Utilizaing COVID-19 Antibody Test Kit

Consultation/Participation fee|JPY 7,500 (Excluding Consumption Tax)

Antibody Testing Research Project

The ICheck project allows you to participate in COVID-19 antibody testing research with consultation by hospitals and clinics

The purpose of ICheck project is to analyze the population percentage of antibodies for the COVID-19. Companies and organizations can receive free antibody test kits for the number of participants by paying the project participation fees. The results of the antibody test will be aggregated and used for research purposes without identifying the names of companies or individuals.

※1 Depending on the situation, we may not be able to respond to your request immediately. Consultation hours are 9:30am to 5:30pm (Monday to Friday) - by emails or phone calls.

Antibody testing and project consultation participation fee per person: JPY 7,500 (Excluding Consumption Tax)

The participants can consult with your hospitals and clinics via emails and phone calls for a month. We accept a project participation at a minimum of 10 participants per company/organization.

Are you prepared for COVID-19?

Do you feel uneasy about the resumption of the economy?

Anxiety #1.

If a cluster appears in the company…

If an employee is infected with COVID-19, the company will be closed for a period of time in order to conduct contact tracing to prevent the spread of infection… The loss in the event of closure would be immeasurable, due to the inability to executing the business.

Anxiety #2

 

If your employees will infect a customer…

When you are infected with COVID-19, you may be asymptomatic with no fever and no symptoms. If an employee is infected and asymptomatic, there is a risk of infecting a customer. Once it occurs, it may interfere with reopening the business.

What to do if it happens?

Sometimes it's difficult to get to a designated hostpitals.

Anxiety #3

 

Congestion at hospitals and clinics

Even if you are infected with COVID-19, you can't receive medical treatment at hospitals and clinics right away; you are required to consult with a public health center first. If a high fever persists and certain conditions are met, the health center will refer you to hospitals and clinics and proceed to PCR testing.

ICheck's extensive participation benefits

You can consult with hospitals and clinics

It is possible to consult with hospitals and clinics for advice on COVID-19 and how to respond to the results of antibody test kits and what to do if you have a positive test result.

We will provide an antibody test kit “for free”

For those who participate in the antibody test research project, we will provide an antibody test kit “for free” to investigate the antibodies of the new coronavirus.

You can check the antibodies at home in just 15 minutes

It is possible to consult with hospitals and clinics for advice on COVID-19 and how to respond to the results of an antibody test kit that what to do if you test positive.

Remote consultation process

The hospitals and clinics will provide you with a customized consultation (by phone or email), based on the results of the antibody check.

I recommend these people

Attention for usage of this service

The purpose of ICheck project is to analyze the population percentage of antibodies for the COVID-19. Companies and organizations can receive free antibody test kits for the number of participants by paying the project participation fees. The results of the antibody test will be aggregated and used for research purposes without identifying the names of companies or individuals.

ICheck uses a reliable and safe kits that detects IgG and IgM antibodies in the blood

ICheck's COVID-19 antibody test kit has been used for a number of clinical trials in Japan and abroad, and the results are shown as below.

Positive reaction detection rate<95.14%>

  Positive Test Sample Non-infectious Tests Total
Sample Size 188 182 370
Positive Results 170 0 170
Negative Results 18 182 200
Detection Sensitivity 90.43% - -
Specificity - 100% -
Overall Efficacy Ratio - - 95.14%

The kit, which was developed in Shanghai in China, has been used in five locations in China (China Medical University, The People's Liberation Army No. 302 Hospital, Wuhan Asia General Hospital, Shenzhen People's Hospital, Zhejiang University School of Medicine) Clinical trials were conducted by the U.S. Department of Health and Human Services (DHS), and a 95.14% efficacy rate was confirmed for 370 samples in total.

Data from a comparative study for antibody testing and PCR, published by Sagamihara Kyodo Hospital

Positive reaction kappa coefficient <0.96>

The closer the kappa coefficient is to 1, the more consistent the comparison between the antibody test kit and the PCR test is likely to be.

