Materials Provided: Test cassette, Pipette, Diluent, Package insert.
Anti Syphilis Test Kit is a rapid direct binding test for the visual detection of anti-syphilis antibodies in human blood as an aid in the diagnosis of syphilis infection. Test results are read visually without any instrument. It is based on the principle of double antigen sandwich immunoassay for determination of syphilis antibodies in whole blood and serum. Purified recombinant syphilis antigens are employed to identify anti-syphilis antibodies specifically. This test is very sensitive and only takes about 10 to 20 minutes.
An immunoassay for the rapid and qualitative detection of anti-syphilis antibodies in human blood. For in vitro diagnostic use only.
For in vitro diagnostic use only.
Do not use test kit beyond expiry date.
The test cassette should not be reused.
The test kits can be stored at room temperature (2 to 30°C) in the sealed pouch till the date of expiration. The test kits should be kept away from direct sunlight, moisture and heat.
Specimen Collection: For whole blood: When the test is performed with whole blood, fresh samples should be used. 1. Clean the area to be lanced with an alcohol swab.
2. Squeeze the end of the fingertip and pierce it with a sterile lancet.
3. Wipe away the first drop of blood with sterile gauze or cotton.
4. Allow the second drop to flow directly into the sample well.
For serum: 1. Collect blood into a container without anticoagulant.
2. Allow the blood to clot and separate the serum from the clot.
3. Use the serum for testing.
If the specimen cannot be tested on the day of collection, store the serum specimen in a refrigerator or freezer. Bring the specimens to room temperature before testing. Do not freeze and thaw the specimen repeatedly.
Test Procedure: 1. Review specimen collection instructions. Test cassette, specimens and controls should be brought to room temperature (18-30°C) prior to testing.
2. Remove the test cassette from its protective pouch (bring the cassette to room temperature before opening the pouch to avoid condensation of moisture on the membrane). Label the cassette with patient or control identifications.
3. For whole blood, dispense 1 drop blood into the sample well. Add 1-2 drops of diluent.
4. For serum, dispense 4 drops (approximately 0.2ml) of the serum into the sample well. Hold the pipette in a straight up and down position, not at an angle.
5. Wait for 10-20 minutes and read results. Do not read results after 30 minutes.
6. For each sample or control, use a separate pipette and cassette.
Interpretation of Results: Negative: Only one colored band appears on the control (C) region. No apparent band on the test (T) region.
Positive: In addition to a pink colored control (C) band, a distinct pink colored band will also appear in the test (T) region.
Invalid: A total absence of color in both regions is an indication of procedure error and/or the test reagent has deteriorated.
V04CX - Other diagnostic agents ; Used as diagnostic agents.