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One-Step Fecal Occult Blood (FOB) Diagnostic Kit

Qualitative Test For The Early Detection of Human Fecal Occult Blood (FOB) In Fecal Specimens

One-Step Rapid Detection Of Human Fecal Occult Blood For Tumor Marker Immuno/Chemistry FOB Fast Test For Cancer

Main Features

- Use of patented immunological and chemical test technique combined to give reliable results

- Patented technology, superior quality

Simple:

- No Instrument Required

Convenient:

- Room Temperature Storage

- Built-in Control

- Self-test at home

Fast:

-Results in 5-30 minutes

- Strong positive results is observed

- Promptly within 3 minutes

Reliable:

- Accuracy higher than 98%

- Early detection of the presence of FOB

INTENDED USE

The One-Step Fecal Occult Blood (FOB) Diagnostic Kit is a qualitative detection of human occult blood in feces for self-testing.

PRINCIPLE

Immune Colloidal Gold Method: The One-Step Fecal Occult Blood (FOB) Diagnostic Kit is an immunochromatographic sandwich method, which employ two specific monoclonal antibodies to selectively identify hemoglobin in test samples.

The result is very specific, and easier to interpret than those of guaiac-based test. The sensitivity is very high with the ability to detect 200ng/ml hemoglobin in feces. In addition, the accuracy of the test is not affected by interfering substances, and dietary restriction is not necessary.
Chemical Method: Hemoglobin has peroxidase activity which can cause peroxide decompose then release oxygen atom.

The oxygen atom oxidizes 3, 3’, 5, 5’-tetramethyl-benzidine indicator to change the color. When the sample has human hemoglobin, the resulting colors range from orange to yellow-green or dark green. Very high blood concentration may cause the color development to continue to dark blue.

SAMPLE COLLECTION AND PREPARATION

1. Collect stool sample by using the sample collection device provided.

2. Unscrew the top of the sample collection device, take out the sample collection stick, and collect the sample by dipping the stick into 3 different places of the stool sample.

3. Put the sample collection stick back in the sample collection device and screw together tightly.

4. If the sample cannot be tested on the day of collection, store the stool sample at 4°C. Bring the specimen to room temperature before testing.

STORAGE

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

ASSAY PROCEDURE

1. Remove the test device from foil pouch by tearing along the notch.

2. Specimen collection. Please see also SPECIMEN COLLECTION

3. Shake the sample collection device several times.

4. Holding the sample collection device upright, carefully screw off the cap of collection device.

5. Squeeze 2-3 drops of the sample solution on the test sample pad.

6. Read the Chemical Method result through the sample pad in 1 minute and read the Immune Colloidal Method result through the result window in 5 minutes.

7. Get the final result according to the synthetically.

INTERPRETATION OF RESULTS

INTERPRETATION OF IMMUNE COLLODIAL METHOD

1. Positive: In addition to the control band (C), a distinct colored band also appears in the test region (T).
2. Negative: Only one colored band appears on the control region (C). No colored band in the test region (T).
3. Invalid: If no bands appear, or a test band appears without a control band, the test should be repeated using a new test device.

INTERPRETATION OF CHEMICAL METHOD

1. Positive: The color of the sample pad changes from orange to yellow-green or dark green in 1 minute after adding the sample.
2. Negative: There is no color change of the sample pad in 1 minute after adding the sample.

3. Invalid: If the color mixed, the test should be repeated using a new test device.

THE FINAL INTERPRETATION

1. If both the Immune Colloidal Method and Chemical Method show positive, the final result is positive which indicates bleeding in specimen.

2. If the Immune Colloidal Method shows positive while Chemical Method shows negative, this indicates occult bleeding. The concentration of hemoglobin in the sample is much lower. The final result is also positive.

3. If the Immune Colloidal Method shows negative while Chemical Method shows positive, this probably because the high concentration of hemoglobin causing antigen excess, and have hook effect. It is suggested that dilute the sample 100 times and retest,

if Immune Colloidal Method shows positive, this indicates the enteron begin to bleed profusely; if Immune Colloidal Method still shows negative, this indicates some substances interfered, the result should be negative.

4. If both the Immune Colloidal Method and Chemical Method show negative ,the final result is nagative.

5. If any one of Immune Colloidal Method and Chemical Method shows invalid, the test result is invalid, please retest with a new one.

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.