2022, 12(3), 746; https://0-doi-org.brum.beds.ac.uk/10.3390/diagnostics12030746 - 18 Mar 2022

Cited by 2 | Viewed by 2333

Abstract

As part of a field study (NCT04473768) in children presenting with severe febrile illness to Kisantu hospital (DR Congo), we retrospectively compiled user experiences (not performance) with handheld diagnostic devices assisting triage: tympanic thermometer, pulse oximeter (measuring heart rate, respiratory rate and oxygen [...] Read more.

As part of a field study (NCT04473768) in children presenting with severe febrile illness to Kisantu hospital (DR Congo), we retrospectively compiled user experiences (not performance) with handheld diagnostic devices assisting triage: tympanic thermometer, pulse oximeter (measuring heart rate, respiratory rate and oxygen saturation), hemoglobinometer and glucometer. Guidance documents for product selection were generic and scattered. Stock rupture, market withdrawal and unaffordable prices interfered with procurement. Challenges at implementation included environmental temperature, capillary blood sampling (antisepsis, order of multiple tests, filling microcuvettes and glucose strips), calibration (environmental temperature, cold chain) and liability-oriented communication with a manufacturer. Instructions for use were readable and contained symbol keys; two devices had printed French-language instructions. Shortcomings were poor integration of figures with text and distinct procedures for the oximeter and its sensor. Usability interview revealed appreciations for quick results, visibility of the display and memory function (three devices) but also problems of capillary blood sample transfer, cleaning, too long of a time-to-results (respiratory rate) and size, fitting and disposal of thermometer probes. Pictorial error messages were preferred over alphanumeric error codes but interpretation of symbols was poor. Alarm sounds of the oximeter caused unrest in children and caretakers perceived the device as associated with poor prognosis. Full article

(This article belongs to the Special Issue Point-of-Care Diagnostics for Low-Resource Settings)

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9 pages, 528 KiB

Open AccessArticle

Diagnosis of Visceral Leishmaniasis in an Elimination Setting: A Validation Study of the Diagnostic Algorithm in India

by Kristien Cloots, Om Prakash Singh, Abhishek Kumar Singh, Anurag Kumar Kushwaha, Paritosh Malaviya, Sangeeta Kansal, Epco Hasker and Shyam Sundar

Diagnostics 2022, 12(3), 670; https://0-doi-org.brum.beds.ac.uk/10.3390/diagnostics12030670 - 09 Mar 2022

Cited by 5 | Viewed by 2366

Abstract

Visceral leishmaniasis (VL) is on the verge of elimination on the Indian subcontinent. Nonetheless, the currently low VL-incidence setting brings along new challenges, one of which is the validity of the diagnostic algorithm, based on a combination of suggestive clinical symptoms in combination [...] Read more.

Visceral leishmaniasis (VL) is on the verge of elimination on the Indian subcontinent. Nonetheless, the currently low VL-incidence setting brings along new challenges, one of which is the validity of the diagnostic algorithm, based on a combination of suggestive clinical symptoms in combination with a positive rK39 Rapid Diagnostic Test (RDT). With this study, we aimed to assess the positive predictive value of the diagnostic algorithm in the current low-endemic setting in India by re-assessing newly diagnosed VL patients with a qPCR analysis on venous blood as the reference test. In addition, we evaluated the specificity of the rK39 RDT by testing non-VL cases with the rK39 RDT. Participants were recruited in Bihar and Uttar Pradesh, India. VL patients diagnosed based on the diagnostic algorithm were recruited through six primary health care centers (PHCs); non-VL cases were identified through a door-to-door survey in currently endemic, previously endemic, and non-endemic clusters, and tested with rK39 RDT, as well as—if positive—with qPCR on peripheral blood. We found that 95% (70/74; 95% CI 87–99%) of incident VL cases diagnosed at the PHC level using the current diagnostic algorithm were confirmed by qPCR. Among 15,422 non-VL cases, 39 were rK39 RDT positive, reflecting a specificity of the test of 99.7% (95% CI 99.7–99.8%). The current diagnostic algorithm combining suggestive clinical features with a positive rK39 RDT still seems valid in the current low-endemic setting in India. Full article

(This article belongs to the Special Issue Point-of-Care Diagnostics for Low-Resource Settings)

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13 pages, 1353 KiB

Open AccessArticle

Pilot Testing of the “Turbidimeter”, a Simple, Universal Reader Intended to Complement and Enhance Bacterial Growth Detection in Manual Blood Culture Systems in Low-Resource Settings

by Barbara Barbé, Ellen Corsmit, Jasper Jans, Kamalpreet Kaur, Roel Baets, Jan Jacobs and Liselotte Hardy

Diagnostics 2022, 12(3), 615; https://0-doi-org.brum.beds.ac.uk/10.3390/diagnostics12030615 - 01 Mar 2022

Cited by 2 | Viewed by 3202

Abstract

Bloodstream infections and antimicrobial resistance are an increasing problem in low-income countries. There is a clear need for adapted diagnostic tools. To address this need, we developed a simple, universal reader prototype that detects bacterial growth in blood culture bottles. Our “turbidimeter” evaluates [...] Read more.

Bloodstream infections and antimicrobial resistance are an increasing problem in low-income countries. There is a clear need for adapted diagnostic tools. To address this need, we developed a simple, universal reader prototype that detects bacterial growth in blood culture bottles. Our “turbidimeter” evaluates bacterial growth, based on the turbidity of the broth and the color change of the colorimetric CO₂ indicator in commercially available blood culture bottles. A total of 60 measurements were performed using 10 relevant microbial species, spiked in horse blood, to compare the turbidimeter’s performance with that of an automatic reference system. The turbidimeter was able to detect growth in all but one of the spiked blood culture bottles. In the majority (7/10) of the species tested, time-to-detection of the turbidimeter was shown to be non-inferior to the reference automated time-to-detection. This was, however, only the case when both the turbidity and color change in the colorimetric CO₂-indicator were used to evaluate growth. We could not demonstrate the non-inferiority of the turbidity measurement alone. Overall, the turbidimeter performed well, but we also identified some improvements that will be implemented in the next version of the prototype. Full article

