scholarly journals Improving access to new diagnostics through harmonised regulation: priorities for action

2014 ◽  
Vol 3 (1) ◽  
Author(s):  
Ruth McNerney ◽  
Kimberly Sollis ◽  
Rosanna W. Peeling
Keyword(s):  
Developing Countries ◽  
Diagnostic Tests ◽  
Clinical Performance ◽  
Point Of Care ◽  
Poor Quality ◽  
International Standards ◽  
Regulatory Oversight ◽  
Adoption And Implementation ◽  
Post Market ◽  
Timely Access

A new generation of diagnostic tests is being developed for use at the point of care that could save lives and reduce the spread of infectious diseases through early detection and treatment. It is important that patients in developing countries have access to these products at affordable prices and without delay. Regulation of medical products is intended to ensure safety and quality whilst balancing the need for timely access to beneficial new products. Current regulatory oversight of diagnostic tests in developing countries is highly variable and weak regulation allows poor-quality tests to enter the market. However, inefficient orover zealous regulation results in unnecessary delays, increases costs and acts as a barrier to innovation and market entry. Setting international standards and streamlining the regulatory process could reduce these barriers. Four priority activities have been identified where convergence of standards and protocols or joint review of data would be advantageous: (1) adoption of a common registration file for pre-market approval; (2) convergence of quality standards for manufacturing site inspections; (3) use of common evaluation protocols, aswell as joint review of data, to reduce unnecessary duplication of lengthy and costly clinical performance studies; and (4) use of networks of laboratories for post-market surveillance in order to monitor ongoing quality of diagnostic devices. The adoption and implementation of such measures in developing countries could accelerate access to new diagnostic tests that are safe and affordable.

scholarly journals Analytical and Clinical Evaluation of Two RT-qPCR SARS-CoV-2 Diagnostic Tests with Emergency Use Authorization in Ecuador

2021 ◽  
Author(s):  
Byron Freire-Paspuel ◽  
Alfredo Bruno ◽  
Alberto Orlando ◽  
Miguel Angel Garcia-Bereguiain
Keyword(s):  
Developing Countries ◽  
Gold Standard ◽  
Diagnostic Tests ◽  
Limit Of Detection ◽  
Clinical Performance ◽  
Evaluation Studies ◽  
Country Of Origin ◽  
Analytical Sensitivity ◽  
Clinical Use ◽  
Deep Impact

Dozens of RT-qPCR kits are available in the market for SARS-CoV-2 diagnosis, some of them with Emergency Use Authorization (EUA) by the Food and Drug Administration (FDA) or at least by a responsible agency of their country of origin, but many of them lack proper evaluation studies because of COVID-19 pandemic emergency. We evaluated the clinical performance of two commercially available kits in South America, the 2019-nCoV kit (Da An Gene, Guangzhou, China) and GenomeCoV19 kit (ABM, Richmond, Canada), for RT-qPCR SARS-CoV-2 diagnosis using the FDA EUA 2019-nCoV CDC kit (IDT, Coralville, IA) as gold standard. We found striking differences among clinical performance and analytical sensitivity in both kits; whereas the 2019-nCoV kit (Da An Gene) has a limit of detection of 2,000 copies/mL and 100% of sensitivity, the GenomeCoV19 kit (ABM) has a poor sensitivity of 75% and a limit of detection estimated to be over 8.000 copies/mL. The GenomeCoV19 kit (ABM) lacks clinical use authorization in Canada; however, the 2019-nCoV kit (Da An Gene) is authorized by the Chinese CDC. Our results support that only SARS-CoV-2 diagnosis kits with clinical use authorization from their country of origin should be exported to developing countries lacking proper evaluation agencies to avoid a deep impact of the COVID-19 pandemic due to unreliable diagnosis.

scholarly journals Assessing Immunity by Quantitative Measurement of SARS-CoV-2 IgG Antibodies in Fingerstick Samples

