scholarly journals The Laboratory Diagnosis of Neisseria gonorrhoeae: Current Testing and Future Demands

Pathogens ◽  
2020 ◽  
Vol 9 (2) ◽  
pp. 91 ◽  
Author(s):  
Thomas Meyer ◽  
Susanne Buder
Keyword(s):  
Neisseria Gonorrhoeae ◽  
Point Of Care ◽  
High Sensitivity ◽  
Laboratory Diagnosis ◽  
Molecular Techniques ◽  
Nucleic Acid Amplification ◽  
Antimicrobial Drugs ◽  
Urogenital Infections ◽  
Future Demands

The ideal laboratory test to detect Neisseria gonorrhoeae (Ng) should be sensitive, specific, easy to use, rapid, and affordable and should provide information about susceptibility to antimicrobial drugs. Currently, such a test is not available and presumably will not be in the near future. Thus, diagnosis of gonococcal infections presently includes application of different techniques to address these requirements. Microscopy may produce rapid results but lacks sensitivity in many cases (except symptomatic urogenital infections in males). Highest sensitivity to detect Ng was shown for nucleic acid amplification technologies (NAATs), which, however, are less specific than culture. In addition, comprehensive analysis of antibiotic resistance is accomplished only by in vitro antimicrobial susceptibility testing of cultured isolates. As a light at the end of the tunnel, new developments of molecular techniques and microfluidic systems represent promising opportunities to design point-of-care tests for rapid detection of Ng with high sensitivity and specificity, and there is reason to hope that such tests may also provide antimicrobial resistance data in the future.

Diagnostic tests for detecting Chlamydia trachomatis and Neisseria gonorrhoeae in rectal and pharyngeal specimens

2021 ◽  
Author(s):  
Paul C. Adamson ◽  
Jeffrey D. Klausner
Keyword(s):  
Chlamydia Trachomatis ◽  
Neisseria Gonorrhoeae ◽  
Bacterial Infections ◽  
Point Of Care ◽  
High Sensitivity ◽  
Population Level ◽  
The United States ◽  
Nucleic Acid Amplification ◽  
Point Of Care Test ◽  
Control And Prevention

Chlamydia trachomatis and Neisseria gonorrhoeae are two of the most often reported bacterial infections in the United States. The rectum and oropharynx are important anatomic sites of infection and can contribute to ongoing transmission. Nucleic acid amplification tests (NAATs) are the mainstays for the detection of C. trachomatis and N. gonorrhoeae infections owing to their high sensitivity and specificity. Several NAATs have been evaluated for testing in rectal and pharyngeal infections. A few assays recently received clearance by the Food and Drug Administration, including one point-of-care test. Those assays can be used for testing in symptomatic individuals, as well as for asymptomatic screening in certain patient populations. Routine screening for C. trachomatis in pharyngeal specimens is not recommended by the Centers for Disease Control and Prevention, though is often performed due to the use of multiplex assays. While expanding the types of settings for screening and using self-collected rectal and pharyngeal specimens can help to increase access and uptake of testing, additional research is needed to determine the potential benefits and costs associated with increased screening for rectal and pharyngeal C. trachomatis and N. gonorrhoeae infections on a population level.

scholarly journals Challenges in Laboratory Diagnosis of the Novel Coronavirus SARS-CoV-2

Viruses ◽  
2020 ◽  
Vol 12 (6) ◽  
pp. 582 ◽  
Author(s):  
Nadin Younes ◽  
Duaa W. Al-Sadeq ◽  
Hadeel AL-Jighefee ◽  
Salma Younes ◽  
Ola Al-Jamal ◽  
...  
Keyword(s):  
Point Of Care ◽  
Accurate Determination ◽  
High Sensitivity ◽  
Laboratory Diagnosis ◽  
The Novel ◽  
Viral Shedding ◽  
Diagnostic Capacity ◽  
Commercial Kits ◽  
Novel Coronavirus ◽  
Diagnostic Technologies

