MOSAIQ™ BY QUOTIENT
The MosaiQ COVID-19 Antibody Microarray
Quotient’s best-in-class contribution to the COVID-19 pandemic
Our response
In a blink, our world has been redefined including MosaiQ by Quotient. Our over thirty years of experience in transfusion diagnostics allowed us to create the MosaiQ COVID-19 Antibody Microarray in response to the COVID-19 pandemic. The proprietary technology behind the MosaiQ instrument has been leveraged to quickly, and accurately bring insights at a moment of need – empowering the decisions that will help to fight against COVID-19 and restore the world back to normal. The best-in-class MosaiQ COVID-19 Antibody Microarray is CE marked, has received the U.S. FDA Emergency Use Authorization (EUA), and available today as a tool in the fight against COVID-19.
Franz Walt, Former Chief Executive Officer, Quotient
“In the global effort to help contain the rapid spread of the new strain of coronavirus, we believe that the MosaiQ technology can provide healthcare workers with an efficient and reliable, high-volume antibody test.”
Best-in-class performance
The MosaiQ COVID-19 Antibody Microarray tests for both IgM and IgG antibodies to SARS-CoV-2, the virus that causes COVID-19, offering one of the earliest antibody detection tests available. Independent and internal studies have confirmed best-in-class performance with 100% sensitivity and 99.8% specificity.
Our response
MosaiQ COVID-19 Microarray & Antibody Testing
The MosaiQ COVID-19 Antibody Microarray demonstrates a best-in-class SARS-CoV-2 testing solution with its early antibody detection, antigen choice, and broad clinical utility.
How the Microarray works: The MosaiQ Reaction
The innovative technology that allowed Quotient to create the MosaiQ COVID-19 Antibody Microarray is powered by the proprietary MosaiQ Reaction that delivers fast, accurate results every 24 seconds on the MosaiQ system – a multiplexing, multimodal solution for central laboratories.
When is the Microarray used: Early antibody detection
The MosaiQ COVID-19 Antibody Microarray can detect seroconversion as early as 24 hours post PCR and detects antibodies as early as 7 days post PCR. This is 7-14 days earlier than detecting the IgG antibody alone. The following illustrative case of a potential response to SARS-CoV-2 depicts typical timing of RNA, IgM, and IgG antibodies. The early onset of the IgM antibodies is what allows the MosaiQ COVID-19 Antibody Microarray to deliver early results of immune response.
Why does it work: Neutralizing Antibody Detection
The MosaiQ COVID-19 Antibody Microarray uses spike protein antigens that bind to ACE2 receptors on human cells, starting infection. An alternative would be to target the nucleocapsid protein, which is responsible for the replication of the virus once infection has occurred. However, antibodies to the spike glycoprotein have a more comprehensive role, as they interfere with the ability of the virus to bind, infect and replicate in human cells.
An assay identifying antibodies to the nucleocapsid protein may not detect the more important antibodies neutralizing the spike protein, which is why the spike protein antibodies are targeted by Quotient’s MosaiQ COVID-19 Antibody Microarray.1
The MosaiQ COVID-19 Antibody Microarray detects antibodies to the spike protein which have a correlation to neutralizing the SARS-CoV-2 virus.
What are the applications of the MosaiQ COVID-19 Antibody Microarray: Broad clinical utility
The MosaiQ COVID-19 Microarray provides insights in a variety of settings throughout the course of virus and pandemic including confirmation of seroconversion and immune response, treatment research, and population survey.
| Confirmation of seroconversion |
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As early as 2-7 days post PCR, MosaiQ, in conjunction with molecular or PCR testing, can confirm a SARS-CoV-2 virus infection. Additionally, if PCR testing is negative, but the patient is symptomatic, antibody testing can provide evidence of an immune response. |
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The spike protein antigen choice progresses the development of therapeutic options, such as the identification of serum likely to be rich in neutralizing antibodies, and vaccine trials including assessment of post-vaccination responders and selection of trial subjects.
