The Syphilis (SYP Tp) Rapid Screen Test is (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.
Syphilis is a sexually transmitted infection caused by Treponema Pallidum (TP). The primary route of transmission is through sexual contact however it may also be transmitted from mother to foetus during pregnancy or at birth resulting in congenital syphilis.    

QUICK DETAILS

Product name:Syphilis Antibody (TP) Rapid Test
Type:Pathological Analysis Equipment
Instrument classification:Class II
Certification:CE / ISO
Storage:2’C-30’C
Packing:Pouch / Box
Format / Size:Cassette: 3.0mm 4.0mm
Accuracy:99.6%
Function:Detect Syphilis IgM and IgG Antibodies

ANTIGEN INFORMATION

Gene Symbols:IGG / IGM

ASSAY FORMAT

Number of Targets Detected:1
Species Detected:Human
Compatible Sample Types:Blood / Finger prick / Serum
Design Principle:Sandwich-based
Method of Detection:Colloidal Gold
Quantitative/Semi-Quantitative:Qualitative
Solid Support:Lateral Flow

TEST PRINCIPLE

Syphilis Rapid Test Device (Whole Blood/Serum/Plasma) detects IgM and IgG antibodies to Treponema Pallidum (TP) through visual interpretation of colour development on the internal strip. Specific recombinant TP antigens are immobilized on the test region of the membrane. During testing, the specimen reacts with recombinant TP-specific antigen conjugated to coloured particles and precoated onto the sample pad of the test. The mixture then migrates through the membrane by capillary action and interacts with reagents on the membrane. If there are sufficient antibodies to Treponema Pallidum (TP) in the specimen, a coloured band will form at the test region of the membrane. The presence of this coloured band indicates a positive result, while its absence indicates a negative result. The appearance of a coloured band at the control region serves as a procedural control, indicating that the proper volume of specimen has been added and membrane wicking has occurred.

TEST PROCEDURE:

1) Bring the pouch to room temperature before opening it. Remove the test strip from the sealed pouch and use it as soon as possible. Place the test strip on a clean and level surface. 
2) For serum or plasma specimen: Hold the dropper vertically and transfer 3 drops of serum or plasma (approximately 100μl) to the specimen pad of the test strip, then start the timer. See illustration below.
3) For whole blood specimens: Hold the dropper vertically and transfer 1 drop of whole blood (approximately 35μl) to the specimen pad of the test strip, then add 2 drops of buffer (approximately 70μl) and start the timer.  
4) Wait for the coloured line(s) to appear. Read results at 15 minutes. Do not interpret the result after 20 minutes.

Important: In order to prevent an incorrect reading, do not read the test results after more than 8 minutes. If the test is read after 8 minutes, the intensity of the coloured lines may change or a new line may appear. To avoid confusion, discard the test device after interpreting the result

PRODUCT SPECIFICATIONS

Syphilis (SYP Tp) Rapid Screen Tests are supplied for both the professional Laboratory Environment and also Point of Care (POC) situations in remote settings. Components of each kit set are:

 COMPONENTS PROVIDED

POC – SYP Tp test kits are individually packed testing kits that incorporate the required components to perform a test in remote settings by medical professionals, first responders and trained personal. The POC – SYP Tp test kit includes the following components:

  • Test Cassette
  • Buffer Solution
  • Lancet
  • Transfer Pipette
  • Prep Pad

Laboratory Environments require the testing device and supporting reagents and therefore the test kit comprises of:

  • 40 Individually packed test cassettes
  • Buffer Solution
EnvironmentsTotal Number of TestsMOQ
Laboratory40 Tests Per Box (Test Cassettes and Buffer Solution only)5 Boxes
Point of Care20 Complete Test Kits per box (Including Lancets, Alcohol Swabs and Pipettes)5 Boxes