2021 ◽  
Author(s):  
Javier T. Garza ◽  
Jacob Quick ◽  
Dev Chatterjee ◽  
Robert Patrick Garr ◽  
Atul Varadhachary ◽  
...  
Keyword(s):  
Clinical Performance ◽  
Point Of Care ◽  
Treatment Options ◽  
Antibody Test ◽  
Cross Reactivity ◽  
International Standards ◽  
Antibody Concentration ◽  
Immune Protection ◽  
Igg Antibodies ◽  
Individual Level

COVID-19 has affected billions of people around the world directly or indirectly. The response to the pandemic has focused on preventing the spread of the disease and improving treatment options. Diagnostic technologies have played a key role in this response since the beginning of the pandemic. As vaccines and other treatments have been developed and deployed, interest in understanding and measuring the individual level of immune protection has increased. Historically, use of antibody titers to measure systemic immunity has been constrained by an incomplete understanding of the relationship between antibodies and immunity, the lack of international standards for antibody concentration to enable cross-study comparisons, and insufficient clinical data to allow for the development of robust antibody-immunity models. However, these constraints have recently shifted. With a deeper understanding of antibodies, the promulgation of WHO antibody standards, and the development of immunity models using datasets from multiple COVID-19 vaccine trials, certain types of quantitative antibody tests may now provide a way to monitor individual or community immunity against COVID-19. Specifically, tests that quantitate the concentration of anti-RBD IgG -antibodies that target the receptor binding domain of the S1 spike protein component of the SARS-CoV-2 virus- show promise as a useful and scalable measure of the COVID-19 immunity of both individuals and communities. However, to fulfill this promise, a rapid and easy-to-administer test is needed. To address this important clinical need, Brevitest deployed its point-of-care-capable technology platform that can run a rapid (<15 minute), quantitative antibody test with a sample of 10 µl of whole blood from a fingerstick. The test we validated on this platform measures the concentration of anti-RBD IgG in Binding Antibody Units per milliliter (BAU/mL) per WHO Reference Standard NIBSC 20/136. In this paper, we present studies used to characterize the Brevitest anti-RBD IgG assay and evaluate its clinical performance, lower limits of measurement, precision, linearity, interference, and cross-reactivity. The results demonstrate the ability of this assay to measure a patient's anti-RBD IgG concentration. This information, together with models developed from recent COVID-19 vaccine clinical trials, can provide a means of assessing the current level of immune protection of an individual or community against COVID-19 infection.

scholarly journals Common evidence gaps in point-of-care diagnostic test evaluation: a review of horizon scan reports

BMJ Open ◽  
2017 ◽  
Vol 7 (9) ◽  
pp. e015760 ◽  
Author(s):  
Jan Y Verbakel ◽  
Philip J Turner ◽  
Matthew J Thompson ◽  
Annette Plüddemann ◽  
Christopher P Price ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Diagnostic Test ◽  
Diagnostic Tests ◽  
Clinical Performance ◽  
Point Of Care ◽  
Clinical Effectiveness ◽  
Diagnostic Test Evaluation ◽  
Diagnostic Technologies ◽  
Diagnostic Horizon ◽  
Evidence Generation

