| one step rapid diagnostic rapid syphilis strip testing kits | |
| Product Code | TLT21 |
| Format | A. strip |
| B.cassette | |
| Specimen | serum/plasma |
| Sensitivity ng/ml | 10-25 mIU/ml |
| Size(mm) | A.strip: 2.5, 3.0 |
| B.cassette: 3.0, 4.0 | |
| Packing, OEM service are also accepted | A. strip:1 test in a single pouch, 5000pcs in a carton |
| B. cassette:1 test in a single pouch, 2000pcs in a carton | |
| Accuracy | Over 99.5% |
specifications︰
Product Introduction:
One Step Anti-Syphilis Strip Test is a rapid direct binding test for the visual detection of anti-syphilis antibodies in serum 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 serum. Purified recombinant syphilis antigens are employed to identify anti-Syphilis antibodies specifically. This one step test is very sensitive and only takes about 10 to 15 minutes.
Directions for Use:
For Strip Format:
A) For Whole Blood specimen:
Remove the strip from the poly pouch and pay it on a flat surface.
Add 1 drop of whole blood into the sample pad, then add 1 or 2 drops of Sample Diluent to the sample well.
Interpret test results at 15 minutes.
B)For serum or plasma specimens:
Remove the strip from the poly pouch and pay it on a flat surface.
Immerse the strip into the specimen vertically, then lay it on a flat surface.
Interpret test results at 15 minutes.
For Cassette Format:
A) For Whole Blood specimen:
Dispense 1 drops of Whole Blood specimen to the “s” well of the test card with the provided plastic dropper according to the figure.
Add 1 or 2 drops of Sample Diluent to the sample well, immediately after the specimen is added, from the dropper tip diluent vial (or all contents from the single test ampule).
Interpret test results in 20 minutes.
B)For serum or plasma specimens:
Dispense 2 or 3 drops (100 μl) of serum/plasma specimen to the “s” well of the test card with the provided plastic dropper according to the figure.
start the timer and wait for the colored line(s) to appear.
Interpret test results in 20 minute.
Interpretation of Results:
Positive: Both purplish red test band and purplish red control band appear on the membrane. The lower the antibody concentration, the weaker the test band.
Negative: Only the purplish red control band appears on the membrane. The absence of a test brand indicates a negative result.
Invalid: There should always be a purplish red control band in the control region regardless of test result . If control band is not seen, the test is considered invalid. Repeat the test using a new test device. Note: It is normal to have a slightly lightened control band with very strong positive samples as long as it is distinctly visible.
