CE ISO Faecal Occult Blood (FOB) with Feces Sample Rapid Test

• Type: IVD Reagent
• Certificate: ISO
• Shelf Life: 24 Months
• Usage: Professional Use
• Sample: Feces
• Result Time: Within 15 Mins
• Model NO.: FOB-DF02
• Principle: Immunochromatography
• Storage: 2~30ºC
• Transport Package: Cartons
• Specification: 25 test/box
• Trademark: Dewei
• Origin: China
• Production Capacity: 100, 000PCS/Day

Product Description

Intended Use

The Faecal Occult Blood (FOB) Rapid Test is a rapid visual immunoassay for the qualitative, presumptive detection of human hemoglobin in human fecal specimens. This kit is intended for use as an aid in the diagnosis of lower gastrointestinal (g.i.) pathologies.

Introduction

Colorectal cancer is one of the most commonly diagnosed cancers and a leading cause of cancer-related death in the United States. Screening for colorectal cancer is likely to improve the odds of detecting cancer at an early stage, reducing mortality.

Earlier commercially available FOB tests utilized a guaiac test, requiring special dietary restrictions to minimize false positive and false negative results. The FOB Rapid Test Device (Feces) is designed especially to detect human hemoglobin in fecal samples using immunochemical methods, improving specificity for the detection of lower gastrointestinal disorders, including colorectal cancers and adenomas, without the need for dietary restrictions.

 

Contents

 

• Rapid test cassette with desiccant.

• Specimen dilution tubes with buffer

• Package insert

 

Storage & Statibility

 

• Store at 2 ~ 30 º C in the sealed pouch for 24 months.

• Keep away from direct sunlight, moisture and heat.

• DO NOT FREEZE.
 

Sample Collection&Storage

• The FOB Rapid Test is intended for use with human fecal specimens only.

• Patients should not collect samples during or within 3 days of their menstrual period if they have bleeding hemorrhoids, blood in the urine, or if they experienced strain during their bowel movement.

• Alcohol, aspirin and other medications taken in excess may cause gastrointestinal irritation resulting in occult bleeding. Such substances should be discontinued at least 48 hours prior to testing.

• No dietary restrictions are necessary before testing.

• Perform testing immediately after specimen collection. Do not leave specimens at room temperature for prolonged periods. Specimens may be stored at 2-8°C for up to 72 hours.

• Bring specimens to room temperature prior to testing. If specimens are to be shipped, pack them in compliance with all applicable regulations for transportation of etiological agents.

Operation

Bring tests, specimens, buffer and/or controls to room temperature (15-30°C) before use.

1. Specimen collection and pre-treatment:

1) Use the specimen collection cards provided in the kit for specimen collection. Follow the instructions on the specimen collection card. Other clean, dry containers may also be used for specimen collection. For best results, performed the test within 6 hours after collection.

2) Unscrew and remove the dilution tube applicator. Be careful not to spill or spatter solution from the tube. Collect specimens by inserting the applicator stick into at least 3 different sites of the feces.

3) Replace the applicator back into the tube and screw the cap tightly. Be careful not to break the tip of the dilution tube.

4) Shake the specimen collection tube vigorously to mix the specimen and extraction buffer. Specimens prepared in the specimen collection tube may be stored for 6 months at -20°C if not tested within 1 hour after preparation.
 

2. Testing

1) Remove the test from its sealed pouch, and place it on a clean, level surface. Label the test with patient or control identification. For best results, the assay should be performed within one hour.

2) Using a piece of tissue paper, break the tip of the dilution tube. Hold the tube vertically and dispense 2-3 drops of solution into the specimen well (S) of the test device.
 

Avoid trapping air bubbles in the specimen well (S), and do not add any solution to the result area.

As the test begins to work, color will migrate across the membrane.
 

3. Wait for the colored band(s) to appear. The result should be read at 5 minutes.

Do not interpret the result after 10 minutes.

 

Detailed Photos

 

Company Profile

About Us

Dewei Medical Equipment Co., Ltd. is a high-tech enterprise specialized in developing and marketing of Medical Consmuables like Clinical Laboratory analyzer and reagents, Hematology Analyzer and Reagents, Washing Solutions, Urine Sediment Reagents and DNA/RNA Preservation Kits.
During the special period, Dewei also develop the reagent kits, like Virus Transport Medium with swab, Rapid test and Saliva Collection Kits.
Dewei products are widely used in hospital clinics, disease control centers, blood banks, veterinary clinics, scientific research center and college laboratories.
 

R&D team
15% annual sales amount is devoted R&D department.
With professional R&D team, Dewei is continuously making new achievements on innovation, gaining numbers of national invention patents and professional technical awards. Meanwhile, Dewei focuses on the improvement of technology to guarantee product quality and pursue product performance.

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