HCV(Hepatitis C Virus) Antibody Rapid Test Kit

For the qualitative detection of HCV antibodies in serum/plasma and whole blood

Intended Use
Rapid Diagnostic Test for Hepatitis C Virus Antibody (Colloidal Gold) is a Chromatographic immunoassay (CIA) for direct qualitative detection of antibodies to Hepatitis C type virus (HCV) in human serum/ plasma and whole blood.

Principle

Rapid Diagnostic Test for Hepatitis C Virus Antibody (Colloidal Gold) is a chromatographic immunoassay (CIA) for the detection of antibodies to HCV in human serum/plasma and whole blood. HCV recombinant antigens are precoated onto membrane as a capture reagent on the test region.

During the test, specimen is allowed to react with the colloidal gold particles, which have been labeled with HCV recombinant antigens. If antibodies to HCV are present, a pink colored band will develop on the membrane in proportion to the amount of HCV antibodies present in the specimen. Absence of this pink colored band in the test region suggests a negative result. To serve as a procedural control, a pink colored band in the control region will always appear regardless the presence of antibodies to HCV.

Sensitivity

A total of 417 HCV Antibody positive specimens were tested by Newscen HCV Antibody Rapid Test

Storage
Store the test kits at temperature 4-30°C,in the sealed pouch for the duration of the shelf life (24 months).

Assay Procedure

1.Place the test cassette on flat surface. Before unseal the pouch, allow the test cassette to reach laboratory temperature(15-30°C) .Use it immediately once unsealed.

2.Open the pouch and add1dropor35pL of specimen into the sample well(S) .

3.After adding the specimen, add1dropor35pL of diluent buffer vertically into the sample well(s) immediately.

4.Avoid dropping specimen or diluent buffer in the observation window.

5.Do not allow the diluent buffer bottle touch the sample well when dropping the diluent buffer so as to prevent the cross contamination with the specimen.

6.Observe the result in 30 minutes once the diluent buffer added.

Interpretation of Results

Add 1 drop (1 drop = 35µl) of sample (whole blood) into the sample well. After all samples completely absorbed, add 1 drop of diluent. Observe the result in 5-15 minutes.

Negative:

No apparent band in the test region (T), a pink-colored band appears in the control region (C). This indicates that no HCV antibody has been detected.

Positive:

In addition to a pink-colored band in the control region (C), a pink-colored band will appear in the test region (T). This indicates that the specimen contains HCV antibodies.

Invalid:

If no band appears in the control region (C), regardless of the presence or absence of line in the test region (T). It indicates a possible error in performing the test. The test should be repeated using a new device.

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.