HCV(Hepatitis C Virus) Antibody Rapid Test Kit

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

Intended Use

Newscen HCV Antibody Rapid Test is for the detection of antibodies to Hepatitis C type virus(HCV) in human serum, plasma or whole blood collected from vein or fingertip. It is intended for use in medical institutions by trained staff.

Principle

HCV(Core and NS 3) specific recombinant antigens are precoated on to the membrane as the capture reagent on the test zone. During the test, specimen is allowed to react with the colloidal gold particles,which have been conjugated with HCV specific recombinant antigens. Antibodies to HCV, if present, will specifically bind to colloidal gold-antigen complex. When the colloidal gold-antigen-antibody complexes move to the test zone, they will specifically bind to the precoated antigens. At the same time, a red colored I in e will develop in the test zone. Absence of this red colored line in the test zone suggests a negative result. To serve as a procedural control, red colored line in the control zone will always appear regardless of the presence of antibodies to HCV.

Reagents and Materials Provided

Each Kit Contains:

☀ 40 test cassettes(individually pouched)

☀ Each pouch contains one cassette with one desiccant bag

☀ One bottle of diluent buffer(5mL)

☀ 40 disposable plastic droppers

☀ Instruction for use

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

For finger stick samples, the following materials are required:

☀ Alcohol pad

☀ Sterile lancet

☀ Sterile gauze or cotton

WARNING

For invitro diagnostic use ONLY

Storage

Newscen HCV Antibody Rapid Test should be stored at 4-30°C(do not freeze) for 24 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, perform the test as early as possible(within 1hour) to avoid test cassette from becoming moist. Do not use the test beyond the indicated expiration date.

The diluent buffer should be stored at 4-30°C(do not freeze) for 24 months from the date of manufacture. After the diluent is opened, it will be stored for 24 months according to the validity period.

Sample Collection and Test Preparation

Finger stick Specimens(Whole Blood)

☀ Clean the area to be lanced with an alcohol pad.

☀ Squeeze the end of the fingertip and pierce it with a sterile lancet.

☀ Wipe away the first drop of blood with sterile gauze or cotton；collect the sample from the second drop.

☀ Use dropper to draw the fresh blood to 1/ 2 of the tube wall and dispense into the sample well.

Finger stick whole blood should be used immediately after collection.

Serum/Plasma specimens:fresh serum or plasma specimen can be used. No special patient preparation required.

Plasma

☀ Collect whole blood into a collection tube(containing EDTA, Na-citrate or heparin) by venipuncture.

☀ Separate the plasma by centrifugation.

Serum

☀ Collect whole blood into a collection tube(containing no anticoagulants) by venipuncture.

☀ Allow the blood to clot.

☀ Separate the serum by centrifugation.

Venipuncture Whole Blood

Venipuncture whole blood can be used immediately after collection or store dupto4daysat 2-8℃.

Assay Procedure

☀ 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.

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

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

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

☀ 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.

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

Built-In Control

Newscen HCV Antibody Rapid Test has a built-in procedural control that demonstrates assay validity. A redline appeared on the control zone(C) indicates that the test runs correctly.

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.