scholarly journals Development and Performance verification of colloidal gold labeled SARS-CoV-2 antigen detection method for routine popular screening of COVID-19 with clinical samples in Poland and China

2021 ◽  
Author(s):  
Chuanxiang Guo ◽  
Li Yao ◽  
Fengling Chen ◽  
Chao Zhang ◽  
Wei Chen
Keyword(s):  
Predictive Value ◽  
Colloidal Gold ◽  
Detection Method ◽  
Age Distribution ◽  
Antigen Detection ◽  
Lateral Flow ◽  
Rapid Screening ◽  
Clinical Samples ◽  
Lateral Flow Strip ◽  
And Performance

In this research, we have constructed and optimized the colloidal gold labeled lateral flow strip (LFS) for rapid detection of antigen of SARS-CoV-2 and rapid screening of COVID-19. Based on the constructed and optimized colloidal gold lateral flow strip, the parameters of the LFS have been well evaluated with the clinical samples in the professional labs. The screening performance have also been evaluated from the aspects including the CT values, age distribution and onset of symptoms. Finally, based on the detection results of 420 clinical samples, the LFS can achieve the screening of COVID-19 with the positive percentage agreement (PPA, sensitivity), negative percent agreement (NPA, specificity), the positive predictive value (PPV) and the negative predictive value (NPV) of 96.8%, 100%, 100% and 96.6%, respectively, indicating the powerful potential for practical screening applications in pandemic control. Of great significance, this developed SARS-CoV-2 antigen detection method has also been successfully utilized for screening of delta-variant of SARS-CoV-2.

A prospective nationwide observational study of agreement of antigen tests on oral pharyngeal swabs or less invasive testing with RT-qPCR, for detecting SARS-CoV-2 in adults: Protocol description (Preprint)

2021 ◽  
Author(s):  
Uffe Vest Schneider ◽  
Jenny Dahl Knudsen ◽  
Anders Koch ◽  
Nikolai Søren Kirkby ◽  
Jan Gorm Lisby
Keyword(s):  
Confidence Intervals ◽  
Predictive Value ◽  
Large Scale ◽  
Reference Method ◽  
Lateral Flow ◽  
Clinical Samples ◽  
Sampling Location ◽  
Analytical Sensitivity ◽  
Clinical Sensitivity ◽  
Antigen Tests

BACKGROUND The SARS-CoV-2 pandemic has resulted in an unprecedented level of world-wide testing for epidemiologic and diagnostic purposes, and due to the extreme need for tests, the gold standard reverse transcription polymerase chain reaction (RT-qPCR) testing capacity has been unable to meet the overall global testing demand. Consequently, although current literature has shown the sensitivity of rapid antigen tests (RATs) to be inferior to RT-qPCR, RATs have been implemented on a large scale without solid data on performance. OBJECTIVE This study will compare analytical and clinical sensitivities and specificities of 50 lateral flow or laboratory based RATs and three Strand Invasion Based Amplification (SIBA)-rt-PCR tests from 30 manufacturers to RT-qPCR on samples obtained from the deep oropharynx. In addition, the study will compare sensitivities and specificities of the included RATs as well as RT-qPCR on clinical samples obtained from the deep oropharynx, anterior nasal cavity, saliva, deep nasopharynx and expired air to RT-qPCR from deep oropharyngeal samples. METHODS In the prospective part of the study, 200 individuals found SARS-CoV-2 positive and 200 individuals found SARS-CoV-2 negative by routine RT-qPCR testing will be re-tested with each RAT applying RT-qPCR as the reference method. In the retrospective part of the study, 304 deep oropharyngeal cavity swabs divided into four groups based on RT-qPCR Cq levels will be tested by each RAT. RESULTS The results will be reported in several manuscripts with different aims. The first manuscript will report retrospective (analytical sensitivity, overall and stratified into different Cq range groups) and prospective (clinical sensitivity) data for RATs with RT-qPCR results as the reference method. The second manuscript will report results for RAT based on anatomical sampling location. The third manuscript will compare different anatomical sampling locations by RT-qPCR testing. The fourth manuscript will focus on RATs that rely on central laboratory testing. Test from four different manufactures will be compared for analytical performance data on retrospective deep oropharyngeal swab samples. The fifth manuscript will report the results of four RATs applied both as professional use and as self-test. The last manuscript will report the results from two breath tests participating in the study. Comparison of sensitivity and specificity between RATs will be done using McNemar for paired samples and chi-squared test for unpaired samples. Comparison of PPV and NPV between RATs will be done by bootstrap test. 95 % confidence intervals for sensitivity, specificity, positive predictive value and negative predictive value are calculated as bootstrap confidence intervals CONCLUSIONS The study will compare the sensitivities of a large number of RATs for SARS-CoV-2 compared to RT-qPCR and will address whether lateral flow based RATs test differ significantly from laboratory based RATS. The anatomical test location for both RAT and RT-qPCR will be compared. CLINICALTRIAL ClinicalTrials.gov NCT04913116

