scholarly journals Limits and Opportunities of SARS-CoV-2 Antigen Rapid Tests: An Experienced-Based Perspective

Pathogens ◽  
2021 ◽  
Vol 10 (1) ◽  
pp. 38
Author(s):  
Verena Schildgen ◽  
Sabrina Demuth ◽  
Jessica Lüsebrink ◽  
Oliver Schildgen
Keyword(s):  
Clinical Setting ◽  
Gold Standard ◽  
Antigen Test ◽  
Public Attention ◽  
High Expectations ◽  
Test Strategy ◽  
Rapid Tests ◽  
Pilot Sample ◽  
Lateral Flow Tests ◽  
Throat Washing

Background: Due to the steadily rising case numbers of SARS-CoV-2 infections worldwide, there is an increasing need for reliable rapid diagnostic devices in addition to existing gold standard PCR methods. Actually, public attention is focused on antigen assays including lateral flow tests (LFTs) as a diagnostic alternative. Therefore, different LFTs were analyzed regarding their performance in a clinical setting. Material and Methods: A pilot sample panel of 13 bronchoalveolar fluids (BALFs) and 60 throat washing (TW) samples with confirmed PCR results, as well as eight throat washes invalid by PCR, were tested with the BIOCREDIT test (RapiGEN), the PanbioTM assay (Abbott), and the SARS-CoV-2 rapid antigen test (Roche). Conclusion: The analyzed antigen test showed an interassay correlation of 27.4%, with overall specificities ranging from 19.4% to 87.1%, while sensitivities of the respective tests ranged between 33.3% and 88.1%. Because these assays did not entirely meet all high expectations, their benefit has to be carefully evaluated for the respective test strategy and setting.

scholarly journals Limits and opportunities of SARS-CoV-2 antigen rapid tests – an experience based perspective

2020 ◽  
Author(s):  
Verena Schildgen ◽  
Sabrina Demuth ◽  
Jessica Lüsebrink ◽  
Oliver Schildgen
Keyword(s):  
Clinical Setting ◽  
Gold Standard ◽  
Antigen Test ◽  
Public Attention ◽  
High Expectations ◽  
Test Strategy ◽  
Rapid Tests ◽  
Pilot Sample ◽  
Lateral Flow Tests ◽  
Throat Washing

AbstractBackgroundDue to the steadily rising case numbers of SARS-CoV-2 infections worldwide there is an increasing need for reliable rapid diagnostic devices in addition to existing gold standard PCR-methods. Actually, public attention is focused on antigen assays including lateral flow tests (LFTs) as diagnostic alternative. Therefore, different LFTs were analyzed regarding their performance in a clinical setting.Material and MethodsA pilot sample panel of 13 BALFs and 60 throat washing samples (TWs) with confirmed PCR results as well as 8 throat washes invalid by PCR was tested with the BIOCREDIT test (RapiGEN), the Panbio™ assay (Abbott), and the SARS-CoV-2 Rapid Antigen Test (Roche).ConclusionThe analyzed antigen test showed an inter-assay correlation of 27.4% with overall specificities ranging from 19.4% to 87.1%, while sensitivities of the respective tests ranged between 33.3% and 88.1%. Although these assays did not entirely meet all high expectations their benefit has to be carefully evaluated for the respective test strategy and setting.

scholarly journals Performances of Four Helicobacter pylori Serological Detection Kits Using Stool Antigen Test as Gold Standard

PLoS ONE ◽  
2016 ◽  
Vol 11 (10) ◽  
pp. e0163834 ◽  
Author(s):  
Susheela D. Biranjia-Hurdoyal ◽  
Sharmila P. Seetulsingh-Goorah
Keyword(s):  
Helicobacter Pylori ◽  
Gold Standard ◽  
Antigen Test ◽  
Serological Detection ◽  
Stool Antigen Test ◽  
Stool Antigen

The Strategy and Advantage in Use of an Electronic Probe for Attachment Measurement

1993 ◽  
Vol 7 (2) ◽  
pp. 152-157 ◽  
Author(s):  
W.B. Clark ◽  
I. Magnusson ◽  
Y.Y. Namgung ◽  
M.C.K. Yang
Keyword(s):  
Clinical Setting ◽  
Gold Standard ◽  
Large Error ◽  
Gingival Tissue ◽  
Time Interval ◽  
Error Sources ◽  
Designed Experiments ◽  
Electronic Probe ◽  
Periodontal Probing ◽  
Attachment Level

