Syphilis Antibodies Test Strip
1. Product Details
Test Name: The Syphilis Antibodies Test Strip
Test Item: Antibodies to Treponema Pallidum
Specimen: whole blood, serum or plasma
The Syphilis Antibodies Test Strip (Whole Blood/Serum/ Plasma) is a qualitative membrane strip based immunoassay for the detection of TP antibodies in whole blood, serum or plasma. In this test procedure,
anti-human IgG is immobilized in the test line region of the strip. After immersing the test strip in a specimen, the specimen reacts with syphilis antigen coated particles that have been applied to the specimen pad. This mixture migrates chromatographically along the length of the test strip and interacts with the immobilized anti-human IgG. If the specimen contains TP antibodies, a colored line will appear in the test line region indicating a positive result. If the specimen does not contain TP antibodies, a colored
line will not appear in this region indicating a negative result. To serve as a procedural control, a colored line will always appear at the control line region indicating that proper volume of specimen has been added and membrane wicking has occurred.
3. Directions for Use
4. Expected Values
(1) The Syphilis Antibodies Test Strip (Whole Blood/ Serum/Plasma) is for in vitro diagnostic use only. The test should be used for the detection of TP antibodies in whole blood, serum or plasma specimens only. Neither the quantitative value nor the rate of increase in TP antibodies can be determined by this qualitative test.
(2) The Syphilis Rapid Test Strip (Whole Blood/Serum/ Plasma) will only indicate the presence of TP antibodies in the specimen and should not be used as the sole criteria for the diagnosis of TP infection.
(3) As with all diagnostic tests, all results must be interpreted together with other clinical information available to the physician.
(4) If the test result is negative and clinical symptoms persist, additional testing using other clinical methods is recommended. A negative result does not at any time preclude the possibility of TP infection.
Hangzhou Laihe Biotech Co., Ltd
Address: Room 521 Floor 5 & Floor 1,Building No. 2B,Tianhe High-Tech Park,No. 688,Bin'an Road,Changhe Sub-district,Binjiang District,Hangzhou City,Zhejiang Province,China