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D006967: Hypersensitivity

Developed by Shray Alag, The Harker School
Sections: Correlations, Clinical Trials, and HPO

Correlations computed by analyzing all clinical trials.

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Correlated Drug Terms (1)


Name (Synonyms) Correlation
drug3936 performance evaluation study of RealDetect RT-PCR Kit for COVID-19 detection Wiki 0.71

Correlated MeSH Terms (0)


Name (Synonyms) Correlation

Correlated HPO Terms (1)


Name (Synonyms) Correlation
HP:0012393 Allergy HPO 0.71

Clinical Trials

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There are 2 clinical trials


1 Performance Evaluation of RealDetect™ COVID-19 RT-PCR Kit for the Detection of SARS-CoV-2 Virus

The novel Severe acute respiratory syndrome coronavirus 2 (SARS-C0V 2) originated in Wuhan, China in December 2019. As of April 15 2020, the virus has spread across 213 countries/territories with 1,914,916 cases and 123,010 deaths and a crude case fatality ratio (CFR) of 6.4%. In Bangladesh, the situation is also grave. As of May 14, 2020, there were 18,863 cases and 283 deaths. In order to suppress COVID-19 transmission, it is important to diagnose COVID-19 patients, which would help in the process of quarantine and isolation of the patients and also in contact tracing. COVID-19 testing can identify the SARS-CoV-2 virus and includes methods that detect the presence of virus itself such as real time reverse-transcription-polymerase chain reaction (RT-PCR), isothermal nucleic acid amplification, antigen) and those that detect antibodies produced in response to infection. Until now, RT-PCR has been known as the best approach for - detection. It would be very useful if Bangladesh had its own locally produced RT-PCR kits, provided that the kits are no less in quality than imported kits in terms of sensitivity, specificity, price etc. The present study aims to carry out the performance evaluation of RealDetect RT-PCR Kit for COVID-19 detection. The RealDetect™ COVID-19 RT-PCR diagnostic panel is a locally produced real-time RT-PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal swab specimens collected from individuals who meet SARS-CoV-2 clinical criteria. The approach is based on the RT-PCR method which uses two (Nucleocapsid 1, Nucleocapsid 2) sets of gene-specific primers and corresponding fluorescent probes to detect two specific regions within the novel coronavirus (SARS-CoV-2) nucleocapsid protein Nucleocapsid gene. This RT-PCR panel detects SARS-CoV-2 Ribonucleic acid (RNA) specifically. The approach does not generate any false positives to other coronaviruses or human microflora. The kit also contains a primer-probe set which detects human housekeeping gene, ribonuclease Protein (RNase P). That is, the Ribonuclease Protein (RNase P) serves as an internal reference control to monitor sample collection, ribonucleic acid (RNA) extraction, and amplification. This is a case control study. The study will analyze 120 samples (60 COVID-19 positive and 60 COVID-19 negative both fresh and frozen) from Institute of Epidemiology, Disease Control and Research (IEDCR). These specimens will be blinded before handing over to Institute for Developing Science & Health Initiatives (ideSHi) for RealDetect Kit. All samples will be analyzed by Real Time PCR System. Necessary validation will also be carried out at the COVID-19 laboratory of the Dhaka Medical College Hospital and an external validation expert will be involved. The Principal Investigator (PI) will also receive the sample information regarding positive/negative status from Institute for Epidemiology, Disease Control and Research (IEDCR) and compare ideSHi and IEDCR data. Unpaired t-test, Wilcox's test, Rank test, Compare test, Mean test, Sensitivity/Specificity test, Regression analysis and Geometric mean with 95% Confidence Interval (CI) will be used to analyze the data. It needs to conduct a univariate analysis.

NCT04403672
Conditions
  1. High Sensitivity and Specificity (With 95% Confidence Interval) of RealDetect™ COVID-19 RT-PCR Kit
Interventions
  1. Device: performance evaluation study of RealDetect RT-PCR Kit for COVID-19 detection
MeSH:Hypersensitivity
HPO:Allergy

Primary Outcomes

Description: Determine Performance evaluation of RealDetect™ COVID-19 RT-PCR kit for the detection of SARS-CoV-2 virus using nasopharyngeal swab specimens collected in the nationwide COVID-19 screening program. RNA extraction from fresh Nasopharyngeal Swab sample in Viral Transport Medium(VTM) of COVID-19 patients from IEDCR (30 positive & 30 negative) Analysis of COVID-19 RNA samples using RT-PCR

Measure: Performance evaluation of RealDetect™ COVID-19 RT-PCR kit

Time: 2 months

Secondary Outcomes

Description: Supply locally manufacturer COVID-19 Reverse transcription polymerase chain reaction (RT-PCR) kit to govt. & private hospitals for diagnosis of COVID-19 patients. RNA extraction from frozen Nasopharyngeal Swab sample in Viral Transport Medium(VTM) of COVID-19 patients from IEDCR (30 positive & 30 negative) Analysis of COVID-19 RNA samples using Reverse transcription polymerase chain reaction (RT-PCR)

Measure: Reduce the price of RT-PCR based COVID-19 diagnostic test kits.

Time: 1 month
2 Multicentric Sensitivity Assessment of Antibody Diagnostic Tests Developed for Diagnosis of SARS-CoV2 Infection

The primary objective of this study is to test the diagnostic sensitivity of antibody tests for the diagnosis of SARS-CoV2 infection, available to clinical laboratories, within a national network of hospitals carrying out research activities. Test the diagnostic specificity of antibody tests for the diagnosis of SARS-CoV2 infection. Complete a systematic evaluation of the different approaches. Perform Health technology Assessment (HITA) of the methodologies under study, in order to verify their reliability to the immunoglobulin levels produced by each individual exposed patient.

NCT04678024
Conditions
  1. Covid19
MeSH:Hypersensitivity
HPO:Allergy

Primary Outcomes

Description: Sensitivity and Specificity Evaluation in Diagnostic Sierological tests

Measure: Sensitivity

Time: Up to 22 - 27 weeks

Secondary Outcomes

Description: Sensitivity and Specificity Evaluation in Diagnostic Sierological tests

Measure: Specificity

Time: Through study completion, an average of 1 year

Other Outcomes

Measure: HTA

Time: Up to 22 - 27 weeks

HPO Nodes


Reports

Data processed on December 13, 2020.

An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.

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