scholarly journals Rapid Detection of Aspergillus fumigatus Using Multiple Cross Displacement Amplification Combined With Nanoparticles-Based Lateral Flow

2021 ◽  
Vol 11 ◽  
Author(s):  
Luxi Jiang ◽  
Xiaomeng Li ◽  
Rumeng Gu ◽  
Deguang Mu
Keyword(s):  
Aspergillus Fumigatus ◽  
Detection Method ◽  
Culture Method ◽  
Lateral Flow ◽  
Clinical Samples ◽  
Specific Detection ◽  
Minimum Concentration ◽  
Whole Process ◽  
Multiple Cross ◽  
Pcr Method

Aspergillus fumigatus is an opportunistic, ubiquitous, saprophytic mold which can cause infection in the lungs, nose, eyes, brain, and bones in humans, especially in immunocompromised patients. However, it is difficult to diagnose A. fumigatus infection quickly. Here, we introduce a new detection method, namely multiple cross displacement amplification (MCDA) combined with nanoparticle-based lateral flow biosensor (LFB) (MCDA-LFB), which was proved to be fast, reliable, and simple for detecting A. fumigatus. We designed a set of 10 primers targeting the gene annexin ANXC4 of A. fumigatus. The best MCDA condition is 66 °C for 35 min. The minimum concentration that can be detected by this method was 10 fg. In the case of 100 sputum samples, 20 (20%) and 15 (15%) samples were positive by MCDA-LFB and PCR method, respectively. MCDA-LFB and traditional culture method showed the same results. Compared with the culture method, the diagnostic accuracy of MCDA-LFB can reach 100%. It showed that the MCDA-LFB method has better detection ability than the PCR method. We found that the whole process could be controlled within 60 min including the preparation of DNA (20 min), MCDA reaction (35 min) and results reporting (2 min). These results show that this assay is suitable for the rapid, sensitive and specific detection of A. fumigatus in clinical samples.

scholarly journals Development of an immunochromatographic lateral flow strip for the simultaneous detection of aminoglycoside residues in milk

RSC Advances ◽  
2018 ◽  
Vol 8 (17) ◽  
pp. 9580-9586 ◽  
Author(s):  
Yaning Sun ◽  
Jifei Yang ◽  
Suzhen Yang ◽  
Qingbo Sang ◽  
Man Teng ◽  
...  
Keyword(s):  
Colloidal Gold ◽  
Simultaneous Detection ◽  
Lateral Flow ◽  
Quantitative Detection ◽  
Lateral Flow Strip ◽  
Immunochromatographic Strip ◽  
Gentamicin Sulfate ◽  
Kanamycin Sulfate ◽  
Neomycin Sulfate

A colloidal gold-based immunochromatographic strip has been developed for the rapid, simultaneous, semi-quantitative and quantitative detection of several aminoglycoside residues in milk, including gentamicin sulfate (GM), neomycin sulfate (NEO) and kanamycin sulfate (KN).

scholarly journals One-Step Reverse-Transcription Recombinase Polymerase Amplification Using Lateral Flow Strips for the Detection of Coxsackievirus A6

