Paper-based nucleic acid amplification tests for point-of-care diagnostics

The Analyst ◽  
2018 ◽  
Vol 143 (10) ◽  
pp. 2213-2234 ◽  
Author(s):  
Navjot Kaur ◽  
Bhushan J. Toley
Keyword(s):  
Nucleic Acid ◽  
Critical Review ◽  
Point Of Care ◽  
Nucleic Acid Amplification ◽  
Nucleic Acid Amplification Tests ◽  
Point Of Care Diagnostics

A critical review of paper-based nucleic acid amplification tests with a focus on integration and sequence of operations.

scholarly journals A simple check valve for microfluidic point of care diagnostics

Lab on a Chip ◽  
2016 ◽  
Vol 16 (22) ◽  
pp. 4436-4444 ◽  
Author(s):  
C. S. Ball ◽  
R. F. Renzi ◽  
A. Priye ◽  
R. J. Meagher
Keyword(s):  
Nucleic Acid ◽  
Point Of Care ◽  
Check Valve ◽  
Nucleic Acid Amplification ◽  
Nucleic Acid Amplification Testing ◽  
Point Of Care Diagnostics

Laser cut microfluidic check valves enable staged reagent delivery, pumping, and point of care nucleic acid amplification testing.

scholarly journals Clinical evaluation of fully automated molecular diagnostic system “Simprova” for influenza virus, respiratory syncytial virus, and human metapneumovirus

2020 ◽  
Vol 10 (1) ◽  
Author(s):  
Ikuyo Takayama ◽  
Shohei Semba ◽  
Kota Yokono ◽  
Shinji Saito ◽  
Mina Nakauchi ◽  
...  
Keyword(s):  
Influenza Virus ◽  
Respiratory Syncytial Virus ◽  
Nucleic Acid ◽  
Point Of Care ◽  
Antigen Detection ◽  
Human Metapneumovirus ◽  
Nucleic Acid Amplification ◽  
Clinical Specimens ◽  
Nucleic Acid Amplification Tests ◽  
Syncytial Virus

Abstract Influenza virus, respiratory syncytial virus, and human metapneumovirus commonly cause acute upper and lower respiratory tract infections, especially in children and the elderly. Although rapid antigen detection tests for detecting these infections have been introduced recently, these are less sensitive than nucleic acid amplification tests. More recently, highly sensitive point-of-care testings (POCTs) have been developed based on nucleic acid amplification tests, which are easy to use in clinical settings. In this study, loop-mediated isothermal amplification (LAMP)-based POCT “Simprova” to detect influenza A and B viruses, respiratory syncytial virus, and human metapneumovirus was developed. Simprova system is fully automated and does not require skilled personnel. In addition, positive results can be achieved faster than with PCR. In this study, the accuracy of the POCT was retrospectively analyzed using 241 frozen stocked specimens. Additionally, the usability of the Simprova at clinical sites was assessed in a prospective clinical study using 380 clinical specimens and compared to those of real-time PCR and rapid antigen detection test. The novel LAMP-based POCT demonstrated high sensitivity and specificity in characterizing clinical specimens from patients with influenza-like illnesses. The Simprova is a powerful tool for early diagnosis of respiratory viral infections in point-of-care settings.

scholarly journals A Robust, Low-Cost Instrument for Real-time Colorimetric Isothermal Nucleic Acid Amplification

2021 ◽  
Author(s):  
Frank Myers ◽  
Brian Moffatt ◽  
Ragheb El Khaja ◽  
Titash Chatterjee ◽  
Gurmeet Marwaha ◽  
...  
Keyword(s):  
Nucleic Acid ◽  
Real Time ◽  
Point Of Care ◽  
Low Cost ◽  
Lamp Assay ◽  
Nucleic Acid Amplification ◽  
Diagnostic Assays ◽  
Isothermal Nucleic Acid Amplification ◽  
Point Of Care Diagnostics ◽  
Time Readout

The COVID-19 pandemic has highlighted the need for broader access to molecular diagnostics. Colorimetric isothermal nucleic acid amplification assays enable simplified instrumentation over more conventional PCR diagnostic assays and, as such, represent a promising approach for addressing this need. In particular, colorimetric LAMP (loop-mediated isothermal amplification) has received a great deal of interest recently. However, there do not currently exist robust instruments for performing these kinds of assays in high throughput with real-time readout of amplification signals. To address this need, we developed LARI, the LAMP Assay Reader Instrument. We have deployed over 50 LARIs for routine use in R&D and production environments, with over 12,000 assays run to date. In this paper, we present the design and construction of LARI along with thermal, optical, and assay performance characteristics. LARI can be produced for under $1500 and has broad applications in R&D, point-of-care diagnostics, and global health.

scholarly journals Utility of Point-of-Care COVID-19 Testing in an Outpatient Otolaryngology clinic

OTO Open ◽  
2021 ◽  
Vol 5 (4) ◽  
pp. 2473974X2110493
Author(s):  
Meera Ganesh ◽  
Craig Cameron Brawley ◽  
Ashoke Khanwalkar ◽  
John Mycanka ◽  
David B. Conley ◽  
...  
Keyword(s):  
Nucleic Acid ◽  
Odds Ratio ◽  
Point Of Care ◽  
Nucleic Acid Amplification ◽  
Advanced Practice ◽  
Provider Type ◽  
Chi Square ◽  
Level Of Evidence ◽  
Nucleic Acid Amplification Tests ◽  
Polymerase Chain