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| Potential immunity testing |
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Post symptoms MosaiQ can confirm immune response in recovering or convalescent patients. |
| Public health and policy development |
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MosaiQ fosters epidemiological research, enabling the survey of population response to SARS-CoV-2 within localized and generalized cohorts.
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MosaiQ System
A unique and innovative solution
A multi-modal, multiplexing, high-throughput solution for SARS-CoV-2 testing, immunoassays, and molecular diagnostics.
The system
The MosaiQ system is a streamlined and efficient solution for any laboratory, utilizing up to four types of different microarrays simultaneously to allow for true multiplex testing. Quotient is continually working on expanding the system’s capabilities by enhancing the microarrays available and seeking further approvals for additional immunoassays, including in the area of molecular diagnostics.
The MosaiQ COVID-19 Antibody Microarray combines with the multiplexing, high-throughput MosaiQ™ instrument to quickly and accurately evaluate samples in central laboratories.
- Each microarray can generate reactions on up to 132 printed biological markers
- Up to 3,000 microarrays can be tested in 24 hours
- Results are provided every 24 seconds after the first result
- Only 5 μl of serum or plasma tested per sample
- Walk-away solution using continuous sample loading
- MosaiQ microarrays are stored at room temperature, saving expensive cold storage space
FAQ
Everything you need to know
The most frequently asked questions about the MosaiQ COVID-19 Antibody Microarray.
Laboratory Professionals
Which antibodies are tested by the MosaiQ COVID-19 Antibody Microarray?
The MosaiQ COVID-19 Microarray tests both IgM and IgG antibodies, detecting seroconversion as early as 24 hours post PCR and antibody detection as early as 7 days post PCR. In many cases, this is 7-14 days earlier than tests that test only IgG antibodies.
What is the clinical performance?
During internal clinical agreement studies, the MosaiQ COVID-19 Antibody Microarray achieved 100% sensitivity and 99.8% specificity.
Is the MosaiQ COVID-19 Antibody Microarray approved in my geography?
CE Marking was achieved on 1 May 2020. FDA Emergency Use Authorization was granted on 25 September 2020.
Which antigens does the test target and why is this important?
The MosaiQ COVID-19 Microarray targets spike protein antigens that are important in correlation with neutralizing antibodies.2
What are the key benefits of testing samples for SARS-CoV-2 on the MosaiQ system?
The MosaiQ COVID-19 Microarray provides a best-in-class experience with its excellent performance and early detection. In combination with the MosaiQ system, up to 3,000 tests can be run in a single day, providing results every 24 seconds. This solution when dedicated to SARS-CoV-2 testing leaves regular laboratory testing uninterrupted and the walkaway solution allows staff to focus on other tasks of need.
Where is the MosaiQ COVID-19 Antibody Microarray manufactured?
The MosaiQ COVID-19 Antibody Microarray is manufactured in a dedicated ISO13485 facility in Eysins, Switzerland.
Healthcare Providers Information Sheet – for US
Patients
What kind of test is the MosaiQ COVID-19 Antibody Microarray?
The MosaiQ COVID-19 Antibody Microarray is an antibody test that detects the presence of IgM and IgG antibodies.
What are antibodies and antibody testing?
In response to infection by an infectious agent (bacteria or virus) the body creates antibodies that are specific to the infectious agent. This enables the body to combat the infection and, in many cases, clear the infection. Antibodies that are developed during this immune response remain in the body and circulating blood for some period of time depending on multiple factors (i.e. level of exposure, antibody class).
Antibodies detected during antibody testing help to identify whether an individual has been in contact with a virus and can help clinicians identify an immune response.
Which antibodies are tested by the MosaiQ COVID-19 Antibody Microarray?
The MosaiQ COVID-19 Microarray tests for both IgM and IgG antibodies, detecting seroconversion as early as 24 hours post PCR and antibody detection as early as 7 days post PCR. In many cases, this is 7-14 days earlier than tests that test for only IgG antibodies.