The recent outbreak of the Coronavirus disease 2019 (COVID-19) has quickly spread worldwide since its discovery in Wuhan city, China in December 2019. A comprehensive strategy, including surveillance, diagnostics, research, clinical treatment, and development of vaccines, is urgently needed to win the battle against COVID-19. The past three unprecedented outbreaks of emerging human coronavirus infections at the beginning of the 21st century have highlighted the importance of readily available, accurate, and rapid diagnostic technologies to contain emerging and re-emerging pandemics. Real-time reverse transcriptase-polymerase chain reaction (rRT-PCR) based assays performed on respiratory specimens remain the gold standard for COVID-19 diagnostics. However, point-of-care technologies and serologic immunoassays are rapidly emerging with high sensitivity and specificity as well. Even though excellent techniques are available for the diagnosis of symptomatic patients with COVID-19 in well-equipped laboratories; critical gaps still remain in screening asymptomatic people who are in the incubation phase of the virus, as well as in the accurate determination of live viral shedding during convalescence to inform decisions for ending isolation. This review article aims to discuss the currently available laboratory methods and surveillance technologies available for the detection of COVID-19, their performance characteristics and highlight the gaps in current diagnostic capacity, and finally, propose potential solutions. We also summarize the specifications of the majority of the available commercial kits (PCR, EIA, and POC) for laboratory diagnosis of COVID-19.

scholarly journals External Quality Assessment for the Detection of Chlamydia trachomatis in Urine Using Molecular Techniques in Belgium

2015 ◽  
Vol 2015 ◽  
pp. 1-8
Author(s):  
Bernard China ◽  
Kris Vernelen
Keyword(s):  
Chlamydia Trachomatis ◽  
Quality Assessment ◽  
External Quality Assessment ◽  
Molecular Techniques ◽  
Nucleic Acid Amplification ◽  
Bacterial Disease ◽  
External Quality ◽  
Sexually Transmitted ◽  
Low Sensitivity

Chlamydia trachomatis is a major cause of sexually transmitted bacterial disease worldwide. C. trachomatis is an intracellular bacterium and its growth in vitro requires cell culture facilities. The diagnosis is based on antigen detection and more recently on molecular nucleic acid amplification techniques (NAAT) that are considered fast, sensitive, and specific. In Belgium, External Quality Assessment (EQA) for the detection of C. trachomatis in urine by NAAT was introduced in 2008. From January 2008 to June 2012, nine surveys were organized. Fifty-eight laboratories participated in at least one survey. The EQA panels included positive and negative samples. The overall accuracy was 75.4%, the overall specificity was 97.6%, and the overall sensitivity was 71.4%. Two major issues were observed: the low sensitivity (45.3%) for the detection of low concentration samples and the incapacity of several methods to detect the Swedish variant of C. trachomatis. The reassuring point was that the overall proficiency of the Belgian laboratories tended to improve over time.

scholarly journals Isothermal Amplification of Nucleic Acids Coupled with Nanotechnology and Microfluidic Platforms for Detecting Antimicrobial Drug Resistance and Beyond

2021 ◽  
Author(s):  
Seyedeh Zahra Alamolhoda ◽  
Nosratollah Zarghami ◽  
Houman Kahroba ◽  
Ahmad Mehdipour ◽  
Mohammad Pourhassan-Moghaddam ◽  
...  
Keyword(s):  
Nucleic Acids ◽  
Point Of Care ◽  
High Sensitivity ◽  
Molecular Techniques ◽  
Isothermal Amplification ◽  
High Tech ◽  
Antimicrobial Drug Resistance ◽  
Resource Limited ◽  
Accessible Point ◽  
Sensitivity Specificity

