Blood (FOB) Test Strip

Please read the instruction before test.

　

Cautions:

   

●      Do not use after the expiration date.

●      Do not open the protective pouch until just before you want to use the test. Do not use if pouch is damaged. Prolonged exposed to humid ambient will cause product deterioration.

●      For in vitro diagnostic use. Do not be taken internally.

●      Do not touch the membrane under thumb grip . Don’t reuse the test devices.

●      Keep out of the reach of child.

●      Avoid skin touching the feces samples and devices used in case of potential infectious.

●      Store in a dry place at 4-30°C or 40-86°F. Do not freeze. Sample collection tube after collecting sample should be stored refrigerated (2-8°C) if not used immediately.

    

　

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  How to collect sample

　

 1. Loosen cap of specimen collection tube and remove applicator stick;

 2. Introduce the applicator stick into the fecal sample six times at different sites so as to get sampling even at spirals;

 3. Return the applicator stick to the specimen collection tube and tighten the cap thoroughly and shake the tube so as to suspend the liquid in the tube.

　

                                                                                      

How to Use the Test

 1. Remove the reaction strip from its foil wrapper by tearing along the slice and place on a clean and level surface.

 2. Shake well the collection tube to ensure that the fecal sample is well mixed.

 3. Break off the tip of the cap on the buffer tube and squeeze the suspended solution into a dry container.

 4. Immerse the strip into the suspended solution of the fecal sample with the arrow end pointing toward the solution. Do not cover the solution over the MAX (maximum) line. You may leave the strip in the solution or take the strip out after a minimum of 15 seconds and lay the strip flatly on a non-absorptive clean surface.

 5. As the test begins to work, you may notice a light red flow moving across the test region (T) and control region (C) on the test strip. Read results within five minutes.
 

　

How to Read the Results

 

Positive

The colored bands appear both in the “C” region and the “T” region.

　

Negative

Only one colored band appears in the “C” region.

 

Invalid:

   The result is invalid if no colored band appears in the control window (C), even if a band appears in the test window (T). You   should repeat the test with a new Hemosure test.

　

　

Attention:
Hemosure cannot be considered as a conclusive diagnosis for gastrointestinal bleeding or pathology and not replace other diagnostic procedures such as EGD, colonoscopy or other X-ray examination. It is only a preliminary screening or an aid to diagnosis.

Contents:
One Hemosure strip test and one desiccant in foil pouch
Buffer tube

Ingredients:
1. Combination of mouse monoclonal antibodies and polyclonal antibodies (sheep or goat) directed against human hemoglobin.
Mouse Monoclonal antibody on a colloidal gold particle.
2. Buffer solution.

Reliability:
According as the studies, the reproducibility of Hemosure is 100% and no variable result observed.

Question and Answers:
1. Q: How does the test work?
A: Hemosure Test is able to detect the presence of occult blood in your feces due to the gastrointestinal disorder.

2. Q: How much hemoglobin in my fecal sample can able to be detected?
A: Hemosure can detect the human hemoglobin (Hb) at levels as low as 0.2ugHb/ml. If the concentration of Hb is too high (≥2000ug/ml) to show positive result, you should dilute the fecal sample with buffer solution and test again.

3. Q: Which factors may affect the test result?
A: Hemosure is specific for human hemoglobin and other animals’ Hb has no interference with Hemosure. Certain medications (such as Aspirin, Indomethaein, glucocorticoids, etc.) may cause gastrointestinal irritation resulting in occult bleeding. This may produce positive results for samples from healthy patients.

4. Q: What should I do if the result shows positive?
A: You should see your doctor who can make a definitive clinical diagnosis after other clinical and laboratory findings have been evaluated.

5. Q: How do I know that the test was run properly?
A: The appearance of a pink-purple colored line in the control window ( C) tells you that you followed the test procedure properly and serves as a procedural control.

6. Q: Why do I have the negative results sometimes when disease is present?
A: Because bowel lesions, including some polyps and colorectal cancers, may not bleed at all or may bleed intermittently, or the blood may not be uniformly distributed in a fecal sample. We recommended that you test by other clinical methods.