How to Use the Syphilis IgM/IgG Field Test Kit for Diagnostics?

Syphilis, a sexually transmitted disease caused by the bacterium Treponema Pallidum, can have serious health consequences if left untreated. The iCARE Syphilis IgM/IgG Field Test Kit offers a rapid, reliable method for detecting antibodies to this bacterium in human whole blood, serum, or plasma, aiding in the diagnosis of Syphilis. This guide provides a step-by-step procedure on using the iCARE Syphilis Rapid Test Card effectively.

Intended Use

The Syphilis IgM/IgG Field Test Kit is designed for healthcare professionals to conduct a preliminary analysis for Syphilis by detecting IgG and IgM antibodies in human specimens. The iCARE Syphilis Rapid Test Card serves as a screening tool among high-risk groups, during regular health examinations, and for blood bank field screen tests. Remember, any reactive result must be confirmed with further testing and clinical findings.

Precautions

  • The kit is for in vitro diagnostic use only.
  • Do not use past the expiration date or if the pouch is damaged.
  • Treat all specimens as potentially infectious.
  • Use the test only once and dispose of it properly to prevent infection risk.

Kit Contents

Each iCARE Syphilis Rapid Test Card includes:

  • Test cards in a foil pouch with a desiccant.
  • A plastic dropper for specimen application.
  • Sample diluent for specimen preparation.
  • A safety lancet for finger blood collection.
  • An alcohol swab for site disinfection.
  • A package insert with detailed instructions.

Note: A timer is required but not provided.

Storage and Stability

Store the kit between 2 and 30°C, and do not open the pouch until ready to conduct the test.

Assay Procedures For Finger Blood Collection:

  1. Prepare Materials: Bring the iCARE Anti-TP Rapid Test Card, sample diluent, alcohol swab, safety lancet, and dropper to room temperature.
  2. Open Pouch: Carefully remove the test card from its sealed pouch.
  3. Collect Blood: Use the alcohol swab to clean the finger, then use the safety lancet to prick the finger. Collect the blood with the plastic dropper.

For Clinics (Whole Blood/Serum/Plasma):

  1. Temperature Equilibration: Allow all reagents and specimens to reach room temperature.
  2. Test Card Preparation: Open the pouch and place the test card on a clean, dry surface. Label it according to the specimen or control being tested.
  3. Specimen Application: Using the dropper, add 3 drops of the specimen to the specimen well, ensuring no air bubbles. Then, immediately add 1 drop of sample diluent to the same well.

Reading the Test Results (Between 15~20 MINUTES)

  • Positive:  Both purplish red test band and purplish red control band appear on the membrane. The lower the antibody concentration, the weaker the test band.
  • Negative: Only the purplish red control band appears on the membrane. The absence of a test band indicates a negative result.
  • Invalid: There should always be a purplish red control band in the control region regardless of test result. If control band is not seen, the test is considered invalid. Repeat the test using a new test device.

Conclusion

The Syphilis Test Kit is an essential tool for the rapid screening of Syphilis. By following these steps, healthcare professionals can ensure accurate and reliable preliminary results, which are crucial for the early detection and management of this STD. Remember, positive results require further confirmation through additional testing methods and clinical evaluation.

About Author:

JAL Medical Singapore
Mr. Andre Han

Managing Director, JAL Medical Singapore

Mr. Andre Han is the Managing Director of JAL Medical Singapore, a strategic subsidiary of a publicly listed biomedical manufacturer headquartered in Hsinchu, Taiwan. The parent company is internationally recognized for its ISO 13485 and GMP-certified production capabilities, delivering high-quality diagnostic solutions to global healthcare markets.
With over 20 years of experience in the medical device industry, Mr. Han brings deep expertise in commercial strategy, product development, and international market expansion. He oversees a comprehensive portfolio that includes in-vitro diagnostic test kits including STD Rapid Test Kits, HCG Pregnancy Test Kit, HIV Test Kit, Ovulation Detection Kit, Dengue Test Kits, Syphilis Test Kits, Herpes Test Kit, Chlamydia Rapid Test Kit, Gonorrhoea Test Kit, Menopause Test Kit, and proprietary blood glucose monitoring systems tailored for both clinical and home environments. Under Mr. Han’s leadership, JAL Medical has:

  • Distributed hundreds of millions of rapid diagnostic test kits globally
  • Secured long-term national tenders in South Africa
  • Expanded into key markets including Laos, Mongolia, Ghana, Kenya, Ukraine, Nigeria, and Japan
Beyond commercial operations, Mr. Han spearheads consultancy initiatives focused on:
  • Rapid test innovation and development
  • Facility optimization and regulatory alignment
  • Enhancing quality, reliability, and affordability across product lines
His strategic vision and commitment to innovation continue to position JAL Medical Singapore as a trusted provider of accessible, high-performance healthcare technologies worldwide.

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