Syphilis

Device Overview

• Test name : Syphilis Ultra Rapid Test Device 

• Brand : ABON™   (REF ISY-U402)

• Procurement Method : Direct Purchase

• Used since : 

• Clinical application : The kits are designed for the qualitative detection of antibodies (IgG and IgM) to Treponema Pallidum (TP) in whole blood.

POCT sites with service agreement signed;

• PENDING

Standard Operating Procedure

• SOP for Syphilis Test

Training & Competency (TO UPDATE)

1.  All HQE staff assigned to perform, or who wish to become operators of, Syphilis testing must:

• Complete the self-directed online training, which includes reviewing in full:

  1. 1. 1. the SOP and

        2. the Instructions for Use (Product Insert).

• Successfully pass the theoretical competency assessment below with a score of 100%.

2. Training and competency assessment must be completed before using the device and every 2 years thereafter for recertification. It must also be repeated earlier if any of the following occur:

• Changes to the test kit

• Any critical error is identified  

NOTE : Please use your personal MOH email to complete the assessment.

• Roles and Responsibility

• Online Training Tutorial and Theoretical Competency Assessment (restricted to MyGovUC domain users)   ApplyNow👆 

• Competent User Lists

Quality Control

Internal procedural controls are included in the test. A colored band appearing in the control region (C) is considered an internal positive procedural control, confirming correct procedural technique. If the control line fails to appear, the test is considered invalid and results should not be reported. If this occurs, the test should be repeated with a new kit. If the problem persists, discontinue using the kit immediately and contact our POCT Support Staff. 

External quality control using positive and negative controls are performed at the laboratory every time a new box of kit is opened. Upon observing the expected results, the kit is ready to be supplied to POC facilities and is ready for use. 

Related Documents

• Patient Result Log Sheet

• Old kits