Attachment level has been used as the "gold standard" for assessment of the progression of periodontal disease. However, the measurement of attachment level by periodontal probing can be subject to a large number of error sources. Recently, we have designed experiments by using an electronic probe to identify the magnitude of error components due to the instrument, gingival tissue condition, position or probing angle, and time interval between replicate probings. Even with a very careful clinical setting, a few percent of uncontrollable large errors or outliers could not be avoided. A previously used 'option-3' probing scheme to reduce the unexpected large error is justified from the mathematical viewpoint.

scholarly journals ASSESSMENT OF PERFORMANCE AND IMPLEMENTATION CHARACTERISTICS OF RAPID POINT OF CARE SARS-CoV-2 ANTIGEN TESTING IN KENYA

2021 ◽  
Author(s):  
Jesse Gitaka ◽  
Eva Muthamia ◽  
Samuel Mbugua ◽  
Mary Mungai ◽  
Gama Bandawe ◽  
...  
Keyword(s):  
Confidence Interval ◽  
Test Performance ◽  
Gold Standard ◽  
Point Of Care ◽  
Turnaround Time ◽  
Ease Of Use ◽  
Control Measures ◽  
Antigen Test ◽  
Rt Pcr ◽  
Predictive Values

Abstract Background: The COVID-19 pandemic has resulted in a need for rapid identification of infectious cases. Testing barriers have prohibited adequate screening for SARS COV2, resulting in significant delays in treatment provision and commencement of outbreak control measures. This study aimed to generate evidence on the performance and implementation characteristics of the BD Veritor rapid antigen test as compared to the gold standard test for diagnosis of SARS COV2 in Kenya. Methods: This was a field test performance evaluation in symptomatic and asymptomatic adults undergoing testing for SARS COV2. Recruited participants were classified as SARS-CoV2-positive based on the locally implemented gold standard reverse transcription polymerase chain reaction (RT-PCR) test performed on nasopharyngeal swabs. 272 antigen tests were performed with simultaneous gold standard testing, allowing us to estimate sensitivity, specificity, positive and negative predictive values for the BD Veritor rapid antigen test platform. Implementation characteristics were assessed using the Consolidated Framework for Implementation Research for feasibility, acceptability, turn-around time, and ease-of-use metrics. Results and Discussion: We enrolled 97 PCR negative symptomatic and 128 PCR negative asymptomatic, and 28 PCR positive symptomatic and 19 PCR positive asymptomatic participants. Compared to the gold standard, the sensitivity of the BD Veritor antigen test was 94% (95% confidence interval [CI] 86.6 to 100.0) while the specificity was 98% (95% confidence interval [CI] 96 to 100). The sensitivity of BD Veritor antigen test was higher among symptomatic (100%) compared to asymptomatic (84%) participants, although this difference was not statistically significant. There was also a lack of association between cycle threshold value and sensitivity of BD Veritor test. The BD Veritor test had quick turnaround time and minimal resource requirements, and laboratory personnel conducting testing felt that it was easier to use than the gold standard RT-PCR. Conclusion: The BD Veritor rapid antigen test exhibited excellent sensitivity and specificity when used to detect SARS-CoV-2 infection among both symptomatic and asymptomatic individuals in varied population settings in Kenya. It was feasible to implement and easy to use, with rapid turnaround time.

scholarly journals Performance of three SARS-CoV-2 immunoassays, three rapid lateral flow tests and a novel bead-based affinity surrogate test for the detection of SARS-CoV-2 antibodies in human serum

2021 ◽  
Author(s):  
Manuel Krone ◽  
Julia Gütling ◽  
Johannes Wagener ◽  
Thiên-Trí Lâm ◽  
Christoph Schoen ◽  
...  
Keyword(s):  
Human Serum ◽  
Sensitivity And Specificity ◽  
Symptom Onset ◽  
Gold Standard ◽  
Neutralizing Antibodies ◽  
Neutralization Test ◽  
Lateral Flow ◽  
Igg Antibodies ◽  
Serum Samples ◽  
Lateral Flow Tests