(This article belongs to the Special Issue Point-of-Care Diagnostics for Low-Resource Settings)

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12 pages, 1784 KiB

Open AccessArticle

Open-Source, Adaptable, All-in-One Smartphone-Based System for Quantitative Analysis of Point-of-Care Diagnostics

by Weronika Schary, Filip Paskali, Simone Rentschler, Christoph Ruppert, Gabriel E. Wagner, Ivo Steinmetz, Hans-Peter Deigner and Matthias Kohl

Diagnostics 2022, 12(3), 589; https://0-doi-org.brum.beds.ac.uk/10.3390/diagnostics12030589 - 25 Feb 2022

Cited by 5 | Viewed by 2903

Abstract

Point-of-care (POC) diagnostics, in particular lateral flow assays (LFA), represent a great opportunity for rapid, precise, low-cost and accessible diagnosis of disease. Especially with the ongoing coronavirus disease 2019 (COVID-19) pandemic, rapid point-of-care tests are becoming everyday tools for identification and prevention. Using [...] Read more.

Point-of-care (POC) diagnostics, in particular lateral flow assays (LFA), represent a great opportunity for rapid, precise, low-cost and accessible diagnosis of disease. Especially with the ongoing coronavirus disease 2019 (COVID-19) pandemic, rapid point-of-care tests are becoming everyday tools for identification and prevention. Using smartphones as biosensors can enhance POC devices as portable, low-cost platforms for healthcare and medicine, food and environmental monitoring, improving diagnosis and documentation in remote, low-resource locations. We present an open-source, all-in-one smartphone-based system for quantitative analysis of LFAs. It consists of a 3D-printed photo box, a smartphone for image acquisition, and an R Shiny software package with modular, customizable analysis workflow for image editing, analysis, data extraction, calibration and quantification of the assays. This system is less expensive than commonly used hardware and software, so it could prove very beneficial for diagnostic testing in the context of pandemics, as well as in low-resource countries. Full article

(This article belongs to the Special Issue Point-of-Care Diagnostics for Low-Resource Settings)

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10 pages, 559 KiB

Open AccessArticle

Performance Evaluation of the STANDARD^TM Q COVID-19 and Panbio^TM COVID-19 Antigen Tests in Detecting SARS-CoV-2 during High Transmission Period in Mozambique

by Nádia Sitoe, Júlia Sambo, Neuza Nguenha, Jorfelia Chilaule, Imelda Chelene, Osvaldo Loquiha, Chishamiso Mudenyanga, Sofia Viegas, Jane Cunningham and Ilesh Jani

Diagnostics 2022, 12(2), 475; https://0-doi-org.brum.beds.ac.uk/10.3390/diagnostics12020475 - 12 Feb 2022

Cited by 7 | Viewed by 2736

Abstract

(1) Background: Laboratory-based molecular assays are the gold standard to detect SARS-CoV-2. In resource-limited settings, the implementation of these assays has been hampered by operational challenges and long turnaround times. Rapid antigen detection tests are an attractive alternative. Our aim is to evaluate [...] Read more.

(1) Background: Laboratory-based molecular assays are the gold standard to detect SARS-CoV-2. In resource-limited settings, the implementation of these assays has been hampered by operational challenges and long turnaround times. Rapid antigen detection tests are an attractive alternative. Our aim is to evaluate the clinical performance of two SARS-CoV-2 rapid antigen tests during a high transmission period. (2) Methods: A total of 1277 patients seeking SARS-CoV-2 diagnosis were enrolled at four health facilities. Nasopharyngeal swabs for rapid antigen and real time PCR testing were collected for each patient. Sensitivity, specificity, positive and negative predictive values, misclassification rate, and agreement were determined. (3) Results: The overall sensitivity of Panbio COVID-19 was 41.3% (95% CI: 34.6–48.4%) and the specificity was 98.2% (95% CI: 96.2–99.3%). The Standard Q had an overall sensitivity and specificity of 45.0% (95% CI: 39.9–50.2%) and 97.6% (95% CI: 95.3–99.0%), respectively. The positive predictive value of a positive test was 93.3% and 95.4% for the Panbio and Standard Q Ag-RDTs, respectively. A higher sensitivity of 43.2% and 49.4% was observed in symptomatic cases for the Panbio and Standard Q Ag-RDTs, respectively. (4) Conclusions: Despite the overall low sensitivity, the two evaluated rapid tests are useful to improve the diagnosis of symptomatic SARS-CoV-2 infections during high transmission periods. Full article

(This article belongs to the Special Issue Point-of-Care Diagnostics for Low-Resource Settings)

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16 pages, 1204 KiB

Open AccessArticle

Monitored Implementation of COVID-19 Rapid Antigen Screening at Taxi Ranks in Johannesburg, South Africa

by Mohammed Majam, Vanessa Msolomba, François Venter, Lesley Erica Scott, Trish Kahamba, Wendy Susan Stevens, Michael Rademeyer, Tanya van Tonder, Sanjida Karim, Rigveda Kadam and Paula Akugizibwe

Diagnostics 2022, 12(2), 402; https://0-doi-org.brum.beds.ac.uk/10.3390/diagnostics12020402 - 03 Feb 2022

Cited by 3 | Viewed by 2765

Abstract

Digital tools can support community-based decentralized testing initiatives to broaden access to COVID-19 diagnosis, especially in high-transmission settings. This operational study investigated the use of antigen-detecting rapid diagnostic tests (Ag-RDTs) for COVID-19 combined with an end-to-end digital health solution, in three taxi ranks [...] Read more.

