Exploring 'best practice' for nucleic acid detection of Neisseria gonorrhoeae

Sexual Health ◽  
2008 ◽  
Vol 5 (1) ◽  
pp. 17 ◽  
Author(s):  
David M. Whiley ◽  
Suzanne M. Garland ◽  
Geoffrey Harnett ◽  
Gary Lum ◽  
David W. Smith ◽  
...  
Keyword(s):  
Nucleic Acid ◽  
Neisseria Gonorrhoeae ◽  
Best Practice ◽  
Current Knowledge ◽  
False Negative ◽  
High Sensitivity ◽  
Nucleic Acid Detection ◽  
Predictive Values ◽  
Neisseria Species ◽  
Negative Results

Nucleic acid detection tests (NADT) have considerable benefits for the detection of Neisseria gonorrhoeae (GC), including high sensitivity across a range of specimen types and use under widely differing settings and conditions. However, sexual health practitioners and others who use data generated by NADT for GC should be aware of some important limitations of these tests. False-positive results caused by cross reaction with commensal Neisseria species have been observed in many assays, and have lead to unacceptably low positive-predictive values in some patient populations. Further, false-negative results can be caused by GC sequence variation, with some gonococci lacking certain NADT target sequences. This review examines the issues associated with gonococcal NADT and considers best practice for use of these assays based on current knowledge. We emphasise the need for supplementary testing and extensive assay validation, and suggest appropriate strategies for these requirements irrespective of the setting in which they are used. Further, we highlight the need to maintain culture-based testing for certain specimen sites as well as for antimicrobial resistance surveillance.

scholarly journals Analysis and Prediction of COVID-19 Patients’ False Negative Results for SARS-CoV-2 Detection with Pharyngeal Swab Specimen: A Retrospective Study

2020 ◽  
Author(s):  
Hui Xu ◽  
Li Yan ◽  
Chun (Martin) Qiu ◽  
Bo Jiao ◽  
Yanyan Chen ◽  
...  
Keyword(s):  
Nucleic Acid ◽  
Time Window ◽  
Clinical Symptoms ◽  
False Negative ◽  
Ct Imaging ◽  
Nucleic Acid Detection ◽  
False Negatives ◽  
Negative Results ◽  
False Negative Results ◽  
Blood Routine

ABSTRACTBackgroundFalse negative results of SARS-CoV-2 nucleic acid detection pose threats to COVID-19 patients and medical workers alike.ObjectiveTo develop multivariate models to determine clinical characteristics that contribute to false negative results of SARS-CoV-2 nucleic acid detection, and use them to predict false negative results as well as time windows for testing positive.DesignRetrospective Cohort Study (Ethics number of Tongji Hospital: No. IRBID: TJ-20200320)SettingA database of outpatients in Tongji Hospital (University Hospital) from 15 January 2020 to 19 February 2020.Patients1,324 outpatients with COVID-19MeasurementsClinical information on CT imaging reports, blood routine tests, and clinic symptoms were collected. A multivariate logistic regression was used to explain and predict false negative testing results of SARS-CoV-2 detection. A multivariate accelerated failure model was used to analyze and predict delayed time windows for testing positive.ResultsOf the 1,324 outpatients who diagnosed of COVID-19, 633 patients tested positive in their first SARS-CoV-2 nucleic acid test (47.8%), with a mean age of 51 years (SD=14.9); the rest, which had a mean age of 47 years (SD=15.4), tested negative in the first test. “Ground glass opacity” in a CT imaging report was associated with a lower chance of false negatives (aOR, 0.56), and reduced the length of time window for testing positive by 26%. “Consolidation” was associated with a higher chance of false negatives (aOR, 1.57), and extended the length of time window for testing positive by 44%. In blood routine tests, basophils (aOR, 1.28) and eosinophils (aOR, 1.29) were associated with a higher chance of false negatives, and were found to extend the time window for testing positive by 23% and 41%, respectively. Age and gender also affected the significantly.LimitationData were generated in a large single-center study.ConclusionTesting outcome and positive window of SARS-CoV-2 detection for COVID-19 patients were associated with CT imaging results, blood routine tests, and clinical symptoms. Taking into account relevant information in CT imaging reports, blood routine tests, and clinical symptoms helped reduce a false negative testing outcome. The predictive AFT model, what we believe to be one of the first statistical models for predicting time window of SARS-CoV-2 detection, could help clinicians improve the accuracy and efficiency of the diagnosis, and hence, optimizes the timing of nucleic acid detection and alleviates the shortage of nucleic acid detection kits around the world.Primary Funding SourceNone.

