25ml Plasma HIV test Cassette

HIV(1+2) Antibody Rapid Test Kit

For qualitative detection of HIV(1+2) antibodies in serum/plasma and whole blood

Main Features

☀ Sensitivity: 100%

☀ Specificity: Higher than 99%

☀ Simple: No Instrument Required

☀ Ambient Storage

☀ Reliable: able to differentiate HIV Type I and Type II

☀ Certified by Authoritative Certification

☀ Unique 3-line Patented Design

☀ Winner of "the 2008 National HIV Antigen Diagnostic Kit for Clinical Performance Assessment"

Principle

1. HIV-1(gp41 and gp120) and HlV-2(gp36) specific recombinant antigens are separately precoated on to the membrane inzone1and2as the capture reagent on the test zone.

2. During the test, specimen is allowed to react with the colloidal gold particles, which have been conjugated with HIV-1andHIV-2 specific recombinant antigens.

3. Antibodies to HIV-1 and/or HIV-2, if present, will specifically bind to colloidal gold-antigen complex.

4. 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 line will develop in zone 1 and/or 2 on the membrane. Absence of these red colored lines in the test zone ( 1 and 2) suggests a negative result.

5. To serve as a procedural control, red colored line in the control zone will always appear regardless of the presence of antibodies to HIV-1/HIV-2.

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 venous 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

Assay Procedure

☀ Place the test cassette on flat surface. Before unseal the pouch, allow the test cassette to reach room temperature(4-30°C) .Use it immediately once unsealed.

☀ Open the pouch and add1drop(30-40uL) of specimen into the sample well(s) .

☀ When the specimen is completely absorbed, slowly add1drop(45-55pL) of diluent buffer vertically into the sample well(s) .

☀ 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 between 15-30 minutes after the diluent buffer added.

Interpretation of Results

Note:‘C'-Control line； ‘1'-HIV-1 Test line； ‘2'-HIV-2 Test line

Negative: No redlines appear within 30 minutes in the test zone( 1 and 2), only a redline in the control zone(C) , which indicates that no antibodies to HIV 1+ 2 have been detected with this test. However, this does not exclude the possibility from infection with HIV.

Positive: One redline in the control zone(C) and one or two red visible lines of any intensity in the test zone( 1 and 2) .This indicates the specimen contains HIV-1 and/or HIV-2 antibodies.

Invalid: No redlines appear in the control zone(C), regardless of whether there is a redline in the test zone( 1 and 2) , indicating that the test is invalid. Discard the test cassette and perform with new cassette.

Built-In Control

Newscen HIV(1+2) 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.

Warning

For Invitro 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) .

Storage

Newscen HIV(1+2) Antibody Rapid Test should be stored at room temperature(4-30℃, 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 room temperature(4-30℃, do not freeze)

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.