ObjectiveSince 2008, the Oxford Diagnostic Horizon Scan Programme has been identifying and summarising evidence on new and emerging diagnostic technologies relevant to primary care. We used these reports to determine the sequence and timing of evidence for new point-of-care diagnostic tests and to identify common evidence gaps in this process.DesignSystematic overview of diagnostic horizon scan reports.Primary outcome measuresWe obtained the primary studies referenced in each horizon scan report (n=40) and extracted details of the study size, clinical setting and design characteristics. In particular, we assessed whether each study evaluated test accuracy, test impact or cost-effectiveness. The evidence for each point-of-care test was mapped against the Horvath framework for diagnostic test evaluation.ResultsWe extracted data from 500 primary studies. Most diagnostic technologies underwent clinical performance (ie, ability to detect a clinical condition) assessment (71.2%), with very few progressing to comparative clinical effectiveness (10.0%) and a cost-effectiveness evaluation (8.6%), even in the more established and frequently reported clinical domains, such as cardiovascular disease. The median time to complete an evaluation cycle was 9 years (IQR 5.5–12.5 years). The sequence of evidence generation was typically haphazard and some diagnostic tests appear to be implemented in routine care without completing essential evaluation stages such as clinical effectiveness.ConclusionsEvidence generation for new point-of-care diagnostic tests is slow and tends to focus on accuracy, and overlooks other test attributes such as impact, implementation and cost-effectiveness. Evaluation of this dynamic cycle and feeding back data from clinical effectiveness to refine analytical and clinical performance are key to improve the efficiency of point-of-care diagnostic test development and impact on clinically relevant outcomes. While the ‘road map’ for the steps needed to generate evidence are reasonably well delineated, we provide evidence on the complexity, length and variability of the actual process that many diagnostic technologies undergo.

scholarly journals Clinical Performance of the cobas Liat SARS-CoV-2 & Influenza AB for the Detection of SARS-CoV-2 in Nasal Samples

2022 ◽  
Author(s):  
Yusaku Akashi ◽  
Michiko Horie ◽  
Junichi Kiyotaki ◽  
Yuto Takeuchi ◽  
Kenichi Togashi ◽  
...  
Keyword(s):  
Infectious Diseases ◽  
Diagnostic Tests ◽  
Clinical Utility ◽  
Clinical Performance ◽  
Point Of Care ◽  
Concordance Rate ◽  
Molecular Diagnostic ◽  
Molecular Assays ◽  
High Concordance

Background and Objective: Point-of-care type molecular diagnostic tests have been used for detecting SARS-CoV-2, although their clinical utility with nasal samples has yet to be established. This study evaluated the clinical performance of the cobas Liat SARS-CoV-2 & Influenza AB (Liat) in nasal samples. Methods: Nasal and nasopharyngeal samples were collected and were tested using the Liat, the cobas 6800 system and the cobas SARS-CoV-2 & Influenza AB (cobas), and a method developed by National Institute of Infectious Diseases, Japan (NIID). Results: A total of 814 nasal samples were collected. The Liat assay was positive for SARS-CoV-2 in 113 (13.9%). The total, positive, and negative concordance rate between the Liat and cobas/NIID assays were 99.3%/98.4%, 99.1%/100%, and 99.3%/98.2%, respectively. Five samples were positive only using the Liat assay. Their Ct values ranged from 31.9 to 37.2. The Ct values of the Liat assay were significantly lower (p < 0.001) but were correlated (p < 0.001) with those of other molecular assays. In the participants who tested positive for SARS-CoV-2 on the Liat assay using nasopharyngeal samples, 88.2% of their nasal samples also tested positive using the Liat assay. Conclusion: The Liat assay showed high concordance with other molecular assays in nasal samples. Some discordance occurred in samples with Ct values > 30 on the Liat assay.

scholarly journals Applying Loop-mediated Isothermal Amplification (LAMP) in the Diagnosis of Malaria, Leishmaniasis and Trypanosomiasis as Point-of-Care Tests (POCTs)

2018 ◽  
Vol 18 (16) ◽  
pp. 1358-1374 ◽  
Author(s):  
M. Auxiliadora Dea-Ayuela ◽  
Cristina Galiana-Roselló ◽  
Aikaterini Lalatsa ◽  
Dolores R. Serrano
Keyword(s):  
Developing Countries ◽  
Diagnostic Tests ◽  
Point Of Care ◽  
Genetic Material ◽  
High Sensitivity ◽  
Good Alternative ◽  
Isothermal Amplification ◽  
Vector Borne Diseases ◽  
Loop Mediated Isothermal Amplification ◽  
Therapeutic Regime

