• On 26 November, Biolidics announced it entered into a distribution agreement with JOYSBIO for their SARS-CoV-2 Antigen Rapid Test Kit.
• The Antigen Rapid Test Kit has received Provisional Authorisation by the Health Sciences Authority in Singapore.
• We arranged for a Q & A with Biolidics on their recent development with this and any other COVID-19 test kit.

Company Background

Incorporated in 2009, Biolidics is a Singapore-based medical technology company.  The company has developed and commercialised the ClearCell® FX1 System, a fully automated CEIVD medical device which relies on a novel patented technology to separate and enrich cancer cells from blood. The ClearCell® FX1 System allows users to perform liquid biopsies to test for the presence of cancer cells (specifically circulating tumour cells, or CTCs) in blood samples or perform further analysis on cancer cells. In March 2020, Biolidics launched its  IgC/IgM antibody test kit for COVID-19. And recently in November, it entered into the distribution agreement of the antigen rapid test kits for COVID-19 (called Colloidal Gold).

1. Why are there different COVID-19 test kits used in different stages of COVID-19?

When a person is infected with COVID-19, the COVID-19 virus load is highest at the onset of infection and Polymerase Chain Reaction (PCR) test is generally used as the diagnostic test to detect the virus.

Antigen tests detect specific proteins from the virus, hence it can be used as a tool for detection of the COVID-19 virus. An antibody test looks for antibodies that are made by our immune system in response to the COVID-19 virus. Antibodies can help fight infections. Antibodies can take several days or weeks to develop after an individual has an infection and may stay in your blood for several weeks or more after recovery.

Neutralising antibody (NAB) test detects COVID-19 viral spike/Angiotensin Converting Enzyme 2 (ACE2) blocking antibodies which may indicate protective immunity against COVID-19.

Antibody tests and antigen tests are beneficial for their ability to produce test results quickly and at lower costs as compared to the more expensive PCR tests which take between one to two days to produce test results. If a person is asymptomatic to COVID-19 and thereafter recovers from COVID-19, the PCR and antigen tests will return a negative result but an antibody test would return a positive result.

This is particularly important as vaccination to COVID-19 is to protect people against COVID-19 before they come into contact with the virus. Vaccination uses your body’s natural defence (aka immune system) to build resistance to the infection of COVID-19 virus.  Vaccines train your immune system to make antibodies and/or elicit T-cell response. After a vaccination is done, antibody tests and NAB tests are recommended to assess if a person’s immune system has produced the antibody.

2. How will both antibody test kits be used during the COVID-19 vaccination process and does it matter which type of vaccine is deployed?

Currently, there are a few COVID-19 vaccines approved for early or limited use and these vaccines can be further classified into 3 main types based on the platforms used including genetic vaccine, viral-vector vaccine, and inactivated coronavirus vaccine.

All vaccines, no matter which type, train your body’s immune system to produce antibodies. Biolidics’ antibody tests and NAB tests are therefore suitable for monitoring the duration of the immune response. In addition, NAB test could be used to monitor the level and duration of “protective immunity”.

There is not enough covid-19 vaccine for everyone in the world currently, hence prioritization population for vaccination is therefore needed.  Pre-vaccination screening using a rapid antibody test could provide a way for such prioritization. A person who tested positive for COVID-19 antibodies should be considered not suitable for vaccination due to a potential safety concern know as vaccine-associated disease enhancement (VADE).

More details of VADE can be found here:

https://www.nature.com/articles/s41579-020-00462-y

3. What is the advantage and disadvantage of an antigen rapid test kit versus a PCR test?

All types of testing have its limitations and there is no diagnostic test that are 100% accurate.

There are 2 key advantages of an antigen test over a PCR test: (a) Antigen test provide results in minutes, as compared to hours required generally for a PCR test, hence it provides a quick turnaround time to identify the SARS-COV-2 infection during the acute infectious phase; (b) Antigen test does not require laboratory or specialised equipment for processing, hence the costs are much lower for antigen test as compared to PCR test. However, the antigen test is less sensitive than PCR test. For the JOYSBIO Antigen Rapid Test Kit distributed by Biolidics, the overall combined clinical sensitivity is 93.9%, and specificity is 98.9% on the basis of 2 clinical studies carried in China and Italy.

The results from the antigen test are only for clinical reference and should not be the only basis for clinical diagnosis and treatment. The clinical management of patients should be considered in combination with their symptoms, physical signs, medical history, other laboratory tests, therapeutic reaction, and epidemiological information.

4. How will antigen test kits be used as a mass testing tool in countries such as Singapore, Indonesia or the Philippines?

In Singapore, the authorities are piloting pre-event testing (https://www.moh.gov.sg/docs/librariesprovider5/default-document-library/factsheet-on-pilots-for-pre-event-testing.pdf ) to identify a model that can be widely implemented so that more large-scale events can safely resume. As mentioned by the Ministry of Health (MOH) in a factsheet, antigen rapid tests will be used for the pre-event testing, which can return “fairly accurate” results within about half an hour.

