Research use only products (RUO)

 

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This product is used for investigation and research of novel coronavirus antibodies
* This product is not an IVD (in-vitro diagnostic) product. This product is NOT used for preventive, diagnostic and therapeutic purposes.

 

Intended use

* Please be sure to read the instruction manual and video before use.

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Instruction manual

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Flyer

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​※ ​Move to the official distributor page

​※ ​Move to the official distributor page

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Features

・ Made in Japan
・ Minimally invasive, only 10 μL of sample needed
・ Whole blood is applicable
・ All necessary reagents are included in the kit
・ Measurement time is only 15 minutes

Specifications

Measurement method: Immunochromatographic assay
Measurement samples: Whole blood, serum, plasma
Sample amount: 10 ul
Measurement time: 15 minutes
Storage temperature: 2℃-25℃
Validity Period: 12 months after manufacture

Kit contents

・ Test stick
・ Reagent
・Standard color chart
※ Disinfectant wipe, lancet and adhesive bandage are not included.

Test protocol

 Please be sure to read the instruction manual and video before use.

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Q&A

Information provided here is only a general example and its validity cannot be guaranteed. We are not responsible for any lost caused by this information. 
For how to use the lancet, please use it properly according to the package insert . For inquiries about the lancet, please contact the medical device manufacturer on the package insert of the lancet product.)

Q. It's hard for blood to come out. 

A. Please promote blood circulation sufficiently before puncture. If you open and close your hand below the heart, or rub your finger which is punctured, blood will come out easily. Also, warm your hands with a heating pad may make blood to come out easily. There are individual differences so please understand that it is not always possible to do puncture or blood collection. (As for puncture procedures, please contact the medical device manufacturer on the package insert of the lancet product.)

Q. Too much blood coming out and it doesn't stop.

A. Wipe the blood with a clean cloth such as clean cotton, and make blood balls again slowly. Make sure to collect the blood ball with a sampler after it becomes the size of a rice grain. If the blood ball is too small, the sampler may not be able to collect it properly.

Q. There's too much blood coming out to make a rice grain-sized blood ball

A. If you are concerned about bleeding due to puncture, please consult your doctor and the manufacturer and of lancet products.

Q. I can't suck well with the sampler

A. Watch the video (https://www.cellspect.com/igg-lf-np-2). Blood amount depends on the lancet (puncture device) used. When using a small lancet, make sure that the blood ball becomes the size of a rice grain before collecting them with a sampler. If the blood ball is too small, the sampler may not be able to collect it properly.

Q. After adding the reagent, I can't see how it flows into the test window.

A. The amount of reagent may be insufficient. Immediately add 1-2 drops of reagent. The test window sheet starts to get wet within one minute, and the test line of control becomes visible. When adding the reagent, make sure that the droplets are correctly dropped onto the sample well. In rare cases, large bubbles may be included in the droplets and the drop amount may be less than the actual amount of one drop. If you add 1-2 drops immediately, the sheet of the test window will get wet within 2 minutes, so please visually check the control line. If the test window sheet is not wet, the control line will not appear even after a few minutes, so perform the above operation immediately.

Q. When operating with a pipette or a capillary sampler made by another company

A. The amount of blood collected is 10 μl. To prevent hemolysis, take a sample carefully and add it gently to the sample well. The handling methods of samplers and pipettes produced by other companies may cause hemolysis, so please handle them carefully. When a hemolyzed sample is added, false positive results may be detected in rare cases, so please be careful when interpreting the results.

 

If the above still can't solve your problem, please send a photo of the entire stick to

our support division (st_support@cellspect.com

Q. Please tell me how to use kits with capillaries.

Thank you for purchasing our products. We apologize for the inconvenience, but as of January 28, 2021, the kits with capillaries are no longer supported as the validity period is expired. This product is the successor. Thank you for your continuous support.

Other precautions

Notes on resale items that are not supported by our compan

We have confirmed the counterfeit of our products and the resale cases. These counterfeits and our unofficial prizes not only differ in specifications and performance from genuine products, but also are not guaranteed in terms of quality and safety. There is a risk of injury and accidents and we are very concerned about the damage to our customers. In addition, there is a possibility of misidentification due to excessive advertising. Please be very careful not to purchase counterfeit products.

Please understand that we are not responsible for any loss or accident caused by customers using counterfeit products or unofficial giveaways from a resale site.
 

This product is not an IVD (in-vitro diagnostic) product . This product is NOT used for preventive, diagnostic and therapeutic purposes.
This product is intended for use in investigation and research.
We apologize for the inconvenience, but we do not accept orders from individual customers who are not from local governments, companies, corporations, organizations, medical institutions, administrative institutions, or research institutions. Thank you for your understanding to avoid using the product for other purposes.

<Precautions on purchasing RUO (Research Use Only) products>

・This product is a research product. Please read/watch the instruction manual/video in advance, and be aware that correct operation may not be met according to the user's operation.
・ Wrong operation or sampling error due to individual characteristics of the blood (easy to coagulate or bleed etc.) may result in failure. (For inquiries about the lancet, please contact the medical device manufacturer on the package insert of the lancet product.)
・When handling samplers and lancets (medical devices), there is no guarantee that blood will be collected smoothly in all cases due to individual differences.
・This kit is based on the test conditions and academic information in the instruction manual, and the same performance is not guaranteed in all cases.

<To those who are considering purchasing or dealing with this product>

This product is not a medical device but a research product (miscellaneous product), so the Pharmaceuticals and Medical Devices Act is not applicable. Therefore, it cannot be used for preventive, diagnostic and therapeutic purposes.
Since the release of this product, the scope and purpose of research have been continuously expanded due to the high public interest, and there are many requests from organizations other than specialized institutions. Therefore, we request distributors to thoroughly explain the above-mentioned sales purposes to prevent misunderstandings and unintended use of consumers.  In addition, we are advancing discussions and cooperation with related organizations regarding the more ideal way of displaying and distribution of giveaways.
We apologize for the inconvenience, but this product is for research purposes, and we do not accept orders from individual customers who are not from local governments, companies, corporations, organizations, medical institutions, administrative institutions, or research institutions. Thank you for your understanding to avoid using the product for other purposes.

 

We will continue to do our utmost to ensure that our products are properly used as research products. Thank you for your understanding.

Product inquiry

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.