Digital tools can support community-based decentralized testing initiatives to broaden access to COVID-19 diagnosis, especially in high-transmission settings. This operational study investigated the use of antigen-detecting rapid diagnostic tests (Ag-RDTs) for COVID-19 combined with an end-to-end digital health solution, in three taxi ranks in Johannesburg, South Africa. Members of the public were eligible if they were aged ≥18 years, could read, and had a cellphone. Over 15,000 participants, enrolled between June and September 2021, were screened for COVID-19 risk factors. A digital risk questionnaire identified 2061 (13%) participants as moderate risk and 2987 (19%) as high risk, based on symptoms and/or recent exposure to a known case. Of this group referred for testing, 3997 (79%) received Ag-RDTs, with positivity rates of 5.1% in the “high-risk” group and 0.8% in the “moderate-risk” group. A subset of 569 randomly selected participants received additional PCR testing. Sensitivity of the Ag-RDT in this setting was 40% (95% CI: 30.3%, 50.3%); most false negatives had high cycle threshold values (>25), hence low viral loads. Over 80% of participants who tested positive completed a 2-week phone-based follow-up questionnaire. Overall, the digital tool combined with Ag-RDTs enhanced community-based decentralized COVID-19 testing service delivery, reporting and follow-up. Full article

(This article belongs to the Special Issue Point-of-Care Diagnostics for Low-Resource Settings)

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12 pages, 2748 KiB

Open AccessArticle

Performance Evaluation of BD FACSPresto^TM Near-Patient CD4 Counter for Monitoring Antiretroviral Therapy in HIV-Infected Individuals in Primary Healthcare Clinics in Thailand

by Kasama Sukapirom, Somrat Matchua, Charin Thepthai, Narinee Srimark, Ladawan Khowawisetsut and Kovit Pattanapanyasat

Diagnostics 2022, 12(2), 382; https://0-doi-org.brum.beds.ac.uk/10.3390/diagnostics12020382 - 02 Feb 2022

Cited by 1 | Viewed by 1523

Abstract

HIV viral load is more reliable tool for monitoring treatment throughout the course of HIV/AIDS, but the test may be expensive in resource-limited settings. Therefore, enumeration of CD4 T-lymphocyte count remains important in these settings. This study evaluated the performance of BDFACSPresto, a [...] Read more.

HIV viral load is more reliable tool for monitoring treatment throughout the course of HIV/AIDS, but the test may be expensive in resource-limited settings. Therefore, enumeration of CD4 T-lymphocyte count remains important in these settings. This study evaluated the performance of BDFACSPresto, a near-patient CD4 counter planned to be used in primary healthcare clinics in Thailand. Results of percent, absolute CD4 count and hemoglobin (Hb) on the FACSPresto were compared with the TriTEST/TruCOUNT/BDFACSCalibur method and a Sysmex hematology analyzer. Phase I of the study was performed in an ISO15189 laboratory. Both percentage and absolute values showed Passing–Bablok slopes within 0.98–1.06 and 0.97–1.13, mean Bland–Altman biases of +1.2% and +20.5 cells/µL, respectively. In phase II, venous and some capillary blood samples were analyzed in four primary healthcare clinics. The results showed good correlation between capillary and venous blood. For venous blood samples, regression lines showed slopes of 1.01–1.05 and 1.01–1.07 for all percentage and absolute values. The overall mean biases were +0.9% and +17.0 cells/µL. For Hb, Passing–Bablok regression result gave slope within 1.01–1.07 and mean bias of −0.06 g/dL. Thus, CD4 enumeration in blood by the FACSPresto is reliable and can be performed to an identical standard at primary healthcare clinics. Full article

(This article belongs to the Special Issue Point-of-Care Diagnostics for Low-Resource Settings)

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13 pages, 1145 KiB

Open AccessArticle

Two-Year Follow-Up of Trypanosoma brucei gambiense Serology after Successful Treatment of Human African Trypanosomiasis: Results of Four Different Sero-Diagnostic Tests

by Raquel Inocencio da Luz, Sara Tablado Alonso, Philippe Büscher, Paul Verlé, Anja De Weggheleire, Dieudonné Mumba Ngoyi, Pati Patient Pyana and Epco Hasker

Diagnostics 2022, 12(2), 246; https://0-doi-org.brum.beds.ac.uk/10.3390/diagnostics12020246 - 19 Jan 2022

Cited by 2 | Viewed by 1587

Abstract

Gambiense human African trypanosomiasis (gHAT), also known as gambiense sleeping sickness, is a parasitic infection caused by Trypanosoma brucei gambiense. During the last decades, gHAT incidence has been brought to an all-time low. Newly developed serological tools and drugs for its diagnosis [...] Read more.

Gambiense human African trypanosomiasis (gHAT), also known as gambiense sleeping sickness, is a parasitic infection caused by Trypanosoma brucei gambiense. During the last decades, gHAT incidence has been brought to an all-time low. Newly developed serological tools and drugs for its diagnosis and treatment put the WHO goal of interruption of transmission by 2030 within reach. However, further research is needed to efficiently adapt these new advances to new control strategies. We assessed the serological evolution of cured gHAT patients over a two-year period using four different tests: the rapid diagnostic test (RDT) HAT Sero K-SeT, ELISA/T.b. gambiense, Trypanosoma brucei gambiense inhibition ELISA (iELISA), and the immune trypanolysis test. High seropositive rates were observed in all the tests, although sero-reversion rates were different in each test: ELISA/T.b. gambiense was the test most likely to become negative two years after treatment, whereas RDT HAT Sero-K-SeT was the least likely. iELISA and trypanolysis showed intermediate and comparable probabilities to become negative. Stage 1 patients were also noted to be more likely to become negative than Stage 2 patients in all four serological tests. Our results confirm previous findings that trypanosome-specific antibody concentrations in blood may persist for up to two years, implying that HAT control programs should continue to take the history of past HAT episodes into consideration. Full article

(This article belongs to the Special Issue Point-of-Care Diagnostics for Low-Resource Settings)

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14 pages, 2126 KiB

Open AccessArticle

Detection of Microorganisms in Body Fluids via MTT-PMS Assay

by Cheng-Han Chen, Yu-Ting Tsao, Po-Ting Yeh, Yu-Hsiang Liao, Yi-Tzu Lee, Wan-Ting Liao, Yung-Chih Wang, Ching-Fen Shen and Chao-Min Cheng

Diagnostics 2022, 12(1), 46; https://0-doi-org.brum.beds.ac.uk/10.3390/diagnostics12010046 - 27 Dec 2021

Cited by 3 | Viewed by 3396

Abstract

Early detection of microorganisms is essential for the management of infectious diseases. However, this is challenging, as traditional culture methods are labor-intensive and time-consuming. The 3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide-phenazine methosulfate (MTT-PMS) assay has been used to evaluate the metabolic activity in live cells and can [...] Read more.