Sample size Sensitivity Specificity kappa coefficient
ICheck (※1) 81 95.2% 100% 0.96
Japanese Company A (※2) 10 40% 100% 0.40
Japanese Company B (※2) 10 0% 100% 0.00
Japanese Company C (※2) 10 60% 100% 0.60
Japanese Company D (※2) 10 80% 100% 0.80
Oxford University (※3) 90 85% 100% 0.86
9 companies in UK (※4) 93〜182 - - 0.64
Chinese Domestic Companies (※5) 434 88.5% 90.5% 0.75

(※1)ICheck, an antibody test kit promoted by Loki Consulting, was studied using the lateral flow immunoassay (LFIA) measurement methods. With 81 samples, 95.2% sensitivity, 100% specificity, and a kappa coefficient of 0.96 with PCR, of these, if we narrowed down the sample cases after 8 days of onset that were positive on the antibody test kit, 69 samples were tested, with a sensitivity of 95 .5%, specificity 97.8% and kappa coefficient with PCR 0.93.
(※2)This is based on data from the Infectious Diseases Society of Japan (April 17, 2020) and is calculated using the kappa coefficient. Click here for reference data.
(※3)The kappa coefficient examined by ELISA at the University of Oxford, UK. Number of samples 90, sensitivity 85%, specificity 100%, kappa coefficient with PCR 0.86. Out of 90 samples, sensitivity 85%, specificity 100%, kappa coefficient with PCR 0.86. However, when we narrowed down the sample to 84 cases after 10 days of onset, the sensitivity was 100% and the kappa coefficient was 1.00. Click here for reference data.
(※4)The kappa coefficients for the 9 UK companies and the 9 antibody test kits examined by the LFIA method are shown below. Sample size, 93, 129, 128, 98, 91, 91, 93, 92, 182 As a person, the average kappa value was 0.64 ± 0.03. Click here for reference data.
(※5)The kappa coefficients examined by LFIA assay in China from 434 samples with a sensitivity of 88.5% and specificity of 90.5% and with a kappa coefficient for the PCR was 0.75.Click here for reference data.

Comments from the Director of Sagamihara Kyodo and Izeki Hospitals

As a designated hospitals and clinics for infectious diseases, Sagamihara Kyodo Hospital has been accepting patients with the new type of corona pneumonia in Sagamihara City in cooperation of the Sagamihara City Public Health Center, since the first case in Japan in January 2020. In Sagamihara City, Kanagawa Prefecture, the first wave (Covid-19) from China arrived in late February, and the second wave via Europe arrived in early April, but since then there has been a lull.

The city has a population of approximately 720,000, but no large-scale epidemiological study has been conducted at this time. However, based on the results of the PCRs in our emergency departments and the aggressive cluster squashing by the health department, the prevalence rate is expected to be around 1.6%, which is lower than in Tokyo. Depending on the prevalence of the disease, the future response by hospitals and clinics and the government will be different, but antibody testing kits, which are essential for large-scale control of infection rates, are unreliable, as recently announced by the Infectious Diseases Society of Japan.

The Oxford University Group's presentation also raised questions about the accuracy of the antibody testing kit (LFIA method). In this study, in the absence of a straightforward method for evaluating antibody testing kits, we used the kappa coefficient to evaluate the accuracy of PCR results.

Verifying the Oxford University publication, the kappa coefficient was 0.86 for the ELISA method.
It should be noted that the kappa coefficient was 1 after 10 days of onset, when the blood antibody level seems to be stabilized, in perfect accordance with the PCR. In contrast, all nine company's LFIA method kits in the UK had a kappa coefficient of around 0.6. The limitation of this report is that the date of onset for the disease is unknown. It is unclear how many cases were included in the early stages of the disease, and it is possible that the results could be more favorable if we focused on cases after 10 days. Data from China also had a kappa coefficient of 0.75, although the date of onset is unknown.

The ICheck kit provided by Loki Consulting, Inc. has a kappa coefficient of 0.9 especially for cases after 8 days of onset, which is 0.96. Further study is needed because only about 81 cases have been evaluated and there seems to be a lull new coronavirus transmissions, but at least it can useful for epidemiological testing.

Adopted as a criterion to resume work by the Malaysia Ministry of Health.

As for the antibody test, also known as serology tests, MOH recommended the usage of serology rapid test kits (RTK) that are validated by Institute of Medical Research (IMR) or the National Public Health Laboratory (NPHL). The rapid antibody tests recommended are Lionrun Shanghai Liangrun Diagnostics Kit, Wondfo, Vazyme, Standard Q Covid-19 igM/IgG Combo, and Healgen.
Article

Various accreditations (registration)

"NMPA Registration
(Chinese white list)"

CE-Certificate
(EU regional medical device distribution certificate)

FDA registration
(U.S. Food and Drug Administration)

Antibody testing is easy to do

STEP 1 Take a blood sample.