One of the main objectives of the WHO is controlling transmission of parasitic protozoa vector- borne diseases. A quick and precise diagnosis is critical in selecting the optimal therapeutic regime that avoids unnecessary treatments and the emergence of resistance. Molecular assays based on Loop- Mediated Isothermal Amplification (LAMP) techniques are a good alternative to light microscopy and antigen-based rapid diagnostic tests in developing countries, since they allow for a large amount of genetic material generated from a few copies of DNA, and use primers that lead to high sensitivity and specificity, while the amplification process can be performed in isothermal conditions without the need of sophisticated equipment to interpret the results. In this review, the main advances in the development of LAMP assays for the diagnosis of malaria, leishmaniasis and Chagas' disease are discussed as well as the feasibility of their implementation in developing countries and use as point- of-care diagnostic tests.

Magnetic Digital Microfluidics for Point-of-Care Testing: Where Are We Now?

2020 ◽  
Vol 27 ◽  
Author(s):  
Yi Zhang
Keyword(s):  
System Integration ◽  
Diagnostic Tests ◽  
Point Of Care ◽  
Digital Microfluidics ◽  
Controlled Environment ◽  
Point Of Care Testing ◽  
Microfluidic Platforms ◽  
Interface System ◽  
Technical Issues ◽  
Sample System

: Point-of-care (POC) testing decentralizes the diagnostic tests to the sites near the patient. Many POC tests rely microfluidic platforms for sample-to-answer analysis. Compared to other microfluidic systems, magnetic digital microfluidics demonstrate compelling advantages for POC diagnostics. In this review, we have examined the capability of magnetic digital microfluidics-based POC diagnostic platforms. More importantly, we have categorized POC settings into three classes based on “where is the point”, “who to care” and “how to test”, and evaluated the suitability of magnetic digital microfluidics in various POC settings. Furthermore, we have addressed other technical issues associated with POC testing such as controlled environment, sample-system interface, system integration and information connectivity. We hope this review would provide a guideline for the future development of magnetic digital microfluidics-based platforms for POC testing.

scholarly journals Advances in Environmental Detection and Clinical Diagnostic Tests for Legionella Species

2021 ◽  
Author(s):  
Rajeshwari Vittal ◽  
Juliet Roshini Mohan Raj ◽  
Ballamoole Krishna Kumar ◽  
Indrani Karunasagar
Keyword(s):  
Developing Countries ◽  
Healthcare System ◽  
Diagnostic Tests ◽  
Clinical Manifestations ◽  
Cost Effective ◽  
Clinical Samples ◽  
Detection Techniques ◽  
Conventional Culture ◽  
Legionella Species ◽  
Mild Fever

Abstract Legionella is a fastidious organism that is difficult to culture in the lab but is widely distributed in environmental, domestic, and hospital settings. The clinical manifestations due to Legionella infections range from mild fever to fatal pneumonia and multiorgan pathologies. Legionella outbreaks though prevalent globally are not reported in developing countries due to difficulties in isolating this organism and the lack of simple diagnostic protocols. Here, we review the literature from across countries to present various methods used to detect Legionella from environmental and clinical samples. We compare the sensitivity and the specificity of the conventional culture-based assays with the recent methods and discuss approaches to develop better detection and diagnostic tests. With better cost-effective detection techniques and regular monitoring of the susceptible sites, which may harbor Legionella colonies, most of the Legionella infections can be prevented. As a result, considerable burden, caused by Legionella infections, on the healthcare system, in especially economically weaker countries, can be mitigated.

scholarly journals An assessment of the Armenian national midwifery curriculum as per international standards

2020 ◽  
Vol 30 (Supplement_5) ◽  
Author(s):  
L Aslanyan ◽  
S Sahakyan ◽  
V Petrosyan
Keyword(s):  
Poor Quality ◽  
International Standards ◽  
Assessment Tools ◽  
Global Competency ◽  
Midwifery Education ◽  
Study Team ◽  
Competency Based ◽  
Document Review ◽  
Provision Of Care