scholarly journals Most but not all laboratories can detect the recently emerged Neisseria gonorrhoeae porA mutants – results from the QCMD 2013 N. gonorrhoeae external quality assessment programme

2014 ◽  
Vol 19 (8) ◽  
Author(s):  
D Luijt ◽  
C Di Lorenzo ◽  
A M van Loon ◽  
M Unemo
Keyword(s):  
Neisseria Gonorrhoeae ◽  
Quality Assessment ◽  
External Quality Assessment ◽  
False Negative ◽  
Molecular Diagnostic ◽  
External Quality ◽  
Diagnostic Assays ◽  
Assessment Programme ◽  
Negative Results ◽  
False Negative Results

We describe the results of the Quality Control for Molecular Diagnostics 2013 Neisseria gonorrhoeae external quality assessment programme that included an N. gonorrhoeae strain harbouring an N. meningitidis porA gene which causes false-negative results in molecular diagnostic assays targeting the gonococcal porA pseudogene. Enhanced awareness of the international transmission of such gonococcal strains is needed to avoid false-negative results in both in-house and commercial molecular diagnostic assays used in laboratories worldwide, but particularly in Europe.

scholarly journals Visualization of Lesions of Metaphyses and Epiphyses of Bones in Newborns and Young Children

2021 ◽  
pp. 82-90
Author(s):  
N. A. Sholokhova
Keyword(s):  
Young Children ◽  
False Negative ◽  
Age Groups ◽  
High Sensitivity ◽  
Negative Results ◽  
False Negative Results ◽  
Inflammatory Processes ◽  
Group 5 ◽  
Magnetic Resonance Imaging Mri ◽  
Diagnostic Capabilities

The aim of this study was to determine the diagnostic capabilities of various methods of radiological diagnostics for lesions of the metaphyses and epiphyses of bones in newborns and young children.The study involved 108 children in the age group 5 days – 12 months with pathological changes in the pineal gland and bone metaphysis. The possibilities and advantages of standard radiography (СR), ultrasound examination (US) and magnetic resonance imaging (MRI) in the early and differential diagnosis of the osteomyelitis process and epiphyseolysis have been determined. High sensitivity (98 %), specificity (99 %) and accuracy (98 %) for ultrasound and sensitivity (94 %), specificity (89 %) and accuracy (95 %) of MRI in diagnosing osteomyelitis in patients of this age groups. At the same time, the possibilities of standard radiography at the stages of early diagnosis of inflammatory processes in the distal parts of the bones were limited due to a number of factors. The use of diagnostic algorithms greatly facilitates the work of a radiologist and reduces the number of false negative results during the initial treatment of patients.

scholarly journals Scanning single-molecule counting system for Eprobe with highly simple and effective approach

PLoS ONE ◽  
2020 ◽  
Vol 15 (12) ◽  
pp. e0243319
Author(s):  
Takeshi Hanami ◽  
Tetsuya Tanabe ◽  
Takuya Hanashi ◽  
Mitsushiro Yamaguchi ◽  
Hidetaka Nakata ◽  
...  
Keyword(s):  
Nucleic Acid ◽  
Single Molecule ◽  
Detection System ◽  
Signal To Noise Ratio ◽  
High Sensitivity ◽  
Nucleic Acid Detection ◽  
Digital Measurement ◽  
Excitation Light ◽  
Target Nucleic Acid ◽  
Fluorescent Molecules

Here, we report a rapid and ultra-sensitive detection technique for fluorescent molecules called scanning single molecular counting (SSMC). The method uses a fluorescence-based digital measurement system to count single molecules in a solution. In this technique, noise is reduced by conforming the signal shape to the intensity distribution of the excitation light via a circular scan of the confocal region. This simple technique allows the fluorescent molecules to freely diffuse into the solution through the confocal region and be counted one by one and does not require statistical analysis. Using this technique, 28 to 62 aM fluorescent dye was detected through measurement for 600 s. Furthermore, we achieved a good signal-to-noise ratio (S/N = 2326) under the condition of 100 pM target nucleic acid by only mixing a hybridization-sensitive fluorescent probe, called Eprobe, into the target oligonucleotide solution. Combination of SSMC and Eprobe provides a simple, rapid, amplification-free, and high-sensitive target nucleic acid detection system. This method is promising for future applications to detect particularly difficult to design primers for amplification as miRNAs and other short oligo nucleotide biomarkers by only hybridization with high sensitivity.

scholarly journals Clinical Neisseria gonorrhoeae isolate with a N. meningitidis porA gene and no prolyliminopeptidase activity, Sweden, 2011 – danger of false-negative genetic and culture diagnostic results