A small amount of blood is drawn from the fingertip and determined with a special test plate.

Step 2 Wait 15 minutes for the results.

It takes about 15 minutes to find out if you have been infected with COVID-19. The test looks for two types of antibodies.

Step 3 Confirm the results.

If there is no line at "C"
The test is invalid because it indicates that the antibody test kit is faulty. We will return the product for replacement. If you get a "C", you are not infected.

If the line appears at the letter "M", IgM antibodies are positive.
You may be infected with COVID-19 and may be in the early stages of infection.

If the line appears at the letter "G", IgG antibodies are positive.
It is believed that you may have been infected with a new type of coronavirus in the past and may have produced IgG antibodies after infection.

If a positive reaction occurs, consult hospitals and clinics

If you test positive for either "G" or "M", you are probably already carrying antibodies to COVID-19, but this does not mean that you will 100% immune to re-infection.

If you are "negative" for both, you are less likely to have been infected with COVID-19 because there are no antibodies in your body and you are at risk for future infection. If you are unsure, please contact your hospitals and clinics by email or phone.

The ICheck consultation service period is provided for one month after delivery of the antibody test kit. Please return the needle to your hospitals and clinics as it is medical waste. Alternatively, they can be disposed of as medical waste.

We participated in an antibody testing project

I'm in a customer-facing job

40's / Real Estate

With real estate rentals, it is often impossible to sign a contract unless you come to the store, so I often talk with customers face-to-face. I was afraid that "if" I was infected, I would be inconvenienced by my customers. I thought it was good etiquette to say that I was being thorough in checking.

The company is offering it as a benefit plan

30's / Call Center

To be honest, I was worried because the call center has a large group of people working in an enclosed space. I was very happy when the company gave out the antibody test kit. I no longer have to worry about it.

I'm relieved, I travel a lot

40's / Business Owner

Because of my job, I travel a lot and meet a lot of different people. I'm careful about washing my hands, wearing a mask, and disinfect, but I was worried because I often ride the train. My wife also told me that, "if I got the coronavirus, it was your fault". I was conflicted by the fact that I wouldn't be able to provide for my family if I didn't go to work, but I was also conflicted by the fact that I couldn't bother my family.

How to participate in the ICheck antibody testing project

1. Membership Registration

Register your company name, contact information and other information.

2. Application

Sign up for as many people as you need. A confirmation email will be sent to your registered email address we receive your application.

3. Payment of Fees

Please pay by credit card or bank transfer.(In case of bank transfer, the bank account to be transferred is indicated in the application confirmation email)

4. Delivery of Antibody Test Kits

After confirming the payment, the antibody test kit will be delivered to the specified address.

5. Antibody Testing

Company representatives should provide each participant with a copy of the ICheck Medical Record sent to them by their hospitals and clinics. Each participant should review the consent form in the "ICheck chart" and participants should follow the procedures to complete the test.

6. Test Result Report

Participants are required to register and report their test results using the "ICheck Medical Record" sent to them by their hospitals and clinics.

7. Health Consultation

If necessary, consult with your hospitals and clinics.

Antibody test project consultation and participation fee: 7,500 yen per person (excluding tax)

You are free to consult with your healthcare provider by email and phone for a month. You can apply with a minimum of 10 participants.

The purpose of ICheck project is to analyze the population percentage of antibodies for the COVID-19. Companies and organizations can receive free antibody test kits for the number of participants by paying the project participation fees.

Frequently Asked Questions

Q. To what extent can we discuss the contents of the health consultation?

Basically, via an email and phone call consultation.

Q. To what extent can we discuss the contents of the health consultation?

Please feel free to contact us for any health concerns about new coronavirus infections, whether or not you have had intimate contact with an infected person, subjective symptoms, and any other health concerns related to the disease.

Q. Is it possible to have a health consultation only when I have a positive test result?

Regardless of the results of the test, if you have any concerns or worries about COVID-19 infection, you can consult your hospitals and clinics at any time within a month.

Q. Is the health consultation available only to those who have participated in the project?

Yes, we will provide you with a free antibody test kit. The antibody test kit will be provided free of charge. The results will also be used as an important reference when conducting health consultations.

Q. What kind of organization is a specialized hospitals and clinics?

This is expected to include designated hospitals and clinics for infectious diseases, local health centers, and counseling centers for people who have returned to Japan and their contacts.

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