SARS-CoV-2 Updates - Diagnostics
Other SARS-CoV-2 updates
Robert Koch-Institut Centre for International Health Protection (ZIG), Germany, Dr. Heinz Ellerbrok
- PCR Primer Diagnostics and Probes & Controls
- Test regions: Nigeria-CDC, Ivory Coast, Democratic Republic of the Congo, Namibia
- Rwanda and Namibia-Diagnostics Training and receive WHO coordination
- Further, we support WHO WPRO in Manila and WHO Headquarters in Geneva with deployment of personnel.
Broad Institute, Harvard, Boston, MA, Pardis Sabeti
- Ran 19 Genomes via ADAPT computational software for PCR and SHERLOCK guide design.
- Sensitive, species-specific, multi-plexed SHERLOCK assay guides for the 5 previously sequenced human associated corona viruses against 186 human associated viruses with genome sequence data
- Training: sequencing and bioinformatics with the MASS DPS. Participants from 9 states taking course
- Developed ADAPT computational software for molecular diagnostic guide design. https://www.biorxiv.org/content/10.1101/2020.11.28.401877v1
- Developed a 1-pot CRISPR-based diagnostic test for SARS-CoV-2, SHINE. https://www.nature.com/articles/s41467-020-19097-x
- Developed Sensitive, species-specific, multi-plexed CRISPR-based assay CARMEN, that could differentiate 5 previously sequenced human associated corona viruses and SARS-CoV-2 and can be used for all human associated viruses with genome sequence data https://www.nature.com/articles/s41586-020-2279-8
- In partnership with ACEGID, established diagnostics in Nigeria, Sierra Leone, and Senegal by February 2020, and supported national testing efforts.
- Established LDT at MGH and described needs to support more clinical labs rapid response to new viral outbreaks. https://jcp.bmj.com/content/early/2021/05/28/jclinpath-2020-207128 and https://www.nejm.org/doi/full/10.1056/NEJMp2025173
- Developed a model that indicates that altruism is the best approach for diagnostic testing https://www.medrxiv.org/content/10.1101/2021.03.16.21253669v1
- Training: provided sequencing and bioinformatics training for US departments of public health with the CDC and Massachusetts DPH, with participants from 8 states taking course
Wyss Institute at Harvard, Donald Ingber
- Low-cost, injection-molded nasopharygeal swabs developed and now commercially available internationally
- Ultrasensitive lab-based and point-of-care diagnostics for multiplexed detection of viral antigens and host antibodies being developed
- Detected anomalous false positive due to sensing experimental SARS-CoV-2 probes in academic research labs
- Assisted in generation of single cell transcriptomics-based tissue atlas for COVID-19 patients
- Engineered, SARS-CoV-2 pseudovirus. Collaborating with GVN (Number Centers/PIs)
- Covid-19 Human Lung and Intestine Chip Models established. Chip models set up in GVN Centers with technology purchased from Emulate, Inc. (com).
- Identified multiple inhibitors of viral entry (measured in this pseudovirus system) and host inflammatory responses (using influenza virus) in Airway Chips, including multiple FDA approved drugs
- Collaborate, Matthew Frieman, University of Maryland: installing Organ Chip instruments on his site for testing identified drugs.
- Chip models enabled repurposing of amodiaquine, which is now in clinical trials for COVID-19 in multiple sites across Africa
Si L et al., A human-airway-on-a-chip for the rapid identification of candidate antiviral therapeutics and prophylactics.
Nat Biomed Eng. 2021 May 3. doi: 10.1038/s41551-021-00718-9. Online ahead of print.PMID: 33941899
Robinson-McCarthy et al., Anomalous COVID-19 tests hinder researchers.
Science. 2021 Jan 15;371(6526):244-245. doi: 10.1126/science.abf8873.PMID: 33446547
Delorey et al. COVID-19 tissue atlases reveal SARS-CoV-2 pathology and cellular targets.
Nature. 2021 Apr 29. doi: 10.1038/s41586-021-03570-8. Online ahead of print.PMID: 33915569
Erica Saphire, La Jolla Institute of Immunology, La Jolla, California
- Funding: Gates, Wellcome and Mastercard
- mAB therapy clearinghouse for evaluation and delivery to determine IgG/IgM efficaciousness everywhere, including LDCs
- Bill & Melinda Gates Foundation supported consortium, CoVIC (covic.lji.org) analyzes the world’s leading therapeutic candidates side-by-side, and uses LJI’s powerful pair of Titan Krios microscopes for high-resolution analysis of the antibody interactions.
