Rapid diagnostics for SARS-CoV-2 virus: point-of-care testing and lessons learned during the pandemic

Context.— Point-of-care (POC) testing has significant potential application in rural and remote Australian communities where access to laboratory-based pathology testing is often poor and the burden of chronic, acute, and infectious disease is high. Objective.— To explore the clinical, operational, cultural, and cost benefits of POC testing in the Australian rural and remote health sector and describe some of the current challenges and limitations of this technology. Data Sources.— Evidence-based research from established POC testing networks for chronic, acute, and infectious disease currently managed by the International Centre for Point-of-Care Testing at Flinders University are used to highlight the experience gained and the lessons learned from these networks and, where possible, describe innovative solutions to address the current barriers to the uptake of POC testing, which include governance, staff turnover, maintaining training and competency, connectivity, quality testing, sustainable funding mechanisms, and accreditation. Conclusions.— Point-of-care testing can provide practical and inventive opportunities to revolutionize the delivery of pathology services in rural and remote sectors where clinical need for this technology is greatest. However, many barriers to POC testing still exist in these settings, and the full potential of POC testing cannot be realized until these limitations are addressed and resolved.

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A novel RT-LAMP workflow for rapid salivary diagnostics of COVID-19 and effects of age, gender and time from symptom onset

10.1101/2021.06.07.21258288 ◽

2021 ◽

Author(s):

Gerson Shigeru Kobayashi ◽

Luciano Abreu Brito ◽

Danielle De Paula Moreira ◽

Angela May Suzuki ◽

Gabriella Shih Ping Hsia ◽

...

Keyword(s):

Viral Load ◽

Symptom Onset ◽

Clinical Performance ◽

Point Of Care ◽

Rapid Diagnostics ◽

Rt Pcr ◽

Point Of Care Testing ◽

Viral Loads ◽

Peak Viral Load ◽

Salivary Diagnostics

Objectives: Rapid diagnostics is pivotal to curb SARS-CoV-2 transmission, and saliva has emerged as a practical alternative to naso/oropharyngeal (NOP) specimens. We aimed to develop a direct RT-LAMP workflow for viral detection in saliva, and to provide more information regarding its potential in COVID-19 diagnostics. Methods: Clinical and contrived specimens were used to screen/optimize formulations and sample processing protocols. Salivary viral load was determined in symptomatic patients to evaluate clinical performance (n = 90) and to characterize saliva based on age, gender and time from onset of symptoms (n = 49). Results: The devised workflow achieved 93.2% sensitivity, 97% specificity, and 0.895 Kappa for salivas containing >102 copies/μL. Further analyses in saliva showed peak viral load in the first days of symptoms and lower viral loads in females, particularly among young individuals (<38 years). NOP RT-PCR data did not yield relevant associations. Conclusions: This novel saliva RT-LAMP workflow can be applied to point-of-care testing. This work reinforces that saliva better correlates with transmission dynamics than NOP specimens, and reveals gender differences that may reflect higher transmission by males. To maximize detection, testing should be done immediately after symptom onset, especially in females.

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External quality assurance for HIV point-of-care testing in Africa: A collaborative country-partner approach to strengthen diagnostic services

African Journal of Laboratory Medicine ◽

10.4102/ajlm.v5i2.556 ◽

2016 ◽

Vol 5 (2) ◽

Cited By ~ 4

Author(s):

Debrah I. Boeras ◽

Rosanna W. Peeling

Keyword(s):

Quality Assurance ◽

Point Of Care ◽

Lessons Learned ◽

Tropical Medicine ◽

External Quality Assurance ◽

Laboratory Diagnostics ◽

London School ◽

Point Of Care Testing ◽

External Quality ◽

Resource Limited

It is important to consider the role of diagnostics and the critical need for quality diagnostics services in resource-limited settings. Accurate diagnostic tests play a key role in patient management and the prevention and control of most infectious diseases. As countries plan for implementation of HIV early infant diagnosis and viral load point-of-care testing, the London School of Hygiene & Tropical Medicine has worked with countries and partners with an interest in external quality assurance to support quality point-of-care testing on the continent. Through a series of collaborative consultations and workshops, the London School of Hygiene & Tropical Medicine has gathered lessons learned, tools, and resources and developed quality assurance models that will support point-of-care testing. The London School of Hygiene & Tropical Medicine is committed to the continued advancement of laboratory diagnostics in Africa and quality laboratory services and point-of-care testing.