Abstract Background Literature suggests increasing evidence that incompetent midwifery education results in poor quality of care. The study compared and evaluated the level of compliance of the Armenian national criterion on midwifery with the global competency standards and developed recommendations for improvement. Methods The study team conducted a document review using a standardized checklist, which was adapted from the International Confederation of Midwives (ICM) core assessment tools. The document review explored if the main knowledge and skills/ability related elements of each ICM competency were separately covered by different modules of the national criterion using a scoring system with categories: not met, partially met, fully met and unspecified. Results Although the national criterion did not have specifically defined competencies, most of the elements required by the ICM were present as specific learning outcomes under different modules of the criterion. Midwifery program curriculum was described as intensive with unnecessarily heavy workload. Additionally, the document review reviled that most of the learning outcome defined in modules of the national criterion focused more on theoretical knowledge rather than practical skills and abilities. Overall, the ICM required competency in provision of care during pregnancy was the most comprehensively covered one in the national criterion, while the competency in facilitation of abortion related care was the lowest covered. National criterion did not highlight the importance of topics such as women's rights and health, principles of epidemiology, statistical methods of research, cultural, local and ethical beliefs. Conclusions The systematic comparison of the national criterion with internationally recognized essential competencies demonstrates significant gaps. The study team recommends revisions to the national criterion to make it competency based. Key messages Midwifery education criteria in Armenia did not reflect internationally accepted midwifery competency’s fundamental philosophy and values. Given the shortcomings of the current national midwifery education criterion, a comprehensive revision of the competencies of midwives in Armenia should be considered.

Clinical assessment of the Roche SARS-CoV-2 rapid antigen test

Diagnosis ◽  
2021 ◽  
Vol 0 (0) ◽  
Author(s):  
Gian Luca Salvagno ◽  
Gianluca Gianfilippi ◽  
Damiano Bragantini ◽  
Brandon M. Henry ◽  
Giuseppe Lippi
Keyword(s):  
Clinical Assessment ◽  
Clinical Performance ◽  
Point Of Care ◽  
High Viral Load ◽  
Rapid Screening ◽  
Clinical Samples ◽  
Molecular Testing ◽  
Antigen Test ◽  
Community Screening ◽  
Final Study

Abstract Objectives Novel point-of-care antigen assays present a promising opportunity for rapid screening of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections. The purpose of this study was the clinical assessment of the new Roche SARS-CoV-2 Rapid Antigen Test. Methods The clinical performance of Roche SARS-CoV-2 Rapid Antigen Test was evaluated vs. a reverse transcription polymerase chain reaction (RT-PCR) laboratory-based assay (Seegene AllplexTM2019-nCoV) in nasopharyngeal swabs collected from a series of consecutive patients referred for SARS-CoV-2 diagnostics to the Pederzoli Hospital (Peschiera del Garda, Verona, Italy) over a 2-week period. Results The final study population consisted of 321 consecutive patients (mean age, 46 years and IQR, 32–56 years; 181 women, 56.4%), with 149/321 (46.4%) positive for SARS-CoV-2 RNA via the Seegene AllplexTM2019-nCoV Assay, and 109/321 (34.0%) positive with Roche SARS-CoV-2 Rapid Antigen Test, respectively. The overall accuracy of Roche SARS-CoV-2 Rapid Antigen Test compared to molecular testing was 86.9%, with 72.5% sensitivity and 99.4% specificity. Progressive decline in performance was observed as cycle threshold (Ct) values of different SARS-CoV-2 gene targets increased. The sensitivity was found to range between 97–100% in clinical samples with Ct values <25, between 50–81% in those with Ct values between 25 and <30, but low as 12–18% in samples with Ct values between 30 and <37. Conclusions The clinical performance of Roche SARS-CoV-2 Rapid Antigen Test is excellent in nasopharyngeal swabs with Ct values <25, which makes it a reliable screening test in patients with high viral load. However, mass community screening would require the use of more sensitive techniques.

Sign in / Sign up

Export Citation Format

Share Document