In-vitro diagnostics (IVD)

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Top > In-vitro diagnostics (IVD) > COVID-19 Antigen Test Kit

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We have started to provide the novel coronavirus (COVID-19) antigen test kit (for medical use) to companies and organizations.

Customers who want to purchase from a company, organization, local government, etc., please note the following in advance in accordance with the Ministry of Health, Labour and Welfare guidelines.


① Customers with a designated collaborative medical institution
 You can purchase directly from us under the guidance of collaborative medical institutions.


② Customers who have not decided on a cooperative medical institution
 You can purchase directly from us by consenting to the guidelines of the Ministry of Health, Labour and Welfare and cooperation with the following medical institution.


  Medical institution name: Medical corporation Soujinkai Sakura Clinic
  3F, Toki Bldg, 3 Chome-5-7 Funabori, Edogawa City, Tokyo
  Consultation/reception for antigen test: 019-681-2099

Inquiries about this product (purchase, quotation)

 E-mail:st_support@cellspect.com
 TEL:019-681-2099

< References of Ministry of Health, Labour and Welfare guidelines >

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(pdfファイル)

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(pdfファイル)

Intended use

Detection of SARS-CoV-2 antigen in nasopharyngeal or nasal swabs (to aid in the diagnosis of SARS-CoV-2 infection)

Measuring principle

This assay is based on immunochromatographic technology using monoclonal antibodies against SARS-CoV-2 antigen. The test stick consists of a sample well, a conjugate pad containing colored nanoparticle-labeled anti-SARS-CoV-2 monoclonal antibody (rabbit) (hereinafter, the colored nanoparticle-antibody), a membrane immobilized with anti-SARS-CoV-2 monoclonal antibody (mouse) (hereinafter, a capture antibody) and an anti-rabbit immunoglobulin polyclonal antibody (goat).

Overall View of the Test Stick

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​Sample dropped on the sample well of the test stick will flow into the conjugate pad due to the capillary phenomenon. The colored nanoparticles-labeled antibody in the conjugate pad will dissolve in the specimen and form the antigen-antibody complex with the SARS-CoV-2 antigen in the sample. The formed antigen-antibody complex continuously move to the membrane and is captured with the capture antibody immobilized on the membrane. The colored nanoparticles of the captured antigen-antibody complex will appear as a red line on the [T1] in the test window. In this kit, appearance of this red line can be visually confirmed to determine the presence of SARS-CoV-2 antigen in the specimen. In addition, the non-complexed antibody conjugated with red nanoparticles will move to the [C] in the test window and be captured with polyclonal antibody against rabbit immunoglobulin immobilized on the membrane. The colored nanoparticles of the captured non-complexed antibody will appear as a red line on the [C] in the test window, indicating that the test is performing successfully.

Measuring Principle

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Flow direction

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Performance

1. Performance

When tests of sensitivity, accuracy, and reproducibility are performed with a positive control (0.5 ng/test) and a negative control (buffer) in accordance with the procedure in the "Test Procedure", this kit meets the following standards.

A) Sensitivity

"Positive" is confirmed when the positive control is tested as a sample. 

B) Accuracy

When the positive control and negative control are tested as samples, "Positive" is confirmed for the positive control and "Negative" is confirmed for the negative control. 

C) Reproducibility

When the positive control and negative control are measured three times for each sample, all positive controls are confirmed to be "Positive" and all negative controls are confirmed to be "Negative". 

2. Limit of detection

The limit of detection of this kit is 0.1 ng/test.

3. Cross-reactivity

 (1) Viruses other than SARS-CoV-2

        Influenza Type A virus protein, Flu A protein (NP Antigen)

        Influenza Type B protein (TOKIO) 

 

 (2) Other coronaviruses

       Coronavirus (HCoV-229E) Nucleoprotein

       Coronavirus (HCoV-OC43) Nucleoprotein

       Coronavirus (HCoV-HKU1) Nucleoprotein

 

No cross-reactivity was detected in all viruses listed in above (1) and (2).

4. Information on reference standard for calibration

Cellspect Co. Ltd in-house reference standards.

5. Clinical performance data (ref 3)

  1) Correlations by using Japan domestic clinically stored samples (nasopharyngeal swabs in transport medium)

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Negative agreement rate: 100%. Positive agreement rate: 75%

Note: The nasopharyngeal swab and the sample diluent were mixed at a ratio of 1: 1 and dropped onto a test stick.

2) Positive agreement rate of this product and RT-PCR method for the viral load in positive samples

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Note: The estimated amount of RNA (copies/5 µL) was adjusted with Ct (cycle threshold value) calculated under the hypothesis that extraction ratio of RNA and other standard molecules in the sample were the same.

 

Note: The copy numbers of virus (copy/test) shows the viral load in one RT-PCR test.

3) Comparison of the sensitivities among this kit and other kits in spike and recovery test

The copy numbers of the virus in test samples were adjusted by spiking the negative nasopharyngeal swab samples to the positive samples. 

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Note: Meanings of the marks in the table:

 +: Positive , - : Negative , N.D. : No data

 

Note: The copy numbers of virus (copy/test) shows the viral load in one RT-PCR test.

4) Results of spike and recovery test 

The copy numbers of the virus in test samples were adjusted by spiking the negative nasopharyngeal swab samples to the positive samples. 

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Note: The copy numbers of virus (copy/test) shows the viral load in one RT-PCR test.

5) Results of spike and recovery test 

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Note: The copy numbers of virus (copy/test) shows the viral load in one RT-PCR test.

Storage method and expiration date

1. Storage Method: 2 ~ 8 °C

2. Validity Period: 12 months from the date of manufacture

Packaging unit

IQVALF101   Quampas COVID-19 Antigen Test Kit 10 tests

IQVALF011   Quampas COVID-19 Antigen Test Kit 1 test

References

1) WHO Website : : “Naming the coronavirus disease (COVID‐19) and the virus that causes it

(https://www.who.int/emergencies/diseases/novelcoronavirus- 2019/technical-guidance/naming-thecoronavirus- disease-(covid-2019)-and-the-virus-thatcausesit#:~: text=Official%20names%20have%20been%20announ ced,%2DCoV%2D2)

2) Report of the WHO-China Joint Mission on Coronavirus Disease 2019 (COVID-19). WHO Kobe Center published in Japanese

3) The Coronavirus Disease 2019 (COVID-19) Pathogen Detection Manual, ver2.9.1. National Institute of Infectious Diseases, Japan

4) Guidelines for the operation of assay for the novel coronavirus (SARS-CoV-2), 3rd edition, National Institute of Infectious Diseases, Japan

5) Guidelines for testing for novel coronavirus (COVID-19) pathogens, 1st edition, issued on October 2, 2020, MHLW, Japan

Intended use

An example of use with nasal swab

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Package insert

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Flyer

Product purchase / inquiry

To purchase this product, please contact the following e-mail address.

 

Email: st_support@cellspect.com

TEL: 019-681-2099

Business hours: Weekdays 9: 00 -17: 00 (excluding Saturdays, Sundays, and holidays)

 

*We cannot offer any support other than the utilization and research of this product.  We cannot provide support for the accidental consequences of research activities (such as detection of antibodies suspected of being infected), please consult your local government or agencies.