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Darmzelftest.nl offers a feacal occult blood test (FOB-test) for home use. Faecal blood can indicate different gastrointestinal disorders.

These disorders can be as different as ulcers, polyps, colitis, fissures and colorectal cancer. These diseases cannot be detected only by visual examination and symptoms are often silent. Only the detection of blood in faeces can indicate a gastrointestinal disorder. Faecal occult blood in stool should be screened at least yearly starting with the age of 45 years.

The Poly-Check FOB test from darmzelftest.nl is a highly specific immunological rapid test. Poly-Check does not require a diet period as current guaiac tests do. A atool sample must be collected over 3 running days to increase the probability of intermittent bleeding detection.

FOB-test(s) can be ordered for only 15,- Euro on this website, using this form. International shipping fees apply to anywhere outside Holland.

PRESENTATION
The box contains the material necessary to perform a test:
- 1 sealed aluminium pouch containing:
1 test device, , 1 desiccant pouch
Only open the protective pouch and use the test after you have collected the faeces samples during 3 days. The desiccant bag should not be used.
- 3 paper faecal sample collection strips.
- 1 syringe containing 2 mL of extraction solution in a protective plastic bag.
- 1 leaflet.

PRECAUTIONS

1. This test is exclusively intended to in vitro diagnostic. External use only. DO NOT SWALLOW.

2. Carefully read the instructions before performing the test. The test is only reliable if the instructions are carefully respected. Respect the indicated number of drops and times.

3. Keep stored between +4°C and +30°C. Do not freeze the test.

4. Do not use after the expiry date indicated on the label and the pouch. Do not use the test if the protective aluminium pouch is damaged.

5. Do not re-use Poly-Check test.

6. Keep out of the reach of children.

7. Important: Women must not perform the test during menstrual periods to avoid false positive results due to menses blood.

PROCEDURE

Before performing the test, stool samples must be collected following the instruction below:

A – Sample collection

First Day

1. Wash your hands with soap and rinse with clear water.
2. The faeces are collected on the special paper strip supplied in the box (see figure 1). Use one paper for each day.
3. Unscrew the syringe cap and dip the stick (about 2 cm) in faeces at 3 different locations (see figure 2).
4. Replace the sample collection stick with the adhering faecal sample into the collection device containing the extraction solution. Screw cap firmly and shake well (see figure 3). Put the syringe back to its plastic bag and keep it in the refrigerator between each collection step.
5. Remove the collection paper strip and dispose it in the toilets.

Second Day

Repeat steps 1 to 5.

Third Day

Repeat steps 1 to 5.

B- Test realization after the 3 days collection period of samples

6. Tear the protective pouch (from the notch) and only get out the device. Discard the small desiccant pouch.
7. Wait for the syringe to be at room temperature before performing the test. Break the tip (see figure 4).
	8. Put the test device on a flat surface (a table for instance) and press the syringe body to add 6 drops in the sample well (see figure 5).

9. Read the result at 10 minutes. Do not interpret after 15 minutes.

RESULT INTERPRETATION

The intensity of the line colour does not have any importance for the interpretation of the test result.

1. Positive result

Two coloured lines appear in the window under the marks T (Test) and C (Control). The intensity of the line T may be clearer than the intensity of the line C. This result means that blood is present in the faeces and that you should consult a doctor.

2. Negative result

Only one coloured line appears under

the mark C (Control). This result means

that no blood is detectable in the faeces

sample.

3. Non valid result

No line appears or a coloured line

appears under the mark T (Test) without out any line under the mark C. In this case, it is not possible to interpret the test, test which must be considered as non valid. It is recommended to repeat the test with a new Poly-Check test and a fresh sample of faeces.

QUESTIONS AND ANSWERS

How does Poly-Check work?

Gastro-intestinal lesions are often bleeding. The blood can be detected specifically by Poly-Check in the faeces. The presence of blood can be explained by several causes: ulcers, haemorrhoids, colorectal cancer. The probability for intermittent bleeding to be detected is increased by the procedure of sample collection over 3 running days.

When can this test be used?

Poly-Check test can be performed at any time of the day before having a motion.

Can the results be incorrect?

The results are accurate as far as the instructions are carefully respected. Nevertheless, the result can be falsified if Poly-Check test gets wet before test performing or stool collecting steps are not correctly performed or if the sample is contaminated with blood from other origins than faeces (cuts, haemorrhoids, menses etc…) or if an incorrect number of drops is dispensed in the sample well.

How to interpret the test if the colour and the intensity of the lines are different?

The colour and intensity of the lines have no importance for result interpretation. The lines should only be homogenous and full.

What is the line that appears under the mark C (Control) for?

When this line appears, it only means that the test correctly worked, but it does not play any role in result interpretation.

What do I have to do if the result is positive?

If the result is positive, it means that blood has been detected in the stool sample and that you should consult a doctor to show the test results. Then, the doctor will decide what you have to do.

What do I have to do if the result is negative?

If the result is negative, it means that the test could not detect blood in stool sample. Meanwhile for the patients aged of 45 years and over or having relatives suffering from colorectal cancer, it is recommended to perform a test every year.

Manufactured by VEDA.LAB

Rue de l’Expansion - ZAT du Londeau - Cerisé

BP 181 - 61006 ALENCON Cedex (France)
Medical and pharmaceutical information :
+33 2 33 27 56 25