2021 ◽  
Vol 12 ◽  
Author(s):  
Jia Xie ◽  
Xiaohan Yang ◽  
Lei Duan ◽  
Keyi Chen ◽  
Pan Liu ◽  
...  
Keyword(s):  
Reverse Transcription ◽  
Clinical Performance ◽  
Quantitative Polymerase Chain Reaction ◽  
Lateral Flow ◽  
Recombinase Polymerase Amplification ◽  
Clinical Samples ◽  
Effective Vaccine ◽  
Lateral Flow Strip ◽  
Coxsackievirus A6 ◽  
One Step

Hand, foot, and mouth disease (HFMD) is a common infectious disease affecting mainly children under 5 years of age. Coxsackievirus A6 (CVA-6), a major causative pathogen of HFMD, has caused outbreaks in recent years. Currently, no effective vaccine or antiviral treatments are available. In this study, one-step reverse-transcription recombinase polymerase amplification (RT-RPA), combined with a disposable lateral flow strip (LFS) assay, was developed to detect CVA-6. This assay can be performed in less than 35 min at 37°C without expensive instruments, and the result can be observed directly with the naked eye. The sensitivity of the RT-RPA-LFS was 10 copies per reaction, which was comparable to that of the conventional real-time quantitative polymerase chain reaction (qPCR) assays. Moreover, the assay specificity was 100%. The clinical performance of the RT-RPA-LFS assay was evaluated using 142 clinical samples, and the coincidence rate between RT-RPA-LFS and qPCR was 100%. Therefore, our RT-RPA-LFS assay provides a simple and rapid approach for point-of-care CVA-6 diagnosis.

scholarly journals Modern understanding about the role of group A β -hemolytic streptococcus in acute tonsillitis

2021 ◽  
Vol 13 (4) ◽  
pp. 66-71
Author(s):  
N. T. Mirzoev ◽  
S. N. Sidorchuk ◽  
Yu. I. Bulan’kov ◽  
K. V. Kas’janenko
Keyword(s):  
Predictive Value ◽  
Bacterial Culture ◽  
Detection Method ◽  
Throat Swab ◽  
Diagnostic System ◽  
Antigen Detection ◽  
Acute Tonsillitis ◽  
Hemolytic Streptococcus ◽  
Streptococcal Antigen ◽  
Group A

Objective: assess the modern value of group А β-hemolytic streptococcus in patients with acute tonsillitis and the effectiveness of the rapid streptococcal antigen detection method.Materials and methods: microbial landscape assessment of acute tonsillitis was based on retrospective analysis of 902 bacterial culture results of a throat swab of patients with syndromes of acute tonsillitis treated in the Infectious Diseases Clinic of the Military Medical Academy named after S.M. Kirov during the period of 2019-2020. The effectiveness of the rapid streptococcal antigen detection method in the oropharynx was determined by a prospective study involving 35 patients with acute tonsillitis.Results: in the study, we have found that bacterial culture results of a throat swab, the following were more common: Nesseria species (39 %), Streptococcus viridans (23 %), and Staphylococcus aureus (17 %). The frequency of detection of β-hemolytic streptococcus was 1 %. The rapid diagnostic system «Streptatest» in patients with acute tonsillitis has demonstrated efficiency, under which that sensitivity of test was 80 %, specificity – 90 %, positive predictive value – 57,14 %, negative predictive value – 96,43 %.Conclusions: the frequency of group A β-hemolytic streptococcus in patients with lesion of lymphoid tissues of the oropharynx has declined significantly nowadays. The rapid diagnostic system «Streptatest» is a highly effective medical product that can be used in both hospital and pre-hospital stage. 

scholarly journals Development of an antibody-based colloidal gold immunochromatographic lateral flow strip test for natamycin in milk and yoghurt samples

2017 ◽  
Vol 28 (6) ◽  
pp. 1283-1292 ◽  
Author(s):  
Liqiang Liu ◽  
Yanni Chen ◽  
Shanshan Song ◽  
Qiankun Zheng ◽  
Xiaoling Wu ◽  
...  
Keyword(s):  
Colloidal Gold ◽  
Lateral Flow ◽  
Lateral Flow Strip ◽  
Strip Test

scholarly journals Lateral Flow Immunoassay Coupled with Copper Enhancement for Rapid and Sensitive SARS-CoV-2 Nucleocapsid Protein Detection