Antibiotic resistance is one of the serious health-threatening issues globally, the control of which is indispensable for rapid diagnosis and treatment because of the high prevalence and risks of pathogenicity. Traditional and molecular techniques are relatively expensive, complex, and non-portable, requiring facilities, trained personnel, and high-tech laboratories. Widespread and timely-detection is vital to the better crisis management of rapidly spreading infective diseases, especially in low-tech regions and resource-limited settings. Hence, the need for inexpensive, fast, simple, mobile, and accessible point-of-care (POC) diagnostics is highly demanding. Among different biosensing methods, the isothermal amplification of nucleic acids is favorite due to their simplicity, high sensitivity/specificity, rapidity, and portability, all because they require a constant temperature to work. Isothermal amplification methods are utilized for detecting various targets, including DNA, RNA, cells, proteins, small molecules, ions, and viruses. In this paper, we discuss various platforms, applications, and potentials of isothermal amplification techniques for biosensing of antimicrobial resistance. We also evaluate the potential of these methods, coupled with the novel and rapidly-evolving platforms offered by nanotechnology and microfluidic devices.

scholarly journals A chemiluminescent protease probe for rapid, sensitive, and inexpensive detection of live Mycobacterium tuberculosis

2020 ◽  
Author(s):  
Brett M. Babin ◽  
Gabriela Fernandez-Cuervo ◽  
Jessica Sheng ◽  
Ori Green ◽  
Alvaro A. Ordonez ◽  
...  
Keyword(s):  
Mycobacterium Tuberculosis ◽  
Signal To Noise Ratio ◽  
Point Of Care ◽  
High Sensitivity ◽  
Drug Susceptibility ◽  
Drug Susceptibility Testing ◽  
High Signal ◽  
Resource Limited ◽  
Tb Diagnostics

AbstractTuberculosis (TB) is a top-ten cause of death worldwide. Successful treatment is often limited by insufficient diagnostic capabilities, especially at the point of care in low-resource settings. The ideal diagnostic must be fast, cheap, and require minimal clinical resources while providing high sensitivity, selectivity, and the ability to differentiate live from dead bacteria. We describe here the development of a Fast, Luminescent, and Affordable Sensor of Hip1 (FLASH) for the diagnosis and monitoring of drug sensitivity of Mycobacterium tuberculosis (Mtb). FLASH is a selective chemiluminescent substrate for the Mtb protease Hip1 that when processed, produces visible light that can be measured with a high signal to noise ratio using inexpensive sensors. FLASH is sensitive to fmol of recombinant Hip1 enzyme in vitro and can detect as few as thousands of Mtb cells in culture or in human sputum samples within minutes. The probe is highly selective for Mtb compared to other non-tuberculous mycobacteria and can distinguish live from dead cells. Importantly, FLASH can be used to measure antibiotic killing of Mtb in culture with greatly accelerated timelines compared to traditional protocols. Overall, FLASH has the potential to enhance both TB diagnostics and drug resistance monitoring in resource-limited settings.One Sentence SummaryA luminescent probe enables sensitive detection of Mycobacterium tuberculosis for diagnostics, treatment monitoring, and drug susceptibility testing.

Nucleic acid amplification-integrated single-molecule fluorescence imaging for in vitro and in vivo biosensing

2021 ◽  
Author(s):  
Fei Ma ◽  
Chen-Chen Li ◽  
Chun-Yang Zhang
Keyword(s):  
Nucleic Acid ◽  
Fluorescence Imaging ◽  
Single Molecule ◽  
High Sensitivity ◽  
Nucleic Acid Amplification ◽  
Single Molecule Fluorescence

Single-molecule fluorescence imaging is among the most advanced analytical technologies and has been widely adopted for biosensing due to its distinct advantages of simplicity, rapidity, high sensitivity, low sample consumption,...

scholarly journals Nanomaterials-Based Electrochemical Sensors for In Vitro and In Vivo Analyses of Neurotransmitters

2018 ◽  
Vol 8 (9) ◽  
pp. 1504 ◽  
Author(s):  
Sharmila Durairaj ◽  
Boopathi Sidhureddy ◽  
Joseph Cirone ◽  
Aicheng Chen
Keyword(s):  
Electrochemical Sensors ◽  
Point Of Care ◽  
Electrochemical Techniques ◽  
High Sensitivity ◽  
Electrochemical Analysis ◽  
Detection Techniques ◽  
Efficient Detection ◽  
Sensitivity And Selectivity