This model may be replicated in the region as economies re-open and antigen test kits can be used as an additional tool to provide more information to health authorities to shape their policies and measures to combat COVID-19. Notably, antigen tests are cheaper than PCR tests, hence it is more cost effective for countries where there are hundreds of millions, if not tens of millions, of population to deploy the COVID-19 test. In addition, with regional countries having a vast geographical spread, antigen test will be more practical because of the high throughput and quick turnaround time without the need for specialised lab and equipment.

5. What is the difference between JOYSBIO Antigen test kit compared with others in the market, for instance, accuracy, technology, etc?

• Ease of specimen collection: Joysbio Antigen test kit uses nasal swab instead of nasopharyngeal specimen for virus detection;
• Good clinical performance (n=364): Sensitivity: 93.9%, Specificity: 98.9%, Accuracy: 97.5%;
• Validated point-of-care usage: Joysbio Antigen test kit is intended for use by trained users in a non-healthcare setting, but not for at-home testing.

6. With your provisional authorisation from Health Sciences Authority in Singapore (HSA) , can your antigen test be sold in other countries such as Indonesia and the Philippines? Who are the potential buyers of your antigen test in these countries?

While the JOYSBIO Antigen Rapid Test Kit has received the Provisional Authorisation from HSA, the sale of this antigen rapid test kit is still subjected to the approval by the respective health authorities in the regional countries.

Under the terms of the JOYSBIO Agreement, the Company has been appointed as the non-exclusive worldwide distributor of the JOYSBIO Antigen Rapid Test Kit for a duration of one year from the date of the JOYSBIO Agreement. In addition, under the terms of the JOYSBIO Agreement, among others, the Company shall automatically become the exclusive distributor of the JOYSBIO Antigen Rapid Test Kit in Singapore and the Philippines if the number of kits ordered by the Company reaches 100,000 units within 90 calendar days in Singapore and 1,000,000 units within 180 calendar days in the Philippines, from the date of the JOYSBIO Agreement (i.e. 26 November 2020), respectively.

As such, we will work towards obtaining the relevant approvals in targeted markets.

We believe that the potential buyers of the antigen test will be government agencies, healthcare institutions, companies with a large labour force, among others.

7. With the approval of Biolidics’ antibody test kit by Indonesia MOH, what are Biolidics next steps?

Biolidics has previously appointed Clearbridge Health as a non-exclusive regional distributor of our antibody test kits in the Philippines, Indonesia, Myanmar and Vietnam. Leveraging on Clearbridge Health’s extensive healthcare business presence in Indonesia, we look forward to more marketing and distribution channels for our antibody test kit to be deployed and used.

Separately, there is also an opportunity for us to bring JOYSBIO Antigen Rapid Test Kit to Indonesia given our experience with the submission and approval process of our antibody test kit by Indonesia MOH.

8. Biolidics is developing a neutralising antibody kit (www.biolidics.com/neutralisation-antibody-test-kits), what is the difference of this kit against your current IgG/IgM antibody test kit?

There have been reported cases of COVID-19 re-infection, hence a person having antibodies against COVID-19 does not mean that re-infection may not happen.

The neutralising antibody kit, that is being developed by Biolidics, utilises A*STAR technology for the detection of COVID-19 viral spike/Angiotensin Converting Enzyme 2 (ACE2) blocking antibodies. The ACE2 blocking antibodies may interfere with the ability of the virus to infect the target cells and may provide an indication of protective immunity against COVID-19.

Most commercially available serology tests against COVID-19, including the Biolidics’ COVID-19 Antibody Test Kit launched on 30 March 2020, detects the IgG and IgM antibodies (a group of antibodies produced by the body in response to the infection of SARS-CoV-2 virus). As such, these serology tests which detect the presence of IgG and IgM are currently used only as an assistive tool in the detection of COVID-19, and they are not able to detect specific antibodies that bind to the SARS-CoV-2 virus which interfere with its ability to infect target cells.

However, it is important to note that there is currently little information on the level of antibodies sufficient to confer protective immunity to an individual and how long such protective immunity against COVID-19 may last in an individual.

9. How will both antibody test kits be used during the COVID-19 vaccination process and does it matter which type of vaccine is deployed?

Due to a potential safety concern know as vaccine-associated disease enhancement (VADE) as mentioned in the response to question 2, it is recommended that a person to undertake a pre-testing using an antibody test (IgG/IgM) to check if there are presence of COVID-19 antibodies before the vaccination process.

After COVID-19 vaccination is done, a person is recommended to undertake a NAB test to assess if there are blocking antibodies being developed that may provide indication of protective immunity against COVID-19, providing more indication on the effectiveness of the vaccine.

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