Early detection of microorganisms is essential for the management of infectious diseases. However, this is challenging, as traditional culture methods are labor-intensive and time-consuming. The 3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide-phenazine methosulfate (MTT-PMS) assay has been used to evaluate the metabolic activity in live cells and can thus be used for detecting living microorganisms. With the addition of NaOH and Tris-EDTA, the same approach can be accelerated (within 15 min) and used for the quick detection of common bacterial pathogens. The assay results can be evaluated colorimetrically or semi-quantitatively. Here, the quick detection by MTT-PMS assay was further investigated. The assay had a detection limit of approximately 10⁴ CFU/mL. In clinical evaluations, we used the MTT-PMS assay to detect clinical samples and bacteriuria (>10⁵ CFU/mL). The negative predictive value of the MTT-PMS assay for determining bacteriuria was 79.59% but was 100% when the interference of abnormal blood was excluded. Thus, the MTT-PMS assay might be a potential “rule-out” tool for bacterial detection in clinical samples, at a cost of approximately USD 1 per test. Owing to its low cost, rapid results, and easy-to-use characteristics, the MTT-PMS assay may be a potential tool for microorganism detection. Full article

(This article belongs to the Special Issue Point-of-Care Diagnostics for Low-Resource Settings)

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21 pages, 5411 KiB

Open AccessArticle

Controlling Droplet Marangoni Flows to Improve Microscopy-Based TB Diagnosis

by Stephanie I. Pearlman, Eric M. Tang, Yuankai K. Tao and Frederick R. Haselton

Diagnostics 2021, 11(11), 2155; https://0-doi-org.brum.beds.ac.uk/10.3390/diagnostics11112155 - 21 Nov 2021

Cited by 3 | Viewed by 2144

Abstract

In developing countries, the most common diagnostic method for tuberculosis (TB) is microscopic examination sputum smears. Current assessment requires time-intensive inspection across the microscope slide area, and this contributes to its poor diagnostic sensitivity of ≈50%. Spatially concentrating TB bacteria in a smaller [...] Read more.

In developing countries, the most common diagnostic method for tuberculosis (TB) is microscopic examination sputum smears. Current assessment requires time-intensive inspection across the microscope slide area, and this contributes to its poor diagnostic sensitivity of ≈50%. Spatially concentrating TB bacteria in a smaller area is one potential approach to improve visual detection and potentially increase sensitivity. We hypothesized that a combination of magnetic concentration and induced droplet Marangoni flow would spatially concentrate Mycobacterium tuberculosis on the slide surface by preferential deposition of beads and TB–bead complexes in the center of an evaporating droplet. To this end, slide substrate and droplet solvent thermal conductivities and solvent surface tension, variables known to impact microfluidic flow patterns in evaporating droplets, were varied to select the most appropriate slide surface coating. Optimization in a model system used goniometry, optical coherence tomography, and microscope images of the final deposition pattern to observe the droplet flows and maximize central deposition of 1 μm fluorescent polystyrene particles and 200 nm nanoparticles (NPs) in 2 μL droplets. Rain-X^® polysiloxane glass coating was identified as the best substrate material, with a PBS-Tween droplet solvent. The use of smaller, 200 nm magnetic NPs instead of larger 1 μm beads allowed for bright field imaging of bacteria. Using these optimized components, we compared standard smear methods to the Marangoni-based spatial concentration system, which was paired with magnetic enrichment using iron oxide NPs, isolating M. bovis BCG (BCG) from samples containing 0 and 10³ to 10⁶ bacilli/mL. Compared to standard smear preparation, paired analysis demonstrated a combined volumetric and spatial sample enrichment of 100-fold. With further refinement, this magnetic/Marangoni flow concentration approach is expected to improve whole-pathogen microscopy-based diagnosis of TB and other infectious diseases. Full article

(This article belongs to the Special Issue Point-of-Care Diagnostics for Low-Resource Settings)

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12 pages, 1421 KiB

Open AccessArticle

Evaluation of an Antibody Detecting Point of Care Test for Diagnosis of Taenia solium Cysticercosis in a Zambian Rural Community: A Prospective Diagnostic Accuracy Study

by Chishimba Mubanga, Inge Van Damme, Chiara Trevisan, Veronika Schmidt, Isaac K. Phiri, Gideon Zulu, John Noh, Sukwan Handali, Richard Mambo, Mwelwa Chembensofu, Maxwell Masuku, Dries Reynders, Famke Jansen, Emmanuel Bottieau, Pascal Magnussen, Andrea S. Winkler, Pierre Dorny, Kabemba E. Mwape and Sarah Gabriël

Diagnostics 2021, 11(11), 2121; https://0-doi-org.brum.beds.ac.uk/10.3390/diagnostics11112121 - 15 Nov 2021

Cited by 3 | Viewed by 2418

Abstract

The lack of cheap, easy-to-use, rapid diagnostic tests has led to the development of several rapid diagnostic tests for cysticercosis. The new prototype two-strip, Taenia solium point of care test (TS POC) detects antibodies against taeniosis (TS POC T) and cysticercosis (TS POC [...] Read more.

