CE ISO 10 Minutes Syphilis Rapid Test Kit Cassette Type Whole Blood Serum Plasma Specimen

CE ISO Syphilis Test Kit Rapid Syphilis Test Cassette Strip Whole Blood Serum Test

[INTENDED USE]
The Syphilis Rapid Test 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.

[CONTENTS]
• Rapid test cassette with desiccant
• Buffer
• Disposable pipettes
• Package insert

[OPERATION]
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. Label the device with patient or control identification. For best results, the assay should be performed within one hour.
• Using the provided disposable pipette, transfer 3 drops of serum/plasma specimen (approximately 75 µL) to the specimen well (S) of the device and start the timer.
OR
Transfer 2 drop of whole blood specimen (approximately 50 µL) to the specimen well (S) of the device with the provided disposable pipette, then add 1 drop of buffer and start the timer.
OR
Allow 2 hanging drops of fingerstick whole blood specimen to fall into the center of the specimen well (S) on the device, then add 1 drop of buffer 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.

[INTERPRETATION OF RESULTS]
POSITIVE: The presence of two lines as control line (C) and test line (T) within the result window indicates a positive result.The result window indicates a positive result.
NEGATIVE: The presence of only control line (C) within the result window indicates a negative result.

INVALID: If the control line (C) is not visible within the result window after performing the test, the result is considered invalid. Some causes of invalid results are because of not following the directions correctly or the test may have deteriorated beyond the expiration date. It is recommended that the specimen be re-tested using a new test.

[ABOUT US]
DEWEI Medical Equipment Co., Ltd is a leading and professional manufacturer of IVD products,it is a high-tech enterprise specialized in developing, manufacturing and marketing of Clinical Laboratory analyzer & reagents, such as Hematology Analyzer & Reagents, Virus RNA Preservation & Extraction Kits, Urine Sediment Reagents and Washing Solutions.
DEWEI products are widely used in hospital clinics, disease control centers, blood banks, veterinary clinics, scientific research center and college laboratories.
Qulity is primary concern, DEWEI team is strict on quality control systems thus our products have CE, ISO, CFDA and other international standards certificates.
The view of DEWEI is to be the most professional and respected enterprise in IVD field, DEWEI will go on providing best service to you by the outstanding R&D and cost-effective products.