SYPH-Check-1 Screening Test on Syphilis

4 490 Ft

    • SYPHILIS TEST is a highly specific immunological rapid test for the detection of anti-TP antibodies.
    • Rapid screening test for home use.
    • Easy to use, only one drop of blood needed.
    • Accuracy: 97,6%
    • Result in just 15 minutes.

    The box contains the material needed to perform one test.

SKU: VS-014 Category:

Description

How does SYPHILIS TEST work?

When present in the body, TP induce the production of specific antibodies by the immune system. These circulating antibodies are able to recognize the spirochaete and to stick on them. SYPHILIS TEST detects specifically these anti-TP antibodies in blood and therefore shows the spirochaete presence.

Syphilis is a veneral disease that progresses through distinct stages of infection: primary, secondary, tertiary and quaternary. These stages produce diverse clinical symptoms, typically producing initial sores known as chancres then syphilitic rash followed by long periods of dormancy. Untreated infection eventually leads to cardiovascular problems and neurosyphilis.

Caused by spirochaete Treponema pallidum (TP), the infection is usually acquired by sexual contact, although the disease may be transmitted by transfusion of infected blood. Intrauterine infection also occurs. The organism has proved virtually impossible to culture in artificial media, and diagnosis of the infection usually depends on the detection of antibodies in the blood, which appear soon after initial infection.

 

PRESENTATION

The box contains the material necessary to perform a test:

– 1 sealed aluminium pouch containing:

1 test device, 1 desiccant pouch, 1 plastic pipette.

Only open the protective pouch when you are ready to perform the test. The desiccant bag should not be used.

– 1 diluent vial containing 1 mL of diluent.

– 1 sterile lancet for blood sampling.

– 1 instruction leaflet.

PRECAUTIONS

  1. This test is exclusively intended to in vitro diagnostic. For 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 as well as reading time.
  3. Keep stored between +4°C and +30°C. Do not freeze.
  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 SYPHILIS TEST.
  6. Keep out of the reach of children.
  7. After use, all components can be discarded in a dustbin.

 

PROCEDURE

Testing procedure always starts with a good preparation. Place the content of the box on a clean, dry and flat surface (e.g. table). Then the testing follows:

  1. Wash your hands thoroughly. Use soap and warm water. Dry your hand with clean towel.
  2. Prepare the test device and the pipette. Take them out from the protective pouch (tear at the notch) and place them in the reach of your hands (you will need them later). Dispose the small dessicant bag.
  3. Prepare the lancet. Hold the lancet without touching the trigger button. Unlock the lancet cap twisting it off ¼ turn until you feel it separates from the lancet and then continue twisting it (2-3 rotations). Don’t pull just twist and discard the cap when finished.
  4. Clean the end of the forefinger or of the middle finger with cotton damped with alcohol.

Rub the chosen finger towards the tip to later on enhance the blood stream.

  1. Press platform firmly against the previously cleaned finger, and press the release trigger button.
  2. The tip will automatically retract into the body of the device.
  3. Rub the finger’s end to obtain enough whole blood sample.
  4. Without pressing the bulb, put in contact the plastic pipette with the blood sample. The blood migrates into the pipette through capillarity to the line indicated on the pipette. You may rub again your finger to obtain more blood if the line is not reached. As far as possible, avoid air bubbles.
  5. Put the blood collected with the pipette into the sample well of the device, by pressing on the pipette bulb.
  6. Wait 30-40 sec for the blood being totally absorbed into the sample well. Unscrew the blue cap of the diluent vial (leave the white cap tightly screwed) and add the diluent as follows:

Hold the diluent vial vertically and slowly add exactly 4 drops in the sample well of the device with an interval of 2-3 seconds between each drop.

  1. Read the result after 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 colour intensity of the T line may be clearer than the intensity of the C line. This result means that blood sample contains anti-TP antibodies and that you should consult a doctor.

  1. Negative result

Only one coloured line appears under the mark C (Control). This result means that no anti-TP antibodies are detected in the blood sample.

  1. Non valid result

No line appears or a coloured line appears under the mark T (Test) without any line under the mark C. In this case, it is not possible to interpret the test, which must be considered as non-valid. It is recommended to repeat the test with another SYPHILIS TEST.

 

QUESTIONS AND ANSWERS

When can this test be used?

SYPHILIS TESTtest should be performed in case of appearance of clinical symptoms, the main ones being chancres and specific rash. The test can be performed at anytime of the day.

Can the results be incorrect?

The results are accurate as far as the instructions are carefully respected. Nevertheless, the result can be incorrect if SYPHILIS TESTtest gets wet before test performing or if the quantity of blood added to the sample well is not correct. The pipette provided in the box allows making sure the collected blood volume is correct. Very early stage of the infection could also lead to negative results due to the low concentration of anti TP antibodies in blood.

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 homogeneous and clearly visible. The test should be considered as positive whatever the colour intensity of the test lines.

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

When this line appears, it only means that the test was performing well.

If I read the result after 15 minutes, will the result be reliable?

No. The test should be read within 10 minutes after adding the diluent.  The result is reliable up to 15 minutes.

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

If the result is positive, it means that anti-TP antibodies are present in blood and that you should consult a doctor to show the test results. Then, the doctor will decide whether additional investigation should be performed.

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

If the result is negative, it means that the test could not detect anti-TP antibodies in blood sample. Meanwhile it is recommended to consult a doctor if symptoms persist.

Additional information

Weight 0.5 kg