For the control of immunity in COVID-19 survivors and vaccinated subjects there is an urgent need for reliable and rapid serological assays. Based on samples from 63 COVID-19 survivors up to seven months after symptom onset, and on 50 serum samples taken before the beginning of the pandemic, we compared the performance of three commercial immunoassays for the detection of SARS-CoV-2 IgA and IgG antibodies (Euroimmun SARS-COV-2 IgA/IgG, Mikrogen recomWell SARS-CoV-2 IgA/IgG, and SERION ELISA agile SARS-CoV-2 IgA/IgG) and three rapid lateral flow (immunochromatographic) tests (Abbott Panbio COVID-19 IgG/IgM, NADAL COVID-19 IgG/IgM, and Cleartest Corona 2019-nCOV IgG/IgM) with a plaque-reduction neutralization test (PRNT50) representing the gold standard. Fifty-seven out of 63 PCR-confirmed COVID-19 patients (90%) showed neutralizing antibodies. The sensitivity of the seven assays ranged from 7.0% to 98.3%, the specificity from 86.0% to 100.0%. Only one commercial immunoassay showed a sensitivity and specificity of greater than 98%.

scholarly journals Lung MRI with hyperpolarised gases: current & future clinical perspectives

2021 ◽  
pp. 20210207
Author(s):  
Neil J Stewart ◽  
Laurie J Smith ◽  
Ho-Fung Chan ◽  
James A Eaden ◽  
Smitha Rajaram ◽  
...  
Keyword(s):  
Clinical Setting ◽  
Gold Standard ◽  
Lung Diseases ◽  
Evidence Base ◽  
Response To Therapy ◽  
Lung Imaging ◽  
Structural Imaging ◽  
Clinical Tool ◽  
Technical Developments ◽  
Lung Mri

The use of pulmonary MRI in a clinical setting has historically been limited. Whilst CT remains the gold-standard for structural lung imaging in many clinical indications, technical developments in ultrashort and zero echo time MRI techniques are beginning to help realise non-ionising structural imaging in certain lung disorders. In this invited review, we discuss a complementary technique – hyperpolarised (HP) gas MRI with inhaled 3He and 129Xe – a method for functional and microstructural imaging of the lung that has great potential as a clinical tool for early detection and improved understanding of pathophysiology in many lung diseases. HP gas MRI now has the potential to make an impact on clinical management by enabling safe, sensitive monitoring of disease progression and response to therapy. With reference to the significant evidence base gathered over the last two decades, we review HP gas MRI studies in patients with a range of pulmonary disorders, including COPD/emphysema, asthma, cystic fibrosis, and interstitial lung disease. We provide several examples of our experience in Sheffield of using these techniques in a diagnostic clinical setting in challenging adult and paediatric lung diseases.

scholarly journals Rapid tests for diagnosing syphilis: validation in an STD clinic in the Amazon Region, Brazil

2007 ◽  
Vol 23 (suppl 3) ◽  
pp. S456-S457 ◽  
Author(s):  
Adele Schwartz Benzaken ◽  
Enrique Galbán García ◽  
José Carlos Gomes Sardinha ◽  
João Catarino Dutra Junior ◽  
Rosanna Peeling
Keyword(s):  
Human Resources ◽  
Health Professionals ◽  
Gold Standard ◽  
Health Workers ◽  
Kappa Index ◽  
Operational Characteristics ◽  
Specialized Equipment ◽  
Rapid Tests ◽  
Positive Results ◽  
Additional Option

Correct, early diagnosis and treatment of syphilis are essential for its control. Traditional diagnostic tests depend on specialized equipment, installations, and human resources. In the search for quick, simple tests, a project was conducted on the validation and reproducibility of four different tests, previously assessed by WHO reference laboratories. The study also verified the operational characteristics and acceptance by patients and health professionals. Samples obtained at an STD clinic were from 541 and 248 patients with 51 and 52 positive results according to FTA-Abs (gold standard) in studies 1 and 2, respectively. The sensitivity varied from 84 to 96%, specificity was greater than 98%, and PPV was > 90%. Reproducibility was > 97% and kappa index 0.94, comparing the results obtained by different health workers. The tests took less than 20 minutes to perform, and more than 90% of patients agreed to wait up to two hours for the results. The tests presented the necessary requirements for use in diagnosis of syphilis, thus providing an additional option for controlling this disease.