Biosensors ◽  
2021 ◽  
Vol 12 (1) ◽  
pp. 13
Author(s):  
Tao Peng ◽  
Xueshima Jiao ◽  
Zhanwei Liang ◽  
Hongwei Zhao ◽  
Yang Zhao ◽  
...  
Keyword(s):  
Signal Amplification ◽  
Nucleocapsid Protein ◽  
High Efficiency ◽  
Protein Detection ◽  
Antigen Detection ◽  
Lateral Flow ◽  
Copper Deposition ◽  
Detection Sensitivity ◽  
Rapid Screening ◽  
Lateral Flow Immunoassay

The coronavirus disease 2019 (COVID-19) pandemic caused by severe acute respiratory coronavirus 2 (SARS-CoV-2) is still raging all over the world. Hence, the rapid and sensitive screening of the suspected population is in high demand. The nucleocapsid protein (NP) of SARS-CoV-2 has been selected as an ideal marker for viral antigen detection. This study describes a lateral flow immunoassay (LFIA) based on colloidal gold nanoparticles for rapid NP antigen detection, in which sensitivity was improved through copper deposition-induced signal amplification. The detection sensitivity of the developed LFIA for NP antigen detection (using certified reference materials) under the optimized parameters was 0.01 μg/mL and was promoted by three orders of magnitude to 10 pg/mL after copper deposition signal amplification. The LFIA coupled with the copper enhancement technique has many merits such as low cost, high efficiency, and high sensitivity. It provides an effective approach to the rapid screening, diagnosis, and monitoring of the suspected population in the COVID-19 outbreak.

scholarly journals A Rapid and Sensitive Detection Method for Pseudomonas aeruginosa Using Visualized Recombinase Polymerase Amplification and Lateral Flow Strip Technology

2021 ◽  
Vol 11 ◽  
Author(s):  
Haitao Yang ◽  
Yan Wang ◽  
Qiankun Yang ◽  
Hui Fan ◽  
Lei Wang ◽  
...  
Keyword(s):  
Pseudomonas Aeruginosa ◽  
Pathogenic Bacteria ◽  
Detection Method ◽  
Lateral Flow ◽  
Recombinase Polymerase Amplification ◽  
Coincidence Rate ◽  
Kappa Index ◽  
Biochemical Method ◽  
Lateral Flow Strip ◽  
Index Value

Pseudomonas aeruginosa is a common opportunistic pathogen that causes acute nosocomial necrotizing pneumonia and is the predominant source of chronic lung infections in patients with the genetic disorder cystic fibrosis. Early diagnosis in infected patients and monitoring P. aeruginosa contamination is therefore of great importance in controlling disease spread and development with timely drugs intervention treatment and cut off infection source. Traditional culture-biochemical methods are time consuming and highly dependent on technicians and expensive instruments. To address these challenges, the present study aimed to develop a rapid, sensitive, and specific, on-site detection method for P. aeruginosa based on recombinase polymerase amplification (RPA) combined with lateral flow strip (LFS) technology. The experimental process included screening and modification of primer and probe sets targeting the unique virulence gene elastase B (lasB); specificity detection in 29 strains of P. aeruginosa and 23 closely-related pathogenic bacteria; sensitivity measurements with gradient-diluted P. aeruginosa genomic DNA and probit regression analysis; and clinical application evaluation using 574 patients samples and calculating coincidence rate and kappa index value in comparison with the culture-biochemical method. The P. aeruginosa RPA-LFS assay could complete the amplification process at 37°C constant temperature within 30 min and results could be visualized by the naked eye within 10 min on LFS. The assay displayed high sensitivity with a limit of detection of 3.05 CFU/reaction. It also demonstrated high specificity by showing no cross reaction with other pathogenic bacteria, and rapidness by being completed in less than an hour. Furthermore, when used with clinical samples, the assay had a coincidence rate of 98.26% with the culture-biochemical method and a kappa index value of 0.9433. These data indicate that the RPA-LFS assay represents a major improvement for P. aeruginosa detection, especially in resource-limited areas.