2012 ◽  
Vol 17 (9) ◽  
Author(s):  
D Golparian ◽  
E Johansson ◽  
M Unemo
Keyword(s):  
Neisseria Gonorrhoeae ◽  
False Negative ◽  
Gonorrhoeae Strain ◽  
Negative Results ◽  
False Negative Results ◽  
Gonorrhoeae Isolate

We describe a Neisseria gonorrhoeae strain, found in Sweden in 2011, that harbours a N. meningitidis porA gene causing false-negative results in PCRs targeting the gonococcal porA pseudogene. Furthermore, the strain had no prolyliminopeptidase (PIP) activity that many commercial biochemical kits for species verification in culture rely on. Enhanced awareness of the spread of such strains and screening for them can be crucial.

CLINICAL APPLICATION OF COVID-19 REPORTING AND DATA SYSTEM IN COMPUTED TOMOGRAPHY OF BILATERAL PNEUMONIA DIAGNOSTIC

2021 ◽  
Vol 31 (4) ◽  
pp. 40-45
Author(s):  
Ugnė Kulnickaitė ◽  
Laura Dobrovaitė ◽  
Kamilė Grigaitė ◽  
Edvardas Jukna
Keyword(s):  
Computed Tomography ◽  
False Negative ◽  
High Sensitivity ◽  
Chest Ct ◽  
Data System ◽  
Negative Results ◽  
Radiological Society ◽  
Evaluation Scheme ◽  
False Negative Results ◽  
Standardized Reporting

Background: the 2019 coronavirus disease pandemic (COVID-19) has spread at an astonishing speed across the world, causing major morbidity and mortality. Computed tomography (CT) examination plays an important role in crisis areas in the diagnosis of COVID-19. COVID-19 Reporting and Data System (CO-RADS) has a five-point scale of suspicion for COVID-19 pneumonia in chest CT picture which standardizes the evaluation scheme and simplifies reporting. Aim: to summarise and present the role of COVID-19 Reporting and Data System in computed tomography of bilateral pneumonia diagnostic. Materials and methods: recently published studies were reviewed to evaluate COVID-19 Reporting and Data System scale as effective tool to detect COVID-19 pneumonia on chest CT scans. Databases from the subscription list of Lithuanian University of Health Sciences were selected: Medline (PubMed), SpringerLink and ScienceDirect. Results: chest CT features, as bilateral involvement, subpleural or peripherally distributed GGO, consolidation, reticulation, crazy paving pattern, air bronchogram signs, intralobular septal thickening, pulmonary vascular enlargement, are considered to be characteristic manifestations of COVID-19 infection. Studies show that Dutch Radiological Society presented CO-RADS scale sensitivity and specificity may vary from 61-88% and 66,4-98%, respectively. Conclusion: chest CT scan has a high sensitivity for COVID-19 diagnosis and could reduce false negative results obtained from RT-PCR tests. Furthermore, a standardized reporting system could increase clarification, minimize reporting variability and help radiologists recognize the results they observe, especially, for less experienced specialists.

The application of viral nucleic acid detection and lung CT in COVID-19 diagnosis

2020 ◽  
Author(s):  
Rui Hu
Keyword(s):  
Nucleic Acid ◽  
Clinical Symptoms ◽  
Virus Disease ◽  
False Negative ◽  
False Negative Rate ◽  
Diagnostic Methods ◽  
Nucleic Acid Detection ◽  
Viral Nucleic Acid ◽  
Early Medical Intervention ◽  
Lung Ct

The Corona Virus Disease 2019 (COVID-19) has the characteristics of fast propagation speed and strong pathogenicity and has attracted wide attention of people, medical workers, and researchers around the world. Accurate, rapid, and timely screening and diagnosis of COVID-19 is of great significance to control the development of the epidemic situation and save the lives of patients. Currently, the detection of viral nucleic acid and lung CT is the main screening and diagnostic methods of COVID-19. Nucleic acid detection has the advantages of fast, strong specificity and high sensitivity, but there is a certain false-negative rate. CT result of lung examination is visual, but it is not typical due to the uncertain time of clinical symptoms and the early medical intervention. Therefore, the diagnosis of COVID-19 should include a combination of epidemiological history, clinical symptoms, imaging, and laboratory tests.

