Tumor Cancer Fob Psa Test Kit Medical Home Poct Psa Rapid Cassette

• Customization: Available
• Type: Test Strips & Test Tube
• Material: Plastic
• Model NO.: PSA
• Ethylene Oxide Sterilization: Without Ethylene Oxide Sterilization
• Quality Guarantee Period: Two Years
• Group: Adult
• Logo Printing: With Logo Printing
• Delivery Time: 2 Weeks
• Transport Package: Cartons
• Specification: strips/cassette
• Trademark: No
• Origin: China
• HS Code: 3822190090
• Production Capacity: 10000000000PCS/Year

Product Description

Fecal Occult Blood Test Instructions              

Introduction: 
The One Step FOB(Fecal Occult Blood)Test cassette is a simple,direct binding immunoassay for the rapid and qualitative detection of human occult blood in feces.The assay is designed to detect lower levels of colorectal bleeding than other biochemical detection methods.The test principle 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-basic test.The sensitivity is very high with the ability to detect 200 ng/mL hemoglobin in  feces.In addition, the accuracy of the test is not affected by interfering substances, and dietary restriction is not necessary.

Clinical significance:
 Fecal Occult Blood (FOB) is a small amount of bleeding in the digestive tract, people can not see blood in the stool by eyes, and a little of red blood cells in the stool was broken, it can only be detected  by chemical or immunological tests. Fecal Occult Blood testing has an important value for the diagnosis of gastrointestinal bleeding , are often used as an screening index  of early diagnosis of gastrointestinal cancer. Colorectal cancer is one of high incidence cancer in china, the mortality is second of common cancer in the city. in the last 20 years, the incidence of colorectal cancer in China has significantly increased. If detected and treated in the the stage of precancerous  and early-stage of cancer , the mortality and morbidity of this disease will be greatly reduced . As known to the world right now,  the colorectal cancer screening methods is  fecal occult blood test. Because most of colorectal lesions are accompanied by bleeding, give us a good cues. However, doctors found that many people do not attach importance to this inspection in clinical, so that delay in treatment, resulting in great losses.

Test principle: 
The One Step Fecal Occult Blood Test is a simple, direct binding immunoassay for the rapid and qualitative detection of human occult blood in feces. The assay is designed to detect lower levels of colorectal bleeding than other biochemical detection methods. The test principle 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-basic test. The sensitivity is very high with the ability to detect 200 ng/mL hemoglobin in feces. In addition, the accuracy of the test is not affected by interfering substances, and dietary restriction is not necessary.
This product is composed of the glass fiber strips of monoclonal antibody against human Hb, anti-mouse IgG solid cellulose nitrate(mixing)membrane and the bonders of absorptive colloidal gold - monoclonal  antibody  against human Hb.  It  adopts  the  principles  of  double  antibody  sandwich  method  and immunochromatography to test the human occult blood in feces.

Intended Use:
Fecal Occult Blood(FOB) Test is Qualitative detection of human hemoglobin in stool samples for the early diagnosis of gastrointestinal bleeding.

Model: Cassette

User: for professional use

Contents:
Each pouch contains one test strip and one desiccant
Each box contains 40 pouch , 40 sample collection tube filled dilution and one operating instruction.

Storage and stability:
 The test strip can be stored at room temperature or refrigerated(2-30ºC). The test device is stable through the expiration date printed on the sealed pouch. The test device must remain in the sealed pouch until use. Do not freeze.

Specimen Collection and Preparation:
    Collect stool sample by using the special sample collection device provided. First, 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. Then, put the sample collection stick back in the sample collection and screw tighter tightly.If the sample cannot tested on the day of collection, store the stool sample at 4ºC. Bring the specimen to room temperature before testing.

Test Procedure:                                    
Before the use please prepare a timer .

1. Remove the test device from its foil pouch by tearing along the notch.
2. Specimen collection.
3. Shake the sample collection device several times.
4. Holding the sample collection device upright, carefully break off the tip of collection device.
5. Squeeze 1-2 drops of the sample solution  into the sample well on the cassette,as in the illustration.
6. Read the test result at 5 minutes. Do not read results after more than 8 minutes.

Interpretatlon of results
Negative: Only one color band appears on the control region . No apparen band on the test region. There is no Fecal Occult Blood.
Positive: Distinct color bands appears on the control and test regions. Both test      line and control line indicatethat There have Fecal Occult Blood.
Invalid:  No visible bang at all. Repeat test with a new test kit.

Limitations of the test:
1.This test is to be used for the qualitative detection of Hb in human stool.
2.Positive results only show that it is the emergence of hemoglobin in stool, but can not distinguish the causes of bleeding. Fecal occult blood may be caused by a variety of reasons other than colonic bleeding, such as hemorrhoids Bleeding ,  gastric ulcer Bleeding, menstrual period or Hematuria contamination.
3.Colon bleeding is not all caused by cancer or precancerous lesions, so the results of the test kit should be comprehensive judged combine to clinical examination and clinical symptoms.
4.Negative result can not rule out bleeding, because the blood may be digested through the digestive tract,  polypus or local lesions is intermittent bleeding, or no bleeding in  early stage; In addition, because of the uneven distribution of gastrointestinal bleeding, so the test results associated with different place of the sample. the test Should be repeated with different samples . 

Warnings & Precautions
For in vitro diagnostic use only

1. For in vitro diagnostic use of FOB specimen only.
2. This test strip is just the selection of qualitative of the fecal occult blood, but can not determine the blood quantity in samples.
3. If at the menstrual period, or hematuria or there's some bleed in oral and nasal cavity, false positive will happen.
4. If the digestive tract is the interim hemorrhage, then if testing at this period, it may be negative.
5. If there's very little blood in digestive tract, it will may be negative.
6. Should guide the patient to collect samples in accordance with the sample collection and handling methods . Patients in the menstrual period, hemorrhoids with bleeding and  Hematuria, shouldn't collected samples to avoid sample contamination.
7. Should collect samples in different parts randomly to increase the accuracy of detection.
8. All stool specimens and infectious materials should be properly handled after used.
9. The Kits can be stored at room temperature and against moisture. The kits should recover to room temperature before use if it stored at low temperature.
10. Once open the pouch, the test device should be used immediately. Prolonged exposure to ambient   humidity will cause product deterioration.
11. Please make tags to avoid confusion when a large amount of specimens for testing.
12. Do not reuse the test devices. Discard it in the dustbin after single use.

Expected values:
The cut off  value of the  FOB test is generally agreed at 200ng/ml.


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