Is the MosaiQ COVID-19 Antibody Microarray approved in my geography?
CE Marking was achieved on 1 May 2020. FDA Emergency Use Authorization was granted on 25 September 2020.
In which geographies are the CE Mark and FDA EUA accepted?
The CE Mark allows for single market access in all EU member states, some individual territories of those member states, as well as EEA member countries, and countries with special agreements with the EU such as Switzerland and Turkey.
The Emergency Use Authorization (EUA) is granted by the US Food and Drug Administration (FDA) to facilitate availability of medical products during public health emergency situations in the USA.
Where can I be tested, and can I order single tests for my family?
The MosaiQ COVID-19 Antibody Microarray is tested on the MosaiQ system, a high-throughput, multiplex screening solution of blood products for professional use within a clinical laboratory setting. Due to the nature of the setting needed for the MosaiQ system, Quotient does not offer single tests to individuals. However, the MosaiQ system may currently be available in your geographic area. Contact us here if you would like to learn more.
Recipient Information Sheet – for US
Contact
Do you still have questions? Contact us here.
See what the press is saying about Quotient
Swiss company races to bring COVID-19 antibody tests to market
While there are few reliable tests on the market at present, Quotient...developed a highly accurate one that can be carried out quickly on its blood screening machines.
Ex-Roche-Manager produziert ersten Schweizer Antikörpertest
Das Startup Quotient bringt den ersten in der Schweiz produzierten Antikörpertest auf den Markt.
Swiss Company Says it Developed Fast, Accurate Virus Antibody Test
… the test runs on an instrument called the Mosai[Q] that can deliver an initial test in 35 minutes, with subsequent results every 24 seconds. After that, up to 3,000 tests per day can be delivered.
Coronavirus: New 'fast and accurate' antibody test developed
We are truly proud to have developed such a fast and accurate test. This is an outstanding performance by our teams in both Edinburgh and Switzerland.
CORONAVIRUS: CARE HOMES AND PRISONS ARE NEXT TO RECEIVE CORONAVIRUS TEST KITS
Quotient has been developing the test in Edinburgh and Switzerland and said it could be used immediately.
Waadtländer Startup Quotient fordert Roche heraus
Wir wollen von der Transfusionsdiagnostik über die Plasma-Industrie bis zur zentralen Labor-Diagnostik den gesamten Markt mit unserer Technologie beliefern können.
Face à la pandémie, la réponse des sciences de la vie en Suisse
Ce sont les tests les plus fiables du monde, en détectant des anticorps sept jours seulement après l’infection, ils sont aussi les plus précoces et ils sont faits en Suisse.
Coronavirus: ‘Fast and accurate’ antibody test developed by Edinburgh researchers
We’ve got such a rich history here and we hope we can now make a difference at this challenging time.
Manuel O. Mendez, Chief Executive Officer of Quotient
We are honored to receive international recognition in the form of this prestigious award. This stands as a testament to our partners’ and our team’s creativity and design efforts throughout the years.
References
1 The Lancet. (April 4 2020). Volume 395. Developing antibody tests for SARS-CoV-2. Anna Petherick
2 Quotient Suisse SA. MosaiQ™ COVID-19 Antibody Microarray Instruction for Use. REF MMSIFU.0035. May 2020.
1. This test has not been FDA cleared or approved;
2. This test has been authorized by FDA under an EUA for use by authorized laboratories;
3. This test has been authorized only for the detection of antibodies against SARS-CoV-2, not for any other viruses or pathogens; and
4. This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Food, Drug and Cosmetics Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
© Quotient Suisse SA, 2020
Quotient MosaiQ and MosaiQ are trademarks or registered trademarks of Quotient Ltd or its subsidiaries in various jurisdictions. Menus and capabilities are subject to change. Not all methods may be available in all territories. Subject to regulatory clearance.