Neurotransmitters are molecules that transfer chemical signals between neurons to convey messages for any action conducted by the nervous system. All neurotransmitters are medically important; the detection and analysis of these molecules play vital roles in the diagnosis and treatment of diseases. Among analytical strategies, electrochemical techniques have been identified as simple, inexpensive, and less time-consuming processes. Electrochemical analysis is based on the redox behaviors of neurotransmitters, as well as their metabolites. A variety of electrochemical techniques are available for the detection of biomolecules. However, the development of a sensing platform with high sensitivity and selectivity is challenging, and it has been found to be a bottleneck step in the analysis of neurotransmitters. Nanomaterials-based sensor platforms are fascinating for researchers because of their ability to perform the electrochemical analysis of neurotransmitters due to their improved detection efficacy, and they have been widely reported on for their sensitive detection of epinephrine, dopamine, serotonin, glutamate, acetylcholine, nitric oxide, and purines. The advancement of electroanalytical technologies and the innovation of functional nanomaterials have been assisting greatly in in vivo and in vitro analyses of neurotransmitters, especially for point-of-care clinical applications. In this review, firstly, we focus on the most commonly employed electrochemical analysis techniques, in conjunction with their working principles and abilities for the detection of neurotransmitters. Subsequently, we concentrate on the fabrication and development of nanomaterials-based electrochemical sensors and their advantages over other detection techniques. Finally, we address the challenges and the future outlook in the development of electrochemical sensors for the efficient detection of neurotransmitters.

scholarly journals An Update on Advances in COVID-19 Laboratory Diagnosis and Testing Guidelines in India

2021 ◽  
Vol 9 ◽  
Author(s):  
K. S. Rajesh Kumar ◽  
Suhail Sayeed Mufti ◽  
Vinu Sarathy ◽  
Diganta Hazarika ◽  
Radheshyam Naik
Keyword(s):  
Large Scale ◽  
Vaccine Development ◽  
Point Of Care ◽  
Diagnostic Testing ◽  
Public Health Intervention ◽  
Laboratory Diagnosis ◽  
Accurate Diagnosis ◽  
Nucleic Acid Amplification ◽  
Rt Pcr ◽  
Outbreak Management

The declaration of COVID-19 as a global pandemic has warranted the urgent need for technologies and tools to be deployed for confirming diagnosis of suspected cases. Diagnostic testing for COVID-19 is critical for understanding epidemiology, contract-tracing, case management, and to repress the transmission of the SARS-CoV-2. Currently, the Nucleic Acid Amplification Test (NAAT)-based RT-PCR technique is a gold standard test used for routine diagnosis of COVID-19 infection. While there are many commercially available RT-PCR assay kits available in the market, selection of highly sensitive, specific, and validated assays is most crucial for the accurate diagnosis of COVID-19 infection. Laboratory diagnosis of SARS-CoV-2 is extremely important in the disease and outbreak management. Development of rapid point of care tests with better sensitivity and specificity is the critical need of the hour as this will help accurate diagnosis and aid in containing the spread of SARS-CoV-2 infection. Early detection of viral infection greatly enhances implementation of specific public health intervention, such as infection control, environmental decontamination, and the closure of specific high-risk zones. Large-scale sequencing of SARS-CoV-2 genome isolated from affected populations across the world needs to be carried to monitor mutations that might affect performance of molecular tests. Creation of genome repositories and open-source genetic databases for use by global researchers is clearly the way forward to manage COVID-19 outbreak and accelerate vaccine development. This review summarizes various molecular diagnostics methods, technical guidelines, and advanced testing strategies adopted in India for laboratory diagnosis of COVID-19.

scholarly journals Antibiotic resistance detection is essential for gonorrhoea point-of-care testing: A mathematical modelling study

2017 ◽  
Author(s):  
Stephanie M. Fingerhuth ◽  
Nicola Low ◽  
Sebastian Bonhoeffer ◽  
Christian L. Althaus
Keyword(s):  
Antibiotic Resistance ◽  
Clinical Pathways ◽  
Point Of Care ◽  
High Sensitivity ◽  
Nucleic Acid Amplification ◽  
Transmission Model ◽  
Antibiotic Resistant ◽  
Sex With Men ◽  
The Impact ◽  
Resistance Detection