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Rapid Electronic Diagnostics of Ebola Virus with Synthetic Nanobody-Conjugated Gold Nanoparticles

10.1101/2021.05.09.443341 ◽

2021 ◽

Author(s):

Xiahui Chen ◽

Shoukai Kang ◽

MD Ashif Ikbal ◽

Zhi Zhao ◽

Jiawei Zuo ◽

...

Keyword(s):

Gold Nanoparticles ◽

Infectious Diseases ◽

Ebola Virus ◽

Semiconductor Device ◽

Point Of Care ◽

Colorimetric Detection ◽

Emerging Infectious Diseases ◽

Rapid Diagnostics ◽

Point Of Care Testing ◽

Training Requirement

The success of controlling emerging infectious diseases relies on the fast development of robust, quantitative assays for point-of-care testing. Here a generalizable strategy is demonstrated for developing inexpensive, simple-to-use, and rapid diagnostics within a few weeks upon the identification of a new viral antigen. Using Ebola virus secreted glycoprotein (sGP) as a target, we design a new assay featuring nanobody-conjugated nanoparticles for rapid, electronic detection (Nano2RED). Nanobodies with the high affinity and specificity were generated by phage display screening of a high-quality combinatorial library (> 109) and site-specifically conjugated to gold nanoparticles (AuNPs) for in-solution colorimetric detection. Our assay can robustly detect the sGP protein from 10 pM to 100 nM in diluted serum and distinguish it from a membrane-anchored isoform, GP1,2, allowing the diagnosis of the viral infection stage. Additionally, a rapid assay protocol was established to decrease the assay time to a few minutes without compromising the accuracy. Lastly, this assay has been integrated with a portable semiconductor device with a digital readout and minimal training requirement for end users. Our method can be widely applied to the point-of-care testing of other infectious diseases.

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O-045: Increasing hepatitis C testing uptake with point of care testing from the needle and syringe exchange desk - lessons learned from the Rapid-EC Feasibility Study

Journal of Viral Hepatitis ◽

10.1111/jvh.39_12922 ◽

2018 ◽

Vol 25 ◽

pp. 28-29

Keyword(s):

Hepatitis C ◽

Feasibility Study ◽

Point Of Care ◽

Lessons Learned ◽

Syringe Exchange ◽

Point Of Care Testing ◽

Testing Uptake

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Primary Diagnostic Tools for SARS-CoV-2 Infection (COVID-19): Mini Review Based on Current Challenges in Molecular Techniques and Point of Care Testing for Screening

International Journal of Pathogen Research ◽

10.9734/ijpr/2020/v5i430149 ◽

2021 ◽

pp. 94-104

Author(s):

K. Kokilavani ◽

Bindu Salim

Keyword(s):

Point Of Care ◽

Developed Countries ◽

Molecular Techniques ◽

Diagnostic Methods ◽

Diagnostic Tools ◽

Attractive Alternative ◽

Screening Methods ◽

Rapid Diagnostics ◽

Point Of Care Testing ◽

The Developed Countries

Pandemic outbreaks are always a challenge for the health care management to control the mortality rate when the preventive measures are not established. The challenge is being faced worldwide with the outbreak of COVID-19 including the developed countries. The only solution is to control the spread by conducting massive screening and isolating affected ones from the healthy ones, which needs the development of screening methods that can reach the maximum population. The next step is to come up with vaccines. The research concentration worldwide is focussed on developing rapid diagnostics and screening at an affordable cost. Multiple studies suggest that Reverse Transcription- Polymerase Chain Reaction (RT-PCR), protein testing and Computed Tomography (CT) should be the principal diagnostic methods for routine testing/ screening in patients with COVID-19. But three factors are still indistinct in those diagnostic methods such as rapidity, sensitivity, and specificity. Thus, alternative approaches that provide higher efficiency and rapid are highly appreciated for the super spread infectious disease detection. Presently, microfluidics-based test kits alternatively called as lab-on-a-chip or Point- Of -Care Testing (POCT) have been widely used in cancer and viral detection. The ability of POCT tests to provide short time results, suitable in low resource clinics or even at home should be an attractive alternative. So, the miniaturized tools suitable for COVID-19 detection will replace the current expensive methods. Despite the limitations, the approved tests are still providing good results for this high risk pandemic. Many articles in the recent past highlighted the POCT method is not less than any other screening methods and by reviewing a wide research background, the importance of developing POCTs for screening such pandemic is presented here.

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