In Vitro Pregnancy Rapid Test Kit

Human Chorionic Gonadotropin (HCG) Tests (Pregnancy tests)

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

Intended Use

Human Chorionic Gonadotropin (HCG) tests are single use, rapid immunoassay for in vitro qualitative determination of human chorionic gonadotropin (HCG) in urine to aid in the early detection of pregnancy. It is intended for use by the lay users.

Principle

Antibodies to HCG are precoated onto membrane as a capture reagent on the test zone. During the test, specimen is allowed to react with the colloidal gold particles, which have been labeled with antibodies to HCG. If HCG is present, a red colored line will develop on the membrane in proportion to the amount of HCG present in the specimen. To serve as a procedural control, red colored line in the control zone will always appear regardless of the presence of HCG.

In normal pregnancy, HCG can be detected in urine after fertilization. Usually, concentration of HCG in urine is at least 25mIU/ml as early as seven to ten days after conception. The concentration increases steadily and reaches its maximum between the eighth and eleventh weeks of pregnancy.

The appearance of HCG soon after conception and its subsequent rise in concentration during early gestational growth make it an excellent marker for the early detection of pregnancy

Reagents and Materials Provided

Each kit contains:

☀ Each pouch contains one cassette with one desiccant bag

☀ Instruction for use

☀ Urine cup

☀ Disposable plastic dropper

Materials Required But Not Provided

Timer or stopwatch

Sample Collection and Test Preparation

☀ First morning urine typically contains the highest concentration of HCG and is therefore the best sample for performing the urine test. However, any urine specimen may be used.

☀ Collect the urine specimen in a clean container. Do not use preservatives.

☀ If the specimen is not used immediately following collection, but is to be used within 48 hours it should be refrigerated (2 to 8℃), and brought back to room temperature before testing. If the specimen is not going to be used for more than 48 hours, it should be frozen at -20℃. A frozen specimen should not be used if stored longer than 2 weeks. Prior to testing, the frozen specimen must be completely thawed, thoroughly mixed, and brought to room temperature.

☀ Urine samples exhibiting visible precipitates should be filtered, centrifuged, or allowed to settle and clear aliquots obtained for testing.

Assay Procedure

Allow the test, urine specimen and/or controls to reach room temperature prior to testing.

☀ Before opening, allow the test cassette to reach room temperature. Use it immediately after opening.

☀ Place the test cassette on a dry, clean, non-absorbent flat surface, add 2-3 drops of urine into Sample well, and start the timer and wait for the colored line(s) to appear.

☀ Read results at 1-5 minutes. Do not interpret the result after 10 minutes.

Interpretation of Results

Negative: No red lines appear within 10 minutes in the test zone (T), only a red line in the control zone (C), which this indicates that the specimen does not contain a detectable level of HCG.

Positive: One red line in the control zone (C) and one red line in the test zone (T). This indicates the specimen contains HCG.

Invalid: If no red lines appear, the test is invalid. Discard the test and repeat with new specimen and new cassette.

Built-In Control

Human Chorionic Gonadotropin (HCG) tests have a built in procedural control that demonstrates assay validity. A red line appearing adjacent to 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.