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

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 ( 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.

Oxford Biosystems

  • 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.

BioMedomics COVID-19

  • 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.

WuXi Diagnostics

  • 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

Diagnostic Solutions

  • 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