scholarly journals Urgent need of rapid tests for SARS CoV-2 antigen detection: Evaluation of the SD-Biosensor antigen test for SARS-CoV-2

2020 ◽  
Vol 132 ◽  
pp. 104654 ◽  
Author(s):  
Francesco Cerutti ◽  
Elisa Burdino ◽  
Maria Grazia Milia ◽  
Tiziano Allice ◽  
Gabriella Gregori ◽  
...  
Keyword(s):  
Antigen Detection ◽  
Antigen Test ◽  
Rapid Tests ◽  
Detection Evaluation

scholarly journals In-Depth Longitudinal Comparison of Clinical Specimens to Detect SARS-CoV-2

Pathogens ◽  
2021 ◽  
Vol 10 (11) ◽  
pp. 1362
Author(s):  
Justine Defêche ◽  
Samira Azarzar ◽  
Alyssia Mesdagh ◽  
Patricia Dellot ◽  
Amandine Tytgat ◽  
...  
Keyword(s):  
Gold Standard ◽  
Clinical Symptoms ◽  
Nasopharyngeal Swab ◽  
Symptom Duration ◽  
Time Points ◽  
Throat Wash ◽  
Washing Method ◽  
Longitudinal Comparison ◽  
First Time ◽  
Throat Washing

The testing and isolation of patients with coronavirus disease 2019 (COVID-19) are indispensable tools to control the ongoing COVID-19 pandemic. PCR tests are considered the “gold standard” of COVID-19 testing and mostly involve testing nasopharyngeal swab specimens. Our study aimed to compare the sensitivity of tests for various sample specimens. Seventy-five participants with confirmed COVID-19 were included in the study. Nasopharyngeal swabs, oropharyngeal swabs, Oracol-collected saliva, throat washes and rectal specimens were collected along with pooled swabs. Participants were asked to complete a questionnaire to correlate specific clinical symptoms and the symptom duration with the sensitivity of detecting COVID-19 in various sample specimens. Sampling was repeated after 7 to 10 days (T2), then after 14 to 20 days (T3) to perform a longitudinal analysis of sample specimen sensitivity. At the first time point, the highest percentages of SARS-CoV-2-positive samples were observed for nasopharyngeal samples (84.3%), while 74%, 68.2%, 58.8% and 3.5% of throat washing, Oracol-collected saliva, oropharyngeal and rectal samples tested positive, respectively. The sensitivity of all sampling methods except throat wash samples decreased rapidly at later time points compared to the first collection. The throat washing method exhibited better performance than the gold standard nasopharyngeal swab at the second and third time points after the first positive test date. Nasopharyngeal swabs were the most sensitive specimens for early detection after symptom onset. Throat washing is a sensitive alternative method. It was found that SARS-CoV-2 persists longer in the throat and saliva than in the nasopharynx.

scholarly journals Validation of the saliva-based H. pylori test, HeliSAL™, and its use in prevalence surveys

2001 ◽  
Vol 126 (2) ◽  
pp. 191-196 ◽  
Author(s):  
M. COCKBURN ◽  
J. COLLETT ◽  
B. COX
Keyword(s):  
New Zealand ◽  
Clinical Diagnosis ◽  
Clinical Setting ◽  
Gold Standard ◽  
Large Scale ◽  
Population Based ◽  
Ease Of Use ◽  
Non Invasive ◽  
Test Sensitivity ◽  
H Pylori

The saliva-based H. pylori test, HeliSAL™, is insufficiently accurate for use in the clinical setting. However, its ease of use and non-invasiveness make it attractive for population-based studies of the epidemiology of H. pylori. We validated HeliSAL™, and comment here on its usefulness in prevalence surveys. One hundred and ninety-six patients receiving endoscopy at a clinic in New Zealand provided saliva samples for H. pylori assessment, which were compared to CLOtest (Delta West Pty Ltd, Western Australia) as a gold standard measure. Nineteen percent were truly H. pylori positive, 41 % were positive according to HeliSAL™. Test sensitivity was 74 % and specificity was 67 %. While HeliSAL™ is not well suited for the clinical diagnosis of H. pylori infection, it may be useful for large-scale prevalence surveys because, provided it is validated locally, mathematical adjustment can be made for misclassification. Being inexpensive, non-invasive, and easily stored and handled, HeliSAL™ may be a valuable tool for studies of the epidemiology of H. pylori.

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