【INTENDED USE】

The Syphilis Rapid Test Device (Whole Blood/Serum/Plasma) is a rapid visual immunoassay for the qualitative, presumptive detection of IgM and IgG antibodies to Treponema Pallidum (TP) in human whole blood, serum or plasma specimens. This kit is intended for use as an aid in the diagnosis of syphilis.

【PERFORMANCE CHARACTERISTICS】

The Syphilis Rapid Test has been evaluated with a TPHA test using clinical specimens. The results show that the sensitivity is 99.6%, the specificity is 99.1% and the accuracy is 99.3% relative to the TPHA test.And successfully obtained the CE certificate.

Sensitivity	99.6%
Specificity	99.1%
Accuracy	99.3%

【TEST PROCEDURE】

Bring tests, specimens, buffer and/or controls to room temperature (15-30°C) before use.

Remove the test from its sealed pouch, and place it on a clean, level surface. For best results, the assay should be performed within one hour.

Using the provided dropper, transfer 3 drops of serum/plasma specimen (approximately 75 µL) to the specimen well (S) of the device and start the timer.

Transfer 2 drops of whole blood specimen (approximately 50 µL) to the specimen well (S) of the device with the provided dropper, then add 1 drop of buffer (approximately 40 µL) and start the timer.

Avoid trapping air bubbles in the specimen well (S), and do not add any solution to the result area.

As the test begins to work, you will see color move across the membrane.

Wait for the colored band(s) to appear. The result should be read at 10 minutes. Do not interpret the result after 20 minutes.

product-530-314

product-750-758

【NTERPRETATION OF RESULTS】

POSITIVE: Two colored bands appear on the membrane. One band appears in the control region (C) and another band appears in the test region (T).
NEGATIVE: Only one colored band appears, in the control region (C). No apparent colored band appears in the test region (T).
INVALID: Control band fails to appear. Results from any test which has not produced a control band at the specified read time must be discarded. Please review the procedure and repeat with a new test. If the problem persists, discontinue using the kit immediately and contact your local distributor.
NOTE:
The intensity of the color in test region (T) may vary depending on the concentration of aimed substances present in the specimen. Therefore, any shade of color in the test region should be considered positive. Besides, the substances level can not be determined by this qualitative test.
Insufficient specimen volume, incorrect operation procedure, or performing expired tests are the most likely reasons for control band failure.

【COMPOSITION】

Individually packed test device	Package insert
Dropper	Buffer

【Why Choose Our SYP Rapid Test?】

Accurate & Reliable Results in 10–15 Minutes
Easy to Use - No Equipment Required,three easy steps: collect sample → add buffer → read result
High Sensitivity & Specificity (>99%),Reliable detection even at early infection stages
CE / ISO13485 Certified
Trusted Brand – Safecare
OEM/ODM service available for distributors,Single-use sealed pouch to avoid contamination
Professional manufacturer with its own factory,Strict quality control ensures batch-to-batch consistency

product-750-756

【STORAGE AND STABILITY】

The kit should be stored at 4-30°C until the expiry date printed on the sealed pouch.
The test must remain in the sealed pouch until use.
Do not freeze.
Care should be taken to protect the components of the kit from contamination. Do not use if there is evidence of microbial contamination or precipitation. Biological contamination of dispensing equipments, containers or reagents can lead to false results.

【WARNINGS AND PRECAUTIONS】

For professional in vitro diagnostic use only.
Do not use after the expiration date indicated on the package. Do not use the test if the foil pouch is damaged. Do not reuse tests.
This kit contains products of animal origin. Certified knowledge of the origin and/or sanitary state of the animals does not completely guarantee the absence of transmissible pathogenic agents. It is therefore, recommended that these products be treated as potentially infectious, and handled by observing usual safety precautions (e.g., do not ingest or inhale).
Avoid cross-contamination of specimens by using a new specimen collection container for each specimen obtained.
Read the entire procedure carefully prior to testing.
Do not eat, drink or smoke in the area where the specimens and kits are handled. Handle all specimens as if they contain infectious agents. Observe established precautions against microbiological hazards throughout the procedure and follow standard procedures for the proper disposal of specimens. Wear protective clothing such as laboratory coats, disposable gloves and eye protection when specimens are assayed.
Humidity and temperature can adversely affect results.
Used testing materials should be discarded according to local regulations.