DUKE-NUS, Singapore, Linfa Wang
- Obtained several isolates. Setting up non-human primate, (NHP) Models
- SARS cross-reactivity/contamination in diagnostics work and IgG/IgM S Protein-based Serology tracing to detect 2 of the clusters
- Data reveals SARS IgG/M does not neutralize COVID-19, but cross-reacts; therefore, ADE is more acute then in other countries.
- Collaborations with Dr. Paul Young, (University Queensland).
- Fecal sample confirms new transmission route
- cPass-Rapid, serological, Ab test specifically for Nab
- Effective for tracking animal viruses and determining vaccine efficaciousness.
- RNA/PCR Testing
- Recognize SARS-CoV-2 (COVID-19) RNA and RNA fragments-specific
- University of Oxford’s Engineering Science Department and the Oxford Suzhou Centre for Advanced Research (OSCAR), was led by Prof. Zhanfeng Cui and Prof. Wei Huang.
- FDA to permit Labs to run tests | Emergency Use Authorization rapid, simple, (no need for a complicated instrument; requires 1/2,' 3x faster; 100% success rate. Built-in checks: False/Negative positives Validated with clinical trials at Shenzhen Louhou Hospital in China, and confirmed with conventional methods. But still in preliminary development.
- IgM/IgG Rapid test
- BioMedomics has developed and launched one of the world’s first rapid point-of-care. lateral flow immunoassays for the diagnosis of coronavirus infection.
- Molecular Systems, high-volume Platform. RT-PCR IgG/IgM, automated 'cobas' SARS-CoV-2 Test 400K shipments began March 13, 2020; Under FDA Emergency Use, and another 400k/week will be shipped to hospitals and reference labs
BGI (Chinese Biotech)
- Huo-Yan Laboratory Solutions
- Real-Time Fluorescent RT-PCR kit for detecting 2019-nCoV (SARS-CoV-2), which can issue results in 3 hours. The kit was certified by National Medical Products Administration and received CE-IVD marking. The kit is already widely used in China, providing a scientific basis for diagnosis of suspected cases and the discharge of recovered patients.
- Integrated testing solutions, improving both the testing in acute and recovery phases of the illness.
- The test series of COVID-19 detection products, includes: 2019-nCoV IgM Detection kit (Enzyme-linked Immunoassay, ELISA), 2019-nCoV IgM/IgG Detection Kit (Enzyme-linked Immunoassay, ELISA) and 2019-nCoV Nucleic Acid Detection Kit (PCR-Fluorescent Probe Method). All these products, as a set of "integrated detection" solution, assist medical institutions to diagnose COVID-19 infection quickly and accurately, and improve epidemic prevention and control capabilities for disease control centers at all levels.
Advaite RAPCOV Test
- Rapid response Dx Testing Kits
- Immunochromatography-IgM/IgG. Immunochromatography technique which highlights the presence of anti-COVID-19 IgM and IgG antibodies in their specific bands and verifies the validity of the test with a third control band. The ADVAITE Rapid COVID-19 test can be used for the presumptive differentiation between: (i) recent (primary or secondary) infection; (ii) non-recent (past) infection; and (iii) no previous infections (Covid-19 virus naïve individuals). This test can be performed in any environment, and results are given within 15-30 minutes and Point-of-Care. Positive results are presumptive and must be confirmed by virus isolation, antigen detection by immunohistochemistry or viral nucleic acid detection for confirmation of COVID-19 virus infection. Will begin supplying to the world market
- Rapid detection; DSL RT-PCR assay
- nasopharyngeal swabs, throat swabs, bronchoalveolar lavages, and bronchial washings
- The test is available, and submitted to FDA for Emergency use
- TaqPath multi-plex RT-PCR Dx Kit
- RNA extracted from nasopharyngeal swabs, nasopharyngeal aspirate (nasal aspirate), and bronchoalveolar lavage (BAL)
- FDA Emergency Authority, (EA) use
- Rapid, The Loop-mediated isothermal amplification/Lamp-based assay
- Results ready in 1.' Near patient, P.O.C. administration
- Awaiting clinical evaluation for Chinese market
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