CE IVD Fingertip 20uL Whole Blood Novel Coronavirus Test Cassette

Novel Coronavirus (2019-nCoV) Antibody IgG/IgM Rapid Test Cassette

Home Use SARS-CoV-2 Antibody IgG/IgM Colloidal Gold Screening Test For IVD

Main Features

1. Fast to get the result in 15～20 mins.

2. High sensitivity and specificity.

3. Simple to use.

4. Certified by Authoritative Certification

5. High Accurate and Reliable

6. Ambient storage.

7. Unique 3-line Patented Design

8. Meet Multiple Criteria as follows:

EN ISO 13485:2016 EN 13612:2002
EN ISO 14971:2012 EN ISO 23640:2015
EN ISO 18113-1:2011 EN ISO 18113-2:2011
EN ISO 15223-1:2016 EN 13641:2002

Assay Procedure

Sample preparation: Fresh serum, plasma or whole blood samples, no pretreatment is required. lf the samples are stored in2~8℃, the samples should be restored at room temperature for15~30 minutes before use, returned to room temperature, and thoroughly mixed before testing.

Reagent preparation: Open the package, the pouch should be sealed well. lf the test reagent stores in the refrigerator, it should be restored to room temperature. Then open the package pouch and take out the test reagent, place it on the platform.

Detection and interpretation: Add10µL serum/plasma or 20µL whole blood sample into S well, after the sample has permeated completely, add 2 drops diluent buffer. Read the result in15-20 minutes, interpret the test result after 20 minutes may cause false result.

Interpretation of Results


Positive of lgG and IgM: One color line in the control zone(C), one color line in the test zone(G) and one color line in the test zone(M) .Indicates IgG and IgM test result is positive.

Positive of IgG: One color line in the control zone(C) and one color line in the test zone(G), indicates lgG test result is positive.

Positive of lgM: One color line in the control zone(C) and one color line in the test zone(M), indicates IgM test result is positive.

Negative of lgG and IgM: Only one color line in the control zone(C) indicates IgG and IgM test result is negative.

Invalid: If no color line appears in the control zone(C), the test is invalid.Discard the test cassette and perform with new cassette.

Built-In Control

COVID-19IgG/lgM Rapid Test Cassette has a built-in procedural control that demonstrates assay validity. A color line appeared on the control zone(C) indicates that the test runs correctly.

Materials Required But Not Provided

Timer or stopwatch
Blood collection devices, for the testing of venipuncture whole blood, serum or plasma
Biohazard disposal container
Disposable gloves
Pipette and pipette tip

For fingerstick samples, the following materials are required:

Alcohol pad

Sterile lancet
Sterile gauze or cotton

Reagents and Materials Provided

1. Test cassette(individually pouched)
2. Each pouch contains one cassette with one desiccant bag
3. Diluent buffer
4. Instruction for use
5. Plastic dropper(optional)

Storage

COVID-19 IgG/IgM Rapid Test Cassette should be stored in dark place at 2-30°C for 12 months from the date of manufacture. Keep the test cassette in sealed pouch until use. Once you have taken the test cassette out of the pouch, use it immediately. Do not use the test beyond the indicated expiration date.

Warning

For in vitro diagnostic use ONLY

Read the package insert completely before use.It is very important that the correct procedure is followed. Fail to add the patient sample may lead to a false negative result (i.e.a missed positive).

Newscen Biopharm Co., Limited is a professional manufacturer of in vitro diagnostic products and related supporting apparatuses, which is jointly founded by Tianjin Pharmaceutical Group, Tianjin Zhongxin Pharmaceuticals Co., Ltd and oversea Chinese entrepreneurs.

Founded in 2003, the company is one national high tech corporation and Tianjin Grade A medical device manufacturer. Over the years, the company has been committed to the research, development, production and sales of in vitro diagnostic products and related supporting apparatuses, and also has provided OEM and ODM and technology transfer and cooperation as well as some other customer market based diversified services to customers at home and abroad.

NewScen is based on independent innovation and relies on the talent sharing at home and abroad, information interaction advantage, antibody preparation and new product R & D technology platform to develop and produce nine series about one hundred kinds of products including tests and instruments and put on the market in succession.

HIV (1 + 2) antibody rapid test Kit and other IVD (In Vitro Diagnostic) devices obtained National Patent and National Class of New Drug Certificate; HCV Antibody Rapid Test is the first double antigen sandwich test HCV patented product; NewScen’s quantitative test broke through the technical difficulty of the colloid gold quantitative detection, opening up a new situation for clinical application of Colloidal Gold test. Rapid immuno assay reader provides an open and common platform for qualitative and quantitative detection of the Colloidal Gold test.

The company has received CFDA medical device certificates of 32 products, 49 independent Intellectual Property Rights, FDA certificates of series of products and European CE certificates of 16 products. Production management is in strict accordance with the regulations of in vitro diagnostic product production as well as international quality management system (ISO 9001, ISO 13485) so as to ensure high product quality. Products are sold throughout the country and in North America, South America, Southeast Asia, Europe, the Middle East, Africa and other international markets.

Currently, the company integrated Colloidal Gold test, immunochromatographic interpretoscope and cloud technology and other technical advantages, and created management integrated POCT system, so as to achieve convenient, accurate and efficient onsite data collection and remote guidance or data sharing of the monitoring center and promote the development of modern testing technique and the improvement of diagnosis and treatment level.

NewScen has obtained the project support from Tianjin or the country for nine times in succession, has been identified as one Hightech Enterprise in Tianjin, has obtained the title of “Top 100 Enterprise in Tianjin” among Tianjin SMEs, and is the rapid diagnostic Hightech demonstration project base and National 863 Project undertaker awarded by the NDRC (National Development and Reform Commission).

Fecal Occult Blood, Serum Ferritin and Hepatitis C rapid test products were named Tianjin independent innovation products; brand “YBT”products have been awarded the title of “Chinese Women and Children Favorite Brand Product” by Chinese Women and Children Development Center; “YBT” trademark was named “Tianjin Famous Trademark”.

“Honesty, Verity, Authenticity, and Innovation", is our persistent commitment.

“Encouraging Our Employees Growing With Company” is the driving force beneath our surging growth.