The lack of cheap, easy-to-use, rapid diagnostic tests has led to the development of several rapid diagnostic tests for cysticercosis. The new prototype two-strip, Taenia solium point of care test (TS POC) detects antibodies against taeniosis (TS POC T) and cysticercosis (TS POC CC). This study evaluated the diagnostic performance of the TS POC CC in the Sinda district in eastern Zambia. A sample of 1254 participants was recruited and tested with the TS POC. Out of the 1249 participants with a valid TS POC result, 177 (14%) tested positive while 1072 (86%) tested negative. All individuals with a positive TS POC and a subset of negative TS POC participants were selected for serum sampling, and were subjected to the recombinant glycoprotein T24H enzyme-linked immunoelectrotransfer blot (rT24H EITB) and the serum B60/158 (serum Ag) enzyme-linked immunosorbent assay (Ag ELISA). Performance characteristics were estimated using a Bayesian approach with probabilistic constraints. Based on 255 complete cases, the estimated sensitivity and specificity of the TS POC CC test were 35% (95% CI: 14–63%) and 87% (95% CI: 83–90%), respectively. The diagnostic performance needs to be improved, possibly by titrating antigen and other reagents’ concentration in the strip to produce a performance similar to existing cysticercosis tests such as the rT24H EITB. Full article

(This article belongs to the Special Issue Point-of-Care Diagnostics for Low-Resource Settings)

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10 pages, 230 KiB

Open AccessArticle

Exploring Primary Care Clinicians’ Views about How Best to Implement a Potential Trial around Point-of-Care Tests for Common Infections in South Africa

by Alice Epps, Charlotte Albury and Oliver Van Hecke

Diagnostics 2021, 11(11), 2100; https://0-doi-org.brum.beds.ac.uk/10.3390/diagnostics11112100 - 13 Nov 2021

Cited by 3 | Viewed by 1609

Abstract

Optimisation of antibiotic prescribing is critical to combat antimicrobial resistance. Point-of-care tests (POCTs) for common infections could be a valuable tool to achieve this in primary care. Currently, their use has primarily been studied in high-income countries. Trials in low-and-middle-income countries face challenges [...] Read more.

Optimisation of antibiotic prescribing is critical to combat antimicrobial resistance. Point-of-care tests (POCTs) for common infections could be a valuable tool to achieve this in primary care. Currently, their use has primarily been studied in high-income countries. Trials in low-and-middle-income countries face challenges unique to their setting. This study aims to explore the barriers and facilitators for a future trial of POCTs for common infections in South Africa. Twenty-three primary care clinicians in the Western Cape Metropole were interviewed. Interview transcripts were analysed using thematic analysis. We identified three key themes. These themes focused on clinicians’ views about proposed trial design and novel POCTs, clinicians’ perspectives about trial set-up, and specific trial procedures. Participants were overall positive about the proposed trial and POCTs. Potential issues centred around the limited space and technology available and participant retention to follow-up. Additionally, impact on clinic workload was an important consideration. These insights will be invaluable in informing the design of a feasibility trial of POCTs in this setting. Full article

(This article belongs to the Special Issue Point-of-Care Diagnostics for Low-Resource Settings)

14 pages, 1186 KiB

Open AccessArticle

Performance of Automated Point-of-Care Respiratory Rate Counting versus Manual Counting in Children under Five Admitted with Severe Febrile Illness to Kisantu Hospital, DR Congo

by Bieke Tack, Daniel Vita, Thomas Nsema Mbaki, Octavie Lunguya, Jaan Toelen and Jan Jacobs

Diagnostics 2021, 11(11), 2078; https://0-doi-org.brum.beds.ac.uk/10.3390/diagnostics11112078 - 10 Nov 2021

Cited by 3 | Viewed by 1848

Abstract

To improve the early recognition of danger signs in children with severe febrile illness in low resource settings, WHO promotes automated respiratory rate (RR) counting, but its performance is unknown in this population. Therefore, we prospectively evaluated the field performance of automated point-of-care [...] Read more.

To improve the early recognition of danger signs in children with severe febrile illness in low resource settings, WHO promotes automated respiratory rate (RR) counting, but its performance is unknown in this population. Therefore, we prospectively evaluated the field performance of automated point-of-care plethysmography-based RR counting in hospitalized children with severe febrile illness (<5 years) in DR Congo. A trained research nurse simultaneously counted the RR manually (comparative method) and automatically with the Masimo Rad G pulse oximeter. Valid paired RR measurements were obtained in 202 (83.1%) children, among whom 43.1% (87/202) had fast breathing according to WHO criteria based on manual counting. Automated counting frequently underestimated the RR (median difference of −1 breath/minute; p2.5–p97.5 limits of agreement: −34–6), particularly at higher RR. This resulted in a failure to detect fast breathing in 24.1% (21/87) of fast breathing children (positive percent agreement: 75.9%), which was not explained by clinical characteristics (p > 0.05). Children without fast breathing were mostly correctly classified (negative percent agreement: 98.3%). In conclusion, in the present setting the automated RR counter performed insufficiently to facilitate the early recognition of danger signs in children with severe febrile illness, given wide limits of agreement and a too low positive percent agreement. Full article

(This article belongs to the Special Issue Point-of-Care Diagnostics for Low-Resource Settings)

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14 pages, 3782 KiB

Open AccessArticle

Challenges Encountered When Evaluating an Antibody-Detecting Point-of-Care Test for Taeniosis in an Endemic Community in Zambia: A Prospective Diagnostic Accuracy Study

by Chishimba Mubanga, Chiara Trevisan, Inge Van Damme, Veronika Schmidt, Isaac K. Phiri, Gideon Zulu, John Noh, Sukwan Handali, Richard Mambo, Mwelwa Chembensofu, Maxwell Masuku, Dries Reynders, Famke Jansen, Emmanuel Bottieau, Pascal Magnussen, Andrea S. Winkler, Pierre Dorny, Kabemba E. Mwape and Sarah Gabriel

Diagnostics 2021, 11(11), 2039; https://0-doi-org.brum.beds.ac.uk/10.3390/diagnostics11112039 - 04 Nov 2021

Viewed by 1650

Abstract

Taenia solium taeniosis diagnosis is challenging because current tests perform sub-optimally and/or are expensive, require sophisticated equipment, infrastructure and trained manpower, and therefore are not community deployable. A recently-developed, multi-strip, T. solium point-of-care test (TS POC) for simultaneous detection of tapeworm (TS POC [...] Read more.

