Human Chorionic Gonadotropin (HCG) Tests (Pregnancy Test)

HCG Rapid Test Kit Pregnancy Fast Urine Detection Cassette In Vitro Test Colloidal Gold

Intended Use

The HCG s/u Gold Rapid Screen Test (RST)is a chromatographic immunoassay for the early detection of human chronic gonadotropin (HCG) in serum/plasma or urine specimens.

Principle

The membrane of the test device was coated with anti HCG antibodies on the test region and goat anti mouse IgG antibodies on the control region. During the test, urine/serum specimen is allowed to react with the HCG monoclonal antibody-colloid gold conjugate, which was pre-dried on the test strip.

The mixture then moves upward on the membrane chromatographically by capillary action. For a positive specimen, the conjugate binds to the HCG forming an antibody-antigen complex. This complex is captured by anti HCG antibody immobilized on the test region (T) and produces a pink color band when HCG concentration is equal to or greater than 25mIU/ml. Absence of this colored band in the test region suggests a negative result.

To serve as a procedural control, a colored band at the control region(C) will always appear regardless the presence or absence of HCG.

Assay Procedure

Remove the device from pouch by tearing and label the device with specimen identification.
Add 2-3 drops (70-100ul) of serum/plasma/urine to the s. Well. Observe the result in 5-10 minutes. DO not interpret results after 10 minutes.

Interpretation of Results

Negative:

Only one colored band appears on the control region (C). No colored band in the test region(T).

Positive:

In addition to the control band (C), a distinct colored band also appears in the test region (T).

Invalid:

If no bands appear, or a test band appears without a control band, the test should be repeated using a new test device.

Storage
The kits should be stored at temperature 4-30°C, the sealed pouch for the duration of the shelf life (24 months).

Precision

Intra-assay: The test strips of the same lot number were used in the specimens containing 25mIU/mL hCG. Results and color are consistent.

Inter-assay: Three lots of test strips were used in specimens containing 25mIU/mL hCG. Results and color are consistent.

Clinical Study

The study included 80 positive and 120 negative patient urine specimens confirmed by routine diagnostic method and tested by pregnancy test strip. The results showed 100% consistency.

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.