COVID-19 IgG LF

使用方法について

​※ Please see here for how to use the product

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​※ ​Move to the official distributor page

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​※ Move to the official distributor page

​※ Please see here for how to use the product

Inquiries about products
E-mail:st_support@cellspect.com 

TEL:019-681-2088 
Telephone reception hours: Weekdays 9:00 to 17:00 (excluding Saturdays, Sundays, and holidays)

※ In case of accidental occurrence of research activities, such as detection of antibodies suspected of infection cases, please consult with your local government as we are unable to provide support.

Inquiries about products
E-mail:st_support@cellspect.com 

TEL:019-681-2088 
Telephone reception hours: Weekdays 9:00 to 17:00 (excluding Saturdays, Sundays, and holidays)

※ In case of accidental occurrence of research activities, such as detection of antibodies suspected of infection cases, please consult with your local government as we are unable to provide support.

This product is not an in-vitro diagnostic drug. It cannot be used for diagnostic or therapeutic purposes. This product is intended for research use only.

<Precautions when purchasing research products>

・This product is for research use. Please check the instruction manual and the operation video in advance, and be     aware of the following risks that the exact operation may not be achieved due to the variation of user's skill.

・The warranty does not cover operational errors or blood sampling failure due to individual characteristics (easy to       clot, easy to bleed a lot, etc.).

   (For inquiries regarding lancets, please contact the medical device manufacturer listed on the package insert that       came with the lancet product.)

・The handling of collection capillaries and lancets (medical device) does not necessarily guarantee smooth blood       collection in all cases due to individual differences.

・The detection kit is based on the test conditions in the user's manual and academic information, and does not           guarantee the same performance in all cases.

 

<To companies handling this product and those considering purchasing this product>
This product is not a medical device but a research product (miscellaneous goods), so it does not fall under the Act on Pharmaceutical and Medical Devices. Therefore, it is clearly stated that it cannot be used for diagnostic or therapeutic purposes.
With the release of this product, it is expected that the scope of the research will expand and become more diverse due to the high level of social concern. Therefore, we ask the distributors to thoroughly explain the above, and from the viewpoint of consumer protection, misidentification of medical devices and research products, and disadvantages to consumers due to unintended use will not occur. We are proceeding with discussions and collaboration with related organizations regarding more desirable display and distribution styles.

 

We will continue to do our utmost to ensure that our products will continue to be used as research products properly. We kindly ask for your understanding and cooperation.

Features

・Made in Japan

・Minimally invasive sample volume as of only 10 μL

・Apply the blood directly

・All necessary reagents are included in the kit.

・Measurement time is only 15 minutes.

Main specifications of the products

Method of measurement: Immunochromatography
Samples of measurement: Whole blood, serum, plasma
Sample volume: 10 μL
Measurement time: 15 minutes
Storage temperature: 2 -8 ℃
Expiration date: This product is valid for 6 months after production.

Kit contents

・Test stick × 1 stick
・Reagent ×1 bottle
・Capillary (for dropping of 10 μL sample)  ×2 pieces
※ Disinfectant cotton, puncture tools, and bandages are not included.

×1枚

×1本

×2本

Operation

Be sure to read the instruction manual before use.

Measurement principle

1. When an IgG antibody of SARS-CoV -2 is present in the sample, an antigen-antibody reaction occurs with        a  recombinant SARS-CoV-2 nucleocapsid protein sensitized with gold colloid on a conjugate pad.
2. The antigen-antibody complex moves toward the membrane.
3. The flowing complex binds to the anti-human IgG antibody on the membrane.
4. As a result, a red line can be seen in the judgment window.
5. This line is not detected when the SARS-CoV-2 IgG antibody is not present in the sample.

Significance of measurement

This kit is a research immunochromatographic kit for detecting human IgG antibodies recognizing the nucleocapsid protein of SARS-CoV-2, which is the causative virus of COVID -19. Virus detection can be broadly divided into two approaches: one is to detect the virus itself, such as PCR method, and the other is to detect the immune response that develops during infection (IgG, IgM, IgA, etc.) In COVID -19, the production of IgM antibodies have not always been confirmed in all infected persons, whereas IgG antibodies have been reported to be produced in many cases regardless of the severity of symptoms. The production of IgG antibodies has been observed in approximately 60 ~ 80% of the infected group around 10 days after the onset, and is confirmed in most of the infected group 14 days after the onset. The persistence of IgG antibodies has been maintained for at least 30 days after onset in many cases, but there are insufficient reports on the details, and further clarification is required.

Related literature

  • Isabel Montesinos et al.

       Evaluation of two automated and three rapid lateral flow immunoassays for the detection of anti-SARS-CoV-2               antibodies

      J Clin Virol. 2020 Jul. PubMed PMID: 32403010

  • Yunbao Pan et al.