Objective To evaluate the utility of point-of-care COVID-19 testing for identifying infected patients in an otolaryngology practice. Study Design Retrospective review of 947 patients tested with a point-of-care nucleic acid amplification test for SARS-CoV-2 (Abbott ID Now). Setting Tertiary otolaryngology clinic setting from July to November 2020. Methods Tests were characterized by provider-specified indication (symptomatic, preprocedural, and universal), subspecialty, provider type, and contemporaneous regional COVID-19 positivity rate, defined as 12%. Positive results were further classified as true or false positive (TP or FP) based on repeat polymerase chain reaction testing wherever available, and true positivity rates were compared among groups by multiway chi-square and Fisher’s exact tests. FP rates within 48 hours of a TP result were also evaluated to assess for batch contamination. Results A total of 947 SARS-CoV-2 nucleic acid amplification tests were performed, yielding 9 TPs (0.95%) and 5 FPs (0.53%). TP rates were significantly different by testing indication, with higher rates among symptomatic patients ( P = .012; vs universal, odds ratio = 7.86 [95% CI, 1.27-83.52]; vs preprocedural, odds ratio = 4.91 [95% CI, 0.79-52.17]); by subspecialty ( P = .011), as driven by higher positivity rates in laryngology; and by encounter, with higher rates among advanced practice practitioners than physicians ( P = .002; odds ratio = 9.97 [95% CI, 2.11-51.16]). TP rates were not significantly different during periods of uncontrolled local outbreak ( P = .660). FP rates were not significantly higher within a 48-hour window of a TP ( P = .192). Conclusion Point-of-care COVID-19 nucleic acid amplification tests in an outpatient otolaryngology clinic identified a low TP rate (<1%) with most cases being clinically suspected. Laryngology and advanced practice practitioner encounters may have higher positivity rates. Level of evidence: 3.

scholarly journals The role of rapid diagnostic point of care IgG/IgM antibody tests in the diagnosis of SARS-CoV-2 infection

2020 ◽  
Vol 4 (1) ◽  
Author(s):  
Nishita Tripathi ◽  
Keyword(s):  
Nucleic Acid ◽  
Point Of Care ◽  
Clinical Importance ◽  
Antibody Test ◽  
High Specificity ◽  
Nucleic Acid Amplification ◽  
Serological Tests ◽  
Nucleic Acid Amplification Tests ◽  
Igm Antibody ◽  
Antibody Tests

Background: Current testing of symptomatic patients for SARS-CoV-2 involves the use of nucleic acid amplification tests, also known as genetic, RNA or PCR to detect viral RNA. The initial use of point-of-care (POC) antibody tests, also known as serological tests in the management of SARS-CoV-2 infection was limited. In this review, we determine the significance of POC antibody serological tests and explore their possible role in the diagnosis and management of patients infected with SARS-CoV-2 virus. Methods: A literature search was conducted in Google Scholar, PubMed, and Embase, and supplemented by searching the Center for Disease Control (CDC), and the Infectious Diseases Society of America (IDSA) websites. We identified 7 articles published in the last 6 months pertaining to the keywords. The sensitivity and specificity of the IgG/IgM antibody tests obtained from these studies were compared and used to determine the clinical importance of the rapid diagnostic antibody test in SARS-CoV-2 infection. Results: Through the literature review, it was found that POC diagnostic antibody tests can be used as an adjuvant with the nucleic acid amplification tests in determining both active and post-exposure antibodies. These rapid antibody IgG/IgM tests had high sensitivity, the ability of a test to correctly identify those with the disease, and high specificity, the ability of the test to correctly identify those without the disease. Conclusion: Emerging studies indicate the importance of POC antibody serological testing as an important diagnostic tool in the current SARS-CoV-2 pandemic. Considering the limitations of the molecular methods of testing, POC antibody tests can help reduce dependency on the molecular assays of testing when used in conjunction with them.

scholarly journals Advances Afoot in Microbiology

2017 ◽  
Vol 55 (7) ◽  
pp. 1984-1988 ◽  
Author(s):  
Robin Patel ◽  
Brad S. Karon
Keyword(s):  
Nucleic Acid ◽  
American Academy ◽  
Medical Care ◽  
Clinical Microbiology ◽  
Point Of Care ◽  
Nucleic Acid Amplification ◽  
Nucleic Acid Amplification Tests ◽  
Link Type ◽  
The Government

ABSTRACT In 2016, the American Academy of Microbiology convened a colloquium to examine point-of-care (POC) microbiology testing and to evaluate its effects on clinical microbiology. Colloquium participants included representatives from clinical microbiology laboratories, industry, and the government, who together made recommendations regarding the implementation, oversight, and evaluation of POC microbiology testing. The colloquium report is timely and well written (V. Dolen et al., Changing Diagnostic Paradigms for Microbiology , 2017, https://www.asm.org/index.php/colloquium-reports/item/6421-changing-diagnostic-paradigms-for-microbiology?utm_source=Commentary&utm_medium=referral&utm_campaign=diagnostics ). Emerging POC microbiology tests, especially nucleic acid amplification tests, have the potential to advance medical care.

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