CITO Syphilis test is an immunochromatographic test for the qualitative detection of IgG and IgM antibodies to Treponema pallidum in whole blood, serum or plasma.
Recommendations for use
To collect a whole blood sample from a fingerstick:
Wash the patient’s hands with warm soapy water or wipe with a cotton swab moistened with alcohol. Dry them. Run your finger from the wrist to the fingertips, middle finger, or ring finger, without touching the puncture site. Pierce the skin with a sterile lancet. Wipe off the first drop of blood. Gently massage the hand from the wrist to the fingers to obtain a sufficient number of drops of blood. Using a pipette, add a drop of whole blood from the finger to the test cassette: Pipette approximately 50 µL of blood into the pipette. Do not use bubbles. Squeeze the pipette and express all the blood into the well on the test cassette. Add whole blood from the patient’s finger drop by drop: Place the patient’s finger over the well on the test cassette. Place 2 drops of blood from the finger into the center of the well or touch the drop that is dripping from the finger directly to the well. Avoid direct contact between the finger and the well. Separate serum and plasma as soon as possible to avoid hemolysis. Use only non-hemolyzed specimens. It is recommended to perform the test immediately after specimen collection. Do not leave specimens at room temperature for extended periods. Serum and plasma specimens can be stored for up to 3 days at 2-8°C. For longer storage below -20°C. Venous whole blood specimens can be stored at 2-8°C for up to 2 days. Do not freeze whole blood specimens. Whole blood specimens collected from a finger should be tested immediately after collection. Bring specimens to room temperature before testing. Thaw frozen specimens and mix thoroughly before testing. Do not freeze and thaw specimens more than once. Specimens should be packaged in a hygienic manner during transport.
Testing procedure
Before performing the test, bring the cassette, samples, and buffer to room temperature (+15 - + 30°C).
Open the sealed pouch, which has been brought to room temperature. Use the test cassette within one hour. For serum and plasma specimens:
Holding the pipette vertically, add 3 drops of serum or plasma (approximately 75 µL) to well (S) on the cassette and time. For venous whole blood samples:
Holding the pipette vertically, add 2 drops of venous whole blood (approximately 50 µL) to well (S) on the cassette, then add 1 drop of buffer (approximately 40 µL) and set the timer. For fingerstick whole blood samples:
Pipette Use: Fill the pipette and add approximately 50 µL of whole venous blood sample from the finger to the well (S) of the cassette, then add 1 drop of buffer (approximately 40 µL) and timer. Drop Method: Allow 2 drops of blood from the finger (approximately 50 µL) to fall into the well (S) of the cassette, then add 1 drop of buffer (approximately 40 µL) and timer. Wait for the appearance of a red line or lines. Record the result after 10 min. Disregard the result after 30 min.
Interpretation of results
Positive: Appearance of two distinct red lines. One line should appear in the control region and the other in the test region (the intensity of the line in the region depends on the concentration of antibodies to TP in the sample. Therefore, the appearance of any shade of red line in the test region should be considered positive)
Negative: One red line appears in the control region. No red or pink line appears in the test region.
Invalid: Control line does not appear. Insufficient specimen was used or the test procedure was not followed. Repeat the test using a new test cassette. If the problem persists, discontinue testing and contact your Farmasco representative.
Storage conditions
Store in the manufacturer's original packaging in a dry place.
Packaging
The package contains: test cassette, disposable pipette, buffer and instructions.
Producer
"Farmasco" LLC, Ukraine.
