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"

Intended Use

The HIV-1/2 Rapid Diagnostic Test (RDT) is a qualitative test for the detection of antibodies to Human Immunodeficiency Virus type 1 and 2 (HIV-1/2) in human serum/plasma. It is considered as an initial screening test for HIV-1/2 antibodies. All positive specimens must be confirmed with Western Blot or other qualified EIA.


Principle

HIV-1/2 RDT is a chromatographic immunoassay (CIA) for the detection of antibodies to HIV-1/2 in human serum/plasma. HIV-1/2 specific 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 HIV-1/2 specific antigens. Antibodies to HIV-1/2, if present, a red colored band will develop on the membrane in proportion to the amount of HIV-1/2 antibodies present in the specimen. Absence of this red colored band in the test region suggests a negative result. To serve as a procedural control, red colored band in the control region will always appear regardless the presence of antibodies to HIV-1/2.

Assay Procedure

Serum/Plasma
Add 70-100 ul or 2-3 drops of serum or plasma into sample well. Observe the result in 5 –30 minutes
Whole Blood
Add 1 drop of whole blood into sample well, after all blood completely absorbed, add 1 drop of whole blood diluent. Observe the result in 5-30 minutes.

Interpretation of Results



Negative:
No apparent band in the test region (1 and 2), only one red band appears in the control region (C). This indicates that no HIV1/2 antibodies have been detected.
Positive:
In addition to the band in the control region (C), other one or two red bands will appear in the test region (1 and 2). This indicates that the specimen contains HIV1/2 antibodies.
Invalid:
If no band appears in the control region(C), regardless of the presence or absence of line in the test region (1 and 2). It indicates a possible error in performing the test. The test should be repeated using a new device.



Storage

Store the test kits at temperature 4-25°C,in the sealed pouch for the duration of the shelf life (24 months).

Reagents and Materials Provided

Each kit contains:
1. 40 test cassettes(individually pouched)
2. Each pouch contains one cassette with one desiccant bag
3. One bottle of diluent buffer(5ml)
4. 40 disposable plastic droppers
5. Instruction for use

Materials Required But Not Provided

1. Timer or stopwatch
2. Blood collection devices, for the testing of venous whole blood, serum or plasma
3. Biohazard disposal container
4. 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
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.