Taenia solium taeniosis diagnosis is challenging because current tests perform sub-optimally and/or are expensive, require sophisticated equipment, infrastructure and trained manpower, and therefore are not community deployable. A recently-developed, multi-strip, T. solium point-of-care test (TS POC) for simultaneous detection of tapeworm (TS POC T) and cysticercus (TS POC CC) human antibodies was evaluated for diagnostic accuracy on consecutively recruited community participants in Sinda district, Zambia. All participants were tested using the TS POC test. All test-positives and 20% of the test-negative participants were invited to give a blood and stool sample for reference testing. Three different reference tests were used for taeniosis diagnosis: recombinant rES33 enzyme-linked immunoelectrotransfer blot (rES33 EITB), copro PCR and copro Ag ELISA. Bayesian analysis with probabilistic constraints was used to estimate sensitivity and specificity. In total, 1254 participants were tested with the TS POC test, of whom 13 tested positive using the TS POC T. Based on 161 participants with complete data, the estimated sensitivity and specificity for the TS POC T test were 38% (95% CI: 5–93%) and 99% (95% CI: 98–100%), respectively. The challenge of highly variable inter-assay performance is highlighted. We recommend either increasing the sensitivity or redesigning the test. Full article

(This article belongs to the Special Issue Point-of-Care Diagnostics for Low-Resource Settings)

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13 pages, 1974 KiB

Open AccessArticle

Development of Quantitative Rapid Isothermal Amplification Assay for Leishmania donovani

by Md Anik Ashfaq Khan, Khaledul Faisal, Rajashree Chowdhury, Prakash Ghosh, Faria Hossain, Manfred Weidmann, Dinesh Mondal and Ahmed Abd El Wahed

Diagnostics 2021, 11(11), 1963; https://0-doi-org.brum.beds.ac.uk/10.3390/diagnostics11111963 - 22 Oct 2021

Cited by 10 | Viewed by 2190

Abstract

Quantification of pathogen load, although challenging, is of paramount importance for accurate diagnosis and clinical management of a range of infectious diseases in a point-of-need testing (PONT) scenario such as in resource-limited settings. We formulated a quantification approach to test the standard-curve based [...] Read more.

Quantification of pathogen load, although challenging, is of paramount importance for accurate diagnosis and clinical management of a range of infectious diseases in a point-of-need testing (PONT) scenario such as in resource-limited settings. We formulated a quantification approach to test the standard-curve based absolute quantification ability of isothermal recombinase polymerase amplification (RPA) assay. As a test of principle, a 10-fold dilution series of Leishmania donovani (LD) genomic DNA prepared in nuclease-free-water (NFW), and from culture-spiked-blood (CSB) were tested, and a 15 min assay was performed. A modified algorithm was formulated to derive the detection outcome. The threshold-record times (Tr) in seconds thus obtained were plotted against the initial load of parasite genomes for log-linear regression analysis. The quantitative RPA (Q-RPA) assay was further evaluated against a LD quantitative (q)-PCR assay with DNA extracted from visceral and post-Kala-azar dermal leishmaniasis case specimens and stratified into different ranges of threshold cycle (Ct). The best-fitted regression models were found linear with mean r²/root mean square error (RMSE) values of residual points (in seconds) estimated as 0.996/8.063 and 0.992/7.46 for replicated series of NFW and CSB, respectively. In both series, the lower limit of detection reached less than 0.1 parasite genome equivalent DNA. Absolute agreement between Q-RPA and LD-qPCR was found for test positivity, and strong positive correlations were observed between the Tr and Ct values (r = 0.89; p < 0.0001) as well as between the absolute parasite loads (r = 0.87; p < 0.0001) quantified by respective assays. The findings in this very first Q-RPA assay for leishmaniasis are suggestive of its potential in monitoring LD load in clinical specimens, and the development of rapid Q-RPA assays for other infectious diseases. Full article

(This article belongs to the Special Issue Point-of-Care Diagnostics for Low-Resource Settings)

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13 pages, 718 KiB

Open AccessArticle

Assessment of the Sedia HIV Self-Test Device: Usability and Performance in the Hands of Untrained Users in Johannesburg, South Africa

by Mohammed Majam, Naleni Rhagnath, Vanessa Msolomba, Leanne Singh, Michael S. Urdea and Samanta Tresha Lalla-Edward

Diagnostics 2021, 11(10), 1816; https://0-doi-org.brum.beds.ac.uk/10.3390/diagnostics11101816 - 01 Oct 2021

Cited by 1 | Viewed by 2063

Abstract

The prevalence of HIV across South Africa places a strain on testing facilities. The use of HIV self-testing (HIVST) devices has been identified as a strategy to ease the burden on these facilities. The usability and performance of the Asante HIV−1/2 Oral Self-Test [...] Read more.

The prevalence of HIV across South Africa places a strain on testing facilities. The use of HIV self-testing (HIVST) devices has been identified as a strategy to ease the burden on these facilities. The usability and performance of the Asante HIV−1/2 Oral Self-Test (Asante) (Sedia Biosciences, Portland OR, USA) device by novice users was assessed and reported on, to inform for the implementation of such devices in South Africa and elsewhere. Convenience sampling was used. Participants used the Asante HIVST device and recorded their interpretation of their results. Participants’ interpretations were compared with those of trained professionals and, thereafter, verified using the rapid diagnostic testing algorithm. Out of the eligible participants, 410 of the 524 (78.2%) were between the ages of 18–35. The usability assessment indicates that 100% of participants used the HIVST device’s information leaflet. However, 19/524 (3.6%) of participants who yielded an invalid result due to critical errors were excluded from the primary efficacy analysis. The average usability score was 98.1%. The sensitivity and specificity results were, 94.7% and 99.8%, respectively. This study shows that the Asante HIV self-test, and similar devices, can be valuable in providing convenient HIV self-testing and immediately available results. To accommodate a greater number of inexperienced users, the instructions may need to be revised. Full article

(This article belongs to the Special Issue Point-of-Care Diagnostics for Low-Resource Settings)

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9 pages, 480 KiB

Open AccessArticle

The Impact of Phototherapy on the Accuracy of Transcutaneous Bilirubin Measurements in Neonates: Optimal Measurement Site and Timing

by Shau-Ru Ho, Yu-Chen Lin and Chi-Nien Chen

Diagnostics 2021, 11(9), 1729; https://0-doi-org.brum.beds.ac.uk/10.3390/diagnostics11091729 - 20 Sep 2021

Cited by 9 | Viewed by 3173

Abstract

Transcutaneous bilirubinometer devices are widely applied to assess neonatal hyperbilirubinemia. However, the optimal skin site and timing of transcutaneous bilirubin (TCB) measurements for the strongest correlation with total serum bilirubin (TSB) levels after phototherapy are still unclear. We conducted a retrospective observational study [...] Read more.