scholarly journals A Detection Method of CryIAc Protein for Identifying Genetically Modified Rice Using the Lateral Flow Strip Assay

2006 ◽  
Vol 47 (3) ◽  
pp. 111-114 ◽  
Author(s):  
Hiroshi AKIYAMA ◽  
Takahiro WATANABE ◽  
Hiroyuki KIKUCHI ◽  
Kozue SAKATA ◽  
Shoko TOKISHITA ◽  
...  
Keyword(s):  
Detection Method ◽  
Genetically Modified ◽  
Lateral Flow ◽  
Lateral Flow Strip ◽  
Genetically Modified Rice

scholarly journals 721. Diagnosis of Histoplasmosis Using the MVista Histoplasma Galactomannan Antigen Qualitative Lateral Flow-Based Immunoassay; A Multicenter Study

2021 ◽  
Vol 8 (Supplement_1) ◽  
pp. S459-S460
Author(s):  
Wassim Abdallah ◽  
Thein Myint ◽  
Richard W LaRue ◽  
Melissa Minderman ◽  
Suphansa Gunn ◽  
...  
Keyword(s):  
Enzyme Immunoassay ◽  
Predictive Value ◽  
Severe Disease ◽  
Antigen Detection ◽  
Bachelor's Degree ◽  
Lateral Flow ◽  
Resource Limited Settings ◽  
Disseminated Histoplasmosis ◽  
Resource Limited ◽  
Galactomannan Antigen

Abstract Background Accurate and timely methods for the diagnosis of histoplasmosis in endemic resource-limited settings are largely lacking. Histoplasma galactomannan antigen detection by enzyme immunoassay (EIA) is the most widely used method for the diagnosis of acute pulmonary and disseminated histoplasmosis in the United States (USA). EIA methods have constraints in resource-limited settings including cost, turnaround time, and the need for large reference laboratories, leading to missed or delayed diagnoses and poor outcomes. Lateral flow assays (LFA) are practical methods that can be used in this setting for Histoplasma antigen detection. Methods Frozen urine specimens were submitted to MiraVista (MVista) for Histoplasma antigen EIA testing from three academic medical centers in highly endemic areas of the USA. They were also blinded and tested for the MVista Histoplasma LFA by skilled MVista technologists. Medical records were reviewed for clinical information. Patients were classified as controls or cases of histoplasmosis. Cases were divided into proven or probable, pulmonary, or disseminated, immune competent or immune suppressed, and mild, moderate, or severe. Results 352 subjects were enrolled, including 66 cases of histoplasmosis (44 proven, 22 probable) and 286 controls. Most of the cases were immunocompromised (68%). 76% had disseminated histoplasmosis. 6% were mild, 66% moderate, and 28% severe. A high degree of concordance was found between LFA and EIA results (kappa 0.837, OR 372.7, LR 204, p< 0.001). Overall, the sensitivity and specificity of the LFA were 78.8% and 99.3% respectively (kappa 0.84, p< 0.001). The sensitivity was higher in proven cases (93.2%), in patient with disseminated (94.7%), moderate (80%) and severe disease (94%), and those with galactomannan levels ≥ 2 ng/mL (97.7%). Specificity was 99.3% in proven cases, 99.3% in patient with moderate and severe disease, and 96.4% in those with galactomannan levels ≥ 2 ng/mL. Table 1. Statistical characteristics of the LFA test for histoplasmosis in different categories. PPV: Positive Predictive Value. NPV: Negative Predictive Value. EIA: Enzyme Immunoassay. The LFA test for histoplasmosis is more accurate in patients with high burden of infection. Conclusion The MVista Histoplasma galactomannan LFA may meet the need for accurate rapid diagnosis of histoplasmosis in resource-limited settings, especially in patients with relatively high disease burden, potentially reducing morbidity and mortality. Disclosures Melissa Minderman, Bachelor's Degree, Molecular Biology, MiraVista Diagnostics (Employee) Suphansa Gunn, Bachelor's Degree, psychology, MiraVista Diagnostics (Employee) Lawrence J. Wheat, MD, MiraVista Diagnostics (Employee)

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