       Serological immunochromatographic approach in diagnosis with SARS-CoV-2 infected COVID-19 patients

      J Infect. 2020 Jul. PubMed PMID: 32283141

      Int J Mol Sci. 2020 Jun. PubMed PMID: 32580529

       Cochrane Database Syst Rev. 2020 Jun 25. PubMed PMID: 32584464

       Am J Clin Pathol. 2020 Jun 25. PubMed PMID: 32583852

      J Infect. 2020 Jun 15. PubMed PMID: 32553841

       Public Health. 2020 May. PubMed PMID: 32334183

References

1.)Keiichi Hiramatsu, Standard Textbook of standard microbiology, 11th edition, Medical study (2012)

2.)Anu Haveri , “Serological and molecular findings during SARS-CoV-2 infection: the first case study in Finland,” January to February 2020 , Eurosurveillance.  Volume 25, Issue 11, 19, Mar 2020.

3.)Wanbing Liu, “Evaluation of Nucleocapsid and Spike Protein-based ELISAs for detecting antibodies against SARS-CoV-2”, J Clin Microbiol. 2020 Mar 30.

4.)Li Guo, “Profiling Early Humoral Response to Diagnose Novel Coronavirus Disease (COVID-19)”, Clin Infect Dis. 2020 Mar 21.

5.)Juanjuan Zhao, “Antibody responses to SARS-CoV-2 in patients of novel coronavirus disease 2019”, Clin Infect Dis. 2020 Mar 21.

6.)Grzelak et al, "SARS-CoV-2 Serological Analysis of COVID-19 Hospitalized Patients, Pauci-Symptomatic Individuals and Blood Donors". (Infectious Diseases (except HIV/AIDS), 24 April 2020) 
7.)Liu et al, "Evaluation of Nucleocapsid and Spike Protein-Based ELISAs for Detecting Antibodies against SARS-CoV-2", Journal of Clinical Microbiology, 2020, JCM.00461-20, jcm;JCM.00461-20v1 

8.)Sun et al, "Kinetics of SARS-CoV-2 Specific IgM and IgG Responses in COVID-19 Patients", Emerging Microbes & Infections, 9.1 (2020), 940–48

Q&A

This information is only a general example and does not guarantee its effectiveness. We are not responsible for loss resulting from this information. Please use the lancet properly according to the package insert. For more information about lancets and how to use lancets, please contact the manufacturer listed on the lancet product documentation.

Q. I have difficulty in getting blood.
A. Please make sure to promote blood circulation before puncture. If you open and close your hands below the          heart or rub the finger to puncture, blood will easily come out. If you have a cold condition, warming your hands     with a body warmer may make it easier for blood to come out. However, there are individual differences in               technique and condition, so please understand that puncture and blood collection may not always be possible        (For puncture operations, contact the manufacturers listed on the lancet package insert.)


Q. I have so much blood that I can't make it the size of a grain of rice.
A. Wipe the blood with a clean item such as clean cotton and slowly make a blood ball again. If the tip of the              capillary is exposed to a large amount of blood (the state of not being the size of a grain of rice), it may be              difficult to aspirate blood into the capillary.)

Q. I have a lot of blood and it doesn't stop.
A. If you are concerned about puncture bleeding, consult the manufacturer of the Lancet product and your doctor.

Q. The capillary doesn’t work very well.
A. Watch the video (https://www.cellspect.com/igg-lf-nucleocapsidprotein). If you make blood the size of a grain of      rice and bring the tip of the capillary slowly from the bottom diagonally into contact with the blood, the suction        will start naturally.
    (If the end of the capillary is lower than the tip, it is easier to suck. It is important to place the capillary handle          below the fingertip.) Add blood quickly to the stick to prevent it from clotting.

Q. I added a reagent, but I can't see it flow into the judgment window.
A. There is a possibility that the amount of reagent is insufficient. Add 1 -2 drops of the reagent immediately.              Within one minute, the sheet of the judgment window starts to get wet, and you can see the line at the end of          detection. When adding the reagent, make sure that the droplet has been dropped onto the sample addition          part.

    In rare cases, large bubbles may be contained in the droplets. In this case, the drop volume may be less than        the actual drop. If 1 -2 drops is added immediately, the sheet of the judgment window will get wet within 2                minutes. Check the line at the end of detection. If the sheet of the judgment window is not wet, the line at the          end of detection will not appear even after several minutes.
 

Q. When using pipettes or another company's capillary
A. The amount of blood is 10 μl. Carefully collect the sample so as not to cause hemolysis, and add it slowly to          the  sample addition part. Please note that some items may cause hemolysis depending on the handling                method of other companies' droppers and pipettes. When adding a hemolyzed sample, false positives may be        detected in rare cases, so please be careful when interpreting the results

If above suggestions still don't work, please send an photo of the entire stick to our company support center (st_support@cellspect.com).

Cellspect Co., Ltd.

〒020-0857

2-4-23 Kitaioka, Morioka, Iwate Prefecture

TEL : +81 19-681-6710 / FAX  : +81 19-903-0418

MAIL : info@cellspect.com

URL : https://cellspect.com

COVID-19 Related Products

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MAIL : support@cellspect.com

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