Transcutaneous bilirubinometer devices are widely applied to assess neonatal hyperbilirubinemia. However, the optimal skin site and timing of transcutaneous bilirubin (TCB) measurements for the strongest correlation with total serum bilirubin (TSB) levels after phototherapy are still unclear. We conducted a retrospective observational study evaluating the correlation of TCB and TSB levels in neonates postphototherapy. The TCB measurements on the forehead and mid-sternum at 0 and 30 min postphototherapy were assessed by using a JM-103 bilirubinometer. Paired TCB and TSB measurements were assessed by Pearson correlation and Bland–Altman plots. We analyzed 40 neonates with 96 TSB and 384 TCB measurements. The TSB level correlated moderately with the forehead TCB level at 30 min postphototherapy (r = 0.65) and less strongly with the midsternum TCB level at 0 min postphototherapy (r = 0.52). The forehead at 30 min after cessation of phototherapy was the best time point and location of TCB measurement for the assessment of neonatal jaundice status. The reliability of TCB measurements varied across skin sites and durations after phototherapy. The effectiveness of TCB measurement to assess neonatal hyperbilirubinemia is much better on covered skin areas (foreheads) 30 min postphototherapy. The appropriate application of transcutaneous bilirubinometers could aid in clinical practice and avoid unnecessary management. Full article

(This article belongs to the Special Issue Point-of-Care Diagnostics for Low-Resource Settings)

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14 pages, 4159 KiB

Open AccessArticle

Usability and Clinical Performance Characteristics of the Asante HIV1/2 Test by Trained Users in Two African Sites

by Mohammed Majam, Naleni Rhagnath, Vanessa Msolomba, Leanne Singh, Michael S. Urdea and Samanta T. Lalla-Edward

Diagnostics 2021, 11(9), 1727; https://0-doi-org.brum.beds.ac.uk/10.3390/diagnostics11091727 - 20 Sep 2021

Cited by 1 | Viewed by 2726

Abstract

HIV self-testing (HIVST) devices are acknowledged as having the potential to enable the acceleration of HIV diagnosis and linkage to care. How efficiently professional and trained users engaged with the Asante HIV-1/2 Oral Self-Test (Asante) (Sedia Biosciences, Portland, OR, USA), and the accuracy [...] Read more.

HIV self-testing (HIVST) devices are acknowledged as having the potential to enable the acceleration of HIV diagnosis and linkage to care. How efficiently professional and trained users engaged with the Asante HIV-1/2 Oral Self-Test (Asante) (Sedia Biosciences, Portland, OR, USA), and the accuracy of the device in comparison to other HIV rapid diagnostic tests (RDT), was assessed to be able to guide the development and adoption of the device in Senegal and South Africa. Using convenience sampling, potential participants were recruited from catchment areas where HIV was prevalent. Trained users performed an HIV test on participants using an Oral HIVST. The professional user’s interpretation of results was then measured against the results of various other RDTs. The South African study had 1652 participants and the Senegalese, 500. Most of the participants in each study were 18–35 years old. Senegal had a higher number of females (346/500, 69.2%) compared to South Africa (699/1662, 42.1%). Asante displayed very high sensitivity and specificity when tested against other devices. In the final enzyme-linked immunosorbent assay (ELISA) comparison, in South Africa, the sensitivity: specificity was 99.1:99.9% and in Senegal, 98.4:100.0%. Senegal further identified 53/63 (84.1%) with HIV-1, 8/63 (12.7) with HIV-2 and 2/63 (3.2%) with HIV-1/2 co-infections. Professional or trained users’ interpretations of Asante results correlated strongly to results when using various RDTs, the ELISA assay and Western blot tests, making it a dependable HIV testing instrument. Full article

(This article belongs to the Special Issue Point-of-Care Diagnostics for Low-Resource Settings)

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13 pages, 313 KiB

Open AccessArticle

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

by Fien Vanroye, Dorien Van den Bossche, Isabel Brosius, Bieke Tack, Marjan Van Esbroeck and Jan Jacobs

Diagnostics 2021, 11(7), 1163; https://0-doi-org.brum.beds.ac.uk/10.3390/diagnostics11071163 - 25 Jun 2021

Cited by 18 | Viewed by 2947

Abstract

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 [...] Read more.

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. Full article

(This article belongs to the Special Issue Point-of-Care Diagnostics for Low-Resource Settings)

Review

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Open AccessReview

Development and Efficacy of Lateral Flow Point-of-Care Testing Devices for Rapid and Mass COVID-19 Diagnosis by the Detections of SARS-CoV-2 Antigen and Anti-SARS-CoV-2 Antibodies

by Wen-Yeh Hsieh, Cheng-Han Lin, Tzu-Ching Lin, Chao-Hsu Lin, Hui-Fang Chang, Chin-Hung Tsai, Hsi-Tien Wu and Chih-Sheng Lin

Diagnostics 2021, 11(10), 1760; https://0-doi-org.brum.beds.ac.uk/10.3390/diagnostics11101760 - 24 Sep 2021

Cited by 26 | Viewed by 12451

Abstract

The COVID-19 pandemic is an ongoing global pandemic caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in 2020–2021. COVID-19 is becoming one of the most fatal pandemics in history and brings a huge challenge to the global healthcare system. Opportune detection, confinement, [...] Read more.