Immunogenicity of Golimumab and its Clinical Relevance in Patients With Ulcerative Colitis

2019 ◽  
Vol 25 (9) ◽  
pp. 1532-1540 ◽  
Author(s):  
Omoniyi J Adedokun ◽  
George R Gunn ◽  
Jocelyn H Leu ◽  
Cynthia Gargano ◽  
Zhenhua Xu ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
False Negative ◽  
Injection Site Reaction ◽  
High Sensitivity ◽  
Fold Increase ◽  
Drug Interference ◽  
Negative Results ◽  
Drug Concentrations ◽  
Antidrug Antibody ◽  
Antibody Titers

Abstract Background Antidrug antibody (ADA) detection with standard bridging enzyme immunoassays (EIA) can yield false-negative results or underestimate titers through drug interference. A more sensitive assay was needed to determine clinical impact of antigolimumab antibodies. Methods A high-sensitivity, drug-tolerant EIA (DT-EIA) was developed and cross-validated against the original EIA, and samples from induction/maintenance studies in golimumab-treated patients with ulcerative colitis were analyzed for ADAs using both methods. Immunogenicity results were compared, and pharmacokinetic, efficacy, and safety associations were evaluated. Results An 8-fold increase in ADA-positive patients (21.8% DT-EIA vs 2.8% EIA) reflected DT-EIA improved sensitivity and drug tolerance. Most newly detected ADA-positive patients (using DT-EIA) had low antibody titers, whereas most with high antibody titers were ADA-positive with original EIA. With DT-EIA, week 44 median trough serum golimumab concentrations among ADA-positive patients were approximately half vs ADA-negative (0.51 vs 0.85 µg/mL [50 mg q4w]; 0.85 vs 1.60 µg/mL [100 mg q4w]). Antidrug antibody impact on golimumab concentrations was more notable at titers ≥1:100. During induction, ADAs had no notable impact on efficacy. During maintenance, proportions of patients maintaining clinical response through week 54 were lower using DT-EIA: 38.1% ADA-positive and 52.8% ADA-negative. Antidrug antibody status had no impact on injection-site reaction incidence. Conclusions A more sensitive DT-EIA identified higher proportions of ADA-positive patients. A trend of decreasing drug concentrations with increasing ADA titers was observed. Pharmacokinetic impact was better elucidated with DT-EIA. Although development of ADA did not preclude efficacy, a trend toward decreased efficacy in ADA-positive vs ADA-negative patients was observed during maintenance treatment. Antidrug antibody status did not impact safety.

scholarly journals Specific circulating immune complexes in acute chagas' disease

1987 ◽  
Vol 29 (1) ◽  
pp. 26-32 ◽  
Author(s):  
Ricardo Corral ◽  
Héctor Freilij ◽  
Saúl Grinstein
Keyword(s):  
Chagas Disease ◽  
Immune Complexes ◽  
False Negative ◽  
High Sensitivity ◽  
Circulating Immune Complexes ◽  
Chronic Patients ◽  
Negative Results ◽  
Acute Toxoplasmosis ◽  
Acute Chagas Disease ◽  
Cruzi Infection

The presence of circulating immune complexes formed by IgM and IgG (CIC-IgM and CIC-IgG) was investigated, using antigen-specific enzyme-immunoassays (ELISA), in 30 patients with acute Chagas' disease who showed parasitemia and inoculation chagoma. Control population consisted of patients with chronic T. cruzi infection (30), acute toxoplasmosis 10), leishmaniasis (8), rheumatoid arthritis (3) and healthy individuals with negative serology for Chagas* disease (30). Acute chagasic patients were 100% CIC-IgG and 96.66% CIC-IgM positive whereas immunofluorescence tests yielded 90% and 86.66% of positivity for specific IgG and IgM antibodies, respectively. Chronic patients were 68% CIC-IgG and 0% CIC-IgM positive. The 30 negative and the 21 cross-reaction controls proved negative for ELISA (CIC-IgM and CIC-IgG). The high sensitivity of ELISA assays would allow early immunologic diagnosis, as well as prompt treatment, of acute T. cruzi infection, thus eliminating the problem of the false-positive and false-negative results which affects traditional methods for detection of circulating antibodies.

Pearls and Pitfalls of Interpretation in CT Colonography

2020 ◽  
Vol 71 (2) ◽  
pp. 140-148
Author(s):  
Michael Schonberger ◽  
Philippe Lefere ◽  
Abraham H. Dachman
Keyword(s):  
Computed Tomography ◽  
Sensitivity And Specificity ◽  
False Positive ◽  
Ct Colonography ◽  
False Negative ◽  
High Sensitivity ◽  
Negative Results ◽  
False Negative Results ◽  
The Common

The accuracy of computed tomography (CT) colonography (CTC) requires that the radiologist be well trained in the recognition of pitfalls of interpretation. In order to achieve a high sensitivity and specificity, the interpreting radiologist must be well versed in the causes of both false-positive and false-negative results. In this article, we review the common and uncommon pitfalls of interpretation in CTC.

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