AbstractAntibiotic resistance is threatening to make gonorrhoea untreatable. Point-of-care (POC) tests that detect resistance promise individually tailored treatment, but might lead to more treatment and higher levels of resistance. We investigate the impact of POC tests on antibiotic-resistant gonorrhoea. We used data about the prevalence and incidence of gonorrhoea in men who have sex with men (MSM) and heterosexual men and women (HMW) to calibrate a mathematical gonorrhoea transmission model. With this model, we simulated four clinical pathways for the diagnosis and treatment of gonorrhoea: POC test with (POC + R) and without (POC − R) resistance detection, culture, and nucleic acid amplification tests (NAATs). We calculated the proportion of resistant infections, cases averted after 5 years, and compared how fast resistant infections spread in the populations. The proportion of resistant infections after 30 years is lowest for POC + R (median MSM: 0.18%, HMW: 0.12%), and increases for culture (MSM: 1.19%, HWM: 0.13%), NAAT (MSM: 100%, HMW: 99.27%), and POC − R (MSM: 100%, HMW: 99.73%). NAAT leads to 36 366 (median MSM) and 1 228 (median HMW) observed cases after 5 years. When compared with NAAT, POC + R results in most cases averted after 5 years (median MSM: 3 353, HMW: 118 per 100 000 persons). POC tests that detect resistance with intermediate sensitivity slow down resistance spread more than NAAT. POC tests with very high sensitivity for the detection of resistance are needed to slow down resistance spread more than using culture. POC with high sensitivity to detect antibiotic resistance can keep gonorrhoea treatable longer than culture or NAAT. POC tests without reliable resistance detection should not be introduced because they can accelerate the spread of antibiotic-resistant gonorrhoea.

scholarly journals Performance assessment of the Allplex™ STI Essential real-time PCR assay for the diagnosis of Neisseria gonorrhoeae and Chlamydia trachomatis infections in genital and extra-genital sites

2019 ◽  
Vol 43 (4) ◽  
pp. 191-200
Author(s):  
Sylvain Robinet ◽  
François Parisot
Keyword(s):  
Detection Limit ◽  
Chlamydia Trachomatis ◽  
Neisseria Gonorrhoeae ◽  
Real Time ◽  
Evaluation Agency ◽  
Nucleic Acid Amplification ◽  
Molecular Diagnostic ◽  
Standard Curve ◽  
Commensal Flora

Abstract Background Commercial kits performing Neisseria gonorrhoeae (NG) and Chlamydia trachomatis (CT) nucleic acid amplification tests (NAATs) for genital samples are recommended in association with culture, but the majority of real-time polymerase chain reaction (PCR) methods have not received regulatory approval for diagnostics in extra-genital sites. Since 2017, only the Hologic® Aptima Combo2 assay has an in vitro diagnostic (IVD) certification from the European Medicine Evaluation Agency. Methods We assessed the Allplex™ STI-Essential Assay (EA) for the diagnosis of NG and CT in both genital and extra-genital sites. The performance of the extraction step was studied by means of a standard curve between the concentration of expected cultivable gonococci and the cycle threshold (Ct). Three later-generation NAATs were used as comparators, particularly to assess the specificity (Sp). Results A relation between the gonococcal concentration, expressed as colony-forming unit (CFU) per milliliter logarithm, and the Ct was shown to be linear irrespective of the matrices (95% confidence interval [CI]). The detection limit was 10 CFU/mL, contrasting with the relatively poor sensitivity of culture due to inhibitory effects such as pH and the overgrowth of the commensal flora. NG molecular diagnostic is complex and the method comparisons showed some discrepancies when Ct was above 34. We decided to include interpretative comments on our reports on the basis of the Ct result. For CT, comparisons displayed a satisfactory agreement, and the detection limit was 50 copies/mL. Conclusions The Seegene Allplex™ STI-EA showed acceptable performance characteristics for the detection of genital and extra-genital NG and CT.

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