The COVID-19 pandemic is an ongoing global pandemic caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in 2020–2021. COVID-19 is becoming one of the most fatal pandemics in history and brings a huge challenge to the global healthcare system. Opportune detection, confinement, and early treatment of infected cases present the first step in combating COVID-19. Diagnosis via viral nucleic acid amplification tests (NAATs) is frequently employed and considered the standard procedure. However, with an increasing urge for point-of-care tests, rapid and cheaper immunoassays are widely utilized, such as lateral flow immunoassay (LFIA), which can be used for rapid, early, and large-scale detection of SARS-CoV-2 infection. In this narrative review, the principle and technique of LFIA applied in COVID-19 antigen and antibody detection are introduced. The diagnostic sensitivity and specificity of the commercial LFIA tests are outlined and compared. Generally, LFIA antigen tests for SARS-CoV-2 are less sensitive than viral NAATs, the “gold standard” for clinical COVID-19 diagnosis. However, antigen tests can be used for rapid and mass testing in high-risk congregate housing to quickly identify people with COVID-19, implementing infection prevention and control measures, thus preventing transmission. LFIA anti-SARS-CoV-2 antibody tests, IgM and/or IgG, known as serology tests, are used for identification if a person has previously been exposed to the virus or vaccine immunization. Notably, advanced techniques, such as LFT-based CRISPR-Cas9 and surface-enhanced Raman spectroscopy (SERS), have added new dimensions to the COVID-19 diagnosis and are also discussed in this review. Full article

(This article belongs to the Special Issue Point-of-Care Diagnostics for Low-Resource Settings)

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Other

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13 pages, 17147 KiB

Open AccessProtocol

Trial Design of a Prospective Multicenter Diagnostic Accuracy Study of a Point-of-Care Test for the Detection of Taenia solium Taeniosis and Neurocysticercosis in Hospital-Based Settings in Tanzania

by Chiara Trevisan, Inge Van Damme, Bernard Ngowi, Veronika Schmidt, Dominik Stelzle, Karen Schou Møller, Mwemezi Kabululu, Charles E. Makasi, Pascal Magnussen, Emmanuel Bottieau, Emmanuel Abatih, Maria V. Johansen, Helena Ngowi, Benedict Ndawi, Kabemba E. Mwape, Gideon Zulu, Pierre Dorny, Andrea S. Winkler, Sarah Gabriël and on behalf of the SOLID Consortium

Diagnostics 2021, 11(9), 1528; https://0-doi-org.brum.beds.ac.uk/10.3390/diagnostics11091528 - 24 Aug 2021

Cited by 5 | Viewed by 2133

Abstract

Taenia solium diagnosis is challenging as trained personnel, good diagnostic tools, and infrastructure is lacking in resource-poor areas. This paper aims to describe the study trial design adopted to evaluate a newly developed rapid point-of-care test that simultaneously detects taeniosis and neurocysticercosis (TS [...] Read more.

Taenia solium diagnosis is challenging as trained personnel, good diagnostic tools, and infrastructure is lacking in resource-poor areas. This paper aims to describe the study trial design adopted to evaluate a newly developed rapid point-of-care test that simultaneously detects taeniosis and neurocysticercosis (TS POC) in three district hospitals in Tanzania. The two-stage design included three types of patients: patients with specific neurological signs and symptoms (group 1); patients with complaints compatible with intestinal worm infections (group 2); patients with other symptom(s) (group 3). For group 1, all patients were tested using the TS POC test (stage 1), after which all positive, and a subset of negative, patients were selected for laboratory reference tests, clinical examination, and a brain computed tomography (CT) scan (stage 2). For groups 2 and 3, a similar design was adopted, but clinical examination and a brain CT scan (stage 2) were only performed in patients who were TS POC test-positive for cysticercosis. Due to the lack of a gold standard, a Bayesian approach was used to determine test accuracy for taeniosis and cysticercosis. For neurocysticercosis, a composite case definition was used as the reference standard. If successful, this study will help the future developments (commercialization and implementation) of the rapid test and improve patient management and disease prevention. Full article

(This article belongs to the Special Issue Point-of-Care Diagnostics for Low-Resource Settings)

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16 pages, 676 KiB

Open AccessProtocol

Trial Design for a Diagnostic Accuracy Study of a Point-of-Care Test for the Detection of Taenia solium Taeniosis and (Neuro)Cysticercosis in Community Settings of Highly Endemic, Resource-Poor Areas in Zambia: Challenges and Rationale

by Inge Van Damme, Chiara Trevisan, Kabemba E. Mwape, Veronika Schmidt, Pascal Magnussen, Gideon Zulu, Chishimba Mubanga, Dominik Stelzle, Emmanuel Bottieau, Emmanuel Abatih, Isaac K. Phiri, Maria V. Johansen, Chishala Chabala, Andrea S. Winkler, Pierre Dorny, Sarah Gabriël and on behalf of the SOLID Consortium

Diagnostics 2021, 11(7), 1138; https://0-doi-org.brum.beds.ac.uk/10.3390/diagnostics11071138 - 22 Jun 2021

Cited by 7 | Viewed by 2077

Abstract

Field-applicable, high-quality, and low-cost diagnostic tools are urgently needed for Taenia solium. The aim of this paper is to describe the design, challenges, and rationale for the design of a diagnostic accuracy study in low-resource community settings in Zambia. The trial was [...] Read more.

Field-applicable, high-quality, and low-cost diagnostic tools are urgently needed for Taenia solium. The aim of this paper is to describe the design, challenges, and rationale for the design of a diagnostic accuracy study in low-resource community settings in Zambia. The trial was designed as a prospective study with a two-stage design to evaluate a new point-of-care test (TS POC) for the detection of taeniosis and (neuro)cysticercosis. Participants within randomly selected households were tested with the TS POC test (index test). Participants who tested TS POC positive for taeniosis and/or cysticercosis and a subset of the negatives were requested to give blood and stool samples for reference testing, and to undergo clinical examination and a cerebral CT scan. The difficulties of conducting a clinical trial in settings with limited research and neuroimaging infrastructure as well as peculiarities specifically related to the disease (low prevalence of taeniosis and the lack of a gold standard) were taken into consideration for the design of this study. The two-stage design increased the efficiency of the study by reducing the number of samples, clinical examinations, and CT scans. Simplified flows and sampling processes were preferred over complex follow-up and randomization systems, aiming to reduce bias and increase the generalizability of the study. Full article

(This article belongs to the Special Issue Point-of-Care Diagnostics for Low-Resource Settings)

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